Case Western Reserve University medical and nursing school researchers hope to drastically increase the number of qualified cancer patients who participate in clinical trials, a critical step in testing and developing new treatments and preventions.
For various reasons--including a lack of awareness that clinical testing exists--less than 5 percent of cancer patients take part in trials of experimental therapies.
As many as half of cancer patients who are eligible still don't enroll, according to the study's investigators, Neal Meropol, MD, from Case Western Reserve School of Medicine and University Hospitals Case Medical Center, and Barbara Daly, PhD, RN, FAAN, from CWRU's Frances Payne Bolton School of Nursing. And both are members of the Case Comprehensive Cancer Center.
The university received a five-year, $1.6 million grant from the National Cancer Institute to develop and test a program that researchers hope will boost participation by focusing on oncology nurses to educate and inform patients about opportunities to help advance cancer research.
"We realize the culture of research does not begin and end with doctors," Meropol said. "In fact, nurses spend more time with patients and represent an opportunity to highlight the importance of clinical trials in finding new cures for cancer."
Clinical trials are used to assess the effectiveness of new methods of diagnosing, preventing and treating patients with, or at risk of, cancer. By participating in the testing, patients gain access to innovations in care that could improve their quality and length of life.
Because nurses spend the most time with patients, they have more opportunities to answer patients' questions and direct them to resources to explore options offered in clinical trials.
Researchers developed a program to increase participation by educating nurses on how to approach patients and discuss clinical trials as a routine treatment option.
In the first year, 30 nurses will be interviewed and another 100 will be surveyed to discover the key factors that may prevent them from sharing information with patients about clinical trials.
Based on what the nurses report, researchers will develop a web-based program, called Oncology Nurse IMPACT, to address those barriers in a series of teaching videos.
A group of 1,030 nurses, recruited nationally from the Oncology Nurses Society's 30,000 members, will participate in testing the intervention. Half will use Oncology Nurse IMPACT tailored to each nurse's concerns. The other half will receive educational materials in the form of online text about clinical trials.
Results of the two approaches will be compared to determine which method worked best to increase discussions about trials between nurses and patients. The group receiving text information will then have the opportunity to also use Oncology Nurse IMPACT after the study is completed.
The work follows earlier studies that analyzed reservations doctors and patients have about clinical trials, said Meropol, the Dr. Lester E. Coleman, Jr., Professor of Cancer Research and Therapeutics at University Hospitals Case Medical Center and Case Western Reserve.
Researchers found doctors and patients have gaps in what they know about clinical trials, as well as some negative attitudes that prevent more patients from participating.
Among the concerns patients reported were:
- A lack of awareness about clinical trials.
- A belief that trials should only be used as a last resort.
- A fear of side effects.
- A fear they will receive a placebo instead of a treatment.
- A concern that a computer, not their physician, will select their treatment on a trial.
Daly, the Gertrude Oliva Perkins Professor in Oncology Nursing and clinical ethics director at University Hospitals Case Medical Center, noted that nurses are particularly attuned to worries that patients have and skilled in counseling and supporting patients.
Given their close relationships with patients, she said, nurses may be particularly effective in correcting misunderstandings, such as those identified in the previous research, and encouraging patients to discuss the option of trials with their oncologist.