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Taking part in cancer prevention clinical trials – what participants need to know Deciding whether to take part in a prevention trial People decide to be part of a cancer prevention clinical trial for many reasons. Some people who have a higher cancer risk participate in a prevention trial because they want to take a more active role in their health care. Some people feel good about contributing to medical knowledge. If the treatments in the study turn out to be effective against cancer, it may help others. For example, prevention trials showed that aspirin helps prevent heart attacks and now many people take aspirin daily on their doctor's advice. It’s important that you weigh the possible benefits and risks for you when deciding to participate in a prevention trial. You also may find it useful to talk with family members or friends, your health care providers and anyone you know who has been in a clinical trial. Prevention clinical trials: weighing the benefits and drawbacks Possible benefits: If the approach being studied is found to be helpful, you may be among the first to benefit. In a cancer prevention clinical trial, your health is carefully monitored. A cancer prevention clinical trial gives you a chance to help scientists learn more about cancer prevention and help others. Possible drawbacks: New approaches may have side effects or risks unknown to the doctors. The side effects, and results, of a new approach may be worse than what's currently recommended. Even if a new approach has benefits, it may not work for you. What happens in a cancer prevention clinical trial? If you decide to join a Phase III cancer prevention trial, you'll work with an experienced research team that includes doctors, nurses and other health care providers. They will give you clear instructions. You may be asked to take a medication. You also may be asked to keep a diary or answer questions about how you're feeling. During the study, your research team will review your health carefully. This means that you may have more tests and doctor visits than you would if you weren't in the study. Team members also may check on you for a while after the trial ends (follow-up). To make the trial results as reliable as possible, it is important for you to follow the research team's instructions. That means having all doctor visits and tests, taking medicines on time and filling out logs or answering questions. Careful review and follow-up help you and scientists find out quickly what treatment is best for reducing cancer risk. Who can participate? Clinical trials try to enroll people who are alike in certain ways, depending on the study's purpose. Every protocol tells who can join that study and spells out the characteristics that people should have. These are called eligibility criteria. They may include age, gender, general health and cancer risk factors. Eligibility criteria are a key part of medical research. They help produce results we can trust. After those results are known, the information can help doctors find out who will be helped by the approach being studied if it's shown to work. For example, a new drug may work for people with one type of risk factor but not for another, or it may work better for men than for women. Eligibility criteria also help protect you. They help make sure that if you are likely to be harmed by something in the study design, you are not exposed to that risk. Most phase III cancer prevention studies use a double-blind research design. This means that neither you nor the doctors know which people are taking the study agent or the control agent. Only the researchers at a central office know. Sometimes a doctor needs to find out if a participant has taken the study agent. A doctor can quickly find this out, if needed, by talking with the central office staff. No one knows whether it is better to be in the intervention or control group until the study is over and the results are ready. If that were known, there would be no need for the study. Either group may have good results or problems. The results help doctors decide whether to advise people to take the study agent for cancer prevention. What is informed consent? Informed consent is a process during which you learn key facts about a clinical study before you decide whether or not to join. These facts include details about the study approach and tests you may have and the benefits and risks that could result. The doctor or nurse will give you a form that goes over key facts. It's called a consent form. If you decide to take part in the study, you'll be asked to sign this form. You can take the form home and discuss it with your family, friends, or others before you make your decision. If you do decide to join the study, be sure to ask for a copy of the consent form so you can look it over at any time. Don't be afraid to ask questions until you get all the facts you need to decide. This is an important decision and you should feel at ease with the choice you make. In fact, you should feel free to ask your research team questions at any time. Informed consent is more than a piece of paper; it's a process that lasts throughout a study. For example, you may be told about new risks or other findings from the study, and asked to sign a new consent form. As always, the choice to join or to continue is yours.
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