Purpose: Realizing that education and awareness are paramount in making clinical trials available to improve overall accrual rates, we sought to create a clinical trial navigation service to improve the accessibility of cancer clinical trials in Florida for physicians and patients. This study was undertaken to evaluate this service. We hoped to identify characteristics of our service that were effective in promoting clinical trial enrollment and to better understand barriers that prevented enrollment.
Methods: Qualitative and quantitative data were gathered to inform the evaluation. This information was drawn from semistructured interview and focus groups as well as data from 6,350 patient questionnaires capturing diagnosis, stage, and treatment history. Quantitative data were analyzed by computing indices of central tendency and dispersion as well as frequency distributions. Qualitative data were analyzed using open coding to identify major themes representing the information.
Results: Our navigation system increased patient awareness of trials; however, this did not lead to an increase in trial enrollment. A key barrier to enrollment was the timing of the patient's awareness of a clinical trial opportunity. Often trial options were realized after a treatment course was initiated. This frequently disqualified the patient from trial consideration. We identified factors underlying the critical role of how physician attitudes toward trials affect enrollment. We also found that government databases were incomplete. Twenty-five percent of clinical trials open in Florida were not listed with Physician Data Query or clinicaltrials.gov, and 15% to 22% were erroneously listed as having sites in Florida. Media efforts to increase patient awareness and use of the navigation service were transient. One-time educational programs did not have a long-term impact on clinical trial inquiries. Patients who spoke with clinical trial navigators were four times more likely to contact a matched trial site. Sharing a common database platform with various organizations increased the likelihood of patients finding trials near home. More than 82% of patients seeking information started their search on other Web sites.
Conclusion: Although we were able to overcome the barriers most commonly cited by patients, we found that taking a strictly patient-focused approach was not enough. Our results underline the critical role of health professionals in guiding patients to clinical trials, by including these options at a time when patients are likely to be eligible.