Informed Consent Form for Patients Taking Chemotherapy

Transcription

1 Patient s Name-Surname: Gender: F... M... Patient ID No: Date of Birth: Father s Name: ID No: Dear Patient/Relative of Patient, It is your incontestable right to obtain information regarding your medical condition and illness, and all sorts of medical treatments, operations, and diagnosis procedures recommended to you. Also, after receiving thorough information about the procedures, benefits and possible side effects of medical treatments and operations, it is at your own consent to allow or not to allow medical practices to be carried out. The fundamental aim of this statement is assisting and illuminating you in taking accurate decisions regarding your health. If you wish so, all sorts of documents regarding your health and treatment can be delivered to you or any relative of yours. This form is prepared as a supportive document for informing you of the risks and alternative treatment methods related to the treatment/medical application being planned to be practiced by the doctor who has been consulting to you. Please read this document carefully and sign this informed consent form after all your doubts and queries, regarding the application, have been cleared by the doctor. 1. PRE-DIAGNOSIS/DIAGNOSIS:... GENERAL INFORMATION ABOUT YOUR ILNESS: What is Chemotherapy? Chemotherapy refers to medical treatment by using drugs to kill the tumorous cells. It can be used both for destroying cancerous cells that are diagnosed through medical consultation or various diagnosis methods, and for destroying the microscopic remains of tumours that were already removed by an operation. In this way, it is aimed to entirely cure the disease if possible, if this is not possible, to extend the living period and ensure quality of life and reduce the level of symptoms as much as possible. The superiority of chemotherapy when it is compared to radiotherapy and operational treatments is that when it is applied it affects all the tumorous cells all around the body at the same time. In this regard, chemotherapy is a systemic treatment. Tumorous cells differ from healthy cells by multiplying themselves much faster than others, following different metabolic ways for growing up and proliferating, needing certain chemicals called growing up factors, having different molecules on their surfaces, becoming dependant to development of new veins, self-protecting themselves from aging and dying from natural courses of aging, and repairing some constituents that are essential for maintaining their living conditions. Chemotherapy drugs are used targeting to destroy all or some aspects of these features of tumorous cells, on the other hand, attempting to protect the healthy cells as much as possible. However, it should be borne in mind that cancerous cells are originated from normal cells, and therefore there are many similarities between the healthy cells and cancerous cells. This means that chemotherapy drugs can harm the healthy cells as well, and therefore cause some side effects, and these side effects may be very serious. Nevertheless, when the severity of the illness is taken into consideration, such side effects are to be considered acceptable and reasonable. Employing specialist doctors and staff in this kind of treatment makes it possible to keep the side effects of chemotherapy treatment at minimum levels. KTR_BF01_RV00 1/

2 2. RECOMMENDED CHEMOTHREAPY:... The document of chemotherapy treatment to be carried out must be attached to this informed consent form. 3. TREATMENT AREA: Right Left Both sides Level:. 4. COURSE OF ANAESTHESIA: Yes No Information was provided about the course of anaesthesia by the anaesthetist, and information was given that an approval will be obtained after the information was provided by the anaesthetist. 5. USE OF BLOOD AND BLOOD PRODUCTS: Yes No Information was given on if blood products are to be used and an approval of the patient is necessary for this course. 6. RISKS OF RECOMMENDED MEDICAL TREATMENT/APPLICATION Are there any side effects of chemotherapy? Decrease in number of blood cells: Keeping the cells existing in blood at a certain level is possible by fast and continuous segmentation of certain cells. Three types of blood cells are important in regards to chemotherapy course; white cells are important especially in increasing the immune system of the body against the infections. Thrombocytes (blood platelets) take responsibility to stop bleeding when the veins are harmed and bleeding starts. Red cells transfer oxygen to tissues. Decrease in the number of first two groups of cells cause bleeding risks, and decrease in the number of red cells is called anaemia. These problems usually are encountered at a non-significant level, however, if severe conditions are to be encountered then they taken under control by giving antibiotics, thrombocytes and red cell transplantation. However, although they happen rarely, fatal bleedings and infections may occur and unless they are cured appropriately they lead to mortalities. Thus, before and after chemotherapy courses blood cell counts must be done within certain periods and results must be given to doctors and/or nurses. Nausea and Vomiting: Unless they are given without taking any precautions, the chemotherapy drugs cause nausea and vomiting up to some extend. However, today drugs preventing nausea and vomiting are available and such drugs corresponding to the level of nausea and vomiting caused by the dosage of chemotherapy are used certainly before the chemotherapy course is given to you. This side effect of chemotherapy can start right from the very beginning of chemotherapy course and may last for a couple of days, in such cases you will be recommended to take some drugs to prevent nausea and vomiting after the chemotherapy course. Today even the most severe vomiting and nausea incidents may be taken under control 70-80% due to the medical treatments with developed drugs. Hair Loss: Cells of hair roots are fast growing cells, thus they are directly affected from most of the chemotherapy drugs and, as a result of this, patient s hair get thinner or patient may suffer from total hair loss. This sort of side effects is generally impermanent and as soon as the chemotherapy sessions are over the hair starts to grow up. So, what is important during treatment is undergoing the chemotherapy sessions without encountering serious health problems. To overcome such a cosmetic problem, the patient may wear a wig or change the hair style. KTR_BF01_RV00 2/

