Patient identifier/label: Page 1 of 6 PATIENT AGREEMENT TO SYSTEMIC THERAPY: CONSENT FORM ORAL
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1 Patient identifier/label: Page 1 of 6 THERAPY: CONSENT FORM FOR ORAL Patient s surname/family name Patient s first names Date of birth Hospital Name: NHS number (or other identifier) Male Female Special requirements (e.g. other language/other communication method) Chemotherapy for Myeloma Oral Pomalidomide and Dexamethasone Responsible health professional Job title Name of proposed procedure or course of treatment (include brief explanation if medical term not clear) Pomalidomide oral therapy daily on days 1 to 21 of the cycle Dexamethasone oral therapy once daily on days 1, 8, 15 and 22 of the cycle (i.e. 4 weekly doses) Cycle duration is 28 days. Treatment continued until progression of disease Location of administration: outpatient day unit inpatient other:..
2 Patient identifier/label: Page 2 of 6 Statement of health professional (to be filled in by health professional with appropriate knowledge of proposed procedure, as specified in consent policy) I have explained the treatment to the patient. In particular, I have explained: The intended benefits Non-curative / Disease control the treatment is unlikely to cure the disease, the aim is to control or shrink the disease and to improve both quality and quantity of life Improved survival Control of symptoms Therapy is given in acute state of the disease, aiming to reach response and to introduce a control of the disease Maintenance therapy given on continuing basis, aiming to prevent disease flaring up and to control the symptoms General risks with this treatment: Significant, unavoidable or frequently occurring: A potentially life threatening side-effect is reduced resistance to infection. It is vital that you contact your doctor or the hospital or if outside of normal working hours the on-call hospital doctor straight away if: your temperature goes above 38ºC (100.4ºF) you suddenly feel unwell (even with a normal temperature). Your doctor or nurse will give you the phone numbers to call should these symptoms occur. These symptoms indicate that you have an infection. It is an emergency and it is very important that you contact the hospital / your doctor. Reduced immune function can activate new or underlying infections. Some patients may be given the following preventative antimicrobial medication: (...) Specific risks and side effects of the drugs used in this treatment: Reduction in the number of white cells (neutrophils) and platelets which may increase the risk of infection and bleeding. If this occurs, it may be required to reduce the dose of Pomalidomide. Common side effects of Pomalidomide include constipation or diarrhoea, loss of appetite, tiredness and sleepiness.
3 Patient identifier/label: Page 3 of 6 Other less common side-effects include numbness or tingling in hands or feet (tell your doctor), skin rash, bone pain. Cancer can increase your risk of developing a blood clot (thrombosis), and having chemotherapy (such as Pomalidomide) may increase this risk further. A blood clot may cause pain, redness and swelling in a leg, or breathlessness and chest pain - you must tell your doctor straight away if you have any of these symptoms. Usually you will be prescribed additional medication reducing the risk of blood clots forming during your Pomalidomide treatment. Some chemotherapy drugs (such as Pomalidomide) may damage the development of a baby in the womb (foetus) causing severe birth defects and leading to the many risks associated with an abnormal pregnancy. Therefore, I have discussed the issues of protected sex and the importance of using a condom as a method of contraception. This is an issue for both men and women. Men will be advised not to get a partner pregnant 4 weeks before, during the period of treatment and for 4 weeks after the completion of treatment. Before starting Pomalidomide treatment a negative pregnancy test will be confirmed for women. There is Pomalidomide treatment-specific pregnancy risk-management programme, requiring monthly follow up and repeated pregnancy tests. Inform the doctor immediately if you think you may have become pregnant during your treatment. Late effects include very rare chance of a second cancer. Dexamethasone can cause irritation of the stomach lining, increase your appetite and cause changes in the blood sugar levels. Other less common side-effects include fluid retention and changes in behaviour (mood swings, difficulty sleeping, anxiety or irritability). Occasionally the following side effects may occur: eye changes, Cushing s syndrome (acne, puffiness of the face, dark marks on the skin), muscle wasting and bone thinning (osteoporosis). Any other risks: I have discussed what the treatment is likely to involve (including inpatient / outpatient treatment, timing of the treatment, follow-up appointments etc) and location. I have also discussed the benefits and risks of any available alternative treatments (including no treatment), and any particular concerns of this patient.
