Making The Decision
Your medical oncologist and the rest of your healthcare team are your partners in deciding if cancer research is right for you. Make sure to discuss all options with them. If you find a study that seems like a good fit, call the study coordinator, most often an oncology nurse, and ask for more detailed information. You may also ask your doctor or nurse to request a certain protocol, or trial plan, and help you understand it. Make sure you feel comfortable with the information you
are given. The protocol outlines important things you must consider when making a decision, including:
- The reason for doing the study
- How many people will be in the study
- Who is eligible to participate
- What drugs you will take
- What medical tests you will have and how often
- What information will be collected
- How often you will be expected to visit the doctor/study team
It is important that you know specific information about your case so you and your medical team can assess whether you are eligible for the trial. Most trials are designed for a very specific type of patient, so the more you know about your particular case, the more time-efficient you will be. Your medical oncologist or oncology nurse can provide you with your history. The information you should know includes:
- The stage of your cancer and your prognosis
- The size of the tumor
- The type of cell
- The location of your tumor
- The standard treatment for your diagnosis
If you have a recurrent cancer (a cancer that has returned), make sure you know:
- The previous treatments you have received
- The names of drugs, dates and number of treatments you have received
From a personal perspective, there are some considerations to be made and many issues you should discuss with your treatment team. For example, is the study being conducted close to your home? If not, will you be able to travel on a regular basis to receive treatment? Are you willing to keep records of how you feel? Does your insurance cover your medical expenses? Are you willing to make a commitment to the program and stick with it?
Also, keep in mind that as a clinical trial participant, you may be asked to:
- Visit a healthcare provider regularly
- Take medication
- Have laboratory and diagnostic tests
- Change your diet and exercise habits
For more information that can help you decide if clinical trials are right for you, or to find a clinical trial, visit CancerCare’s web site.
Understanding Your Rights
While there is much to be gained by participating in a study, there are some potential risks as well. Side effects from the medication may occur and there are no guarantees that treatment will work or be as effective as the standard treatment. To read more about the pros and cons of clinical trials, visit CancerCare’s web site.
There are safeguards in place to protect your rights and ensure your safety. Your treatments will be carefully monitored by healthcare professionals who specialize in cancer care. Clinical trials are also monitored by a healthcare team, as well as by government health authorities and a medical ethics group. All trials are evaluated by review boards, which includes medical professionals, ethicists, members of the community, and patient advocates. Review boards protect the
rights of clinical trial participants. An Institutional Review Board (IRB) or Institutional Ethics Committee (IEC) approves all clinical trials, makes sure they are scientifically sound and that each participant has an understanding of what to expect.
There are a few key points to keep in mind throughout the trial. First and foremost, your participation is voluntary. You do not have to participate and you may withdraw from the study at any time.
Second, if you have a bad reaction to a treatment that threatens your safety or health, you will be removed from the trial. Your well-being is the most important consideration. The medical team will closely monitor your response to treatment from start to finish.
Finally, you have the right to an informed consent. By law, you must be given all of the facts about a study, including details about the treatments and tests you may receive, along with their risks and benefits. You will be asked to sign a consent form at the beginning of your participation and, if new findings develop during the trial, you will be asked to sign a new or revised consent form. Informed
consent is an ongoing process throughout the study. The consent form may be intimidating because it tends to list the risks more than the proposed benefits. Take the form home and discuss it with your family members. This is an important decision and you want to make sure you understand what is happening from beginning to end. Do not hesitate to ask your treatment team questions about the trial. Remember that signing a consent form does not bind you to the study. Even after signing
the form, you may change your mind and withdraw at any time.
Informed consent is the process of learning key facts about a clinical trial and the purpose of it before you decide to participate. These facts include:
- Why the research is being done
- What the researchers want to accomplish
- Who sponsors the trial
- What will be done during the trial and for how long
- What risks are involved in the trial
- What benefits can be expected from the trial
- What other treatments are available
For more information about your rights and how you are protected, visit the National Cancer Institute’s web site, (Protecting Participants in Clinical Trials), which features a guide to understanding informed consent and the ways participants are protected before and during a study.
How It Happens
The path a patient follows to enter a clinical trial varies, depending on the type and stage of the disease. The chart below represents the experience a typical patient may have.
Questions About Clinical Trials to Ask Your Treatment Team
Being on the receiving end of a cancer diagnosis is a life-altering experience and one that takes some time to understand. Once you are ready to consider your treatment options, ask your medical oncologist about clinical trial opportunities for your type and stage of cancer. Keep in mind that participating in a clinical
trial is not right for everyone, and not everyone is eligible for a clinical trial. However, considering the possible benefits, clinical trials are worth exploring.
To get the most information possible from your doctor and oncology nurse, bring this list of questions and a pen to write down the answers. Also, it helps to bring along a family member or friend who can help you understand and absorb the information provided by the doctor, nurse, and others involved in your health care.
Here are some questions to ask your medical oncologist, oncology nurse, and the researchers running the clinical trial. The answers to these questions may help you decide if joining a trial is right for you:
- What is the purpose of the study?
- What are the potential benefits, and are there any foreseeable risks or discomforts?
- How long will I be in the study?
- How often will I need to visit the clinic/hospital?
- What tests will I need?
- Is there a chance I will receive a placebo in the study?
Have other people been treated with this drug before in clinical studies? What were the results?
- What medications, treatments and procedures should I avoid while in the study?
- Will I continue to see my own personal doctor?
- What are my treatment options if I don’t participate in the study?
- Will there be any costs to me?
- Will I learn of the study results? If so, when?
- How many volunteers will participate in the study?
- Will my medical records remain confidential?
- Who is sponsoring the trial?
- If I decide not to participate in the trial will my doctor still treat me?
- When the trial ends, can I continue to receive follow-up care and who will provide it?
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