AN EXPLORATION OF THE EFFICACY OF ARM MASSAGE IN FACILITATING INTRAVENOUS CANNULATION FOR ADMINISTRATION OF CYTOTOXIC CHEMOTHERAPY

AN EXPLORATION OF THE EFFICACY OF ARM MASSAGE IN FACILITATING INTRAVENOUS CANNULATION FOR ADMINISTRATION OF CYTOTOXIC CHEMOTHERAPY Final Report November 2004 Dr Emma Ream, Senior Lecturer King s College London Ms Catherine Oakley, Lead Cancer Nurse, Princess Royal University Hospital Ms Jibby Medina, Research Associate. King s College London Professor Alison Richardson, Professor of Cancer & Palliative Nursing Care. King s College London

Acknowledgements This study was supported by a European Oncology Nursing Society (EONS) Roche Research Award. We thank the nurses, massage therapists and patients that took part in this study for their contribution. Without their invaluable collaboration this research project would not have been performed. In particular the research team would like to recognise the contributions made by Dee Bryan, Bettina Donkin and Helen Hannon in the conduct of this work. This report should be referenced as: Ream E, Oakley C, Medina J, Richardson A (2004) An exploration of the efficacy of arm massage in facilitating intravenous cannulation for administration of cytotoxic chemotherapy. King s College London Exploration of the Efficacy of Arm massage 1

Exploration of the Efficacy of Arm massage 2

Abstract Purpose: The purpose of this exploratory study was to examine the outcomes of providing massage to patients on a Chemotherapy Day Unit, prior to administration of chemotherapy. Multi-method design: Prospective, randomised controlled trial, interviews, focus group Setting: Chemotherapy Day Unit within a cancer unit in South East England Samples: 52 patients; 68% female. Aged 24-79 years (mean = 59yrs) with breast (50%), colorectal (30%), haematological (12%) or lung (8%) cancer. All provided questionnaire data: 28 (54%) patients in the arm massage group (15 of whom were also interviewed) and 24 (46%) in the control group. 9 nurses; all female. Aged 24-49 years (mean = 34yrs). All provided questionnaire data; 2 were interviewed. 7 massage therapists; all female. Aged 33-59 years (mean = 46yrs). All participated in the focus group. 3 service stakeholders; all female. Aged 38-49 years (mean = 45yrs). All were interviewed. Methods: A multi-method study was conducted to determine the benefits of providing arm massage prior to intravenous cannulation. Primarily this comprised a randomised controlled trial (RCT), which investigated the impact of massage on the cannulation process and patients experiences of it. Patients were randomised to either the arm massage (experimental) group or the control (standard care) group. Data were collected from patients on up to 6 cannulation episodes. Investigator-designed questionnaires were completed by both patients and nurses on these occasions. These questionnaires gathered data on pain and anxiety both expected and experienced and time taken to cannulate. Semi-structured interviews were carried out with patients and service stakeholders, along with a focus group conducted with the massage therapists, to further inform understanding of the benefits of massage and the impact of its provision on the chemotherapy service. Resulting quantitative and qualitative data were analysed and triangulated to gain detailed understanding of its outcomes. Exploration of the Efficacy of Arm massage 3

Results: Statistical modelling through backwards stepwise regression, suggested that massage had a statistically significant effect on anxiety and pain, when combined with other factors such as a patients age, gender, or drug regime. When analysed on its own, its benefits appeared marginal. In both study groups 25% of cannulations were unsuccessful on first attempt. In order to understand this, factors other than massage including the patients gender, age and the drug regime they having were analysed. These factors did impact significantly on the outcome variables of anxiety, pain and time taken to cannulate. Female patients, younger patients, and those on vesicant drug regimes, were significantly more likely to anticipate and experience high levels of procedural pain. Further, they were more likely to feel anxious, and typically took longer to cannulate. Implications: Although massage, on its own, did not impact significantly on the main outcomes of the study pain, anxiety, and time taken to cannulate the patient and stakeholder interviews did highlight general positive effects and benefits of massage. These were neither sought nor captured by the questionnaire tools utilised in this study. Patients that did benefit were typically young and female. The qualitative data that were collected suggest that massage made attendance for chemotherapy less stressful and more palatable, and may have helped in making veins easier to see and palpate. Many positive feelings and emotions were mentioned in the patient interviews with regards to experiences of arm massage. Patients felt privileged to receive the treatment, which was relaxing and perceived as a treat. Likewise, those providing it referred to being privileged in being able to do so. Massage enhanced the experience of care for patients having chemotherapy and had a positive impact on the environment in which they received it. Exploration of the Efficacy of Arm massage 4

Contents Section Page 1 Introduction and Aims... 11 1.1 Introduction... 11 1.2 Aims... 12 2 Literature Review... 13 2.1 Complementary therapies... 13 2.1.1 General massage... 14 2.1.2 Aromatherapy massage... 16 2.2 The experience of chemotherapy... 17 2.3 Cannulation for chemotherapy... 18 2.4 CAM in the NHS... 20 3 Method... 23 3.1 Introduction... 23 3.2 Study aims... 23 3.3 Research questions... 23 3.4 Massage treatment... 24 3.5 Research design... 24 3.6 Sampling... 25 3.6.1 Patients... 25 3.6.2 Nurses... 27 3.6.3 Stakeholders... 27 3.6.4 Massage therapists... 27 3.7 Access arrangements... 28 3.7.1 Patient sample... 28 3.7.2 Nurse sample... 28 3.7.3 Therapist sample... 29 3.8 Instruments... 29 3.8.1 Questionnaires... 29 3.8.2 Patient telephone interview schedule... 31 3.9 Stakeholder interview schedule... 31 Exploration of the Efficacy of Arm massage 5

