This clinical trial compares the effects of the standard paper-based Survivorship Care Plan versus (vs.) a new smartphone application (app), POST-treatment Healthcare Outcomes for Cancer survivors (POSTHOC), on symptoms and mood in early post-treatment survivorship. At the end of cancer treatment, many people are still dealing with symptoms of cancer and side effects of treatment. Survivorship Care Plans are plans provided to individuals at the completion of cancer treatment and describe the details of a person’s diagnosis and treatment, as well as provide recommendations for follow-up appointments, referrals, and healthy behaviors to quicken recovery and prevent the cancer from coming back. Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the person’s health status changes. Therefore, there is a need to digitize Survivorship Care Plans to improve the accessibility, modifiability, and longevity of the plan. In addition, with current technology, there is an opportunity for Survivorship Care Plans to be linked with mobile devices and activity trackers so that people can track health behaviors and compare them to their clinical goals, enabling people to take charge of their own health. The POSTHOC app digitizes the Survivorship Care Plan with goals to integrate it into the digital medical record and may allow researchers to gain more information on the relationships between lifestyle behaviors (i.e., nutrition, physical activity, and sleep) and common cancer related symptoms such as distress, fatigue, pain, numbness/tingling, and how much these symptoms interfere with daily life.
Additional locations may be listed on ClinicalTrials.gov for NCT05499663.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To assess how many participants view or log data in the app at least 3 times per week over the 12-week study.
II. To obtain a preliminary estimate of the effect of the POSTHOC app vs. usual care on cumulative patient-reported symptom burden.
III. To obtain a preliminary estimate of the effect of the POSTHOC app vs. usual care on patient-reported and objectively measured health behaviors (physical activity, diet, sleep).
EXPLORATORY OBJECTIVE:
I. To assess the acceptability and usability of the POSTHOC app by participants in the POSTHOC intervention group at week 6 and week 12 using questionnaires.
MECHANISTIC (EXPLORATORY) OBJECTIVES:
I. To obtain preliminary estimates of the effects of the POSTHOC app vs. usual care on patient-reported symptoms including neuropathy (Chemotherapy-Induced Peripheral Neuropathy [CIPN]20), pain (Brief Pain Inventory), cognitive impairment (Functional Assessment of Cancer Therapy-Cognition [FACT-Cog]), fatigue (Brief Fatigue Inventory), and anxiety and depression (Hospital Anxiety and Depression Scale and Distress Thermometer), as well as clinician-reported patient health (e.g., Eastern Cooperative Oncology Group [ECOG] performance status), and healthcare utilization (e.g., number of unplanned medical encounters).
II. Assess how key symptoms are affected using ecological momentary assessment.
III. To assess cross-sectional associations between health behaviors (physical activity, diet, sleep) and cumulative symptom burden at baseline.
IV. To explore associations between changes in health behaviors (physical activity, diet, sleep) and cumulative symptom burden from baseline to 6 weeks and baseline to 12 weeks.
V. To explore associations between adherence to the intervention and changes in the same measures.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive access to the full version of the POSTHOC app, which includes a digital version of their Survivorship Care Plan, and choose to focus on nutrition or exercise for 12 weeks. Patients also wear a Fitbit on study.
ARM II: Patients receive usual care with a paper based Survivorship Care Plan. Patients also receive access to a "light" version of the POSTHOC app and wear a Fitbit on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Maryland/Greenebaum Cancer Center
Principal InvestigatorAmber Kleckner