4 Patient identifier/label: Page 4 of 6 The following information has been provided: 24 hour chemotherapy service contact details Signed:. Name (PRINT). Date.... Job title... Contact details (if patient wishes to discuss options later)... Statement of interpreter (where appropriate) Language Line ref: I have interpreted the information above to the patient to the best of my ability and in a way in which I believe s/he can understand. Signed.. Date... Name (PRINT).. Copy accepted by patient: yes/no (please ring)
5 Patient identifier/label: Page 5 of 6 Statement of patient Please read this form carefully. The benefits and risks of the proposed treatment should have been discussed with you. You will be offered a copy of this completed consent form. If you have any further questions, do ask we are here to help you. You have the right to change your mind at any time, including after you have signed this form. I agree to the course of treatment described on this form. I understand that you cannot give me a guarantee that a particular person will administer the treatment. The person will, however, have appropriate training and experience. I understand that any treatment in addition to those described on this form will only be carried out if it is necessary to save my life or to prevent serious harm to my health. I have been told about additional procedures which may become necessary during my treatment. I have listed below any procedures which I do not wish to be carried out without further discussion. Patient s signature.. Date.. Name (PRINT) A witness should sign below if the patient is unable to sign but has indicated his or her consent. Young people/children may also like a parent to sign here (see notes). Signature Date... Name (PRINT). Confirmation of consent (to be completed by a health professional when the patient is admitted for the treatment, if the patient has signed the form in advance) On behalf of the team treating the patient, I have confirmed with the patient that s/he has no further questions and wishes the treatment to go ahead. Signed:. Name (PRINT). Date.... Job title... Important notes: (tick if applicable) See also advance decision (eg Jehovah s Witness form) Patient has withdrawn consent (ask patient to sign /date here)....
6 Patient identifier/label: Page 6 of 6 Guidance to health professionals (to be read in conjunction with consent policy) What a consent form is for This form documents the patient s agreement to go ahead with the investigation or treatment you have proposed. It is not a legal waiver if patients, for example, do not receive enough information on which to base their decision, then the consent may not be valid, even though the form has been signed. Patients are also entitled to change their mind after signing the form, if they retain capacity to do so. The form should act as an aide-memoire to health professionals and patients, by providing a check-list of the kind of information patients should be offered, and by enabling the patient to have a written record of the main points discussed. In no way, however, should the written information provided for the patient be regarded as a substitute for face-to-face discussions with the patient. The law on consent See the Department of Health s Reference guide to consent for examination or treatment for a comprehensive summary of the law on consent (also available at Who can give consent Everyone aged 16 or more is presumed to have the capacity to give consent for themselves, unless the opposite is demonstrated. If a child under the age of 16 has sufficient understanding and intelligence to enable him or her to understand fully what is proposed, then he or she will have the capacity to give consent for himself or herself. Young people aged 16 and 17, and legally competent younger children, may therefore sign this form for themselves, but may like a parent to countersign as well. If the child is not able to give consent for himself or herself, some-one with parental responsibility may do so on their behalf and a separate form is available for this purpose. Even where a child is able to give consent for himself or herself, you should always involve those with parental responsibility in the child s care, unless the child specifically asks you not to do so. If a patient has the mental capacity to give consent but is physically unable to sign a form, you should complete this form as usual, and ask an independent witness to confirm that the patient has given consent orally or non-verbally. When NOT to use this form If the patient is 18 or over and lacks the capacity to give consent, you should use form 4 (form for adults who lack the capacity to consent to investigation or treatment) instead of this form. A patient lacks capacity if they have an impairment of the mind or brain or disturbance affecting the way their mind or brain works and they cannot: understand information about the decision to be made retain that information in their mind use or weigh that information as part of the decision-making process, or communicate their decision (by talking, using sign language or any other means). You should always take all reasonable steps (for example involving more specialist colleagues) to support a patient in making their own decision, before concluding that they are unable to do so. Relatives cannot be asked to sign a form on behalf of an adult who lacks capacity to consent for themselves, unless they have been given the authority to so under a Lasting Power of Attorney or as a court appointed deputy. Information Information about what the treatment will involve, its benefits and risks (including side-effects and complications) and the alternatives to the particular procedure proposed, is crucial for patients when making up their minds. The courts have stated that patients should be told about significant risks which would affect the judgement of a reasonable patient. Significant has not been legally defined, but the GMC requires doctors to tell patients about serious or frequently occurring risks. In addition if patients make clear they have particular concerns about certain kinds of risk, you should make sure they are informed about these risks, even if they are very small or rare. You should always answer questions honestly. Sometimes, patients may make it clear that they do not want to have any information about the options, but want you to decide on their behalf. In such circumstances, you should do your best to ensure that the patient receives at least very basic information about what is proposed. Where information is refused, you should document this on page 2 of the form or in the patient s notes. References: 1- South East London Cancer Network, Agreed lists of Chemotherapy Regimens 2- Macmillan Cancer Support, Cancer Information 3- Royal Marsden NHS Foundation Trust, Consent Forms
Patient identifier/label: Page 1 of 6 PATIENT AGREEMENT TO SYSTEMIC THERAPY: CONSENT FORM DOCETAXEL + PREDNISOLONE. Patient s first names
Patient identifier/label: Page 1 of 6 PATIENT AGREEMENT TO SYSTEMIC THERAPY: CONSENT FORM DOCETAXEL + PREDNISOLONE Patient s surname/family name Patient s first names Date of birth Hospital Name: Guy s
Patient identifier/label: Page 1 of 6 PATIENT AGREEMENT TO SYSTEMIC THERAPY: CONSENT FORM CYTARABINE CONTINUOUS INFUSION
Patient identifier/label: Page 1 of 6 CYTARABINE Patient s surname/family name Patient s first names Date of birth Hospital Name: Guy s Hospital St. Thomas Hospital King s College Hospital Lewisham Hospital
Patient identifier/label: Page 1 of 5 PATIENT AGREEMENT TO SYSTEMIC THERAPY: CONSENT FORM IMATINIB. Patient s first names.
Patient identifier/label: Page 1 of 5 Patient s surname/family name Patient s first names Date of birth Hospital Name: Guy s Hospital St. Thomas Hospital King s College Hospital Lewisham Hospital NHS number
Patient identifier/label: Page 1 of 6 PATIENT AGREEMENT TO SYSTEMIC THERAPY: CONSENT FORM FMD. Patient s first names.
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PATIENT AGREEMENT TO SYSTEMIC THERAPY: CONSENT FORM WEEKLY RITUXIMAB. Patient s first names. Date of birth
Page 1 of 5 FORM WEEKLY RITUXIMAB Patient s surname/family name Patient s first names Date of birth Hospital Name: Guy s Hospital St. Thomas Hospital King s College Hospital Lewisham Hospital NHS number
Patient identifier/label: Page 1 of 6 PATIENT AGREEMENT TO SYSTEMIC THERAPY: CONSENT FORM TRASTUZUMAB (HERCEPTIN) Patient s first names.
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Patient identifier/label: Page 1 of 6. Patient s first names. Date of birth
Patient identifier/label: Page 1 of 6 PATIENT AGREEMENT TO SYSTEMIC THERAPY: CONSENT FORM ENZALUTAMIDE Patient s surname/family name Patient s first names Date of birth Hospital Name: Guy s Hospital St.
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Patient identifier/label: Page 1 of 5 GENERIC CONSENT FORM Patient s surname/family name Patient s first names Date of birth Hospital Name: NHS number (or other identifier) Male Female Special requirements
Patient identifier/label: Page 1 of 6 PATIENT AGREEMENT TO SYSTEMIC THERAPY: CONSENT FORM VISMODEGIB. Patient s first names.
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Patient identifier/label: Page 1 of 6 PATIENT AGREEMENT TO SYSTEMIC THERAPY: CONSENT FORM CHOP 21 + RITUXIMAB
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Patient identifier/label: Page 1 of 6 PATIENT AGREEMENT TO SYSTEMIC THERAPY: CONSENT FORM PAZOPANIB. Patient s first names.
Patient identifier/label: Page 1 of 6 PATIENT AGREEMENT TO SYSTEMIC THERAPY: CONSENT FORM PAZOPANIB Patient s surname/family name Patient s first names Date of birth Hospital Name: Guy s Hospital St. Thomas
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