3.10 Therapist focus group... 32 3.11 Pilot work... 32 3.12 Data analysis... 32 3.12.1 Questionnaire data... 32 3.12.2 Interview and focus group data... 33 3.13 Ethics... 33 4 Results... 35 4.1 Introduction... 35 4.2 Sample accrual and attrition... 35 4.2.1 Patient sample... 35 4.2.2 Therapist sample... 36 4.3 Demography of patient sample... 37 4.3.1 Demography of patients interviewed... 38 4.4 Demography of nurse sample... 39 4.5 Demography of therapist sample... 40 4.6 Demography of stakeholders... 41 4.7 Patients cannulation experiences... 41 4.7.1 Experience of pain... 42 4.7.2 Anxiety... 44 4.7.3 Time taken to cannulate... 46 4.7.4 Cannulation on first attempt... 48 4.8 Attitudes towards, and perceptions of, massage... 48 4.9 Factors affecting cannulation... 52 4.9.1 Variable factors... 52 4.9.2 Demographic factors affecting cannulation... 62 4.9.3 Experience of first treatment... 73 4.10 Models explaining factors impacting on cannulation... 74 4.10.1 Model explaining anxiety prior to cannulation... 75 4.10.2 Model explaining anxiety following cannulation... 76 4.10.3 Model explaining anticipated pain prior to cannulation... 77 4.10.4 Model explaining procedural pain... 78 4.10.5 Model explaining time taken to cannulate... 78 4.11 Impact of massage service on delivery of chemotherapy day care... 79 4.12 Impact of massage service on cancer services... 80 4.13 Summary of results... 82 Exploration of the Efficacy of Arm massage 6

5 Discussion... 83 5.1 Introduction... 83 5.2 Massage and cannulation... 83 5.2.1 Massage and time taken to cannulate... 84 5.2.2 Massage and cannula usage... 85 5.2.3 Massage and procedural pain... 86 5.2.4 Massage and feelings of anxiety... 87 5.3 Massage and well being... 88 5.4 Factors affecting cannulation... 89 5.5 Study limitations... 90 5.6 Recommendations for practice... 91 5.7 Recommendations for future research... 92 6 References... 95 7 Appendices... 99 Appendix 1: Arm massage protocol... 100 Appendix 2: Patient information sheet... 102 Appendix 3: Patient Consent form... 108 Appendix 4: Therapist information sheet... 109 Appendix 5: Patient Questionnaire... 115 Appendix 6: Nurse Questionnaire... 120 Appendix 7: Patient Interview schedule... 123 Appendix 8: Stakeholder interview schedule... 124 Appendix 9: Focus group guide... 126 Appendix 10: Model explaining anxiety prior to cannulation (SPSS output)... 128 Appendix 11: Model explaining anxiety following cannulation (SPSS output)... 129 Appendix 12: Model explaining anticipation of pain prior to cannulation (SPSS output)... 132 Appendix 13: Model explaining procedural pain (SPSS output)... 134 Appendix 14: Model explaining time taken to cannulate (SPSS output)... 135 Exploration of the Efficacy of Arm massage 7

Figures Figure 3.1 Research design... 24 Figure 3.2 Sequence of data collection... 25 Figure 4.1 Flow diagram of patient accrual and attrition... 36 Figure 4.2 Massage therapist accrual and attrition... 37 Figure 4.3 Time taken to cannulate according to gender... 63 Exploration of the Efficacy of Arm massage 8

TABLES Table 2.1. Models of CAM provision... 21 Table 4.1 Patient demographics... 38 Table 4.2 Demographics of patients that were interviewed... 39 Table 4.3 Nurse demographics... 40 Table 4.4 Demography of therapists that participated in focus group... 40 Table 4.5 Anticipated pain... 42 Table 4.6 Procedural pain following cannulation... 43 Table 4.7 Anxiety prior to cannulation... 45 Table 4.8 Anxiety after treatment administration... 46 Table 4.9 Time taken to cannulate (minutes)... 47 Table 4.10 Association between massage and vein palpability/visibility prior to cannulation... 47 Table 4.11 Feelings when massaged... 50 Table 4.12 Feelings generated by massage according to gender... 51 Table 4.13 Effect of ease of cannulation on time taken... 53 Table 4.14 Effect of ease of cannulation on procedural pain... 54 Table 4.15 Effect of ease of cannulation on anxiety following cannulation... 54 Table 4.16 Effect of ease of cannulation on time taken to cannulate... 55 Table 4.17 Impact of vein visibility/palpability on procedural pain... 55 Table 4.18 Impact of vein visibility/palpability on anxiety... 56 Table 4.19 Impact of vein visibility/palpability on time taken to cannulate... 56 Table 4.20 Association between vein palpability/visibility and cannulation on first attempt... 57 Table 4.21 Time taken to cannulate according to the nurse that cannulated... 58 Table 4.22 Procedural pain according to the nurse that cannulated... 59 Table 4.23 Anxiety following cannulation according to the nurse that cannulated... 59 Table 4.24 Failed cannulation according to the nurse that cannulated... 60 Table 4.25 Effect of cannula size on anxiety... 61 Table 4.26 Effect of cannula size on procedural pain... 61 Table 4.27 Association between gender and insertion of cannula on first attempt... 62 Table 4.28 Time taken to cannulate (in mins) according to gender... 63 Exploration of the Efficacy of Arm massage 9

