Tell me more. The cancer patients experience of being introduced to research. Commissioned by NISCHR CRC and conducted at Velindre Cancer Centre

Transcription

1 Tell me more The cancer patients experience of being introduced to research Commissioned by NISCHR CRC and conducted at Velindre Cancer Centre Jenny Kowalczuk and Andrew Rix 10/02/2014 1

2 Contents 1 Executive summary Method Summary findings Recommendations Introduction Lay summary of the project Background to the project Velindre Cancer Centre Project Personnel Methods Mystery Shopper Tenovus Workshops Staff and patient data collection Results Service improvement Discussion & Recommendations Strengths and weaknesses of the present service evaluation Conclusions and recommendations References Current NHS Resources

3 Contents, continued. 7 Appendices Project Governance NIHR CRN Mystery Shopper Tool Flyer staff focus groups Flyer patient focus groups GP survey Research Concepts Patient Validation

4 1 Executive summary This service evaluation sought to look at the current practice of introducing the idea of research to cancer patients, prior to their referral or during their attendance at Velindre Cancer Centre (VCC). It aimed to identify whether the experience could be made easier for patients at a time when the volume of information they receive can be overwhelming. 1.1 Method Qualitative researchers were commissioned by NISCHR CRC to facilitate, record, transcribe and content analyse focus groups of VCC patients and staff. Data was also collected by the Project Management Team: a Mystery Shopper exercise (one staff member and one consumer representative visited VCC and scored against a structured response form) workshop sessions at a conference (outcomes from two small group discussions with approximately 50 conference participants, notes were made and themes identified) a short, semi-structured survey of GPs 1.2 Summary findings Analysis of data, and specifically from the staff and patient focus groups, suggest that any overall communication strategy for raising awareness of clinical research must address different patient information needs at different points on the patient journey Pathway Our findings indicate that for communication purposes often complex pathways for cancer patients can be simplified into three stages: pre-diagnosis diagnosis post-diagnosis 4

5 These stages were recognised by patients taking part in focus groups and correspond to qualitatively and quantitatively different needs for information, for this reason this simple model is used to structure presentation of findings from this service evaluation work Pre-diagnosis Pre-diagnosis, patients reported having little awareness of, or interest in, clinical trials. Their knowledge of research concepts is general and low. Our findings suggest awareness raising messages to familiarise with NHS research activity and its role in delivering standard treatment and improving treatment is appropriate at this stage. We found some evidence that poor experiences in treatment and care may erode the essential element of trust in the research offer transaction Diagnosis Diagnosis can be described as a cognitive and emotional crisis, a watershed moment on the patient journey, as it is the point at which patients must come to terms with a life threatening illness they previously may have denied. Patients in the focus groups describe being unable to cope with complex information at this time and unable to make sense of the information necessary to give informed consent to participate in a trial. This study found patients assumed positive outcomes from trial participation, negating any risks. This bias was strengthened by a strong underlying belief that the NHS would not harm or expose patients to risk Post-diagnosis Only after accepting a diagnosis do patients actively seek information specific to their diagnosis and this study found patients were most willing to find out more about clinical trials at this time. Patients described wanting to take control and for this reason information on trials and new treatments was actively sought by some and welcomed by most. Patients also described being highly motivated to take part in trials as a way to use their experience to benefit others in the hope of finding more effective treatments for cancer. 5

6 1.2.5 Trust Patients describe an overriding trust in the clinical staff of the NHS and the NHS as an organisation. Deep trust in consultants and surgeons enabled patients to think positively about participation in a clinical trial. This trust in professionals was supported by a deeper trust in the NHS as a healthcare system: its ideology, values, systems, personnel and services. Trust in the NHS and its staff also resulted in patients negating or reducing their understanding of risk from taking part in a trial. Our findings suggest a strong, positive bias for overcoming a diagnosis among patients that is strengthened by trust in the NHS and its clinical staff. This has implications for the way benefits from trials are presented and how informed consent may be assessed. Our findings suggest that trial recruitment is dependent on trust, but that the strength of this trust may also be a barrier to informed consent, with awareness and assessment of the risks of participating in a trial Knowledge Patient knowledge of clinical trials and research concepts was found to be low. Our findings suggest all patients would be responsive to simple generic information about clinical trials and the positive outcomes from trials, told as human stories, before diagnosis. Patients in the focus groups who had participated in trials said knowing general information about trials would have made the process of trial recruitment less stressful. Findings from discussions with staff confirmed that patients knew little about trials or research when first approached about taking part in a trial. Educating patients about trials and research early would not only reduce stress for patients, it would make recruitment less time consuming for staff. We found patients had an almost insatiable desire for information post-diagnosis. This study suggests that only after diagnosis do patients become receptive to complex information about clinical research, wanting information specifically relevant to their own diagnosis. These findings suggest that matching the level of information to the patient s ability to absorb it at different stages on their journey will be crucial to achieving positive regard for research through well timed, well crafted messages as part of an overall communication strategy for raising awareness of clinical trials. 6

7 1.2.7 Velindre Cancer Centre Findings from this service evaluation show a high level of trust and respect among patients referred to Velindre Cancer Centre (VCC). Patients expressed gratitude for the personalised care received from what was described as a human-scale centre. Patients were found to be unaware of the research reputation of VCC and that it was a centre of research activity was a surprise. Patients described how knowing that VCC was also an active research centre would build greater confidence and trust, as well as support invitations to participate in trials. Findings from staff groups suggest that the internal patient pathway to recruitment in a clinical trial is subject to chance factors that are a barrier to access to trials for patients. These include staff access to patients in busy clinics, research staff access to consultation rooms and uninterrupted consultation time, and failure to identify all eligible patients as a result of clinical staff being unfamiliar with all currently recruiting/open trials. 1.3 Recommendations Trials and trial recruitment Our findings from both focus group discussions and the Mystery Shopper exercise suggest a number of quick win opportunities exist at VCC that could support improving the cancer patients experience. These include: VCC s branding external and internal communications strengthening clinical networks across referral centres further supporting the Multi Disciplinary Team (MDT) to extend research awareness, and pro-active approaches to patient education. Our findings suggest these opportunities would result in better alignment of recruitment with the patient treatment pathway Implications for NHS This service evaluation also supports wider patient awareness activities to ensure that patients become familiar with the role patients play in developing and improving treatments through 7

8 participation in clinical trials. This service evaluation suggests all patients would welcome awareness raising messages to familiarise them with NHS research activity, but not specific information on recruitment to clinical trials. Our findings suggest that trust in clinical staff and the NHS as a whole support, if not make possible, trial recruitment and suggest continued attention must be paid to consistent reputation building to support trust in the NHS, its services and personnel Implications for communication strategy Findings from patient groups suggest two inter-related communication strategies to support patient awareness and understanding of clinical trials. For pre-diagnosed patients communication should seek to deliver a consistent message that clinical research delivers improved treatments for patients, that all benefit from and can all be part of. Findings from this study on the importance of trust in the wider NHS system imply that a communication strategy to raise awareness of clinical trials should also include supporting larger, ongoing trust in the NHS, its services and its clinical staff. Communication post-diagnosis needs to support patients strong need for high quality, detailed and specific information about their disease Recruitment Our findings suggest diagnosis is a time of major adjustment for patients. Patients described being unable to cope with information and decisions about trials at the same time as their diagnosis and unfortunately, this was the time when most of the patients were approached to take part in clinical trials. Our findings suggest achieving informed consent concurrent with a cancer diagnosis may be extremely difficult and this may also have wider implications for recruitment into trials on other disease pathways. This difficulty in comprehension was also confounded by patients strong bias to a positive outcome, resulting in patients disregarding information on risk, assuming instead that a clinical trial only offers benefits. The present study found that while patients were highly motivated to take part in research, they did not always have an accurate understanding of research concepts, or the balance 8

9 between risk and benefit. There was a widely held assumption that as clinical trials were delivered through the NHS patients would not be exposed to harm or risk. Internal processes may need to be reviewed to examine these difficulties in understanding, as well as provide the resources needed to deliver accessible and inclusive clinical trial recruitment for all eligible patients. This service evaluation recommends that where possible, and diagnosis to treatment targets permitting, every effort should be made to avoid recruitment to trials at diagnosis. Additionally, findings from this service evaluation relating to trust suggest informed consent may be difficult to achieve where patients place substantial trust in their clinician. Our findings suggest recruitment processes may need to further examine how risks and benefits are presented to patients, especially presenting clinical trial conditions as a benefit, given patients bias for positive information Short term recommendations VCC brand to include reference to research activity. Engage clinicians from the referring network more closely o activities to support information sharing o checklists and awareness raising to support clinical trial inclusion in the decision making processes of the MDT. VCC patient facing information to include positive on brand clinical trial messages, from first appointment letters, to starter packs and everything in between. Provide a dedicated cancer clinical trials information point in patient waiting areas at VCC providing printed information, access to the internet and the in-person support of a clinical trials nurse. Develop a VCC protocol for communication and contact with patients at diagnosis to create an information and recruitment free time. Strengthen patient awareness materials with human stories about patient participation in clinical trials. Review all clinical trials information on the VCC website to make it accessible to all patients, linked to from all other pages, use of human stories and video to make the information engaging. 9

10 1.3.6 Long term recommendations Consider seeking support for a sponsored communications campaign using multiple print, social and broadcast channels to raise awareness of NHS research for all patients and the public. Work collaboratively with cancer research charities to address advertising and fundraising that promotes research as basic science and balance with human stories and images. 10

11 2 Introduction This service evaluation report is about how cancer patients acquire information about clinical research. Based on qualitative data from staff and patients, it identifies opportunities to improve patients understanding and experience of being introduced to clinical trials. The service evaluation was carried out by NISCHR CRC and funded by an innovation grant from Tenovus, with data collection between September and November The service evaluation was overseen by a Project Management Team led by NISCHR CRC and including VCC staff, patient and public representatives. (See Appendix 7.1.) 2.1 Lay summary of the project Improvements to the care and treatment of cancer patients depend on evidence generated through research. In order to improve care in a systematic way it is essential that patients are routinely given the opportunity to contribute to clinical trials. Wide-scale collaborative involvement is needed to answer questions and improve treatments in a timely way. This is part of the rationale behind UK Government investment in a national research infrastructure which provides professional research teams who support people and clinical teams to take part in high quality research aimed at improving care. An active portfolio of cancer research studies and a dedicated research infrastructure have been developed in Wales and the UK since However, many cancer patients still do not expect to be approached about clinical trials and in many parts of the NHS research is still not viewed by staff as a routine part of clinical care. This service evaluation sought to identify ways to improve how the idea of research is introduced and explained to cancer patients as part of their referral and treatment at Velindre Cancer Centre (VCC). It aimed to identify whether the experience can be made easier for 11

