What to Know
Medical Factors
First, understand what specific treatment is being offered in the trial and how it is different from the standard treatment for your cancer. You will also want to know the eligibility criteria for the trial, so that you understand fully why you might either be selected or excluded from the trial. Keep in mind that being accepted or turned down for a trial has nothing to do with whether your health will get better or not. It simply means the characteristics of your cancer or your general health match or do not match what researchers need for this particular study.
If there are potential side effects of the new treatment, you should be told about these ahead of time, as well as any steps that will be taken for pain relief. You will want to know how the treatment might limit you physically or affect your day-to-day life. Although these details will be outlined in the "informed consent" statement of the clinical trial (required by law), it's still a good idea to discuss these things face-to-face with someone involved in the clinical trial.
Practical concerns
A number of practical issues can come up when you participate in a clinical trial, so it's best to know beforehand what is required of you. This way, you'll have time to prepare yourself for what's ahead, and you'll have fewer uncertainties. You will want to know:
- How long the treatment will take?
- What time commitment you will be required to make?
- Where the trial will take place? If travel to another facility, city, or state is required, it's good to know this and weigh the benefits of the trial against the potential drawbacks of increased travel.
Cost is often an important factor for many patients. Since most health plans do not cover experimental treatments, you may have to spend time and energy trying to get reimbursed for your care. (You should find out whether your insurance covers the doctor and hospital fees associated with the clinical trial before you join it.)
On the plus side of the cost issue, the project's sponsor usually covers the cost of the new drugs used in the trial. You should also include in your calculations the costs associated with additional travel, hotels, meals, and parking you may have to pay for when you take part in a clinical trial.
Lastly, you will want to know whether you can have family members with you when you get treatment. By carefully reading written materials on the clinical trial or asking questions of the people in charge, find out how much of a role family members can have in decision-making and in assisting you during treatment.
Emotional considerations
Patients in clinical trials are often asked to make adjustments that affect their feelings and attitude. For example, being part of a clinical trial may mean you will have to change doctors. Often, too, you will have to deal with more health care professionals in a trial, such as researchers and other support personnel. So it is important to consider whether these changes might make you uncomfortable, or whether you welcome the increased attention.
Taking part in a clinical trial often sounds to people like they will be a "guinea pig." For reassurance that the project is safe, and to make sure that your well-being is protected, carefully read the informed consent document, and then talk to someone on the clinical trial staff. And remember: you have the right to end your participation in a trial at any time, for any reason.
Often, people who are considering joining a clinical trial will have concerns about the use of placebos, or inactive pills. They may be afraid that they will receive no treatment at all if they are assigned to a placebo group. It's important to remember patients who join clinical trials are given at least the best treatment currently available and sometimes, the chance to receive the new treatment being tested. Placebos are rarely used in cancer clinical trials and are never used in place of treatment. Placebos may be used in cancer prevention clinical trials, where treatment is not the issue of investigation.
Finally, it is important to be as clear as possible with yourself about what you expect from the clinical trial. It is impossible to say in advance how effectively a given treatment will work -- experimental or otherwise -- so there will always be uncertainty. On top of that, patients often choose to participate in a trial only after the current standard of treatment has not worked, so there is a temptation to think of the trial as a "last chance." You must try to resist these negative thoughts if you decide to go ahead with a clinical trial. A positive attitude will help you to get through the discomfort you will feel during treatment. It is worth keeping in mind that, in many cases, clinical trials have been extremely helpful to patients for whom the current standard of treatment was ineffective.