Table 4.29 Association between gender and vein palpability/visibility prior to cannulation...... 64 Table 4.30 Procedural pain following cannulation experienced according to gender... 64 Table 4.31 Association between gender and level of pain following cannulation... 65 Table 4.32 Anxiety following cannulation experienced according to gender... 66 Table 4.33 Association between gender and anxiety following cannulation... 66 Table 4.34 Procedural pain following cannulation experienced according to age... 67 Table 4.35 Association between age and level of pain following cannulation... 68 Table 4.36 Anxiety experienced after cannulation according to age... 68 Table 4.37 Association between age and anxiety experience after cannulation... 68 Table 4.38 Time taken to cannulate according to age... 69 Table 4.39 Association between age and time taken to cannulate... 69 Table 4.40 Chemotherapy regime classifications... 70 Table 4.41 Association between nature of regime and insertion of cannula on first attempt... 70 Table 4.42 Time taken to cannulate (in mins) with vesicant and other regimes... 71 Table 4.43 Association between nature of regime and ease of cannulation... 71 Table 4.44 Procedural pain following cannulation experienced with vesicant and other regimes... 72 Table 4.45 Association between nature of regime and level of pain following cannulation...... 72 Table 4.46 Anxiety following cannulation experienced with vesicant and other regimes... 73 Table 4.47 Association between nature of regime and anxiety following cannulation... 73 Table 4.48 Trends in anxiety and anticipated pain over time... 74 Table 4.49 Model of factors impacting on anxiety prior to cannulation... 75 Table 4.50 Model of factors impacting on anxiety following cannulation... 76 Table 4.51 Model of factors impacting on anticipated pain prior to cannulation... 77 Table 4.52 Model of factors affecting patients pain following cannulation... 78 Table 4.53 Model of factors affecting time taken to cannulate patients... 79 Exploration of the Efficacy of Arm massage 10

1 Introduction and Aims 1.1 Introduction Cancer is a life threatening disease. More than 270,000 new cases were diagnosed in 2000 in the UK (1). Of the one in three people who are diagnosed with cancer throughout their lives (2), approximately 60% will receive chemotherapy during their treatment (3). Chemotherapy is often a source of distress and discomfort for patients not least because of its side effects. Further, the physical experience of cannulation can be for some individuals a traumatic and painful experience (4). It is widely recognised that the experience of having chemotherapy can be a dreaded one for patients (4-7); the prospect of cannulation and the treatment process itself causes stress and discomfort. This is often accompanied by anxiety and fear of pain and their illness itself. Others report feeling distressed because of their lack of knowledge about chemotherapy (4, 6); these feelings can impact negatively on the process (8). Attempts to improve the manner in which patients are cannulated and the treatments given are likely to enhance the process and outcome of treatment. Therapies that fall under the umbrella of complementary and alternative medicine (CAM) are increasingly being accessed by patients with cancer as a means to treat their symptoms and enhance feelings of well being (9, 10). CAM has been found to have a positive effect on nausea (11, 12) and pain perception (10, 12, 13), and significantly reduces anxiety (10-14). The Chemotherapy Day Unit, where the study was conducted, has been offering a complementary therapy service to outpatients since August 2001. Tailor-made treatments have been offered to patients. Patients have been having massage to the head, neck, shoulders, arms, legs and feet; these treatments have been administered to enhance wellbeing and alleviate psychological symptoms such as stress and anxiety. Chemotherapy patients have received gentle effleurage arm massage while waiting for treatment and it was suggested this might reduce anxiety and contribute to less traumatic cannulation. It was also speculated that this might result in fewer cannulation attempts. Exploration of the Efficacy of Arm massage 11

To investigate whether the massage was impacting on the experience of cannulation, a multi-method study was undertaken. 1.2 Aims The study aimed to determine: 1. The value of providing arm massage prior to intravenous cannulation 2. The potential impact of this therapy on the chemotherapy service In order to explore these aims fully the following research questions were developed: Does a 10-minute gentle effleurage arm massage with basic carrier oil prior to intravenous cannulation for administration of chemotherapy: 1. Reduce time taken for successful cannulation 2. Reduce number of cannulas used 3. Reduce pain associated with the procedure 4. Reduce feelings of stress and distress in patients and health professionals 5. Enhance patients wellbeing Further, the research was designed to address the following: 6. How does integration of a massage service impact on chemotherapy day care services? The report that follows provides an account of the study conducted to explore these research questions. Chapter 3 outlines the relevant literature and provides the background and context to the study. This is followed by a description of the methods used to execute the study. Chapter 5 provides an account of the results derived from both the quantitative and qualitative data analysis. Finally, in Chapter 6, a discussion of the main findings, limitations of the study and recommendations for future research are presented. Exploration of the Efficacy of Arm massage 12

