Abstract
OBJECTIVE: To describe patient, research staff, and clinician perspectives regarding the effects of telehealth and remote clinical trial operations on safety, quality, and experience in gynecologic oncology clinical trials. METHODS: This qualitative study used semistructured interviews conducted from May to June 2022 with purposively sampled clinical trial participants, research staff, and clinicians involved in gynecologic oncology clinical trials with telehealth utilization. Participants described telehealth in clinical trial experiences, including benefits and barriers to receipt and provision of care, satisfaction, and quality. Transcripts were coded and analyzed with a modified content analysis approach based on research objectives and emergent themes. An adapted version of the validated Telehealth Usability Questionnaire was administered to all invited participants. RESULTS: Five patients, seven clinicians, and five research staff were interviewed. Patients and clinicians reported that telehealth, remote testing, and medication delivery positively affected quality of life by reducing financial burden, wait times, and transportation needs. Interviewees did not report telehealth-related changes in treatment-related adverse effects, referrals for urgent evaluation, or compromise of privacy but expressed concerns about the lack of physical examinations. Patients reported that telehealth increased scheduling burden without negative effects on care quality, counseling comprehension, relationships with trial teams, or satisfaction. Clinicians and research staff reported improved workflows regarding remote consent, sponsor interactions, and documentation but challenges with virtual patient education and off-site testing. Clinicians highlighted disparities for patients with limited technology access and reported institutional and insurance-based telehealth policies as barriers. Survey responses supported qualitative findings. CONCLUSION: Despite notable limitations, patients, research staff, and clinicians recommended continued utilization of telehealth and remote clinical trial operations in clinical trials. Future clinical trial designs should consider telehealth inclusion.