Digitizing Survivorship Care Plans Through the POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC) Mobile App: Protocol for a Phase II Randomized Controlled Trial

Abstract

Background: Survivorship care plans (SCPs) are provided at the completion of cancer treatment to aid in the transition from 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 The plans are currently paper-based and become outdated as soon as a patient's health status changes.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, SCPs can be linked to 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, POSTHOC (POST-Treatment Health Outcomes of Cancer Survivors), that digitizes the SCP was developed, with goals of integrating it with wearable technologies and electronic medical records. Herein, we are conducting a randomized controlled trial that evaluates the POSTHOC app versus the traditional SCP on total symptom burden in the early posttreatment period.

Methods: We will recruit 54 patients who have recently completed curative therapy for cancer (any type) in person and remotely. They will be randomized 2:1, POSTHOC:usual care (unblinded). Those randomized to the POSTHOC group will receive their SCP 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 (web-based questionnaire), diet (24-hour Automated Self-Administered [ASA24]), and physical activity (Fitbit Charge 6 [Google LLC]). We will also collect quantitative and qualitative feedback on the usability of the app from those in the POSTHOC arm to improve the app for future implementation studies, with a specific focus on patient-provider communication. For feasibility, we will calculate the percentage of patients who used the POSTHOC app at least 3 times per week. We will use linear mixed models to evaluate the effects of the POSTHOC app versus those of usual care on other outcomes at weeks 6 and 12.

Results: This trial is open to accrual in the University of Maryland Medical System as of March 2024, and as of July 3, 2024, a total of 20 participants have consented.

Conclusions: This study is among the first to digitize the SCP in a mobile app and test the effects of a mobile health-delivered behavioral health intervention on symptom burden in cancer survivors. Our results will provide evidence about the effects of health self-management on symptoms. This knowledge will be integral to larger randomized controlled studies, integration with the electronic medical record, and nationwide implementation.

Trial registration: ClinicalTrials.gov NCT05499663; https://clinicaltrials.gov/ct2/show/NCT05499663.

International registered report identifier (irrid): DERR1-10.2196/59222.

Keywords: clinical trial; mHealth; mobile health; mobile phone; oncology; posttreatment; symptoms.

Figure 1

Study schema. In this randomized controlled trial, participants will first consent and download the POSTHOC (POST-Treatment Health Outcomes of Cancer Survivors) and Fitbit apps. After baseline assessments, they will be randomized and be in the study phase for 12 weeks. Our team will contact all participants at least every 2 weeks, and assessments will occur at weeks 6 and 12. We will then conduct an exit interview to solicit qualitative feedback on the app and the study.

Figure 2

Screenshots of the POSTHOC (POST-Treatment Health Outcomes of Cancer Survivors) app. (A) The home screen for participants randomized to the POSTHOC arm of the clinical trial. Here, participants see whether they have recorded any symptoms and any dietary data they have entered. Steps, minutes of moderate and vigorous exercise, and sleep data are pulled from the Fitbit app. A green check indicates whether the goal was met for the day. Participants may navigate to the survivorship care plan (SCP; “My Care Plan”), Settings (gear in the top right), Symptoms, and Nutrition from here. (B) The SCP is divided into 6 sections based on the American Society for Clinical Oncology (ASCO) template for SCPs, survivorship guidelines from the National Comprehensive Cancer Network, and the University of Maryland Medical System’s SCP template. (C) Ecological momentary assessment (EMA) is administered 4 times per day for 7 days at baseline, week 6, and week 12. While the SCP will be manually entered into the POSTHOC app for this trial, it is an ultimate goal to interface the platform with the medical record so that the plan can be updated as a person’s health and goals change.