Multiple Case Study of Factors Associated with Enrollment of Women with Persistent or Recurrent Ovarian Cancer in Clinical Trials in Central Florida

Study Purpose: Ovarian cancer, the most lethal gynecologic cancer, has had a relatively stable mortality rate since 1975, despite a decrease in mortality for all gynecologic cancers combined. Standard-of-care advances are needed to reduce ovarian cancer morbidity and mortality. Advances must, however, undergo a long, rigorously controlled research process that can take more than ten years before becoming available to the public. Further, few women with persistent or recurrent ovarian cancer are offered or enrolled in the clinical trials that do exist at select sites throughout the nation. The purpose of this multiple-case study is to identify necessary and/or sufficient factors associated with enrollment in ovarian cancer clinical trials, and to identify facilitators and barriers within the practice setting that, in the longer term, can be used to inform targeted interventions to improve trial access and accrual. The multilevel factors that were explored were aligned with the Consolidated Framework for Intervention Research (CFIR). The study sought to answer two research questions. (1) Based on Qualitative Comparative Analysis [QCA (Ragin, 1989)], what necessary and/or sufficient factors would enable a woman with recurrent or persistent ovarian cancer to enroll in a clinical trial in Florida? (2) What barriers and facilitators, practitioner and patient-specific, exist with regard to enrolling women with ovarian cancer in clinical trials? Materials and Methods: This multiple case study used online surveys to obtain quantitative and qualitative data from two populations: women with ovarian cancer and nurses at various referring practice sites. Data from Moffitt Cancer Center’s Total Cancer Care protocol was requested to conduct chart reviews that would identify prospective participants. Qualitative comparative analysis (QCA), which is useful for determining causality in small sample sizes, was used to determine necessary and/or sufficient factors associated with enrollment by women with ovarian cancer in clinical trials, as well as barriers and facilitators related to clinical trial enrollment. Results: Women with ovarian cancer who participated in clinical trials were stage III/IV, wanted information, and engaged in discussion about clinical trials, making those factors necessary for enrollment in a study. Facilitators for participation were discussion with the provider of care, to some extent the existence of patient-accessible clinical trial literature in the practice, knowledge that health insurance covers standard of care costs, and having a provider who offers clinical trials. Absence of those factors thus constitutes a barrier. For nurses, the impact of having a practice team plan was related to enrolling women with ovarian cancer in clinical trials, and feeling informed and comfortable with questions women might ask about trials. Conclusion: Clinical trials are an underutilized priority for improving the standard of care and reducing the high rate of morbidity and mortality associated with ovarian cancer. The data show deficits and needs within two key interrelated populations: medical oncology practice nurses and women with ovarian cancer. Opportunities exist within each level of the Consolidated Framework for Implementation Research (CFIR); interviews should be used to confirm the findings, which can be used to establish an interventional protocol to increase clinical trial enrollment by women with ovarian cancer