3 Other Skin and Nail Problems: Some chemotherapy drugs cause loss of hair at the other parts of body, skin drying, and changes of colour of pigments. White lines may appear on nails during the repeating courses of chemotherapy, however such physical changes are entirely harmless. Some drugs such as Taksoter (Dosetaksel) may make nails fragile and fractures may appear on nails, and nails may be dislocated from their places. Such drugs such as Kapesitabin may cause rash, cracks, and swelling in palms and soles which may be painful skin problems. Should you feel that such health problems started during your treatment, you must immediately inform your doctor. Side Effects on Oral (mouth) Cavity, Stomach and Intestinal System: Our digestive system, being comprised of mouth, stomach and intestines is formed by cells that are constantly segmenting and thus constantly regenerating. Chemotherapy can destroy the nature of these cells and this may cause to health problems such as aphtha, aphthaous ulcers, diarrhoea, difficulty in swallowing food and drinks, and stomach ache. Such health problems are usually temporary and can be recovered through supportive care. However, you must contact to your doctor as soon as you are aware of such problems. Side Effects on Genital System and Health: Some drugs may cause menstrual irregularity or menopause, and such effects may be permanent. However, in the cases of some tumours, menopause may be preferred due to some medical reasons. When they are used in certain doses, some drugs may cause temporary or permanent infertility in men and women. Thus, if you wish to have children after the treatment period, you must discuss this issue with your doctor before your treatment starts. Using chemotherapy drugs on pregnant or nursing mothers can cause very serious health problems on their children. If you are in such a medical condition you must immediately inform your doctor, and if you have even the slightest suspicion about pregnancy, you must immediately carry out pregnancy tests and ensure that you are not pregnant. Women must not be pregnant during chemotherapy courses. If necessary, along with the measures of contraception, further precautions such as using condoms must be taken in order to prevent the transfer of remains of chemotherapy drugs. Side Effects on Kidneys and Urinary Tract: As a general rule, sufficient amount of liquid must be taken during chemotherapy. Taking sufficient liquid helps to remove the remains of dead cells and excess chemotherapy drugs. In addition, side effects of drugs, such as cisplatine and metotreksat- which can directly harm the kidneys, can also be prevented by sufficient liquid intake. Furthermore, some drugs, such as ifosfamid and siclophosphamid can cause bleeding in the urinary tract. To prevent this, again, sufficient amount of liquid is taken and some preventive medicine is used. If your intake of liquid is insufficient because of nausea-vomiting or because of the narrowness caused in the gastrointestinal tact due to a tumour, or in fact, you notice a decrease in the amount of your urination, you should contact your doctor promptly; otherwise, if this situation is not treated, it could lead to permanent damage in the kidneys and in some rare case, it can be fatal. Allergic Reactions: Theoretically all drugs, and so forth chemotherapy drugs can lead to allergic reactions. These generally appear in the form of contractions or rush, and these reactions, which appear in sensitive individuals, may sometimes be life threatening. In treatments requiring use of paclitaxel, rituximab, bleomycin, L-asparaginase, which are known to cause a higher risk of allergic reactions, protective treatment before the major treatment are applied KTR_BF01_RV00 3/

4 and patients are kept under observation. If you are aware of having any allergic reactions to any type of drugs, be sure to inform your doctor about it. Side Effects on the Heart: Some drugs such as; Adriamycin, epirubicin, idarubicin, novantrone, a high dose of cylophosphamide, fluorouracil could have serious side effects on the heart. Preceding treatment with the above mentioned drugs, a detailed evaluation of the heart health must be made and periodical controls of the heart must be carried out throughout the treatment process. In addition, the dose of the drugs being used should be kept below a certain level. Furthermore, radiotherapy and certain drugs should be avoided, as they have a tendency to increase the side effects of the chemotherapy. Through these precautions, the damage of the heart is kept at minimum and in fact they lead to complete avoidance of any side effects on the heart. If you are aware of any kind of health problems with your heart or suffer from any kind of heart problem during the chemotherapy treatment, be sure to inform your doctor about it. This could mean a change in the drugs being used, as a part of the treatment. Side Effects on the Nerve System: The use of drugs during the chemotherapy, a feeling of restlessness, nerviness, sleeplessness or sleepiness could be seen as side effects. However, these symptoms are usually not dependent on only the drugs being used. Certain drugs, such as ifosfamid, in very rare occasions lead to the loss of consciousness or epilepsy attacks. Drugs such as; onkovin, oxaliplatin cisplatin, begin showing symptoms by the numbness in fingertips, and if precautions are not taken, could lead to a stronger symptom of loss of strength, which also leads to damage on the neural transmissions. Specially, the use of the cisplatin drug could lead to permanent damage on the sense of hearing. Your doctor has noted the side effects of drugs, which are suggested to you, in the space provided below. (These side effects are not mentioned above.) Make sure you have read them thoroughly. The summary provided above is related to the most important side effects which may be encountered during the chemotherapy process. However, bare in mind that there are many drugs used in chemotherapy and each drug shows individual differences. In this respect, do not expect the side effects to be unavoidable. Generally, patients suffer from a couple of light-medium strength side effects, majority of which are able to be overcome with the help of supportive treatments. The reason why the side effects are being explained in detail is to make sure you receive your treatment with a higher understanding and so that you can contact your doctor as soon as you feel any disnormality. Please make sure you read the explanations provided thoroughly and be sure to be clear about them. Do not hesitate to inquire your doctor and/or nurse of any questions that may come into mind. After signing the first page of this form as a decision of accepting the treatment proposed to you, details of your treatment will be provided to you (i.e. which drugs will be used by which application methods and by which intervals, and so on), side effects and how they will be observed will be explained and a description will be provided regarding which examinations will be required. We would like to thank you for your attention and we wish you a successful treatment process. KTR_BF01_RV00 4/