2 Literature Review 2.1 Complementary therapies Complementary therapies and alternative medicine (CAM) are increasingly being accessed by cancer patients. Appraisals of CAM, such as those carried out by Rees et al (9) and Buckley (15), have documented its popularity (16). Typically its provision is enthusiastically received by patients; especially for emotional and psychological support. Most commonly they are used alongside orthodox medical treatment, rather than as a replacement. Moreover, there has been increased integration of aspects of CAM into NHS cancer services. Integration of complementary therapy approaches with orthodox cancer care has been influenced by patients accessing (or seeking to access) CAM surveyed to be between 9% and 30% of patients with cancer and by growing evidence of the value of CAM in achieving positive patient outcomes. The therapies shown by surveys to be the most widely used by cancer patients are the touch ones, such as massage and aromatherapy (17), along with mind-body therapies, such as relaxation (18). Although the evidence base for complementary therapies is still limited, it does not imply that they are ineffective. Rather, it is a reflection of the limited resources that have been devoted to research in the past, and that many of the trials have been of poor methodological quality (15), and yielded inconsistent findings (14). The therapy that appears to have the best scientific evidence as far as cancer care is concerned is acupuncture for chemotherapy and radiotherapy-induced nausea. Few formal trials have been conducted into touch therapies such as aromatherapy, massage and reflexology (18). This project evaluates massage as preparation for cannulation prior to patients receiving intravenous chemotherapy. In order to provide some context to the study a brief review of the application of massage within cancer care will follow. Subsequent to this, studies Exploration of the Efficacy of Arm massage 13

investigating patients experience of chemotherapy, and in particular aspects of the experience that provoke anxiety and discomfort, will be reviewed. Finally, the current provision of CAM within the context of the NHS will be outlined. 2.1.1 General massage As stated above, some of the most popular complementary therapies accessed by patients are the massage therapies; with aromatherapy massage being a popular choice. Massage is used mainly for the relief of musculo-skeletal pain, including that caused by tension. It has been suggested that a further benefit of massage is the relief of other kinds of pain such as cancer pain by inducing a state of relaxation (18). Unfortunately methods used to evaluate the benefits of massage for cancer patients vary greatly and have yielded inconclusive evidence of its effect (18). Massage has been examined in terms of its effect on a range of symptoms and specific populations. Massage ranging from full-body massage (19) to localised massage of the feet (20), has been administered to populations ranging from a sample of mixed cancer patients (20), to solely female (9, 21) or male patients (10), or those undergoing autologous bone marrow transplantation (ABMT) (11). Contexts have included the palliative (22, 23), hospice (19) and inpatient oncology setting (24, 25). Samples have ranged from 87 patients (20) to 8 single case studies (21). These studies have aimed to assess massages general effects (22, 23); its impact on symptom distress (10, 24, 26); and its effect on specific symptoms such as nausea (20). Qualitative (15, 21, 22) and quantitative (10, 20) evaluations have been carried out. Outcome measures used in quantitative evaluations have included a number of measures such as the State-Trait inventory to measure anxiety (11), Visual-Analogue Scales (VAS) to measure pain perception (25), and the Hospital Anxiety and Depression Scale (HADS) (14, 26). These studies and service evaluations have shown massage to have a range of effects from being generally beneficial (14, 21, 23), to having an ability to reduce specific symptoms such as nausea (11) and anxiety (10, 13). Studies prominent in the literature on cancer care are outlined below. Studies have found that general massage not only significantly reduces anxiety levels in cancer patients (14), it has also been described as being universally beneficial by Exploration of the Efficacy of Arm massage 14

patients, it assisted relaxation and reduced physical and emotional symptoms (p.67) (14). In addition, therapeutic massage - of the feet, back, neck & shoulders - has also been found to be a beneficial intervention for cancer patients, not only reducing anxiety levels, but also promoting relaxation and alleviating pain perceptions (10). Furthermore, therapeutic massage was found to reduce the perception of pain and reduce anxiety (13) in radiotherapy and chemotherapy patients. Smith et al (13) found that following a therapeutic massage nursing intervention patients symptom distress was reduced, and subjective quality of sleep improved slightly (whereas sleep deteriorated significantly in the control group). In a study by Ahles et al (11), specifically with patients undergoing (ABMT), general massage therapy was found to have immediate effects. Following receipt of their first session of Swedish/Esalen shoulder, neck, face and scalp massage, patients distress, fatigue, nausea, and anxiety were significantly reduced as compared to the control group. Mid-treatment - patients had up to 9 sessions - anxiety was significantly reduced in both the intervention and control groups (but this reduction did not differ significantly between the groups). And at the pre-discharge assessment stage of the study, fatigue was found to have significantly reduced in the massage group (it also significantly reduced in the control group; consequently the 2 groups did not differ significantly). Using a phenomenological qualitative approach Billhult & Dahlberg (21) evaluated the experience of 10 consecutive days of massage of the hand/forearm, or foot/lower part of the leg, in eight female patients on an oncology ward. Participants were interviewed and it was found that the essential meaning of receiving massage as part of daily care was described as getting a meaningful relief from suffering (p.180) (21). Furthermore, from the qualitative data gathered through interview, Billhult & Dahlberg (21) found that the massage provided relief from suffering because patients: Experienced being special Found it beneficial to have the opportunity to develop a positive relationship with the therapist Experienced a sense of feeling strong Experienced more of a balance between autonomy and dependence Found and reported that it just feels good Exploration of the Efficacy of Arm massage 15