12 patients at a time when the volume of information they receive can be overwhelming. Data mainly stems from workshops and focus groups with patients and VCC staff at which communication about clinical trials during diagnosis and treatment was explored to identify what has worked well or less well for them. From an analysis of the data a communications model was developed to inform future service improvement. 2.2 Background to the project The Research Governance Framework for Health and Social Care in Wales (2 nd edition 2009) stated that Research is essential to the successful promotion and protection of health and wellbeing. The Welsh Government s Together for Health - Cancer Delivery Plan (2012) set an annual research-related target that at least 10% of newly-diagnosed patients in Wales should be supported to participate in high-quality clinical trials on the NISCHR Clinical Research Portfolio. However, a national survey in England, published on International Clinical Trials Day, May 2012, highlighted that most people surveyed were unaware that research is a core part of the work of the NHS (conducted by OnePoll on behalf of the National Institute for Health Research Clinical Research Network). As a result it is not surprising that when cancer patients are introduced to clinical trials as part of their treatment it is often an unfamiliar concept for them. Derek Stewart, a long time advocate of patient involvement in research and the founder chair of the National Cancer Research Institute Consumer Liaison Group argues that the link between research and improvements in patient care should be better promoted in the health service: We do research to find the best treatments and care for patients I have said for years that I would like to chisel these words at the entrance to every hospital, clinic and doctor s surgery. There ought to be posters throughout the hospital, in waiting areas and clinics. We should have flags and banners. 12

13 This message is echoed internationally: I d love to see if it would work to give people different messages about clinical trials throughout their journey through the health care system. The oncology office is the last place they should hear this information for the first time ASCO Enhancing Clinical Trial Awareness and Outreach 2009 Journal of Oncology Practice 5(4): A report published in 2011 by GlaxoSmithKline and Cancer Research UK, following a round table summit with ten cancer service users, also strongly supported the view that all patients should be made aware of relevant research from the first point of presentation. (GSK and CR-UK 2011) 2.3 Velindre Cancer Centre Velindre Cancer Centre (VCC) is a research-active cancer treatment centre with studies open and available for a range of cancer types. When volunteers are invited to participate in clinical trials, specialist research staff spend time in clinics introducing the idea of research and explaining what individual studies entail to patients and their families. This can be at a time when there is already an overwhelming amount of information being conveyed to people, including details of their disease and treatment options. The impact of this is described by Ellis et al (2001): In the oncology setting, many patients are invited to participate in clinical trials soon after the diagnosis of their cancer. Patients often report feeling stressed and vulnerable at this time, and there is anecdotal evidence that these feelings may affect patients attitudes toward randomised trials. Women who had a better understanding of issues about clinical trials had more favourable attitudes toward randomised trials and were more willing to consider participation in a clinical trial. 13

14 Clinical teams have a duty to inform patients about all their treatment options, including clinical trials for which they may be eligible. However, explaining the concept of clinical trials takes time and puts further pressure on the service; as a result it is often left to research staff. This can mean that not all patients are considered for trials for which they may be eligible: wider engagement of multi-disciplinary teams needs to be developed if patients are to be approached more systematically and have the information in more easily understood pieces. A range of initiatives exist at VCC to improve the patient experience, a number of which are led by the Project Improvement Team (PIT), which exists to identify clinical areas for improvement. The team are currently reviewing the information sheet for newly-referred patients and plan to include generic information about clinical trials Objectives of the project The project aimed to identify opportunities to improve the cancer patients experience of being introduced to clinical research and to involve patients and multidisciplinary staff in the process. The project team sought to do this via a Mystery Shopper exercise, group discussions in two Tenovus conference workshops, a GP survey and commissioned focus groups. Current practice and resources were reviewed in VCC including a Mystery Shopper evaluation and a survey of South East Wales GPs. Clinical and non-clinical staff focus groups explored when and how they communicate with patients generally to identify whether the experience of introducing the concept of research to patients can be improved. Patient focus groups explored people s communication experiences since their cancer diagnosis and if and how they were made aware of research. Information and examples of good practice and good communication were sought as well as areas needing 14

15 improvement. The groups were asked to talk about research and explore where their impressions had come from. The focus groups were facilitated by commissioned qualitative researchers. They analysed the data obtained and presented findings to the Project Management Team. Findings from the service evaluation, Mystery Shopper and Tenovus Conference are presented in this report. The evaluation describes, with the input of patients and staff, a patient communication pathway and identifies areas for improvement specific to VCC as well as wider implications for NISCHR CRC and NHS Wales. 2.4 Project Personnel The work presented in this report was carried out by Jenny Kowalczuk and Andrew Rix (service evaluation), and the NISCHR CRC Project Management Team (Mystery Shopper and Tenovus Conference Workshop) between August 2013 and December

16 3 Methods 3.1 Mystery Shopper Approach An English survey published on International Clinical Trials Day, May 2012, highlighted that most people surveyed were unaware that research is a core part of the work of the NHS. A Mystery Shopper exercise commissioned by the National Institute for Health Research Clinical Research Network (NIHR CRN) in England provides information about the experience of patients seeking general information about clinical research. Representatives visited hospital sites to record sources of information available, for example notice boards, websites, reception areas. To provide a baseline assessment for the present service evaluation, NISCHR CRC undertook a small scale Mystery Shopper exercise at VCC to provide a baseline against which future changes from the project could be assessed Instrument The NIHR CRN gave permission for their survey tool to be used by the Tell Me More project in VCC (NIHR CRN Mystery Shopper questionnaire is included in Appendix 7.2) Data collection One of the project s consumer representatives and one member of NISCHR CRC staff who did not work in VCC undertook the survey in July They visited VCC on two different occasions and made assessments of the following public and patient facing areas: Main reception Outpatient s reception Pharmacy reception Radiotherapy reception They also each made an independent assessment of the VCC website using criteria in the Mystery Shopper survey. 16

17 3.1.4 Analysis Responses to the survey were collated and summarised by the Project Management Team. 3.2 Tenovus Workshops Approach Tenovus, funders of the project, invited the Project Management Team to facilitate a workshop about the project at their Research Conference on 10 th October This was recognised by Tenovus and the Project Management Team as an opportunity to gather supporting data for the project by eliciting and collecting opinions about the communication of generic clinical trials with a diverse group of individuals Workshops Two 45-minute workshops took place during a one-day conference organised by Tenovus and attended by volunteers, fundraising groups, lawyers, doctors, scientists, nurses and patients. The workshops followed a simple format - the project was introduced by the project manager and there were two brief inputs: a research nurse at VCC outlined, via an audio recording, the importance of the current project to find out how to improve communication about clinical trials with patients a patient representative from the Tell Me More Project Team told her personal story of being diagnosed with cancer and her introduction to clinical trials. Workshop participants were then split into small groups and asked to respond to one of five questions about cancer clinical trials. Each workshop was facilitated by two moderators who recorded discussions on flip charts and made notes Participants Workshop attendees were self selecting and representative of this diverse group of conference attendees. No record of attendees was kept. The workshops were attended by approximately 50 conference attendees, with 40 in the first workshop and 10 in the second workshop. 17

18 3.2.4 Instrument Questions were designed to enable open discussion of key project topics. The questions were: Question 1. How informed do you feel about clinical research/trials, where they happen and who they are available to? Question 2. How should the wider public be informed about clinical research/trials? Question 3. Is it timely for a GP to be talking about research when a patient presents with symptoms? If so what is appropriate and when? Question 4. When a patient is going through diagnosis (e.g. scans, blood tests) should clinical research / trials be introduced? Question 5. What information do you think should be made available in patient waiting areas that will inform about clinical research / trials? Analysis All notes and flip chart notes were transcribed, collated and summarised by question by the workshop facilitators. This data was passed to the qualitative researchers for summary and checked by the workshop facilitators. 3.3 Staff and patient data collection Approach This service evaluation project sought to gain understanding of the processes involved in introducing the idea of research to cancer patients, prior to their referral or during their attendance at Velindre Cancer Centre (VCC). Central to this was describing the patient communication journey and how it corresponded to clinical pathways for diagnosis, treatment and care. The communication journey was then used to explore expectations of communication and patient needs for information in relation to clinical trials Method Staff and patients at VCC took part in focus groups lasting approximately two hours and facilitated by two researchers. The group sessions were recorded and transcribed and these 18

19 scripts were later content analysed using AtlasTi software. A short semi structured survey was sent to GPs in South East Wales Staff groups Staff focus groups were conducted in a meeting room in VCC during the working day. The discussion was structured to explore the patient pathway, patient knowledge of clinical trials, opportunities and barriers to promoting patient knowledge of clinical trials and process of recruitment to clinical trials and problems encountered Patient groups Patient focus groups lasted approximately two hours. The discussion explored the patient pathway and patients information needs. The second half of the discussion explored issues around knowledge and understanding of research concepts and trust in healthcare professionals, and explored ideas for how communication of clinical trials could be improved GP Survey The views of a small convenience sample of GPs referring patients for diagnosis and onwards into VCC were collected using a short, semi-structured questionnaire Participants A total of 15 (16) 1 members of VCC staff, 3 (6) referring GPs and 17 (24) patients took part in the service evaluation Staff Staff were invited to participate in a service evaluation project to identify opportunities to improve the cancer patients experience of being introduced to clinical research at VCC. A copy of the staff invitation flyer for the focus groups is included in Appendix 7.3. Recruitment into two focus groups was targeted to obtain the views of staff directly involved in clinical trials and those with a more general remit. The first focus group consisted predominantly of research staff. The participant mix of research (7), non-research (6) and administrative staff (2) was designed to ensure that a range of staff perspectives on the research offer to patients and their 1 Figures in brackets indicate target number of participants 19