5 7. The Probability of Success of the Suggested Medical Application The success of the medical application depends on the degree of the illness, the reason behind it and the response one s body gives to the treatment. 8. Possible Alternative Medical Applications As far as radiotherapy is concerned, there are no other alternatives for this treatment, as a treatment for your illness at this stage. 9. Potential Benefits from the Suggested Medical Application It is to get the illness under-control/ treated. 10. Issues about which the Patient Needs to be Cautious About During Remission and Prior to Medical Application Preparation Prior to Chemotherapy: If the patient s consciousness and age is appropriate, your doctor will consult you on details of the process prior to the application. Please make sure to provide information of the following to your doctor: medical problems, medication(s) being used, if present; bleeding problems, and/or allergic reactions to certain things (such asdrugs, latex gloves, plasters) or any other illnesses. What will happen after the Treatment has been completed? Certain effects of the chemotherapy might continue for a couple of weeks after completing the treatment. Remission and proper nutrition at this stage holds great importance. Your doctor will continue to observe your condition through regular appointments. You have the opportunity to move your appointments forward, if you have any worries or in need of inquiry about your condition. You will be informed, through the epicrisis report, on the type of application used by the radiotherapy doctor. Please bear in mind that this report may not be an answer to all possible questions and do not hesitate to consult your doctor on issues which you need to be enlightened on. Your doctor will no be able to enlighten you on these issues unless you consult them. 11. Possible Results of Refusing the Suggested Medical Applications Your child s/patient s has been pathologically diagnosed and staging of the illness have been completed. Not applying radiotherapy, which has no other alternative treatment(s) in our day, and/or not applying chemotherapy to your patient may mean; not taking the illness under control. It is necessary to follow the suggested medical treatment. Scope of the Suggested Treatment and Consent I have been verbally informed about the suggested treatment in detail and have read information regarding the process. All my relevant questions have been answered to. I allow blood and blood product procedures in unexpected and emergency situations. The doctor has informed me of additional medical applications which may be come across as predicted from before and/or beyond prediction during the medical application process. I accept further medical attempts, which my doctor may need to follow, so as to prevent serious health problems and as a necessity to save my life. As for the medical attempts mentioned above, I am aware that the following may be used for my treatment: x-ray, endoscopy, ultrasonography, scintigraphy, computerized tomography, magnetic resonance, and alike. I am also aware that the use of some of these devices may lead to negative effects on my health and I accept them to be used if found necessary during my treatment process. KTR_BF01_RV00 5/

6 I am informed an average cost of the additional medical attempts which may be necessary. As a part of health application procedures, I authorize and consent tissue(s)/organ(s) which may be removed and images of these or tissue/cell culture to be used in scientific research and to be stored or disposed of as appropriate. I.., have read and understand the contents of this form and I agree to the necessary applications to be made by Near East University Hospital doctors under the authorization, observation and direction of Dr.throughout the treatment process. With an open consciousness, I accept and allow all of the mentioned above and also care of other working staff of health. I consent all types of drugs, examinations and medical attempts which are necessary as part of my treatment process. Signature: Date: Time: If the consent has been provided by the legal representative of the patient; Degree of Legal Representative: The Patient is unconscious The Patient is below the age of 18 The Patient has not got legal right to provide approval Emergency Witness (if applicable, someone other than the staff of the hospital); Name-Surname: Signature: Date: Time: Statement of Health Professional; Name-Surname: Signature: Date: Time: Statement of the Interpreter (if needed); Name-Surname: Signature: Date: Time: This part is to be signed by: Patients himself/herself if over the age of 18. Patients who are between the ages of are to sign this alongside his/her legal representative. Patients with closed consciousness, below the age of 15, in emergency condition and those who have not the ability to decide will be represented by their legal representative and thus, he/she will sign this form on their behalf. KTR_BF01_RV00 6/