Of significance is that such physical and emotional benefits were gained in a relatively short period of massage. Grealish et al (20) looked at the effect of foot massage on symptoms suffered by patients hospitalised with cancer. On the occasions where the patients had massage (on 2 out of 3 evenings), a significant immediate effect on patients perceptions of pain and nausea was found; massage additionally had a significant effect on the sensation of relaxation. These authors recommended the use of foot massage as a complementary means of helping patients to manage the symptoms of pain and nausea. A further study examining the effects of massage on patients with cancer was carried out by Wilkie et al (19). This study focused specifically on full-body massage (where this was possible) as a potential non-pharmacologic therapy to relieve cancer pain. When compared with a control group (routine hospice care), quantitative data analysis revealed that, immediately after the massage, pain intensity, pulse rate, and respiratory rate were significantly reduced. This led them to conclude that the massage intervention produced immediate relaxation and pain relief. 2.1.2 Aromatherapy massage Aromatherapy massage differs from other forms of massage in that essential oils are used with the aim of improving both the emotional and physical well being of an individual; the benefits of these oils is gained through touch and inhalation, whereas massage is solely a touch therapy. In relation to cancer patients, aromatherapy is thought to enhance symptom control and reduce psychological distress (27). Hadfield (26), in working with a group of patients with malignant brain tumours, found that aromatherapy massage (of the foot, hand or neck/shoulder) affected the autonomic nervous system, inducing relaxation. Hadfield (26) concluded that an aromatherapeutic massage intervention appeared to be a good way of offering support, and of improving the quality of life in this particular population, who are often faced with restricted treatment options and poor prognosis (26). Exploration of the Efficacy of Arm massage 16

Focusing on symptom control, Evans (22) carried out an audit into the physiological and psychological effects of aromatherapy massage (usually to the face and/or extremities) on cancer patients receiving palliative and terminal care. Both the qualitative and descriptive ststistical data indicated that most participants found it soothing and/or relaxing, and that they felt better afterwards. The massage was described as: beneficial, making patients feel much better, and an excellent supplement to the medical care provided and good for pain (p.240) (22). A recent Cochrane review (12) examined the evidence on the effectiveness of the use of aromatherapy and massage on symptom relief and physical and psychological wellbeing. It concluded that the impact of massage / aromatherapy in cancer patients was as follows: Its impact on depression was variable Three studies found a reduction in pain following the intervention Two studies found a reduction in nausea Individual trials measured reduction in other symptoms such as fatigue, anger, hostility, and digestive problems, and improved communication, but none of these findings were replicated Interventions were consistently found to have an effect on reducing anxiety Despite the variable findings highlighted by this review, it has been suggested that stress relieving techniques that have been found to enhance well being, such as massage, should be made available to patients to augment and ease the experience of cancer treatment and recovery (p.362) (28). 2.2 The experience of chemotherapy Chemotherapy is something that many patients with cancer dread. Apart from the prospect of the side effects of chemotherapy, there are number of psychological issues that arise as result of receiving treatment (6). For some patients the very thought of going in for their treatment is often a distressing component of the whole process; another major concern for patients stems from contemplating a needle being inserted (usually in their arm) for the administration of their chemotherapy treatments (4). In fact, it is non-physical symptoms such as these that account for 54% of the 15 most severe side effects experienced by patients receiving cancer chemotherapy, as rated in a survey by Coates et al (4). Exploration of the Efficacy of Arm massage 17

Studies such as those carried out by Rhodes et al (6), McDaniel & Rhodes (7), and Ream et al (8) have further confirmed the fact that patients often dread chemotherapy, with the experience often dominated by the sensory aspect of insertion of a needle for the Intravenous (IV) line. Furthermore, patients are known to be unhappy when difficulties arise with IV access and needles (5); these difficulties are a key source of stress and discomfort to patients (4). Concerns linked to the procedural element of receiving chemotherapy are often accompanied by psychological responses; some patients express uncertainty, fear, anxiety, and distress due to lack of knowledge of chemotherapy, and cancer in general (6). In reality, distress, anxiety and fear of pain are common reactions to a cancer diagnosis and even the prospect of chemotherapy (8). It is because of these reactions and their effects on the process of cannulation that it is viewed as important to attempt to not only improve ease of cannulation but also reduce patients anxiety during drug administration. 2.3 Cannulation for chemotherapy Chemotherapy is one of the most frequently administered treatments in patients with cancer. In many instances this treatment is administered via peripherally-sited IV cannulas. Insertion of these portals is usually technically easy - following training and with experience - but can be problematic and time consuming in patients requiring repeated cycles of chemotherapy (29), due to the toxic effects of the chemotherapy and the damage caused to the veins by repeated cannulation. Furthermore, patients often find cannulation painful (8). For some individuals the pain and associated stress and distress results in their increasing needle phobia with each cycle of treatment. Cannulation is often more difficult when individuals are afraid of needles or fearful because previous attempts have been painful or unsuccessful (29). With these facts in mind, Lenhardt et al (29) looked at the effect of local warming on the insertion of peripheral venous cannulas for the administration of chemotherapy. Neurosurgical patients hands and forearms were covered with a mitt for 15 minutes (passive warming), and leukaemia patients hands and forearms were covered for 10mins with a carbon fibre heating mitt (active warming). This was carried out to determine whether active local Exploration of the Efficacy of Arm massage 18