20 information needs were included. Additionally, recruitment of a variety of staff to the focus groups was intended to signal an organisational commitment to making clinical trials relevant to all staff and extending clinical trials awareness beyond those professionally engaged in clinical trials. Research active GPs (13) and non research active GPs (11) identified by NISCHR CRC were invited to complete a short survey on their views on patient participation in research studies (see Appendix 7.5). A total of 3 (6) GP surveys were returned Patients Patient participants were recruited into three focus groups by the VCC Clinical Trials Unit staff. Participants were recruited from the patient population as a whole at VCC to include trial and non-trial patients. Patients were recruited from personal invitations from nursing staff supported with a flyer produced for the project and included in Appendix 7.4. In total, 10 women and 7 men took part, all of whom had been diagnosed with cancer (breast, liver, bowel, prostate). Some were recently diagnosed and some were in long term remission. About half had been involved in some stage of a clinical trial at VCC. One was a patient representative at VCC Patient training and consent Recruitment and consent in principle of patients into the focus groups was undertaken by the VCC staff who were members of the Project Management Team via NISCHR CRC. Prior to patient participation in the focus groups, participants received: A briefing letter setting out the aims of the service evaluation A consent form to complete Directions and details of venue and time. NISCHR CRC drafted the consent form, and ensured it was completed and kept as a record. NISCHR CRC also put in place staff support during the focus group events and made sure there was a nurse present at the patient events for support or in case of medical need. Focus group participants were also given a telephone number should they wish to give feedback or have support after the data collection events. 20

21 3.3.4 Instruments Clinical research concepts To assist in collecting data on patient knowledge of clinical trial concepts, a list of concepts patients were likely to be introduced to was developed for discussion with staff. Concepts were identified for the list from a content analysis of the patient-facing materials collated by NISCHR CRC. This content analysis of patient-facing materials identified broad categories of clinical trial concepts: The need for research Research design (types of trial, randomisation, duration) Risk (safety procedures, ethics, monitoring) Experience (practicalities, tests, monitoring, and contact with nursing staff). This list of concepts was then roughly structured by ranking concepts in order of complexity and a table of concepts was created for use in the staff focus groups (see Appendix 7.6) General Practitioners A short semi-structured survey was prepared following analysis of data from the staff focus groups. The survey was sent from the Director of Operations at NISCHR CRC via to approximately 20 GPs in South East Wales. The complete sent to GPs is included in Appendix 7.5 and questions sent to GPs are given in Figure 1 below. 21

22 Figure 1: Summary of GP questionnaire GP Questions 1. Do you ever discuss participation in clinical research/clinical trials with your patients? 2. If so, can you tell us: the concerns commonly discussed with you the nature of any common misunderstandings or confusion whether patients tend to talk to you about clinical research before they take part in a trial, during, or after? 3. How familiar are you with current cancer clinical trials available for your patients in primary care, diagnostics, surgery or treatment and how do you find out about the trials? 4. How comfortable and prepared are you to discuss clinical research in cancer services? 5. Is there any information or insight you need but don t have? 6. Is there anything else you would like us to know about supporting patients understanding of clinical trials/clinical research concepts before and after they decide to take part in a study? 22

23 Patients Instruments and questions for the patient focus groups were developed following initial analysis of data from the staff focus groups, presentation of staff findings and discussion with the Project Management Team. It was agreed patient discussions would focus on trust, complexity in the communication process and describe experience of communication on the patient pathway. A short discussion protocol was devised to explore how trust and complexity influence the awareness, understanding and expectations of patients in relation to clinical trials at different points on the patient pathway as well as explore opportunities to improve communication about clinical trials. See Figure 2 for a model of the generalised cancer patient pathway used for discussion in the patient focus groups. 23

24 Figure 2: Model of generalised cancer patient pathway showing key personnel and communication opportunities. Waiting area Consulting room Information point Appointment letter Waiting areas Consulting rooms Appointment letter New patient pack Waiting area Consulting room Information point Leaflet Letter Waiting areas Consulting room Information point Patient Info Sheet Leaflet SETTING PERSONNEL OPPORTUNITIES 24

25 3.3.5 Ethics As an NHS service evaluation, ethical approval was not required (as confirmed with the Research and Development Manager at Velindre NHS Trust). However, as the service evaluation involved patients and recorded their views, including some personal information, this evaluation adheres to NHS ethical standards. All audio data collected for the service evaluation will be stored securely by NISCHR CRC for twelve months after the completion of the service evaluation. After this period of time, the data will then be securely destroyed. NISCHR CRC, as part of recruiting patients to the focus groups, ensured they were appropriately briefed with a briefing sheet sent with instructions for attending the focus group. Patients consented to participate and be recorded for the purposes of the service evaluation; consent included their ability to opt-out at any time Patient validation Patients were invited to validate findings presented in this report. A summary of findings was prepared (see Appendix 7.7) and sent to all patient participants with an explanatory letter and pre-paid response form. Patients were asked to respond if they had comments or further observations on the findings. No patients responded to the call for comments on summary findings Data analysis The data was analysed in two sets staff (VCC staff and GPs) and patients using a thematic content analysis approach. The staff focus group discussions were analysed prior to the patient focus groups to inform discussions in the patient groups. All data was entered into Atlas Ti for coding. Two rounds of coding took place: an initial round to establish coding categories and produce a model of the patient pathway, and a further round to refine the coding structure, following discussion interim results with the Project Management Team. Coded data was reviewed and synthesised to inform all recommendations. 25

26 4 Results 4.1 Service improvement Results are presented using a simplified patient pathway model of pre-diagnosis, diagnosis and post-diagnosis. This model was identified from patient focus group data as an accurate way to describe patient information needs at different points on the patient journey Staff Groups Pre-diagnosis Staff described early introduction and raising awareness of clinical trials among the general patient population as highly desirable. Clinical staff in secondary care were identified as ideal for delivering messages about clinical trials and introducing trials as part of treatment. The GP was suggested as an early opportunity to raise awareness of clinical trials, but dismissed as problematic and anxiety provoking for patients. Some consultants at Velindre Cancer Centre were proactively supporting colleagues in secondary care with information and resources. One research nurse said: I know that Dr. _ is trying to encourage surgeons to mention trials at that point where they have been given a diagnosis. They ve got a rough treatment plan and they know that they are coming to Velindre, so it s mentioned at that point that there are trials at Velindre. Staff recognised that patients need for and ability to process information changed along the patient pathway. One staff member described this and said: she [the patient] said at each stage she is given information and she said that she was given the information at the exact right stages. She said if she was given trials information at the beginning of her journey it just would have just confused her totally, but that was one view from one patient this morning. Participant, Staff Group 2 26

27 Another recognised patients were filtering information, absorbing only what was relevant. They said: I suppose the individual patient would only take in as much information as they could absorb and understand. So if they were reading something that was outside something they understood they would reject that in a sort of way anyway. Participant, Staff Group 2 Staff expressed a desire for general awareness raising and education of the wider patient population to support recruitment to clinical trials. Suggestions included a public relations approach to building awareness, with increased media activity through and better branding of VCC. They said: you ve got opportunities in the media to talk about, you know very generic stories about patients you know about a patient who s participated in a trial, what it means to have participated in a trial... you can do something for national trial week which I didn t know we did but apparently we do you can have media stories then a little bit about research in Velindre, most people are familiar with the Marsden you say research, Marsden is in most people s head they would join the two together [but] they wouldn t necessarily think of Velindre as being a big research organisation or the biggest in Wales, so a lot of media and public relations opportunities. Participant, Staff Group The MDT The MDT was seen as the primary channel for raising awareness of clinical trials with patients before arriving at Velindre Cancer Centre for treatment. Issues with the MDT that needed to be overcome to realise the opportunity, included: treatment options presented without clinical trials, staff then reluctant to introduce the trial option later MDT staff may be unfamiliar with all open clinical trials MDT staff may not feel positively enough to recommend a clinical trial MDT staff may reduce access to patients by pre-judging their willingness or ability to participate in clinical trials research 27

28 how MDT staff introduce clinical trials is not monitored or supported. Staff suggested the MDT needed support, and suggested: the introduction of a standing agenda item a checklist including clinical trials repeated exposure to messages about clinical trials signposting for where to find out more about open clinical trials building stronger relationships between referring consultants. VCC staff members said: trial eligibility is a kind of thing that you try and document at an MDT but you know what you don t know is the quality of the discussion between the clinician and the patient... I mean there are some trials that clinicians don t necessarily believe in and then that s going to be a half hearted discussion. So at an MDT some surgeon might say, well that s interesting, I ll mention it to the patient, [but] you have then no control over the quality of what they mention to the patient or indeed whether they do it at all. So I think if a clinician is prepared to make sure that their information is up to date and looks for information on trials, if we did that routinely then you start to know the trials that are open and you re you know making an effort and you re just reminding patients that the information is there. Participants, Staff Group 2 Staff expressed the desire for referring colleagues to become familiar with open clinical trials and to be supported in recommending clinical trials with treatment options. They said: I mean I suppose it s making sure clinicians, I mean we have, the list of open trials is on local websites, cancer research websites and NCRI websites, so theoretically I mean is almost reminding clinicians that when you ve got a patient in clinic, click on the link and see what open trials So I think if a clinician is prepared to make sure that their information is up to date and looks for information on trials, if we did that routinely then you start to know the trials 28

29 that are open and you re you know making an effort and you re just reminding patients that the information is there. Participants, Staff Group Diagnosis Staff were acutely aware of difficulties of introducing clinical trials at diagnosis. There was evidence that patients struggled to understand the implications of participating in clinical trials at this time. One participant reported how doctors may advise research staff a patient had been introduced to a clinical trial, but how patients have no knowledge of this conversation: I have been asked to see patients and I ve been told by the doctor that they know about the trial and then the patient knows nothing about the trial... why they have turned up here they have been referred as if we ve got trial here and that s brave, but that s not always what patients understand, trial what trial? Nobody said anything about a trial to me... Participant, Staff Group 1 Accommodating time for coming to terms with a diagnosis was problematic for research staff. They described being under pressure from targets for treatment times and for clinic time. They recognised how newly diagnosed patients had specific needs and how patients responded differently to the trial conversation at different points on the treatment pathway. One research nurse said: We usually mention it at a first visit as part of the general consultation about treatment options. For some people their focus is on getting to Velindre and having that consultation and starting treatment and for some people it s just sort of overwhelming that it s one more thing to think about. I think the time when we discuss it when it perhaps feels more relaxed is maybe it s somebody who already known to us and they may have progressed or had a recurrence and then you are talking about treatment options, without the same sense of urgency and then we can discuss trials then and I think, I hadn t really thought of this before talking now but I think there is a sort of difference in their response to that. Often when they come as a first visit to Velindre, 29

