Sunday May 19, 8:00 am Eastern Time
SOURCE: UC Davis School of Medicine and Medical Center
Understanding Cancer Patients' Needs, Concerns Is Key to Improving Clinical
UC Davis Cancer Center Study Finds Patients Need Practical Information
ORLANDO, Fla., May 19 /PRNewswire/ -- 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 will be presented at the
annual meeting of the American Society of Clinical Oncology in Orlando,
Fla., May 18 to 21.
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
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.
UC Davis Health System is an organization of the UC Davis School of
Medicine, its affiliated teaching hospital, UC Davis Medical Center and its
physician group, UC Davis Medical Group.
UC Davis Health System
4900 Broadway, Suite 1200
Sacramento, CA 95820
Web address: http://news.ucdmc.ucdavis.edu
SOURCE: UC Davis School of Medicine and Medical Center
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