warming facilitated peripheral venous cannulation. It was found that it took significantly less time, with fewer failed attempts, to insert a cannula in the active warming group. These findings lead to the conclusion that active warming of the limb significantly facilitates insertion of peripheral venous cannulas; reducing time and number of attempts. Wendler (30) studied the effects of Tellington Touch (TT) a form of touch therapy entailing gentle physical touch (originally developed for the calming of horses) on patterns of mean blood pressure, heart rate, state anxiety, and procedural pain (anticipated versus perceived pain) in a sample of healthy individuals awaiting venipuncture. Participants were randomly assigned to the intervention (TT) or control group (who received a social visit). The 5-minute intervention was delivered by a nurse - trained in the TT procedure - to the upper back, upper arms and shoulders. Data collection determined that those in the intervention group experienced decreases in mean blood pressure and heart rate, which were both statistically and clinically significant (although this change was transient). Anxiety provoked by cannulation, and the anticipation of receiving chemotherapy, often results in vasoconstriction rendering the procedure more difficult (29). As a result, intravenous cannulation can have many associated costs. It can be costly in terms of the health professionals time and the cannulas wasted in the process. It can also increase treatment time and anxiety for patients. In some instances, poor venous access and needle phobia necessitate insertion of central venous catheters like Hickman catheters, or peripherally inserted central venous catheters (PICCs) for administration of chemotherapy (31). Although these provide long-term venous access in patients undergoing chemotherapy, there are greater associated costs; the cost of insertion, whether surgically or angiographically are greater. Also the risk of systemic sepsis is greater. For many patients it would appear advantageous if the cannulation process could be enhanced through complementary, inexpensive and noninvasive methods such as massage. Exploration of the Efficacy of Arm massage 19

2.4 CAM in the NHS Approximately half the hospices and oncology departments within the UK offer a form of complementary therapy to patients, and over 50% of those that offer CAM are reported to offer more than five different therapies (Kohn (In press) cited in NICE Guidance (32)). Wilkes (17) carried out a survey, which included gathering information on provision of complementary therapies in palliative care settings. He reported that of the 108 hospices surveyed 70% of them offered massage, 68% offered aromatherapy, and 66% offered the mind-body therapy of relaxation. Later, Rees et al (9) evaluated the use of complementary therapies in cancer patients. Based on data gathered from 714 women diagnosed with breast cancer in the South Thames region, it was found that massage/ aromatherapy was the most commonly received therapy (22% of the sample). Therapists were mostly visited to treat symptoms of cancer rather than to cure it or slow it down. It was recorded that 70% of NHS hospital oncology departments in England and Wales claimed to be using some form of CAM to benefit cancer patients. Massage was reported to be offered in just over a third of these NHS hospitals, and relaxation and aromatherapy were available in almost half the departments. This study was the first in the UK to provide precise estimates for the use of complementary medicine among this group of patients (9). A national survey was carried out by Kohn (18) examining cancer patients use of complementary therapies throughout the UK. As a result she has outlined five key discrete models for the provision of CAM in cancer care (See Table 3.1). Exploration of the Efficacy of Arm massage 20

Table 2.1. Models of CAM provision MODEL 1: Hospital based individuals 2: Provision within a multi-disciplinary setting 3: Patient groups within a healthcare setting 4: Independent approaches within the NHS 5: Independent organizations Source: Kohn (18) PROVISION Provided within a hospital setting by professionals who themselves practice complementary therapies; such as nurses, doctors, physiotherapists and radiographers Provided within a multi-disciplinary setting (such as hospice or information and support centre), and planned and managed as a discrete service e.g. Richard Dimbleby Cancer Information and Support Service at Guys and St Thomas' Hospital Whereby certain patients are offered access to therapeutic or supportive techniques, within a healthcare setting. These techniques or therapies are psychological treatments intended to alter negative perceptions of cancer, and promote positive attitudes, decreasing stress and potentially influencing survival e.g. Behavioural Oncology Unit, Aberdeen Royal Infirmary. Whereby they are 'external' (that is independently organized to cancer services), but still provided within context of NHS e.g. NHS homeopathic hospitals Whereby organisations offer services for patients with cancer independent of the NHS. Often aspects of the work carried out by these organizations has subsequently been adapted for use within the NHS e.g. Bristol Cancer Help Centre These models of delivery of CAM in cancer care have scope to overlap. For example, cancer care within a given service could be delivered by adopting aspects of Models 1 and 3. These models are key to planning integration of CAM with orthodox cancer care, whether they are provided within NHS facilities or commissioned by the NHS. Kohn (18) considered that provision of CAM, in line with one or more of these models, will most likely be determined by current patterns of prioritisation within services budgets; and will be guided by current standards outlined by organisations such as NICE. Exploration of the Efficacy of Arm massage 21