30 there is often a sense of urgency. There may have been delays or perceived delays and their focus is on cracking on with treatment. Participant, Staff Group 1 Others described the need to be diplomatic and said: normally you d have before you d see a patient you d see the doctor or the specialist nurse are they ok to approach, have they just been given bad news and are they upset or very... - you wouldn t choose that time to go in and give them all this information, you d make sure that they were ok already I think it depends on where you pick them up where they are in their treatment pathway because they may not be aware of their full diagnosis or the treatment options available to them so its a very diplomatic delicate situation about who and when approaches the patients so it should be handled as part of a multidisciplinary approach. Participants, Staff Group Post-diagnosis Post-diagnosis, patients wanted more information about their diagnosis and treatment. Staff supported patients need for information directly and by signposting to resources. Staff helped patients manage information, by helping them regulate the amount of information and assessing quality. One staff member said: And you see some patients you know they come to clinic and they want all the information at once and they re just tell me about it and you just know that you ve got to gauge it and you just stress to them look on your first visit here we ll just go at your level, your pace and as time goes on and whether you want to participate you know we ll just give you a bit of information bit by bit until you know you feel comfortable with the whole process of it all really. Participant, Staff Group 2 30

31 Patient Knowledge Staff described low levels of understanding about clinical trials and having to start at first principles (why we need research), introducing basic research concepts before introducing specific risks and benefits. They said: I would say that I mean probably two thirds to three quarters of patients haven t thought about trials and research and you know it can be quite a difficult discussion to have with patients but you know we feel it s an important discussion and we try and offer it to as many as possible. Participant, Staff Group 2 Staff pointed to common misunderstandings about clinical trials, which persisted even after a trial had been explained several times. Patients frequently questioned randomisation, for example: [randomisation] it s not our choice, it s not the doctors choice, we have no, we can t influence, you are always going to have the patient that seems like they understand and then they go out of the door and gone and so it s... can you re-randomise me? Participant, Staff Group Channels for information The importance of friends and family as information brokers was recognised by staff. One member of staff said: sometimes for patients, for older patients it s their younger you know sons or daughters who ask, they re the ones who have been on the internet and picked up the information and it probably is more common in the kind of, you know the worse the outcome the poorer you know, the more difficult to treat the cancer, the more likely they will ask about those options. Participant, Staff Group 2 Staff saw part of their role as signposting good quality information resources for patients: 31

32 we signpost them to different websites I suppose, that would be you know recommendations. You know you might say this is Macmillan or certainly for lymphoma, I say Lymphoma Association. Participant, Staff Group 2 Staff described mainstream media as a blessing and a curse. For many, the Daily Mail created problems often raising expectations, resulting in disappointment for patients and making staff look as though they were withholding treatments. Staff welcomed health reporting, but were concerned about poor quality reporting. Common misunderstandings about new treatments from press articles about basic science, suggested cancer charities may have a role in highlighting the role of clinical trials. I think it is difficult you know because it s people who clutch these Daily Mail articles on this wonder drug and you know, I mean you know as I said we are very happy to answer questions but sometimes you know it can be quite a difficult conversation when people, when something sounds wonderful and you re having to say well you know it s not quite as simple as that. What I think is unhelpful is some of the press articles that are out there because often they re talking about laboratory tests and not about actual people and like I said I don t have to deal with that but to me certainly when I was trawling through it, it was definitely some of it would have been quite unhelpful. Participants, Staff Group Trust Trust given to consultants by patients, was reported to be fundamental in managing the possible risk of participating in a clinical trial. This finding was also supported in patient discussion groups: Patients can be very trusting, and they trust you not to put them at risk if you put them into a trial. Participant, Staff Group 1 32

33 The hardest patient, the most worrying patient is the very accepting patient because anything you say doctor, I m happy to sign you just tell me what to do. Participant, Staff Group 2 With this strong trust, came responsibility: I think that we re always in a position of trust as well - there are some patients who are so desperate they would take anything, but it s up to us to make sure they are right for the trial and no matter how desperate they are they have to be. Participant, Staff Group 1 Clinical staff were grateful and respectful of patients willing to take part in trials. They said: A lot of the palliative patients want to be involved in research and are happy to help even though it s not going to help them, they want to help people in the future. I find this especially with Urology, the elderly men, they are selfless. They saying it s going to help me, it s going to help in future, they are just willing to help... I m absolutely amazed at how wonderful patients are at you know going in at a very difficult time for them and they really, you know they give it everything. Participants, Staff Group The Velindre Cancer Centre Microsystem Staff described a complex pathway for new patients at VCC. This system included chance factors research staff had to work around to minimise. These included: availability of consultation rooms access to patients time with patients pressure of time to treatment targets Staff described substantial pressures that could be relieved with better resourcing of rooms, time and role recognition. They said: 33

34 even if you know the patient is consented...we d be going through some questions with patients which can be quite personal and emotional and I will be interrupted, you know by consultants... I understand that patients need to have the time with consultants, but because they are involved in research we need the time as well with patients. It s a controversial issue it s about having appropriate space to talk to the patient and not being rushed out of a room because someone else needs to use that room. I d say it was organised chaos really, yes organised chaos. Participants, Staff Group 1 Given these pressures staff were keen to suggest how patient recruitment could be made easier. One suggestion was to have patient education events, similar to the ones for new patients for chemotherapy: so wouldn t it be better to for them to have a completely separate time for them to come to be seen to so you ve just got that with them then, oh it s a little bit like our chemotherapy education sessions that we run or oral sessions that we run that they get booked in and you ve got that allotted time with them? Participant, Patient Group 1 Using data from the staff groups, we have summarised the internal pathway to consent to clinical trial at VCC in Figure 3 below. Patients come to VCC from two distinct routes routine screening and diagnostics these patients may have different expectations of treatment at VCC Findings from GP survey Issues and concerns discussed relating to clinical trials with the GP included: The effect on the doctor-patient relationship of declining a clinical trial Whether the doctor thinks participating in a clinical trial is a good idea Indirect requests for information or support by mentioning in passing. 34

35 GPs said they would be comfortable discussing clinical trials, but did not feel it was their role to do so. GPs said they didn t have any specific information on trials, but only the patient s perspective on a trial or trial invitation. One respondent suggested they had a role in signposting information and resources for patients. Respondents stressed cancer patients comprised a very small percentage of all patients and clinical trials therefore did not present often. GPs were supportive and willing to support patients, but there was no evidence for any more than a supporting role in awareness-raising. 35

36 DECLINES TRIAL SCREEN FOR PROTOCOL Tell Me More Final Report Figure 3. The internal pathway for new patients (from screening and diagnostics) at VCC showing recruitment and consent to trial treatment option. All Patients LOW AWARENESS AND KNOWLEDGE RAPID INCREASE IN TRIAL SPECIFIC KNOWLEGE DECISION MAKING SCREENING RECRUITMENT PATIENT DECISION Consultant PRESENT TRIAL AS TREATMENT OPTION DISCUSS LIST Candidates for the trial DISCUSS LIST NO NO Research Nurse DISCUSS WITH PATIENT RN to find patient, time, room Patient receptive YES Patient Info Sheet YES STANDARD TREATMENT Consent to participate MIS- CONCEPTIONS MAY PERSIST NO YES Consented patients 36 TRIAL Eligible patients

37 4.1.3 Patients Simplifying the patient journey Cancer pathways are complex and site specific. In discussion, patients shared experience of a simplified pathway. They described a journey in two halves from concern to diagnosis, and from diagnosis to treatment. These halves were punctuated by diagnosis which they described as a watershed moment. This simplified journey was universally and spontaneously reported by patients in this service evaluation. Findings suggest each stage of this simplified journey needs a different approach to communications. Pre-diagnosis patients need general, non-specific information delivered through a wide variety of channels to increase knowledge and strengthen trust in the NHS. Post-diagnosis, information needs increase, becoming complex and specific. The journey stages and implications for communications are presented in Figure 4 below. 37

38 Figure 4: Two stages of the patient journey, two contrasting approaches to communicating clinical research Pre-diagnosis Post-diagnosis Messages General and simple Specific and complex Channel Media, leaflets, passive sources. One-to-one with clinical staff, patient information sheets, family. Key messages NHS does research and research is a normal part of NHS treatment and care Improvements in NHS services, treatments and care, come from research that may involve patients Treatment and care today Velindre Cancer Centre is a recognised research centre, you may be asked to take part in a clinical trial. At Velindre Cancer Centre, your treatment options now or in the future may include taking part in a clinical trial are the result of patients taking part in clinical trials in the past. Knowledge General knowledge of concepts and patients role in clinical trials. Clinical Trials are part of treatment options, specific research concepts. Trust & reputation All NHS research has ethical approval and is carefully monitored so patients receive the best treatment delivered safely Velindre Cancer Centre is a centre of research excellence and works to improve cancer treatments and outcomes for all patients. 38

39 Pre-diagnosis channel and advisors Introducing clinical trials early on the patient journey was described by focus group participants as inappropriate and counterproductive. Patients said they could not consider future possibilities without a diagnosis. Patients reacted negatively to the suggestion clinical trials might be introduced as part of treatment options before diagnosis. Early introduction as part of treatment would cause anxiety: Moderator: People who could be invited into a trial do you think that it would be useful to know more about trials, you know earlier on? Participant: No not really. I don t see the point in worrying people. Participant, Group 1 it would make you think you have got cancer. I think it should only be mentioned once you know. Participants, Patient Group 3 Patients suggested that early mentions of clinical trials may reduce access or create unnecessary barriers to participation or understanding. One patient said: My surgeon said that going on a trial wouldn t make any difference to the treatment. Participant, Patient Group 2 Patients also said primary care was not the right place to introduce clinical trials. They said even post-diagnosis it was unlikely they would involve their GP. I went to my GP because I saw something that wasn t right. I don t think I d have wanted my GP to say okay we ll refer you and then if it is cancer you could be offered a trial. I don t think I d, I don t think I d want that. 39

40 Moderator: Would there ever have been an occasion where you would have gone to your GP with a complaint relating to your side effects? Participant: Well I d probably ring up Velindre wouldn t I? Participants, Patient Group 3 We asked patients when would be the right time to introduce clinical trials as part of treatment, they said: after diagnosis with their consultant. As one patient said: The person who knows if the trial is suitable for you is probably the oncologist when you re talking about starting the treatment. So I think it should start from there. Patient Group 3 40

