Leveraging Health Technology to Address POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC): Protocol for a Phase II Survivorship Care Plan Mobile App Randomized Controlled Trial (Preprint)

BACKGROUND Survivorship care plans are provided at the completion of cancer treatment to aid in the transition from being on active treatment to long-term survivorship. They describe the details of a patient’s diagnosis and treatment and offer recommendations for follow-up appointments, referrals, and healthy behaviors. The plans are currently paper-based and become outdated as soon as a patient’s health status changes. There is a need to digitize these plans to improve their accessibility, modifiability, and longevity. With current technology, survivorship care plans can be linked with mobile devices and activity trackers so that patients can track health behaviors and compare them to their clinical goals, taking charge of their own health. OBJECTIVE A mobile app called POSTHOC (POST-treatment Healthcare Outcomes for Cancer survivors) was developed that digitizes the survivorship care plan with goals to integrate it, wearable technologies, and electronic medical records. Herein, we are conducting a randomized controlled trial that evaluates the POSTHOC app vs. the traditional Survivorship Care Plan on total symptom burden in the early post-treatment period. METHODS We will recruit 54 patients who have recently completed curative therapy for cancer (any type). They will be randomized 2:1, POSTHOC:usual care. Those randomized to the POSTHOC group will be provided with their survivorship care plan via the app and will choose to focus on nutrition or exercise for the duration of the study, based on their individual plan and personal preferences. Those randomized to the control group will get a paper-based plan. At baseline, 6 weeks, and 12 weeks, we will evaluate patient-reported outcomes including total symptom burden, diet (ASA-24), and physical activity (Fitbit Charge 6). We will also collect quantitative and qualitative feedback on the usability of the app from those in the POSTHOC arm in order to improve the app for future implementation studies with a specific focus on patient-provider communication. RESULTS As of March 2024, this trial is open to accrual in the University of Maryland Medical System. CONCLUSIONS This study is among the first to digitize the survivorship care plan in a mobile application and test the effects of a mobile health (mHealth)-delivered behavioral health intervention on symptom burden in cancer survivors. Our results will provide evidence about the effects of self-management of health on healthcare usage and treatment symptoms. This knowledge will be integral to larger randomized controlled studies, integration with the electronic medical record, and nationwide implementation. CLINICALTRIAL ClinicalTrials.gov NCT05499663; https://clinicaltrials.gov/ct2/show/NCT05499663