NICE recently published a guidance document (32) on improving supportive and palliative care for adults with cancer. The recommendations emphasise collaboration between stakeholders and service users in order to make decisions regarding: The range of complementary therapies to be provided within the context of the NHS The regulation of practice and training standards The nature of information to be provided on CAM to patients with cancer The NICE guidelines are complemented by the National Council for Hospice and Specialist Palliative Care Services (NCHSPC) guidelines (33) for the use of complementary therapies in supportive and palliative care. These provide broad advice in relation to CAM and on how to meet requirements of clinical governance. Together, these documents aim to inform those responsible for developing CAM in the statutory and voluntary sectors; and they emphasise the importance of integration of CAM within the NHS. A complementary therapy service has been established within the Chemotherapy Day Unit in the acute NHS Trust, in which the study was carried out, since August 2001. This has provided patients waiting for intravenous chemotherapy with gentle effleurage arm massage. Patients, nurses and therapists have reported that this has reduced patients anxiety, enabled less traumatic cannulation and can result in fewer cannulation attempts. This study aimed to determine, primarily through conduct of a randomised controlled trial (RCT) the benefits of providing arm massage prior to intravenous cannulation. However qualitative data were also collected to further inform understanding potential impact of this therapy on the chemotherapy service. This study will provide new evidence on the impact and potential of this relatively easy-touse and non-invasive intervention. It will help to determine which individuals, if any, benefit most from this approach and will reflect on barriers and facilitators to the process. It will provide understanding, hitherto lacking, of the outcomes of arm massage for cannulation in patients undergoing chemotherapy. Exploration of the Efficacy of Arm massage 22

3 Method 3.1 Introduction This chapter is organised to provide a description of the methods employed in the investigation. 3.2 Study aims The study aimed to investigate the impact of arm massage prior to chemotherapy. Principally through the conduct of a randomised controlled trial (RCT) it sought to determine: 1. The value of arm massage prior to intravenous chemotherapy 2. The potential impact of this therapy for the chemotherapy service Patients, nurses and therapists provided data through completion of questionnaires, or participation in interviews or a focus group. These three different elements, outlined in this chapter, provided complementary and detailed data on the efficacy, suitability and popularity of using gentle arm massage to assist cannulation for administration of chemotherapy. 3.3 Research questions This study addressed the following research questions: Does a 10 minute gentle effleurage arm massage with basic carrier oil prior to intravenous cannulation for administration of chemotherapy: 1. Reduce time taken for successful cannulation? 2. Reduce number of cannulas used? 3. Reduce pain associated with the procedure? 4. Reduce feelings of stress and distress in patients and health professionals? 5. Enhance patients wellbeing? Exploration of the Efficacy of Arm massage 23

3.4 Massage treatment The massage intervention was a standard procedure, guided by a detailed protocol (Appendix 1). Each therapist received additional training in the procedure to ensure the same treatment was administered to those in the experimental group. All therapists followed operational policy that had been agreed by the Trust. 3.5 Research design The research adopted a multi-method design. It entailed conduct of a randomised controlled trial (RCT) to determine the efficacy of the massage intervention, and collection of qualitative data through undertaking a range of interviews and a focus group. It was envisaged that the combination of these approaches would allow the impact of the service from different perspectives to be attained. Further, it would allow in-depth understanding of the conditions required for such a service to be introduced, and provide insight into which particular individuals derived more or less benefit from it (Figure 3.1). Figure 3.1 Research design RCT element Qualitative element Patient questionnaire Nurse questionnaire Patient interviews (massage group) Stakeholder interviews Therapist focus group Statistical analysis descriptive, inferential & modelling Qualitative analysis Framework Analysis Detailed understanding of the massage service & its impact The RCT element entailed collection of data through completion of paired questionnaires. Both patients who were cannulated and the nurses who cannulated them completed a questionnaire. Together, these paired questionnaires provided information on the same Exploration of the Efficacy of Arm massage 24

cannulation episode. They recorded time taken to cannulate, the ease with which the cannula was placed and the number of attempts this required. Levels of pain and anxiety experienced by the patient throughout were also recorded. Further details of the questionnaires are given in section 3.8. These questionnaire data were collected from individuals in both the intervention and control groups on their first ever cannulation for chemotherapy and on subsequent cannulations for treatment, up to a maximum of 6 occasions. On completion of this element of the study, a random sample of patients were invited to participate in a telephone interview to explore their experiences further. Patients, and the other samples, involvement in the study is presented diagrammatically below (Figure 3.2). The stakeholder interviews and therapist focus group were conducted at the end of the study. Figure 3.2 Sequence of data collection Control group Questionnaires completed when cannulated (2-6 times) Experimental group Questionnaires completed when cannulated (2-6 times) Interview when questionnaire element finished Nurses Stakeholder Questionnaires completed after cannulating Interviews at end of study Therapists Focus group at end of study 3.6 Sampling 3.6.1 Patients The study sought inclusion of 50 patients that had not previously received chemotherapy. A convenience sample was drawn, thus the first 52 individuals that met the inclusion criteria, and were willing to take part, were recruited to the study. Exploration of the Efficacy of Arm massage 25

To be eligible patients were: 18 years of age, or older due to commence first course of intravenous chemotherapy for treatment of breast, lung, colorectal or haematological cancer able physically and emotionally to cope with the research protocol able to speak and write in English Patients were excluded if they: had previously had intravenous chemotherapy were having chemotherapy via a peripherally inserted central catheter (PICC) or Hickman line had signs of bilateral lymphoedema The size of the study was not determined through conduct of power calculations as there were limited data from previous studies on which to base this. Instead, the research hers opted for a sample size that would allow data to be collected on 100 cannulation episodes over the planned period when data would be collected. Retrospective review of chemotherapy administered at the study site where data were collected had determined that it was feasible to collect data on 100 cannulation episodes - 50 in the experimental group and 50 in the control- over a 6 month period. It was also anticipated that this number of cannulation episodes would be sufficient to determine between-group differences, and allow statistical modelling of the factors impacting on cannulation to be undertaken. 3.6.1.1 Randomisation of patients Patients were randomised at the outset to either the experimental or control groups. Once randomised to a study arm, they remained within that arm for the duration of the study. Thus, those randomised to the massage arm had massage each time they attended for chemotherapy, prior to placement of the cannula, and vice versa. Patients were randomised through selection of a card detailing the group they were to be allocated to. One hundred identical envelopes were filled detailing the group patient participants were to be allocated to. These envelopes were sealed and placed in a secure box. There were equal numbers (n=50) of envelopes with Experimental group cards as there were Control group cards. On consenting to take part in the study an envelope was Exploration of the Efficacy of Arm massage 26