41 Pre-Diagnosis content and message Pre-diagnosis, patients said general information, not related to recruitment would be acceptable. Findings suggest this information could usefully include: General information How research leads to treatment Telling a human story Pre-diagnosis, patients described living with uncertainty. Some described a state of denial and only after diagnosis did they accept they had cancer. They said they would not be interested or able to relate information about taking part in research to themselves and too much information would be counterproductive. Knowing too much too early was frightening for patients. One said: I did that [find out about cancer] first thing and frightened the life out myself so that after that point I filtered everything from my partner who looked at everything before I did and I trusted her to kind of give me the information I needed. Participant, Patient Group 3 Another patient described skilful and gradual release of information as being caring in itself, and said: I thought they were very clever the way they fed me information to me, because initially it was just trying to find out what it was. And it was a gynaecological problem, then they sort of drip fed all there seems to be something else there, it could be, they didn t mention the word cancer, but they were very clever at drip feeding me information and for me that worked... Participant, Patient Group 3 Patients agreed being familiar with research concepts earlier could have been useful. They said information must be general and unrelated to a potential diagnosis. One said: 41

42 I think it would be useful, and I can t remember, you have your letter for your appointment or whatever to say that during the course of your treatment you may be offered the option of trials depending on various things, because then it s there in your mind. Participant, Patient Group 3 Patients were asked if being introduced to the possibility of taking part in clinical trials with their first appointment letter was acceptable. Reaction was positive but a statement must be carefully worded to avoid sounding as though research participation was obligatory or universal. One patient suggested something similar to advice that medical students are present in consultations. She said: I think it would be useful, and I can t remember, you have your letter for your appointment or whatever to say that during the course of your treatment you may be offered the option of trials depending on various things, because then it s there in your mind. Because one of the things I did was I had a medical student with me and I think I had a letter from xxx saying when you come to see me I ll ask if you would be willing to have a medical student to go through the treatment with you so that they understand the patient s perspective and I had time to think about it, chat to my husband, yes I think I d be happy to do that. Because they were getting, it s giving them another, another facet. So for me, and I know everybody s different, I think you know the first letter I get for my first appointment to say you may, as part of your treatment, be invited to join a clinical trial and maybe a little bit of information about what that might mean. Participant, Patient Group 2 Others said it would be an acceptable approach, before the difficult moment when treatment options were being faced for the first time. They said: Moderator: So it s an acceptable thing to do in a letter and it wouldn t provide you with a shock? Participant: I don t think so. Participant: No I don t. 42

43 Participant: I think if it s in an initial letter it s in your mind. Participant: I think if it was worded you were offered a trial not that you might be taking part in a trial, it s your choice at the end isn t it. I suppose you don t want a huge long letter do you, but again from my point of view that maybe you even mention it s a Centre of Excellence and it is because it s done so much research and so many trials and you may be given the opportunity to be involved in something like that, I don t know. Participants, Group Pre-diagnosis knowledge and understanding Patients who had not taken part in clinical trials only had a basic understanding of randomisation, risk and the need for clinical trials. This supported findings from staff focus groups, where staff reported explaining research from first principles with the majority of patients. I knew nothing about chemotherapy and I knew nothing about trials. Yes, I m a teacher, so I knew about you know, experiments, you know control groups and so forth. So I understood the process but that wasn t explained to me. Patient Group Diagnosis Diagnosis, without exception, was a watershed moment for patients. At this point on the patient journey, patients found themselves confronting the reality of their diagnosis. All patients described this moment as difficult, full of emotion and not conducive to clear thinking or decision making. One young woman said: I was handled very sensitively because I fell apart. Participant, Patient Group 3 One man described this time as a roller coaster and said: 43

44 I think in the early stages of diagnosis, you know what I mean, when I say about booking a holiday when I first found out it s a terrible state of mind to be in, whereas you live from day to day and you don t see the point of planning anything. I mean do I buy green bananas, I don t know. It makes you realise that some people leave planning their retirement or their pension plans and they think oh there s tomorrow, there s tomorrow but when you realise there may not be too many tomorrows it s a terrible state of mind to be in and to be honest unless you get really angry and you fight, trials, medical trials are not the first thing to occur to you, well not to me anyway. I was so busy trying to cope with the emotional aspect of it that initially even if somebody had given me a two-hour talk on medical trials in the beginning it wouldn t have sunk in at all. Participant, Group 2 Patients struggle to absorb any new information at the time of diagnosis, not only information about clinical trials. The emotional work of adjusting to a diagnosis, made this time the wrong time to introduce clinical trials. My time has been taken up the first couple of months, being in a bit of a state of limbo when you first get the diagnosis, to finding out then, you have the initial CAT scan, then you have another one to see how it s progressing, so you don t really know whether to plan next year s holiday or no, so you re in a bit of a state of flux and trying to get on with my job and my life, research was one of the last things that entered my head. Medical trials are not the first thing to occur to you, well not to me anyway. I was so busy trying to cope with the emotional aspect of it that initially even if somebody had given me a two-hour talk on medical trials in the beginning it wouldn t have sunk in at all. Participants, Patient Group 2 I wasn t offered the trial until I went to Velindre and I was having chemotherapy and oh there s a trial, you can go into it because it was my first appointment and it was a barrage of information. Now I consider myself a fairly intelligent woman but it was, in the end I was a bit confused, I thought it was a bit too much information. Participant, Patient Group 3 44

45 When patients had been introduced to the concept of taking part in a trial prior to referral to VCC, it wasn t always well supported or followed through. One patient wasn t given further information by her surgeon, even though she would have been happy to receive it at the time. Arriving at VCC, she described the information on the clinical trial as a bombardment: Actually now you ve reminded me that they did mention it...at an Outpatient Clinic, said they might be doing some trials but didn t give any information and told I would be told when I went to Velindre, [but] I wasn t given any information... And then when I went to Velindre I was bombarded. Participant, Patient Group Post-diagnosis advisors and channel Making sense of information was a collaborative effort with clinical staff for most patients, although some put all their trust in their medical advisors. Patients said: Consultant was the most trusted source Nurses gave support in decision making Families filtered and made sense of information. Patients spontaneously indicated preferred sources of information. General information sources such as leaflets and posters were acceptable before diagnosis, but after diagnosis the consultant was always the preferred source of information. Other sources of information played a supporting role. Family, friends or other patients helped find, filter and interpret information for patients. Research and specialist nurses were also important in supporting the consultant s advice; giving information and helping patients reach a decision about treatment. Relationships with trial nurses and specialist cancer nurses were highly valued. These nurses often made themselves available for queries and conversations on demand. One participant described checking and double checking information with her nurse. Well I did read this and I thought, I m really not sure, you know I knew what was happening so my clinical nurse is lovely and she gave me her phone number so could phone her any time. Participant, Group 3 45

46 Family members were an important source of support. One partner was described as making sense of information immediately after her diagnosis, when she couldn t deal with it herself. Moderator: But was it a surprise to you that you were invited to take part in a trial? Participant: Yes now that s, I was surprised because, because you just need to know and just want to take in all that s going to happen to you, and then all of a sudden she was talking about something else and I was thinking oh my God I can t take all this in now but thankfully my husband was with me as well so it was like two heads are better than one and of course we did have time to take this home and read it and understand it more and had important numbers to phone and asking questions. Patient Group 1 Passive information sources like leaflets and posters also had an important role to play in raising awareness and introducing the idea of taking part in a clinical trial. One man described how joining a clinical trial began with a leaflet: I picked up a leaflet on the reception desk at Velindre Hospital My time has been taken up the first couple of months, being in a bit of a state of limbo when you first get the diagnosis, to finding out then, you have the initial CAT scan, then you have another one to see how it s progressing, so you don t really know whether to plan next year s holiday or no, so you re in a bit of a state of flux and trying to get on with my job and my life, research was one of the last things that entered my head. Participant, Patient Group 2 Trusted websites included Cancer Research UK, Macmillan and NHS sites which were often signposted by clinical staff. I went on the Macmillan site on the internet and their information is tremendous. Participant, Patient Group 1 Not all patients were concerned about trustworthiness of their sources as they were looking for hope not evidence. One patient with a challenging diagnosis said: 46

47 If somebody gives you something that gives you a degree of hope or something like that, if somebody on the street could have told me and I d be on the internet looking at it or I d have been looking at something like that, it helps if you have that relationship because you can have that honest dialogue about it, but I would have taken the information from anyone. Participant, Patient Group Post-Diagnosis message and content Post-diagnosis, all patients wanted more information on both their disease and treatment options. Those with poor diagnoses were the most diligent in seeking out information on their cancer: Participant: I would need to know, I m an information freak so I d rather have the whole shebang in front of me and come to terms with it but that s part of my job. I ve done that and it s part of my make-up. Moderator: So you would want quite a lot of information? Participant: As much as possible. Moderator: And you would seek that out yourself Participant: I d seek it myself, I d seek the advice and information if I didn t understand or I didn t want but I would make sense of everything myself, like you say I d have to come to terms with and things like that. I d like to understand. It s my way of dealing with it. Yeah. Participant, Patient Group 2 Patients said relevant information became highly salient. They reported seeking out information on new treatments and approaches, scanning the print media and the internet, sometimes finding complex medical information including information on clinical trials, new drugs and research papers. Some passed the job of finding and making sense of content to a family member or friend. Some patients reported eliciting and valuing first hand information on 47

48 treatments and side effects from other patients. All patients found they were sensitised to information, post-diagnosis. I just seem to pick things up as I go along, reading in the papers and then I check on things you know on the internet and what have you. Participant, Patient Group 2 Some patients accepted information from any source, credible or not, if it gave them hope of an improved outcome. Patients were highly selective in the information they looked for and used. We found information needs becoming increasingly specific post-diagnosis. Some patients were more critical of information than others. One described approaching news on treatments critically and said: the last one I saw was in that really popular newspaper The Mail and there was a particular drug used in conjunction with chemotherapy for people with melanomas, which if a melanoma turns into a metastasis which I m familiar with, I think oh right, that s when I sort of became really aware and really dug into the article and that s when I became aware of the statistic of a 53% success rate, cure rate and then the footnote in the article was the cost of it, where it was available and it wasn t available to me and I didn t, because it wasn t available to me I didn t take too much notice after that. Participant, Patient Group Trust We found evidence of strong trust in the NHS system and all members of the clinical team. This trust proved fundamental to accepting invitations to join clinical trials. Findings suggest the level of trust a patient had in the system, the organisation and their doctor increased as patients progressed on their treatment journey. We found some negative references to healthcare professionals, but all related to prediagnosis. For example: You don t go to the doctors unless you ve got to do you. 48

