The goals of this project were to: 1) identify the cultural, economic and environmental barriers to early-phase clinical trial accrual faced by patients and oncologists and 2) identify the components of an intervention model to be implemented and evaluated in a subsequent intervention trial to increase participation in early-phase clinical trials. Both qualitative and quantitative methods were used to collect data to identify and assess barriers and to guide the development of a set of recommendations for an intervention model that would be implemented and evaluated in a subsequent intervention trial. Formative and quantitative research was conducted, including telephone interviews with cancer patients and two surveys: one with 114 oncologists and one with 100 cancer patients (50 enrolled in an early-phase clinical trial and 50 who never participate, even if invited).
Bexar County, Texas
For oncologists, the top enabling factors for referring patients to trials were the desire of the patient or family to try something new, the possibility of therapeutic benefit to patient and gaining knowledge by participating. Top barriers for physicians were related to the extra work and time of recruiting and referring patients, lack of awareness about the trials, eligibility criteria too strict and barriers related to personal factors. For patients, the top enabling factors were the possibility of controlling cancer, extending length and quality of life and obtaining high-quality care and follow-up. Trust in the center conducting the trial, hope, and advice/encouragement from doctor and family members were also mention as important motivating factors. Top barriers for patients were lack of knowledge and information about the study, lack of understanding, doctors not discussing clinical trials options with patients, socioeconomic barriers and patient beliefs and attitudes. Based on survey results, main components of an intervention model to increase referral to and participation in early-phase clinical trials were identified and assess by a small group of patients and oncologists.