Protocol/Study #: Version Date:
USE THE APPROVED LETTERHEAD FOR YOUR INSTITUTION
OFFICIAL TITLE OF PROJECT
(Lay title in non-technical Language such as A study to see whether treatment A or treatment B is better for patients with cancer XXXX.)
CONSENT FORM
This form is part of the process of informed consent. It is designed to explain this research study and what will happen to you if you choose to be in this study.
If you would like to know more about something mentioned in this consent form, or have any questions at anytime regarding this research study, please be sure to ask your doctor or nurse. Read this consent form carefully to make sure you understand all the information it provides. You will get a copy of this consent form to keep. You do not have to take part in this study and your care does not depend on whether or not you take part.
(IF the sponsor is a drug company)
This study is sponsored by (Pharmaceutical Company), the company that manufactures the drug (drug name) to be used in this study. This study will take place at various centres throughout Canada and the United Statesand the Cross Cancer Institute/Tom Baker Cancer Centre is one of the centres. (The Sponsor) will reimburse Alberta Health Services for costs related to conducting this study.
(OR IF the sponsor is a cooperative group) This study is being conducted by the Radiation Therapy Oncology Group (RTOG) a cooperative oncology research group of which the Cross Cancer Institute/Tom Baker Cancer Centre is a member. This study will take place at various centres throughout Canada and the United States, and the Cross Cancer Institute/Tom Baker Cancer Centreis one of the centres. (Pharmaceutical Company) which manufactures the drug (drug name) will supply the drug for the study. Alberta Health Services will be reimbursed for research related costs.
(IF the patient's physician is part of the study team:) Your doctor, who is one of the researchers, will discuss the study with you. (OR IF the patient's physician is not part of the study team:) Your doctor has given us permission to ask you to be in this study.
Your participation in this study is entirely voluntary. Please take your time to make your decision. It is recommended that you discuss with your friends and/or family about whether to participate in this study.
“WHY IS THIS STUDY BEING DONE?”
You are being asked to take part in this study because you have (type of) cancer.
(All studies -- give specifics of what the standard treatment is, what its response rate is, and/or effects and/or outcome, and why this study is worth doing and, if a drug is involved, what is different about this drug compared to standard therapy? State what the experimental aspects of the study are.)
This study is being done because______.
(Explain in one or two sentences. Examples are: “Currently, there is no effective treatment for this type of cancer,” or “We do not know which of these two commonly-used treatments is better.”)
“WHAT DO WE HOPE TO LEARN?”
We hope to learn (purpose).
The purpose of this study is to (see below)______. (Ensure that you include the primary and secondary objectives of the study.)
Describe what the phase of this study means.
(If Applicable)
(Phase I study): Test the safety of(Drug/Intervention)and see what effects (good and bad) it has on you and your cancer.
OR
Find the highest dose of a (Drug/Intervention) that can safely be given without causing severe side effects. In order to determine this dose, some patients on this study may experience severe side effects.
(Phase II study): To find out what effects (good and bad)(Drug/Intervention)has on you and your (type of)cancer.
(Phase III studies): To compare the effects (good and bad) of the(New Drug/Intervention)with (commonly used Drug/Intervention) on you and your (type of) cancer to see which is better.
“WHAT IS INVOLVED IN THIS STUDY?”
In this study, you may receive one of ____ treatments. You will be “randomized” to receive one of the treatments described below. Randomization means the treatment that you are assigned will be determined by chance. It is like flipping a coin. Randomization is done by a computer. Neither you nor the researcher will choose which treatment you will be assigned.
You will have an (Equal/One in Three/Etc.) chance of being assigned to treatment A - Z. You and your doctor will not be told which treatment you are receiving. (Only applies to double-
blind randomized studies) You will be followed to see what effect the treatment(s)has/have on your health.
(It is easier for the patient to understand the treatment schema in either a table or flow chart.)
For Example
Treatment A / 5-FU / X / X / X
CPT-11 / X / X / X
Leucovorin / X / X / X
Treatment B / 5-FU / X / X / X
CPT-11 / X / X
Radiation Therapy / X / X
OR
Treatment A – (Describe)
Example:
If you get treatment A, you will have to come to the outpatient department at the Cross Cancer Institute/Tom Baker Cancer Centre twice a week for a total of 8 weeks. During these visits, you will be given treatment A.
Treatment B – (Describe)
Example:
If you get treatment B, you will have to be admitted to the University of Alberta/Calgary Hospital for three days at the beginning of the study. During your hospital stay, you will be given treatment B.
