PCN534 BARRIERS AND FACILITATORS TO IMPLEMENTING ELECTRONIC PATIENT-REPORTED OUTCOMES (PROS) IN CANCER CLINICAL TRIALS: INTERVIEW RESULTS FROM CLINICAL RESEARCH STAFF AND PATIENTS

Abstract

Collection of patient-reported outcomes (PROs) is common in cancer trials. Implementation approaches and PRO survey completion rates vary. Little is known about research staff and patient impressions of barriers and facilitators to PRO data collection. Thirty-four clinical research associates (CRAs) at sites administering two multicenter cancer trials in the U.S. National Cancer Trial Network that included PROs (NCT01262560 in lung cancer; NCT01515787 in rectal cancer) were randomly selected for semi-structured interviews (N=16) and group discussion (N=18) focused on barriers and facilitators to PRO data collection including technology, training, workflow, effort, and communication. Patients in two trials (NCT01262560; NCT00578006 in multiple cancer types) underwent semi-structured interviews (N=81) on similar topics. Interviews were recorded, transcribed, and de-identified. Coding and thematic analysis employed Dedoose and ATLAS.ti software. CRAs noted challenges training patients with low computer avidity, but found patients gained comfort and facility with experience. Simplifying user interfaces and passwords was suggested. Wireless network connectivity was an early problem for ePROs (before 2015), but subsequently resolved. Balancing PRO tasks with other CRA roles required effort, although the time required for PROs was minute compared to other duties. CRAs reported patient enthusiasm about PROs. Thorough patient training and buy-in from site clinicians were seen as key facilitators of patient compliance. Patients noted that completing PROs became more challenging as they became sicker, but staff reminders and availability of technology assistance helped address this. Technology problems (lost passwords, connectivity) were frustrations. Staff engagement was highly valued. CRAs and patients emphasize the importance of simple ePRO interfaces, minimal password requirements, reliable technology connectivity, thorough initial training, staff reminders to report if a survey is late, and ongoing support and engagement by research staff and clinicians. These elements should be considered in future design and implementation of PRO data collection in clinical trials.