49 Participant, Patient Group 1 Secondary care was also a challenging experience for some. Patients described high patient throughput, and a lack of continuity in care. I found the Royal Gwent, which is my hometown hospital; I felt that was a cattle market. I was there for 16 days and I ended up in 7 wards. I was just shifted around left, right and centre, saw a different doctor virtually every time. In the University of Wales Hospital you ve the escalator and on top of the escalator there is a massive big portrait of [INAUDIBLE] Bevan and every time I ve been there I have looked at him and I thought God I bet you re turning in your grave now. You know for a Welsh man being so labour, so political and being the inventor then, shall we say, of the NHS and the NHS gone like it has you know. Participants, Patient Group 2 Patients appeared to be prepared to discount poor experiences early in their journey, as treatment options narrowed. Some patients defended poor care earlier on to support the strong positive view of the treatment and care they were receiving at VCC. I work for a large retailer which a lot of people have a lot of bad things to say about but there are good people that work in it and I think it s the same with hospitals. If a hospital has a bad name or a bad record, you can t dismiss every individual in that hospital or that institution just because of that. Participant, Patient Group 2 Trust in consultants was so strong some patients accepted their doctor s advice without question. One patient said she would do whatever her consultant surgeon asked her to do: Well as far as I m concerned with Professor Grimmer and his team, I ve been going back and forth there over the past two and a half years because I trust him very much so I m quite willing to have any treatment or information by going up there, you know with the distance, I don t mind at all, I ll do it because I trust the man implicitly. 49

50 Participant, Group 2 Patients described a high level of trust in the NHS. This trust resulted in the view shared by all patients in our groups, that they were not exposed to risk by taking part in a clinical trial. They strongly believed the NHS would not put them at risk of harm: I think you know you need to listen to all the arguments, the pros and cons of everything but at the end of the day, you put your life basically in the hands of people that you trust. Participant, Patient Group 3 Surgeons and consultants were the point of reference for patients; their views and advice were always taken. Patients described their consultants with great respect and as trusted advisors: No honestly if the consultant asked me or the doctor asked me or a qualified person asked me, look this is not working John, we ve got this stuff out, we think it s going to be beneficial to you, would you mind trying it and you know and then come back in a couple of days and say yes or no, but I d certainly take notice that a person was asking me. Participant, Patient Group 2 Trust in the consultant was undoubtedly supported by conferred trust from the NHS system and trust in VCC. Trust in VCC was significant and beyond general trust in the system. Patients described strong, positive relationships with staff and described being treated as real people, not just a number. Patients said VCC delivered a warm and personal type of care that was beyond normal delivery of NHS healthcare. One reason for this was the scale of VCC - it was small enough to feel welcoming and manageable, frequent contact with individual members of staff enabled patients to build good relationships: Participant: And this is what makes Velindre a little bit special you see because you feel that you are back to, yeah, it is a caring hospital. Participant: It is the old way kind of hospital. 50

51 Participant: Yes when you look at it, it is quite a small unit. Participant: It is a small, it is small yes. Participants, Patient Group 3 In contrast to the majority, one participant, who had experienced the loss of his wife to cancer and a very late diagnosis himself of cancer, was highly suspicious of healthcare and had little trust. His view suggests that while the doctor is automatically given trust by a patient, it needs to be supported by the wider healthcare system delivering safe, effective and timely treatment and care: We believe what doctor say like you know that s good for you so yes thank you it s good for me yeah, that s it, that s the end of it. He didn t say look it has not been tried before and we will try it on you, then I would be having the second thought you know. Participant, Patient Group 1 Another participant described a general mistrust from lack of information on doctors performances. He wanted evidence of hospital performance to support decisions made for each step of his treatment. He was completely informed about active clinical trials for his form of cancer, had sought out a trial and found out that he could take part in the trial at VCC. The changing degree of trust patients described on their pathway suggest that specific trust building communication activities need to be mapped to the stages of pre-diagnosis, diagnosis and post-diagnosis, shown in Figure 5 below. 51

52 Figure 5: Trust and communication of clinical research on the patient journey Pre-diagnosis Diagnosis Post-diagnosis NHS ORGANISATION CONSULTANT/SURGEON TRIAL INVITATION (CONSULTANT OR NURSE) Aim Positive Reputation Positive Reputation Positive Relationship Proposition anticipated Vision The NHS does research to support improvements in treatment and care. VCC is a cancer research centre, patients may be invited take part in League tables, recommendation, patient experience website Patients enjoy trusted relationships with clinical team, including research staff. clinical research as part of treatment options. Level of trust Healthcare is safe, effective, equitable and timely. Treatment and care that is safe, effective hygienic, timely and Surgeon or consultant treat me as an individual. Participating in a trial is an appropriate treatment option. caring. Channel Press and public media, passive information. Website, all communications and branding. One to one communications supporting research Face-to-face, consultant first, research nurse second. awareness. Issues Delayed diagnosis, hospital closures, waiting, availability of drugs & reduced Lack of reputation building activity Possible conflict in recommendations or information between referring surgeon and VCC. Trial invitation on diagnosis, or before relationship with consultant established. treatment options Activity Government sponsored communication Brand building Strengthening professional networks Wider VCC information support 52

53 Patient knowledge In the discussion groups a range of research concepts were presented to explore patient knowledge of clinical trials. General knowledge of clinical trials was found to be low. Patients currently or previously participating in a clinical trial were more knowledgeable, but most did not understand risks and benefits, randomisation and other concepts. Patients reported limited awareness and knowledge of clinical trials before diagnosis. Knowledge was limited to general knowledge from newspapers, unfortunately this was mostly bad news: Moderator: did you have any idea about clinical research? Participant: No I didn t really know anything. Participant: Well you knew they go on because you read in the press when things go wrong don t you. Participant: Yeah. Participant: You don t hear about the good things. Participant: No you don t no. And the good things far outweigh the bad things don t they? Participants, Patient Group 2 Patients described confusion between consent to treatment and consent to take part in clinical trials, some patients didn t know if they d been in a trial or not. One participant was confused by differences in delivery of treatment and clinical trials research, he said: [A person] I am very friendly with and working with for 40 years, played golf with for about 20 years had exactly the same operation as me about six weeks before me, now he was offered a similar treatment to me. Now he refused the intravenous stuff, now is that a part of an experiment or not? Participant, Patient Group 1 53

54 There was also confusion over basic science and clinical trials patients were unaware of research to improve existing treatment. There was little understanding of the phases of clinical trials. There was a general and incorrect assumption that trials tested new drugs, rather than improve existing treatments. Patients referred to being a lab rat or guinea pig and there was a general, underlying negative view of clinical trials: Moderator: And then what did you get when you got to Velindre? Participant: A meeting. I was given the pros, the cons, what to face. Moderator: And was this a leaflet or what? Participant: No verbal to start with then what phase the drug was on. There s three phases for a drug. They ve tightened things up since the elephant man, when that big experiment went wrong. They used to trial drugs on students and things. Participant, Patient Group 3 Randomisation was understood at a simple level, but the specific details of clinical trial randomisation poorly understood. Some patients were surprised when they couldn t choose which arm of the clinical trial they would be on. One woman said: of course we did have time to take this home and read it and understand it more and had important numbers to phone and asking questions. So when we went back and discussed it in more detail, because as I said earlier I thought I could choose what I wanted but I couldn t. But yeah I was surprised initially that I hadn t that choice you know. Participant, Group 1 Some patients were confused between eligibility and randomisation, assuming all those eligible, received clinical trial treatment: 54

55 Participant: think it s random, I don t think random should be in it. I mean you ve got to be tested to see if you re capable of taking the drug for a start, so that wouldn t be random. Moderator: Well the eligibility bit decides whether you re eligible. Participant: Oh yes and then you go down to randomisation and there s two of us eligible and you pick out the fittest. Moderator: That wouldn t be random though would it? Participant B: Eligible, really that s the question. Why they thought that I was eligible and it s because I passed, ticked all the boxes, because I had to have a heart ECG and tests. Moderator: So that makes you eligible but it doesn t pick you randomly. Participants, Group 2 Some patients were well informed, for example this participant had a good understanding of blinding, but she d been a nurse. The hospital doesn t know what you are on. The only time that they know is if like I went in for an operation, an emergency appendix operation, so they had to know what. Participant, Patient Group 3 Patients assumed that clinical trials carried little or no risk. They assumed that trial treatments could be no worse than the existing treatment. Both of these assumptions were made because the clinical trial was being conducted by the NHS. Patients were unaware trial treatment may be less effective than standard treatment, or actually harmful. Patients described clinical trials as win-win because they delivered improved treatments and also standard treatment would be better for being delivered under clinical trial conditions: the minute a trial was mentioned to me I was more than happy but of course the end result of that was that I was always going to be a winner anyway because I was, the way 55

56 that my trial was set up was that I was either going to have what was already existing or I was going to have the new drug, so therefore to me it was a win/win situation. It was never in dispute that I would go on this trial. It was always something that I would benefit from. Participant, Patient Group Clinical trials and trial recruitment Where treatment options were limited, patients were found to be more open to clinical trial options and were active participants in searching for trials; I ve had the option of looking at what trials were offering before this one was identified was very much part of the discussion from the beginning, you know that trials did exist and the doctor would look at what trials were existing. Participant, Patient Group 2 One patient with an incurable form of cancer was clear that taking part in clinical trials was a good thing to do. For this patient, she was clear from the start she wanted to be given the opportunity to participate in research activity: If I d been asked to go on a trial early in the diagnosis I would have said yes because as I said what have I got to lose and if you could help somebody anyway then why not? Participant, Group 2 Patients clearly described two reasons for taking part in trials: altruism and self-interest. All patients said they wanted to contribute to better treatment and outcomes for future patients. This altruistic drive was strong, especially for those who had already lost friends or relatives to cancer: Moderator: Could we just start by asking you what you understand by the idea of clinical trials? 56