(If the elements of the treatment are common for all treatments do one paragraph for all the treatments and wherever possible use table formats.)
“HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?”
About ( ) people will take part in this study (at the CCI, TBCC or worldwide?)
“WHAT WILL MY PARTICIPATION INVOLVE?”
If you take part in this study, you will have the following tests and procedures:
(List procedures and their frequency under the categories below in a table format. For randomized studies, list the study groups and under each describe categories of procedures. Include whether a patient will be at home, in the hospital, or in an outpatient setting. If objectives include a comparison of interventions, list all procedures even those that are considered standard)
(Wherever possible use a table format for each of the following):
- Procedures that are part of regular cancer care and may be done even if you do notjoin the study.
- Standard procedures being done because you are in this study.
- Procedures that are being tested in this study.
An example of a table
Initial / Day 14 / Day 28Blood Test / X / X / X
Lung Function Test / X / X
X-Rays & Scans / X / X / X
Quality of Life Questionnaire (time to complete) / X / X
Physical Exam – blood pressure, etc / X / X / X
(Use and modify the table which exists in the protocol to a lay version).
(If Applicable) Pathology Review (Do not use if Pathology Review is NOT part of the study)
All or some of your tumour was removed by biopsy or surgery. Some of this tumour tissue was examined by a pathologist to help make your diagnosis. The remaining tumour tissue is stored in the pathology department. If you participate in this study, this tissue will be sent to (a central office) for review and research investigation associated with this protocol (list tests that will be performed). You will not have to provide any other tissue. After the study testing is finished, any tissue left will be destroyed.
(If Applicable) Sample Banking for Future Research
You may also be asked whether your (tissue/blood) can be stored for future research. If so, you will be given another consent form asking for your permission.
(If this condition applies to your application, then ensure to include the tissue/blood banking consent form.)
“HOW LONG WILL I BE INVOLVED IN THE STUDY?”
You may be in this study for as long as (Months/Weeks, until a certain event).
(Where appropriate, state that the study will involve long-term follow-up.)
“WHAT ARE THE SIDE EFFECTS?”
Every medical treatment including the standard treatment has side effects, which your doctor will explain to you. It is important that you know and understand the possible side effects of the treatments given in this study.
(If Applicable)
(IF the study involves radiation treatment) You will receive a separate sheet and/or booklet that will give you more information about treatment involving radiation.
(OR IF the study involves chemotherapy) You will receive a separate sheet and/or booklet that will give you more information about treatment involving chemotherapy. (Combine the two sentences if both radiation and chemotherapy are given in this study.)
The following are the side effects of each drug used in this study. These side effects may or may not be more severe when the drugs are taken together. These are the side effects we know about at present. However, since this is a study of new treatments there may be other side effects that we do not know about yet.
Drug / Route / Common / Less Common / RareZoledronic
Acid / IV /
- Fever
- Fatigue (tiredness)
- Anorexia or loss of appetite
- Headaches
- Low levels of calcium in the blood, which may cause muscle cramps
- Insomnia
- Anxiety
- Kidney failure
- Severe allergic reactions
- Permanent damage to the jawbone and might require surgery to remove the damaged area. This might be more likely to happen in patients who have certain dental procedures. If you see a dentist, you should inform them that you may be receiving zoledronic acid.
(Use the following sample table and if possible keep the table on one page)
IV = Intravenous (into a vein)
SC = Subcutaneous (under the skin)
IM = Intramuscular (in a muscle)
PO= Oral (by mouth)
(If there are additional side effects that you feel should be mentioned in the context of this study, please list)
You may feel some discomfort from the needle when study treatments are given or blood drawn. There is also a small risk of fainting, swelling, bruising, bleeding or (rarely) local infections at the site of the needle punctures which will be used for giving your study medications, as well as for taking blood samples.
(Applicable for studies with CT component) As part of this study, you will have CT scans and/or x-rays. There is a potential risk of radiation exposure from these CT scans and x-rays, however, this risk is considered small. The amount of radiation exposure from one CT scan is
about the same as the amount of radiation a person would get from natural surroundings in three years. Sometimes an intravenous (into a vein) contrast dye is given with a CT scan. Although the dye is relatively safe, occasionally side effects or reactions occur. These may be mild (such as skin rash or hives) to severe (such as breathing difficulties or shock). The doctors and staff of the Radiology Department are trained to treat these reactions if they occur.Even if you do not participate in a study, you may need CT scans as part of standard care. If you participate in this study, you might receive more scans than your doctor would normally do.
