Innovative clinical trial design enhances accessibility of behavioral intervention trials

Shilpa Mokshagundam; Riham Suleiman; Amanda Tapia; Michaela McGree; Karen Ishitani; Kelly Gunderson; Olivia Haugo; Michelle Lampman; Adam Shultz; Amanda Bonikowske; Jessica Gorzelitz; Amanika Kumar

doi:10.1016/j.ygyno.2026.01.517

Objectives Geography is a significant barrier to clinical trial enrollment. Decentralized clinical trials (DCTs) leverage telehealth services to allow for some or all trial activities to occur outside of the traditional clinical setting. This study aims to quantify and qualify patients' experience of telehealth in two DCTs in gynecologic oncology. Methods Two separate and fully DCTs were conducted within our institution. Both were behavioral intervention trials focused on exercise and nutrition practices in two distinct gynecologic oncology patient populations, the first including patients with advanced ovarian cancer undergoing neoadjuvant chemotherapy and the second including endometrial cancer survivors in surveillance. Telehealth was utilized for study recruitment, consent, weekly study clinical visits and physical function testing. Telehealth visits were conducted via Zoom®and supported through our institution's electronic patient portal. Feasibility of remote trial activities and acceptability of telehealth were evaluated using the Telehealth Usability Questionnaire (TUQ). Qualitative analysis of exit interviews from one of the previously described DCTs was performed. Results Among 103 patients enrolled in the two DCTs, the mean age was 66.1 years and mean BMI was 32.5 kg/m2. There were 838 scheduled telehealth visits between patient and clinician, of which 697 (83.2%) were completed. There were 79 no shows (9.4%) and 62 cancelled visits (7.4%). Technology issues were experienced in 51 of the completed visits (7.3%), the most common of which was difficulty related to video connectivity and buffering (47.1%). In 68 visits (9.8%), patients experienced a delay in connecting via the telehealth system. The majority of such visits (86.8%) had to be completed via phone call. Patients reported general satisfaction with the use of telehealth for completion of trial activities, with an overall mean TUQ score of 5.9 (SD 0.67) on a scale of 1–7, with 7 indicating highest level of agreement. Patients reported highest level of agreement in the domain “satisfaction”, with a mean score of 6.3 (SD 0.84) and lowest agreement in the domain “reliability”, with a mean score of 4.4 (SD 2.2). Qualitative analysis of exit interviews demonstrated overall appreciation for the convenience of remote clinical trial activities. Participants suggested an initial in-person visit to allow for better orientation to technology platforms. Conclusions Within two separate DCTs, telehealth was generally feasible for a behavioral intervention clinical trial. While a subset of patients experienced technology issues related to video function, patients reported high overall satisfaction with telehealth via the TUQ. This study demonstrates that this novel DCT design, through which trial activities are conducted virtually, is acceptable within gynecologic oncology patients and has the potential to address geographic and logistical barriers to clinical trial enrollment.

Innovative clinical trial design enhances accessibility of behavioral intervention trials

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