57 Female Speaker: It s helping others in the future. Well helping others which I was going to do and I d like to be a part. My husband had lymphoma as well before me but unfortunately he didn t make it but I was determined to be part of a trial, yes, research trial. Participant, Patient Group 2 Patients also had clear self interest in taking part in clinical trials. They hoped to gain better treatments and better outcomes from taking part. However, these patients may not have appreciated the risks from taking part in a trial. We found patients may not have understood randomization. Well whoever, whoever was treating me and said John I think, we ve got this new drug that s coming out and we think it s better than anything else, would you accept a trial on it. It d be no problem to me. I mean anything that s going to prolong my life or hopefully prolong my life is going to be beneficial. So you re not going, I don t think anything in their right mind is going to turn it down really are they. Participant, patient Group 1 We found patients experience of clinical trial recruitment supports the pre and post-diagnosis model. Support for recruitment can be mapped to the patient journey and is set out in Figure 6 below. 57

58 Figure 6: Mapping recruitment communication to the patient journey Pre-diagnosis Diagnosis s Post-diagnosis PRIMARY CARE SECONDARY CARE FIRST CONTACT VCC VCC TREATMENT Aim Patients have a general awareness of clinical research in the NHS Patients are aware of patient participation in research generally and at VCC specifically Message n/a At VCC, if there s a eligible trial for your type of patients cancer, you may be invited to take part Promote In NHS research. In VCC as Trust In the referral organisation hospital or clinic Complexity Simple, generic Simple, clinical trial concepts, signposting Patients perceive VCC as strongly associated with research activity Avoid recruitment to trials on diagnosis whenever possible. In VCC and clinical staff Specific to cancer, detailed information on trials, signposting to other resources Patients expect invitations to participate in research as part of treatment and care We think you may be eligible to take part in this clinical trial... In the consultant and the research team Specific to cancer, detailed information on trials, signposting to research personnel 58

59 5 Discussion & Recommendations 5.1 Strengths and weaknesses of the present service evaluation The focus group part of the service evaluation benefited from having relatively long sessions with both staff and patients, and from having two facilitators. Participants had the time to become comfortable with each other and to open up and help each other, not just to talk about their experience but to make sense of their experience. The quality of the data available for analysis shows in both the breadth and depth of the subject matter covered and was reinforced by patients reporting after the events that they felt better informed, were pleased to have taken part and quite enjoyed it. One participant commented that it was unlike a previous experience ( stilted and almost threatening ) and several suggested that the kind of focus group discussion that took place would be helpful to anyone facing a decision about taking part in a clinical trial. Similarly, the workshops which were run at the Tenovus Conference generated insightful data because they were facilitated by a past patient and past research nurse with insight into the clinical trial recruitment process at a high profile event and the Mystery Shoppers were lay representatives not familiar with the places they visited. More generally the service evaluation benefitted from replicating and learning from previous studies. The weaknesses were that, in the case of the patient focus groups, staff at VCC were responsible for participant recruitment which may have led to some selection bias (better informed, more articulate) and also over-representation of those with actual experience of clinical trial participation. The Tenovus Conference workshop participants were to an extent self selecting, from those who had the interest to attend a conference with a heavy emphasis on the benefits of research. The external facilitators original plan had been to hold separate focus groups for: Those who had no experience of clinical trials Those who had been asked but for reasons of eligibility had not (yet) taken part Those with clinical trial experience. 59

60 In practice, discrete focus groups were not possible to recruit and each group contained a mixture of all three categories. Although this presented some initial problems (explaining different experiences) this may have led to better group dynamics as the participants were able to exchange different experiences which allowed more of a compare and contrast approach. The Project Management Group felt mixed groups were acceptable as the patient experience being explored was not about taking part in research. It did produce some problems in the analysis too as it wasn t always clear whether participants had experience or not, but overall mixed groups were seen as providing richer data than might have been available from more heterogeneous ones. 5.2 Conclusions and recommendations Figure 7: Summary of conclusions and recommendations Pre-diagnosis Diagnosis Post-Diagnosis Communication Awareness that the Ring fence information Awareness that VCC is Goal NHS does clinical free time for patients a research centre and research with patients during this watershed that research options to improve existing moment of emotional are routinely offered treatments and adjustment. to eligible patients as introduce new part of their treatment treatments. and care. Key Message Today s treatment VCC respects patients VCC is a research and care is only need for personal time centre, patients may possible because of to come to terms with be asked to take part patients taking part in their diagnosis. in research as part of NHS research in the treatment and care. past. Delivery Information materials, Information materials, posters and displays, website, links from 60

61 key message delivered repeatedly by all healthcare staff. website to key resources, one to one information point, nursing staff, consultant. VCC Action Strengthen links to Communication Create a culture of referring hospitals by protocol, review of pride in research building professional trial recruitment activity and promote relationships and activity at this time, research projects to all wider public upstream support for staff. awareness. trial awareness Pre-diagnosis Early communication activity should focus on general awareness raising about NHS research aimed at the wider patient population and general public. Messages should highlight patients role in improvements in treatment, how participating in clinical trials is a normal part of NHS activity and how patients of all kinds may be invited to take part in trials to improve treatments, services and care. Raising awareness of clinical trials can build on the strong altruistic drive of patients in improving treatment for others in the future. These positive messages about people and improvements, could be supported by public and patient awareness campaigns, stronger research-led branding at VCC and embedding clinical trial activity into the culture at VCC Pre-diagnosis recommendations Review VCC brand or mission statement to include a phrase that encapsulates research activity. o One suggestion from discussions of findings with the Project Management Team was the use of NISCHR CRC s strapline Today s Research; Tomorrow s Care, or a similar message communicating research activity s link to improved treatment, with tagline for VCC. o Test branding concepts about research with staff and patients to ensure that messages are acceptable to patients and communicate messages accurately and effectively. 61

62 Consider seeking support for a sponsored communications campaign to raise awareness of clinical trials for all patients. o emphasise patient participation and research concepts including how clinical trials result in improved treatment. o produce human interest stories about patients who have taken part in clinical trials, successful trials that have improved treatment as a result of patient participation in trials based in Wales. Deliver a wider public awareness campaign with sponsorship (government or other), to convey the message that today s treatments depended on people taking part in clinical research in the past. To include for South Wales local transport, television, radio and press to communicate research awareness and protect and build the trusted NHS reputation. Continue to address negative stereotypes of clinical trials directly lab rats and guinea pigs and in general awareness raising campaigns of patient participation. Confronting and addressing these stereotypes is currently included in NISCHR CRC Randomised Controlled Trials Communication Skills training for staff and this could be used as the basis for patient education. Work collaboratively with cancer research charities to address advertising and fundraising that promotes the idea that research is about basic science. Explore working with their communications teams to balance these basic science messages with patients role in securing improvements in cancer treatments Supporting the wider referring network This service evaluation found that patients sometimes were aware of early mentions of clinical trials by consultants and surgeons in referring hospitals, this information was not followed up and supported with further resources. Additionally, findings from staff focus groups point to difficulties in ensuring the MDT supports access to clinical trials for all patients. At present clinical trials awareness is supported with quarterly cancer network meetings for each disease site. Findings from the present service evaluation suggest that further action could be taken to raise awareness of VCC clinical trials activity and strengthen professional relations across the referring network Referring network recommendations Host networking events outside of clinical practice, similar to the opening of the new radiography wing, for clinical staff from the referring network in secondary care. 62

63 Seminars or workshops to build professional research expertise or events to announce successes or developments related to research at VCC; raise awareness of research generally and at VCC specifically with the referring network. Support clinical trial starter packs by following up distribution with consultants and surgeons. Offer an introduction to clinical trials by the research nurse supporting the clinic in the referring hospital Diagnosis This service evaluation identified difficulties for patients introduced to clinical trials at the same time as a diagnosis. Findings suggest that information shared at this time may be incomprehensible. We recommend that every effort is made to ring fence time at diagnosis and support early introduction of clinical trial information for VCC trials recruiting new patients upstream. Achieving a research silent diagnosis period for patients could be supported by training and awareness raising for clinical staff attending MDTs to bring attention to the importance of this issue. Additional ad hoc support could also be offered to consultants and surgeons likely to refer patients eligible for open clinical trials recruiting new patients. This additional support could come from NISCHR CRC Research Network nurses to highlight studies recruiting new patients Diagnosis recommendations First appointment letter for VCC include message that clinical trials to improve treatments for cancer take place at Velindre and patients may be invited to take part in a clinical trial as part of their treatment and care. Include the Macmillan booklet on clinical trials with the letter or a purpose designed leaflet for VCC. For open clinical trials where VCC may need to approach patients at diagnosis, continue to promote clinical trial awareness among referring consultants and surgeons in secondary care. Provide regular updates on new patient clinical trial recruitment and eligibility protocols, provide supporting materials for consultants and patients. Highlight the difficulties of recruitment at diagnosis to referring centres. Consider developing a VCC protocol for managing communication with patients at diagnosis, to include for prospective clinical trial recruitment, and where possible given national targets for time to treatment, give them ring fenced, information free, personal time to come to terms with their diagnosis. 63

64 Consider developing communication guidelines or checklists for clinical trial recruitment of new patients at diagnosis, to counter patient disregard or minimising of risk and incomplete understanding research concepts Post-diagnosis Findings from this service evaluation suggest that after adjusting to their diagnosis, patients are ready to learn more about their treatment options and their diagnosis. As clinical trials recruit patients at all times on their journey, systematically raising clinical trial awareness among all patients at VCC will support ongoing recruitment, promote patient-to-patient and family member learning, and reduce stress for patients if invited to take part in clinical trials Post-diagnosis recommendations Strengthen awareness of VCC research activity through developing patient awareness materials with a strong positive message about patient participation and improvements to treatment for display in waiting areas at VCC. Review VCC website with specific reference to research activity and patient facing information on clinical trials participation. Include content for patients currently participating in a trial that covers information and news on clinical trials, contact numbers, and possibly a user forum or community page. Reduce the amount of material to read and consider including clips of patients talking about their experiences of clinical trials in video clips. Clinical staff could also introduce research at VCC on video. Explore how patient s consent to clinical trial participation notification for GPs could be supported in addition to legal obligations and good practice, with personalised information such as summary details of the clinical trial, information on possible side effects and contact details for VCC, to be sent by the patient s consultant. Include link to VCC clinical trials information, or NISCHR Clinical Research Portfolio online. Provide a dedicated cancer clinical trials information point in patient waiting areas at VCC providing printed information, access to the internet and the in person support of a clinical trials nurse to correspond to busy clinic times, to offer specific and personal information to patients at VCC. Ensure regular media releases broadcast information about new clinical trials and improvement research currently underway at VCC. Make sure to broadcast news on clinical trial outcomes and the part played by patients at VCC, especially successful trials that have resulted in changes to standard treatment. Identify and support Patient Clinical Trial Ambassadors from current or patients with experience of research. Present findings suggest that patients who have participated in 64