These side effects maybe temporary, long term and/or permanent. However, most of the side effects listed above are reversible. That means they will stop once the drug is discontinued or its dose lowered. (State long-term side effects if any, e.g. second malignancies, infertility, etc. in the table)
If you have any side effects, either those on the list or others, or if you want more information on how the drug(s) could affect you, you should call the doctor or nurse in charge of the study. Their telephone numbers are on page (insert page #) of this form.
If we get any new information about the drugs/treatments/side effects in this study, you will be told about them so that you can continue to get the best care possible.
Unique Side Effects/Special Precaution
List side effects that are unique or precautions that need to be taken that may prevent and/or intensify side effects.
"WHAT ARE THE REPRODUCTIVE RISKS?"
The effects of (drug) on the human reproductive system are unknown. There may be unforeseeable risks to a pregnant woman and/or fetus. Therefore, it is very important that if you are sexually active (male/female), you use an effective method of birth control during participation in the study and for three months following treatment. This may include, but is not limited to, abstinence, birth control pills, an IUD, condoms, implants or being surgically sterilized.
While you agree to take the necessary precautions for birth control, it is very important that your partner uses an effective method of birth control as well.
If you or your partner becomes pregnant during the course of the treatment, you must inform your doctor immediately. Your doctor will ensure that you receive information about the options available in relation to the pregnancy and that you and your partner are fully supported in whichever option is chosen.
The effect of (drug) in breast milk is also unknown. If you are breast-feeding, you cannot participate in the study.
“WHAT ARE MY RESPONSIBILITIES?”
You must be willing to attend all scheduled study visits and undergo all of the procedures described above. It is very important that you inform the study doctor or study nurse of any side effects or health problems that you may be experiencing as well as any medications (prescribed or holistic) that you are taking while on this study.
(If applicable, include statement about Quality of Life questionnaires, medication diaries etc.)
“WHAT ARE MY ALTERNATIVES?”
You may choose not to participate in this study. Other treatments that could be considered for your cancer may include the following:
(1)radiation therapy;
(2)chemotherapy;
(3)surgery; or
(4)no treatment except medications to relieve symptoms.
These treatments could be given either alone or in combination with each other. Please talk to your doctor about the known benefits and risks of these other treatment options. Your doctor can also discuss with you what will happen if you decide not to undertake any treatment at this time. With the last choice (4), your cancer is expected to grow and your disease could spread.
“ARE THERE ANY BENEFITS TO PARTICIPATING IN THIS STUDY?”
Participation in this study may or may not be of personal benefit to you. However, based on the results of this study, it is hoped that, in the long-term, patient care can be improved.
"WHAT HAPPENS IF I BECOME SEVERELY ILL?” (For double-blinded studies only:)
You and your doctor will not be told which study treatment you are receiving except in the case of an emergency. If you have an emergency, your doctor will be told which study treatment you are receiving so that you can get proper care.
“CAN I WITHDRAW FROM THIS STUDY?”
In discussion with you, your doctor at the Cross Cancer Institute/Tom Baker Cancer Centre, either at his/her own initiative or at the request of the sponsor of this study, may withdraw you from the study at any time if it is in your best interests. Taking part in this study is voluntary;
you may withdraw from the study at any time if you wish to do so. If you decide to stop participating in the study, we encourage you to talk to your doctor first.
Your doctor can take you off the study treatment early for reasons such as:
- The treatment does not work for you and your cancer gets worse.
- You are unable to tolerate the study treatment.
- New information becomes available that indicates the study treatment is no longer in your best interest.
- Your doctor no longer feels this is the best treatment for you.
If you stop treatment early, we would like to keep track of your medical condition indefinitely to look at the long-term effects of the study treatments. (If required)
Should you decide to withdraw from the study at any time, information collected on you up until that point would still be provided to (the Sponsor).
“ARE THERE COSTS TO ME FOR TAKING PART IN THIS STUDY?”
(IFall elements of the treatment are free:) You will not have to pay for the treatment you receive in this study.
(IFsome payment is required:) You will not have to pay for drug A/Treatment B used in this study. However, you will need to pay for drug C [note especially: G-CSF]. You will have to pay for the drugs you need for side effects. If you are covered by a private insurance company, you may get some or all of your money back, but if you do not have private insurance, you will not get any money back.
(OR All studies where at least some of the treatment cost is covered by the sponsoring agency:) It is also possible that the Sponsor (Sponsor's name) that is providing the drug(s) (name the drug(s))may decide to put the drug (name the drug(s)) on the market. After the study is over, you may have to pay for the drug if you continue on it. (If there are expected to be extra costs, please estimate how much.)