Low Enrollment of Adult Patients in Clinical Trials: Is Communication Still a Problem?

BACKGROUND-

Currently, only 3-5% of all adult cancer patients participate in clinical trials (CT), in contrast to 60-70% of pediatric cancer patients. Low enrollment to CT has negative consequences like increased cost of study conduct, late emergence of standard therapy, and premature closure of study. Current literature suggests that enrollment into CT has been historically low for racial and ethnic minorities, women, and the elderly. Genevieve Frank reported in a paper about the survey study done with 6,000 cancer patients that 85% of the participants were either unaware or unsure that participation in CT was a treatment option.

We conducted a self-report survey study among 125 patients at Trinitas Comprehensive Cancer Center (TCCC). Study objectives were to determine their level of awareness about the availability of clinical trials at TCCC, willingness to participate, the barriers that would impact their decision to participate in a CT and to examine differences between Hispanic and non-Hispanic patients with regard to these factors.

METHODS-

Patients included in the study were 18 years of age or older and able to give written informed consent. Patients with cognitive impairment, psychiatric or addictive disorders were excluded. The consent form and survey were translated into Spanish by an accredited translation company. Diagnostic and demographic data from patient medical records were collected. Surveys included questions designed to identify factors that might influence a participant's willingness or pose barriers to participation in CT. In an initial analysis of responses, 12 questions were chosen to reflect "willingness", and 12 different questions were selected to reflect "barriers." All answers were either YES/NO or AGREE/DISAGREE, coded as 1/0, making it possible to sum responses within each set to provide a "Willingness Score" and a "Barrier Score" for 115 participants, based on completed responses. 12 diagnostic or demographic variables were dichotomized to assess their relationship to willingness or barriers regarding participation in trials using a series of T-tests.

RESULTS-

There were 125 evaluable surveys. 64% of our surveyors were female, 87% had cancer diagnosis and 63% were in active treatment. It was astonishing to know that 85% pts did not know about CT before they participated in the survey. 64% did not know about the availability of CT in TCCC. 85% answered that they never discussed about CT with their health care providers. 77% reported never receiving brochures about CT. The most notable barriers were opposition to CT with a placebo arm (68%), or with randomization (60%). 35% indicated distrust of research from pharmaceutical companies. Interestingly, half answered that family disapproval would not be a barrier. Also on the positive side, 70% expressed trust in government funded research, 79% felt researchers did not take advantage of people, 80% believed CT could offer good treatment options, and 70% disagreed that being in a CT was to be treated as a guinea pig. 77% would participate for the chance to improve quality of life, and 65% for the chance to reduce their side effects. At a nominal p<0.05, participation was found to be more likely for those married or partnered, and for those with more than a high school education. Barrier scores were significantly higher for non-married, non-partnered individuals, or when annual income was reported as <$40,000. Those with Medicare as primary insurance showed a trend toward willingness for participation in clinical trials (p=0.079). Other factors examined, such as gender, age, race, ethnicity, cancer diagnosis, number of prior treatments, stage of diagnosis were not statistically significant.

CONCLUSIONS-

Our study indicated a clear communication gap between patients and their health care providers about the discussion of CT. This impacts patient's enrollment in CT. Open label, non randomized, non placebo containing studies were more favored by patients. Unlike other published results, we did not find differences in willingness to participate by sex, race, ethnicity (Hispanic vs non Hispanic) or age, while those with partners, higher level of education and income favored participation in CT. The limitation of our study is that the small sample size is small and enrollment was based at a single institution.