65 clinical trials and are able to support other patients by answering questions and discussing their experience of taking part in trials Clinical Trial recruitment recommendations The present service evaluation found that both patients and staff identified barriers to informed consent to trial participation. These barriers related both to the delivery of services at VCC and the patient experience of recruitment. Our findings suggest that wider, ongoing communication efforts to educate patients and the public about clinical trials will help overcome obstacles to recruitment. Additionally, a number of specific measures could be taken to promote recruitment Patient knowledge and understanding recommendations Review communication of key concepts, especially risk communication and other concepts identified in this service evaluation as prone to misunderstandings. Consider delivering group education events for all patients where research concepts can be discussed, misunderstandings shared and the process of recruitment into clinical trials clarified in a supportive learning environment. Support patients own research, especially internet research. Consider commissioning further research to examine patients own research ability, activity and strategies in the context of strengthening VCC and NISCHR CRC s own communication strategies for supporting awareness and understanding of clinical trials. Findings from this service evaluation suggest patients post diagnosis actively seek information, little is known about how they approach their own information needs. There is likely to be a considerable return on a relatively small investment in terms of communication efficacy and patient experience/empowerment VCC culture recommendations The present service evaluation identified a number of actions that could be taken by VCC to support research by aligning its own culture with a research focus: Promote clinical trial awareness throughout the organisation, engaging all staff in ownership of research excellence. Ensure research staff have necessary access to patients, consulting rooms and resources to fully support informed choice in clinical trial recruitment. Educate all staff in clinical trials, its importance at VCC and for patients in the future, to ensure they respect and support recruitment and trial treatment. 65

66 Strengthen branding to improve patients perceptions of VCC as a centre of research activity where they may participate in clinical trials. Continue to deliver training and support for all staff in understanding clinical trials and how to address patients own research queries. Support staff in initiating their own research projects. Update all staff on clinical trial outcomes and trial recruitment regularly in internal VCC newsletters and staff communications. 66

67 6 References Anguita, M New initiatives to encourage patients to participate in clinical trials. Nurse Prescribing Vol 10 no 3 ASCO Enhancing Clinical Trial Awareness and Outreach 2009 Journal of Oncology Practice 5(4): Ellis, P.M; Butow, P.N; Tattersall, M. H. N; Dunn, S.M; Houssami, N Randomized Clinical Trials in Oncology: Understanding and Attitudes Predict Willingness to Participate. Journal of Clinical Oncology, Vol 19, no 15: pp Hoffner, B. Bauer-Wu, S. Hitchcock-Bryan, S. Powell, M. Wolanski, A. Joffe, Steven Entering Clinical trial: is it Right For You? Cancer 118(7) Jenkinson, C. Burton, j. Cartwright, J. Magee, H. Hall, I. Alcock, C. Burge, S Patients attitudes to clinical trials: development of a questionnaire and results from asthma and cancer patients. Health Expectations, 8, pp GSK and CR-UK Report Building a service user led vision of medical research and information National Institute for Health Research Clinical Research Network Survey 2012 (conducted by OnePoll) NHS Wales Improving Healthcare White Paper Series No.11: The Listening Organisation ensuring care is person-centred in NHS Wales. 67

68 6.1 Current NHS Resources NISCHR CRC Patient information Screens Developed with Velindre Cancer Centre (VCC) in 2013 and reviewed by VCC patient group. These are for screens in VCC patient waiting areas. Clinical Research Treatment Unit leaflet Information about Phase I trials, produced by Velindre Cancer Centre s Clinical Research Treatment Unit Website Velindre Cancer Centre There is also a leaflet produced by Velindre Cancer Centre s Clinical Trials Unit called Clinical trials listed on the following page: Clinical Trials leaflet Cancer Research UK NIHR CRN based in England We do research resource pack for NHS Trusts 68

69 The National Institute for Health Research Clinical Research Network has published a resource pack to support NHS Trusts in raising the level of patient awareness about both clinical trials generally, and local opportunities for patients to engage in trials. The launch of the pack follows the NIHR Clinical Research Network s Mystery Shopper report, which found that patients can struggle to access general information about clinical research to enable them to initiate the question of research participation with their doctor. OK to ask Campaign launched by NIHR in England, aimed at patients. Mystery Shopper Survey carried out in England. National Cancer Patient Experience Survey Includes questions on research: Patient-Experience-Survey-National-Report pdf Clinical Trials Gateway For patients to search for clinical trials: 69

70 7 Appendices 7.1 Project Governance Project Manager Barbara Moore, NISCHR CRC Communications and Engagement Manager Project funder Tenovus Project Management Group Lucy Seago, NISCHR CRC Director of Operations Jane Darmanin, VCC Clinical Trials Unit Manager Sara Shankland, NISCHR CRC Research Network Manager Barbara Moore, NISCHR CRC Communications and Engagement Manager Sue Edwards, NISCHR CRC Personal Assistant Project Planning Group Lucy Seago, NISCHR CRC Director of Operations Jane Darmanin, VCC Clinical Trials Unit Manager Sara Shankland, NISCHR CRC Research Network Manager Barbara Moore, NISCHR CRC Communications and Engagement Manager Sue Edwards, NISCHR CRC Personal Assistant Mel Doel, Patient Representative Jim Fitzgibbon, Consumer Representative Anna Coote, NISCHR CRC Communications Officer Amanda Jackson, VCC Research Nurse Jenny Kowalczuk, Qualitative Researcher Andrew Rix, Qualitative Researcher 70

71 Project Reference Group All members of the Planning Group plus: Karen Diment, VCC Service Improvement Manager Sarah Townsend, Velindre NHS Trust R&D Manager Eve Gallop-Evans, Consultant Oncologist Paul Shaw, Clinical Oncologist 71

72 7.2 NIHR CRN Mystery Shopper Tool 72

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77 7.3 Flyer staff focus groups 77

78 7.4 Flyer patient focus groups 78

79 7.5 GP survey Dear Colleague Your practice has been identified as caring for patients who are treated at Velindre Cancer Centre. We would be grateful if you could complete the questionnaire below if you are a GP or forward it to your GP colleagues. Your views on supporting patients understanding of cancer clinical research A team from Velindre NHS Trust has been funded by Tenovus to conduct a small service improvement project to explore patients understanding of clinical research in cancer services. We are aiming to learn more about: what patients understand about clinical research who they discuss research with on their patient journey how patients learn about clinical research as a potential part of their treatment As a GP the project team would like to invite you to share your views and experience of discussing clinical research with your patients. The project group is looking for opportunities in the patient pathway to introduce the concept of clinical research to patients so that if and when they are invited into a clinical research study they are already more familiar with the concept of clinical research. Your views will help us identify potential improvements in the content of communication about clinical research for patients and how that communication is delivered. A series of focus groups with patients and staff are taking place in Velindre Cancer Centre, but we also hope that you will be able to contribute to this study and help us identify how communication about clinical research with cancer patients takes place. Can you please take the time to us your answers to the following six questions by 18 th October 2013? 1. Do you ever discuss participation in clinical research/clinical trials with your patients? 2. If so, can you tell us: the concerns commonly discussed with you the nature of any common misunderstandings or confusion 79

80 whether patients tend to talk to you about clinical research before they take part in a trial, during, or after? 3. How familiar are you with current cancer clinical trials available for your patients in primary care, diagnostics, surgery or treatment and how do you find out about the trials? 4. How comfortable and prepared are you to discuss clinical research in cancer services? 5. Is there any information or insight you need but don t have? 6. Is there anything else you would like us to know about supporting patients understanding of clinical trials/clinical research concepts before and after they decide to take part in a study? Many thanks for your help. Please respond by return of to this address: NISCHRcrc@wales.nhs.uk Yours sincerely Lucy Seago Director of Operations NISCHR Clinical Research Centre 80

81 7.6 Research Concepts The commissioned qualitative researchers have created a list of concepts in clinical trials, with a short example of how the concept may be introduced. In the next box please briefly describe how familiar you are or any difficulty you have with this concept, a word or two is sufficient. We have also left several boxes for concepts we may not have included, please feel free to add more concepts. Concept Example Patient Issues Need for research All treatments available today have been part of clinical research in the past Standard treatment Clinical research is needed to improve existing treatment and diagnosis NHS does clinical research Clinical research is an integral part of delivery of NHS diagnosis and treatment Clinical trial You may be asked to take part in clinical research as part of your treatment Randomisation Blinding Timing Not all patients taking part in a study receive the new drug or procedure as part of their treatment Patients and sometimes their doctors may not be aware of who receives the new treatment and who does not To take part in a research study you may 81

82 need to make a decision before your treatment begins Voluntary Taking part in a research study is your choice, it is not compulsory Informed consent for research Eligibility Risk Risk Risk Monitoring Monitoring You must give your informed consent to take part in a research study Sometimes even though a patient is invited into a study they are not eligible to take part Clinical research in the NHS is safe but there is a chance that it may be harmful in an unforeseen way The treatment studied may be more effective than standard treatment, but it may also be less effective You may have some unexpected side effects from the treatment in a clinical research study Patients in clinical research are closely monitored and may be asked to attend more checkups Even after a study has finished you may still need to attend for checkups or monitoring References for patient facing materials Macmillan Cancer Trials Leaflet, and web pages: 82

83 CRUK Leaflet Understanding clinical trials for cancer, Ref CTL001 September 2012 Website - Trials and Research Health Talk Online What are clinical trials and why do we need them? _trials/topic/3630/ Royal Marsden Clinical trials, your questions answered. PDF downloaded from Mayo Clinic Website, Research at Mayo Clinic NHS Choices Clinical trials and medical research information prescription Velindre Cancer Centre Clinical Trials, (Leaflet reviewed March 2010) 83

84 7.7 Patient Validation 84

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