Study Design

This was a randomized, phase 2 clinical trial assessing a video-based, personalized webpage as a complement to standard patient education for clinical trial patients. The institutional review board (IRB) at the Dana-Farber Cancer Institute (DFCI) approved this intervention and determined that this randomized, phase 2 trial did not meet the requirements for registration to a WHO-accredited trial registry as it was an ancillary, noninvasive trial.

The Postwire application was chosen as it is Health Insurance Portability and Accountability Act (HIPAA)–compliant and uses secure sockets layer technology to prevent hacking and ensure privacy. All patients provided written informed consent. This study was pilot-tested before the initiation of patient recruitment and enrollment to optimize workflow and minimize technology malfunctions. A safety run-in of 9 weeks took place to carefully monitor patients and protocol procedures, and adjustments were made as necessary to optimize workflow and study conduct.

The study consisted of 2 arms: the video-based intervention arm and the control arm. Patients were randomized 2:1 to the intervention arm or control arm and were stratified by therapeutic or parent clinical trial protocol type (targeted, hormone, or combination therapy). Patients randomized to the control arm received standard clinical trial oral anticancer therapy education and care without a video-based personalized webpage. Patients enrolled in the intervention arm had access to a video-based personalized webpage in addition to standard of care educational materials.