Ovarian cancer is characterized as the most lethal gynecologic cancer and mortality due to this disease has not changed in over 50 years. Several novel therapies against ovarian cancer are in development at Mayo Clinic (MC) and elsewhere. Ultimately, the availability of new agents against this cancer requires patients to enroll in clinial trials in sufficient numbers, yet, <5% of adult patients with cancer are enrolled in clinical trial, and participation among older individuals and women (characteristic of ovarian cancer) is often lower. This study focuses on understanding decision making about clinical trial participation among women with ovarian cancer, with emphases on the role of family members and the acceptability of novel therapeutic approaches.
The aims are: (1): Describe patient and family perceptions regarding decisions to participate in a clinical trial with regard to: decision processes (weighting of information, timing of decision, perceived control over decision, cognitive vs. affective focus);perceived vs. actual patient-family discordance in initial attitude toward participation including how discordance was resolved;and decision outcomes (decision satisfaction, decision regret);(2): Describe associations between patient (demographic) and disease (early vs. advanced stage;primary diagnosis vs. recurrence) characteristics and decisions about clinical trial participation;and (3): Explore patient and family attitudes and acceptability surrounding specific novel therapeutic trials using approaches involving immunotherapy and virotherapy. To achieve these aims, 40 patients with epithelial, primary peritoneal, or fallopian tube cancer who have accepted, declined or are currently deciding about (any phase) trial participation and 1-2 family members each (80-120 individuals) will be invited to complete a theory-informed, semi-structured interview. A qualitative approach that triangulates responses from patients and family members (obtained separately) provides the greatest opportunity to identify specific processes, influences, and biases surrounding trial decisions that are presently unknown. An Ovarian Specialized Program of Research Excellence (SPORE) at MC ensures that this study is informed by state-of-the-art science, and that the results are readily applicable to emerging clinical trials.
Understanding how ovarian cancer patients make decisions about clinical trial participation and view novel therapeutic approaches will enhance the success of translational science efforts through increased participation in emerging clinical trials. Data from this project will clarify the role of the family in research participation decisions and ultimately be used to inform larger, quantitative studies and optimize trial design.