selected from the shuffled envelopes in the box by the recruiting nurse. Thus, each patient had an equal chance of being allocated to either of the two groups. 3.6.2 Nurses All nurses that cannulated the sample of patients participating in the study were invited to take part in the study. This included permanent members of nursing staff and those on 6- month secondment as part of an educational Rotation Programme for inexperienced cancer and palliative care nurses. 3.6.3 Stakeholders A purposive sample of three stakeholders was invited to take part in an interview in which to explore the running, impact and potential of the massage service. To gain a wide perspective it was decided to involve the Lead Nurse for Cancer Services, the Manager of the Volunteer Therapists and the Nurse managing the Chemotherapy Day Unit. 3.6.4 Massage therapists In addition to attaining the patients, nurses and stakeholders views, it was decided to provide opportunity for the therapists to share their experiences of providing massage to patients prior to chemotherapy and to understand the challenges and benefits of providing such a service from their perspective. Literature on the conduct of focus groups suggests that groups of between 4 to 12 members are recommended. The basis for this recommendation is that groups larger than this can become unwieldy and inhibit all members sharing their insights. Conversely, small groups can provide an insufficient range of perceptions. It was decided for this study to conduct only one group and to invite all those providing massage on completion of the study to attend. If all had attended this would have resulted in a group of nine therapists; in the event a convenience sample of seven people could be present at the time the group was scheduled, and all took part. Exploration of the Efficacy of Arm massage 27

3.7 Access arrangements 3.7.1 Patient sample As per usual care, patients met with their doctor in the outpatient clinic to discuss and determine their treatment plan. When a decision was made for chemotherapy, the doctor and clinical nurse specialist assessed whether the individual met the eligibility criteria for this study. If they did, the clinical staff issued them with the Patient Information Sheet concerning the study (Appendix 2). A verbal explanation of the study was given at this time by the clinical staff, and patients were encouraged to read the sheet prior to their next planned meeting with the oncology team prior to their treatment. They next met with the chemotherapy team when they attended the treatment suite in the Day Unit for their Work- Up (usually a minimum of 24 hours later). This meeting provided patients with the opportunity to discuss their treatment with a chemotherapy nurse. At this meeting individuals were given further verbal explanation of the aims of the study, and their potential role in it, by the chemotherapy nurse. Individuals willing to take part then signed the consent form (Appendix 3). In addition to providing written consent to take part, participants checked a box to indicate whether or not they were happy to be interviewed over the telephone on completion of the study. A sample of 15 was randomly selected from those that checked the box, and were in receipt of massage. These patients were contacted by the nurses on the Day Unit to check that they remained happy to be interviewed and for their names and contact details to be forwarded to the research team. One of the researchers then telephoned them at home and arranged a time when they could call back to interview them over the telephone. 3.7.2 Nurse sample The nurses cannulating patients on the Day Unit were provided details of the study by members of the research team who provided oral and written information regarding it. The data collection process was discussed and considered in detail prior to the study commencing. All nurses that agreed to take part (in the event all that worked on the unit) provided written consent before the study commenced. Exploration of the Efficacy of Arm massage 28

3.7.3 Therapist sample The therapists met regularly with their manager, and at one such meeting the latter provided them with details of the study and gave out information sheets (Appendix 4) explaining plans for the conduct of the therapist focus group. The manager provided them with the scheduled meeting date and time and gathered names of those willing and able to attend. Willing participants signed their consent form prior to attending the focus group, and returned them to the research team at the focus group. 3.8 Instruments 3.8.1 Questionnaires Two brief self-report questionnaires were designed by the research team, one for completion by patients on the occasions they were cannulated, and the other by the nurses that performed the procedure. This pair of questionnaires was designed with the study aims in mind; the study aimed to determine whether gentle effleurage arm massage reduced pain associated with cannulation, reduced feelings of anxiety before and during the procedure, and enhanced feelings of wellbeing. They were informed by work conducted by Lenhardt (29) and Wilkinson et al. (23). 3.8.1.1 Patient Questionnaire The questionnaire filled in by patients (Appendix 5) was made up of 3 sections and completed by them in 2 stages. Stage 1 - Prior to the cannula being placed: All the patients completed Section 1 detailing their feelings of anxiety, and their perceptions of how uncomfortable they anticipated the placement of the cannula would be. Patients did this by means of two separate 11-point numeric rating scales ranging from 0 to 10 (i.e. one for pre-anxiety and one for pre-pain). Stage 2 - After the patients had had their intravenous treatment: All the patients completed Section 2 by recording how anxious they were following cannulation and the pain they actually experienced during the procedure. Once again, patients did this by means of two Exploration of the Efficacy of Arm massage 29