Page 1 of 6 FORM FERRERI / IELSG PROTOCOL 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 (or other identifier) South London Healthcare NHS Trust: Princess Royal University Hospital Queen Elizabeth Hospital Queen Mary s Hospital Male Female Special requirements (e.g. other language/other communication method) Chemotherapy for Lymphoma FERRERI / IELSG PROTOCOL Intravenous High Dose Methotrexate & High Dose Cytarabine Responsible health professional Job title Name of proposed procedure or course of treatment (include brief explanation if medical term not clear) High dose methotrexate and high dose cytarabine chemotherapy: Intravenous Methotrexate day 1 Intravenous Cytarabine twice a day on days 2 and 3 Every 21 days for 4 cycles
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 procedure to the patient. In particular, I have explained: The intended benefits Improved survival Control of symptoms Induction therapy given in the acute state of the disease, aiming to shrink the tumour Curative to give you the best possible chance of being cured Maintenance therapy given on continuing basis, aiming to prevent disease flaring up and to control the symptoms Disease control / Palliative the aim is not to cure but to control the disease and reduce the symptoms. The aim is to improve both quality and quantity of life General risks with this treatment: Significant, unavoidable or frequently occurring: Common side-effects include bruising or bleeding, anaemia (low number of red blood cells), feeling sick (nausea) and being sick (vomiting). This treatment can also cause tiredness, hair loss, loss of appetite, sore mouth and mouth ulcers. The treatment can cause either diarrhoea or constipation. There may be increased risk of tumour-lysis syndrome in the presence of high tumour burden (high number of cancer cells present in the body). Precautions will be taken to minimise the risk of complications with preventative supplementary medicines. Less common, but 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. Potential side-effects with the anti-sickness medication may include: constipation, headaches, indigestion, difficulty sleeping and agitation.
Page 3 of 6 Some chemotherapy drugs can damage women s ovaries and men s sperm, with risk of infertility and early menopause in women. I have warned the patient about the likelihood of: early menopause in women infertility (in men and in women) Some chemotherapy drugs may damage the development of a baby in the womb (foetus), leading to the many risks associated with an abnormal pregnancy. Therefore, I have discussed the issues of protected sex. This is an issue for both men and women. The patient has been advised not to become pregnant / not to get a partner pregnant during the period of treatment. Specific risks and side effects of the drugs used in this treatment: Methotrexate can cause damage to the kidneys. To prevent this from happening you will receive intravenous hydration with this treatment and an antidote, folinic acid, usually starting 24 hours after the methotrexate dose. You will also have regular blood tests after the methotrexate treatment so that we can monitor how effectively your kidneys are working and ensure that the methotrexate is being removed from your body by your kidneys. Methotrexate can temporarily change the way your liver works, although it will return to normal when the treatment finishes. This will be monitored during your treatment by blood tests. Methotrexate can cause a rash or dry skin, which might be itchy. Methotrexate can cause changes to your lungs. Tell your doctor if you become breathless or develop a cough. Cytarabine can cause gritty and sore eyes (conjunctivitis) and you will be given eye drops to prevent this and to reduce the severity. Cytarabine can also cause a skin rash. Rarely, cytarabine can affect your nervous system and you must tell your doctor if you feel dizzy or suffer with confusion whilst receiving this treatment.
Page 4 of 6 What the treatment is likely to involve (including inpatient / outpatient treatment, timing of the treatment, follow-up appointments etc) and location. Any other risks:... I have also discussed what the procedure is likely to involve, the benefits and risks of any available alternative treatments (including no treatment) and any particular concerns of this patient. The following leaflet/tape has been provided: Macmillan/Cancerbackup leaflets for Methotrexate and Cytarabine chemotherapy 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)
Page 5 of 6 Statement of patient Please read this form carefully. If your treatment has been planned in advance, you should already have your own copy of page 2 which describes the benefits and risks of the proposed treatment. If not, you will be offered a copy now. 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 procedure and course of treatment described on this form. I understand that you cannot give me a guarantee that a particular person will perform the procedure. The person will, however, have appropriate training and experience. I understand that any procedure 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 procedure, 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 procedure 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)....
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 www.doh.gov.uk/consent). 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 http://www.selcn.nhs.uk/portal/index.asp 2- Macmillan Cancer Support, Cancer Information http://www.macmillan.org.uk/cancerinformation/cancertreatment/treatmenttypes/chemotherapy/chemotherapy.aspx 3- Royal Marsden NHS Foundation Trust, Consent Forms Risk Table Verbal description a Risk Risk description b Very common 1/1 to 1/10 A person in family Common 1/10 to 1/100 A person in street Uncommon 1/100 to 1/1000 A person in village Rare 1/1000 to 1/10 000 A person in small town Very rare 1/10 000 to 1/100 000 A person in large town a EU-assigned frequency b Unit in which one adverse event would be expected