Patient satisfaction with telehealth as an element of hybrid decentralized clinical trials (DCTs): A cross-sectional study of oncology clinical trial participants.

Abstract

e13884 Background: Decentralized elements (DEs) of clinical trials (CTs) such as Telehealth (TH) allow some trial related activities to occur without requiring patients (pts) to travel to the clinical trial site. Having the option to substitute TH for some in-person visits in a hybrid DCT may help pts access clinical research in oncology. Methods: Pts enrolled in oncology CTs at an academic clinical trial site in Sydney, Australia who underwent at least one TH visit with an investigator were invited to complete a de-identified modified Study Participant Feedback Questionnaire (SPFQ) to evaluate satisfaction levels on a 5-point Likert scale for various aspects of TH and CTs, their willingness to continue TH visits and to provide suggestions as free text. Logistic regression was used to assess factors associated with a willingness to continue TH and patient suggestions were analysed using content analysis. Results: Between June 2024 to January 2025, 120 pts were invited to participate, and 102 valid questionnaires were returned. Median age was 64 (range 21-92), 65% of pts were male, 84%/15% of pts were White/Asian, 77% resided in a metropolitan area and 64% resided within 60 minutes’ drive to the trial site. Primary cancer diagnoses included Genitourinary (49%), Breast (14%), Gastrointestinal (14%) and Lung (13%). 51% of pts were ECOG PS 0 and 91% of pts had an advanced stage cancer. Classes of investigational products (IPs) included antibody-drug conjugates (32%), targeted therapy (25%), immunotherapy (15%) and combinations of multiple therapies (25%). 60% were enrolled in a phase I or II trial, and 72% of IPs had an intravenous administration route. 86% of pts (score ≥4) indicated they were satisfied with their experience with TH during their clinical trial. 93% of pts indicated the TH visit was scheduled at a convenient time, 97% felt that they were adequately informed of their test results and 97% felt satisfied that their questions had been answered during the TH visit. 85% of pts indicated that they would consider additional TH trial visits if this was an option in the future. There were no significant differences found in future willingness to use TH between patient, cancer, or trial-related factors. Pts suggested having an option to choose between in-person or TH, having adequate technology to conduct TH and being able to conduct other trial-related activities remotely would improve their experience. Conclusions: Pts were overwhelmingly satisfied with their TH visits whilst enrolled in an oncology clinical trial and the majority were willing to continue if this was an option for future encounters. Willingness to use TH was similar across a wide variety of patients, IPs, and phases of CTs. Future oncology clinical research protocols should consider incorporating TH and other DEs as an option if appropriate, to reduce travel burden and improve patient access to CTs.