(ORLANDO, Fla.) -- Advances in cancer treatment depend on carefully controlled trials of new therapies, yet only two to four percent of cancer patients nationwide take part in these pivotal studies. Understanding the decision to participate in a clinical trial -- from the patient’s point of view -- is a first step toward devising strategies to increase participation, according to researchers at UC Davis School of Medicine and Medical Center.
“We really need to understand the patient’s perspective better,” said Debora Paterniti, assistant professor of general medicine and author of a new study designed to fill that gap. The study was presented Sunday at the annual meeting of the American Society of Clinical Oncology in Orlando, Fla.
In the study, Paterniti closely observed cancer patients as they contemplated whether to participate in phase I and phase III clinical trials at UC Davis Cancer Center. Carried out over a three-month period, the observations focused not only on physician-patient and researcher-patient interactions, but also on physician-physician and patient-family interactions.
The observations turned up five broad categories of potential barriers to participation: lack of resources on the part of patients; health insurance restrictions; confusion about the difference between research and medical care; confusion about study procedures; and misunderstandings of the illness and its severity.
The observations also turned up three potential barriers to truly voluntary clinical trial participation by patients: desire on the part of a patient to please a family member or physician; a feeling by the patient that no other options exist; and perceptions by patients that they are required to be in a clinical trial.
In phase two of the study, Paterniti and her colleagues are now conducting in-depth interviews with patients. After all the data have been gathered, the researchers hope to use their findings to propose strategies that will help ensure patient autonomy and truly informed consent in clinical trials. Other goals: to determine strategies to help increase the diversity of patients enrolled in clinical trials; to decrease barriers to consent for vulnerable populations, such as children and the elderly; and to arrive at strategies that will help increase the overall number of patients who volunteer for the studies.
Paterniti found that patients need practical information about how participation in a clinical trial will fit into their lives: Can a particular patient, for example, realistically participate in a study that requires a drive to a cancer center four times a week?
“Patients need enough information about a clinical trial so that they can think about the risks and benefits, weigh quality of life versus quantity of life, and decide whether the trial will fit into the overall context of their lives,” Paterniti said.
Informed patients are likely to have a greater sense of autonomy, to be more satisfied with their treatment -- and to stick with a clinical trial through its completion, Paterniti said.
Previous research by UC Davis Cancer Center investigators, published in the March 13, 2001 issue of the Journal of Clinical Oncology, found that both doctors and patients sometimes hold misconceptions that can discourage enrollment in clinical trials. In that study, more than a third of the doctors declined to refer patients to clinical trials, mistakenly believing that no trials were available or that their patients were too sick to be accepted. In reality, more than 150 clinical trials were available during the study period.
Moreover, a third of the patients who were considered for clinical trial participation declined to participate, many of them out of a mistaken belief that investigational treatments are not as effective as standard treatment. In fact, many investigational treatments are at least as effective as conventional therapy, and cancer patients who participate in clinical trials frequently have higher survival rates than those who receive standard care.
UC Davis Cancer Center has one of the most vigorous clinical trials programs in the country. About 14 percent of new cancer patients seen at the center participate in a clinical trial, far above the national average.
For the year 2001, UC Davis Cancer Center ranked first among Southwest Oncology Group (SWOG) centers in the number of patients enrolled in trials. Sponsored by the National Cancer Institute, SWOG is one of the world’s largest cancer clinical trials organizations. Its membership consists of nearly 4,000 of the nation's leading physicians at 283 institutions throughout the United States and Canada. Over the past 13 years, SWOG-sponsored research has yielded 10 new U.S. Food and Drug Administration-approved cancer therapies.
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