Willingness of gynecologic cancer patients to participate in clinical trials.

ABSTRACT

OBJECTIVES: Fewer than 5% of cancer patients enroll in clinical trials, delaying their completion and the progress of patient care. Patients who are elderly or members of ethnic minorities participate at even lower rates than the general population. The objective of this study was to identify the factors that motivate or inhibit patient enrollment specifically within the gynecologic oncology population. METHODS: An anonymous, voluntary survey was administered to all new patients presenting in the outpatient gynecologic oncology office for an initial consultation. The questionnaire was developed based on prior surveys in the general oncology literature and included questions about age, demographic information, interest in participation in research, and reasons for declining or desiring participation. Groups were compared with Fisher's Exact Test. RESULTS: There were 98 surveys submitted, of which 79 surveys were completed and included for analysis. The median age of patients was 50 years and the majority (86%) was Caucasian. Only 38% stated they would be unwilling to participate in clinical research, while 20% of the patient population stated they would be willing to participate in clinical trials and 42% were unsure. Factors that reached statistical significance (p=.05) in willingness to participate were age less than 50 years, education level beyond high school, and possession of private insurance. CONCLUSIONS: The percentage of women with gynecologic malignancies willing to participate in clinical trials greatly exceeds the number enrolled. Increasing the use of educational materials, improving patient awareness of clinical trials, and offering enrollment to all patients may increase accrual.