What Should Oncology Professionals Teach Their Patients about Clinical Trials?

December 29, 2008
Roxanne Williams-Truax, RN, BSN, OCN

ONCNG Oncology, December 2008, Volume 9, Issue 12

Research has shown that individuals are more inclined to participate in additional clinical trials if they have a positive experience and are treated with respect by the researchers.

Research has shown that individuals are more inclined to participate in additional clinical trials if they have a positive experience and are treated with respect by the researchers. Another reason patients might participate in clinical trials is to help test treatments that can help other patients in the future. A group study of 1,700 patients conducted by the Coalition of Cancer Cooperative Groups found that 96% of surveyed participants said they were treated with the utmost respect and dignity, 92% described their experience as positive, and 91% said they would recommend a friend or family member to participate in a clinical trial.

The oncology nurse’s role

In the US, recruiting patients to participate in cancer clinical trials has been difficult; only 3—5% of adult patients are enrolled in clinical trials. Oncologists and their staff can play an important role in educating patients about the benefits of clinical trials and explaining why participating in them is a viable, even preferable, option. Education and information delivered by a trusted member of the care team could help increase trial enrollment and provide patients with access to new treatments. Oncology nurses can help patients learn about currently available clinical trials, explain why they should participate, help allay patients’ fears and clear up misconceptions, and review what the treatment plan will involve. Properly educated patients will see their concerns about participating diminish and understand that clinical trials are an attractive option.

An important nursing role is patient preparation and monitoring. Patients will have many questions that need to be answered before they agree to participate in clinical trials. This is where the nurse can make a dramatic impact in helping patients make a decision. Each patient must sign an informed consent form that covers safety, risks, benefits, and adverse events associated with the drug being tested. The form also covers alternate treatments and addresses confidentiality issues, in addition to the costs that are covered before participating. The oncology nurse should review the consent in its entirety and be prepared to answer any and all questions.

Nurses can explain that the trial drugs are tested in pre-clinical studies in the laboratory before they are tested on humans. Although this form of testing can provide a lot of useful information, it doesn’t always give answers about side effects and effective dosages. Testing is often done on mice and may not translate entirely to humans. The oncologist should make sure the patient is aware of this and the nurse should review this information with the patient and make sure they understand that there is no guarantee that the drugs will work, and they could have unexpected side effects. It should also be made clear to patients that an advantage of participating in a clinical trial is that they are closely monitored. Safeguards are put in place, and each study is specifically designed to ensure that the rights of the participants are protected.

Patients must understand the specific eligibility criteria that must be met before they can enter a clinical trial. Nurses should also explain the risks and benefits that are always associated when entering a trial, but take great care to present this information in a non-biased way so the patient can make an informed decision. It is important that patients understand that the treatment may not be effective; that the study might require more time and testing than the standard treatment; and that new, unapproved drugs may produce unexpected or unknown side effects.

Keeping patients aware of the risks and benefits enables them to make an informed decision, and oncologists and their nursing staff will know that they played a crucial role in the process. It is also important that patients play an active role in their treatment as their progress will be closely monitored during the trial. Often, clinical trials are offered at state-of-the-art medical facilities and led by medical experts. At Duke University Medical Center, the nurse is assigned to a specific protocol and follows the patient or group of patients throughout the study, allowing for continuity of care.

How are trials monitored?

Committees are set up to review clinical trials to make sure they are safe and protect patients from harm. Most institutions that host studies use an institutional review board (IRB) that is made up of physicians and nurses, research scientists, and members of the community. The IRB ensures the protection and welfare of patients involved in clinical trials. It also makes sure federal laws are followed. The FDA also plays a key role in approval of clinical trials and the regulations that must be followed. During a trial, the FDA places rules on what testing needs to be done to follow patients closely, such as lab work and diagnostic tests. Representatives might check in periodically to review data collected, which will help determine if the tested drug is effective or is producing unacceptable adverse effects. Informing patients about these committees can help them feel that their safety is a priority.

Insurance coverage

Patients frequently ask about the cost of participating in clinical trials and want to know whether insurance will pay for them to enroll in a trial (conversely, many patients may choose not to participate because they are afraid of being denied coverage). Oncology nurses should inform their patients that although insurance coverage varies from state to state, in general, when a patient enrolls in a clinical trial, the cost of the tests and oncology visits are billed to insurance, because this would happen even if the patient was receiving standard treatment. There are funding sources that might pay for special tests or additional testing required to monitor the patient and also for the study drug. Sometimes trials provide food and lodging, particularly if participating in the trial requires extra travel or time in the clinic setting. Patients should understand that insurance providers may limit which types of trials they will cover. It is important to know that insurance companies are not all the same and patients should be encouraged to check their policy to clarify coverage. Medicare will cover participation in clinical trials for treatment, specifically those conducted by the National Cancer Institute, Cooperative Groups, or other federally funded studies. To learn more, oncology nurses should direct patients to the American Cancer Society’s website.

Confidentiality

Confidentiality is a prominent concern. Patients should understand that they are protected by HIPAA and other federal privacy rules that provide safeguards for privacy, security, and authorized access to their medical information. The consent forms the patient signs should identify who can view their records. Another way oncology nurses can ease a patient’s concerns about confidentiality is by letting them know that they are identified only by a unique code number and initials.

Education

Educating patients about clinical trials can help them to make an informed decision about participation in a trial, and they should know that it is a decision only they can make. Participation is voluntary, and a patient can withdraw at any time without affecting their medical care. They should be encouraged to ask questions and know what is going to happen during the trial. Educating patients about risks and benefits, safety, costs, and confidentiality may alleviate their fears and make the experience less stressful.

Oncology nurses can play an important part in the effort to increase clinical trial enrollment by educating their patients without bias or judgment.

Ms. Williams-Truax is an oncology nurse practicing in phase I clinical trials at Duke University Medical Center. She wishes to acknowledge Sue Schneider, RN, PhD, FAAN, associate professor and Director Graduate Oncology Nurse Specialty, Duke University School of Nursing, and Tracy Gosselin RN, MSN, Director of Oncology Services, Duke University Medical Center, for their contributions to this article.