Title: Leveraging Technology to Address Health Outcomes of Cancer Survivors

Study Overview
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Brief Summary
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At the end of cancer treatment, many patients are still dealing with symptoms of cancer and side effects of treatment. Many are also left in a surreal mental state with uncertainty regarding the future of their health. Survivorship Care Plans are plans that are provided to individuals at the completion of cancer treatment (i.e., chemotherapy, surgery, radiation). Survivorship Care Plans describe the details of a person's diagnosis and treatment, as well as provide recommendations for follow-up appointments, referrals, and healthy behaviors to accelerate recovery and prevent recurrence (e.g., diet, exercise, smoking cessation). Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the person's health status changes.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. Charles River Analytics developed an app called POSTHOC (POST-treatment Healthcare Outcomes for Cancer survivors) that digitizes the Survivorship Care Plan with goals to integrate it into the digital medical record. Herein, phase I/II feasibility/preliminary efficacy randomized controlled trial is being conducted among 54 patients with cancer who recently completed adjuvant treatment for cancer (e.g., chemotherapy, radiotherapy, surgery) to compare 12 weeks of the POSTHOC app as part of the Survivorship Care Plan vs. the usual care Survivorship Care Plan on total symptom burden. Participants 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. At baseline, 6 weeks, and 12 weeks, patient-reported outcomes will be evaluated including total symptom burden, diet, and physical activity. Extensive quantitative and qualitative feedback will also be collected on the usability of the app from those in the POSTHOC arm in order to improve the app for future implementation studies.

Official Title
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Leveraging Technology to Address POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC-II): A Phase II Survivorship Care Plan Randomized Controlled Trial

Conditions
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Symptoms and Signs, Survivorship, Cancer

Intervention / Treatment
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* Behavioral: POSTHOC app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have had a cancer diagnosis (any type) Will soon or have recently completed treatment (within the past 12 weeks) with chemotherapy, radiotherapy, or surgery with curative intent Must have received, plans to receive, or open to receiving a Survivorship Care Plan (SCP) as per their provider Have access to a device capable of running the POSTHOC app and Fitbit app (e.g., Android or Apple smartphone) and reliable Internet access Be at least 18 years of age Be able to read and understand English, and Be able to provide written informed consent Exclusion Criteria: Have planned surgery, radiotherapy, or surgery during the study period (hormonal and biologic therapy is allowed)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POSTHOC app<br> | Behavioral: POSTHOC app<br>* The POSTHOC app is a smartphone application that will deliver the Survivorship Care Plan and promote healthy lifestyle behaviors consistent with the individual's Care Plan<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative number of times participants log/view data in the app | The number of times participants log/view data in the app will be counted over the 12-week study | 12 weeks | 
| Usefulness | 7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful | 6 weeks | 
| Usefulness | 7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful | 12 weeks | 
| Likely to recommend | 7-point Likert scale flanked by 1=not at all likely to recommend to others and 7=extremely likely | 6 weeks | 
| Likely to recommend | 7-point Likert scale flanked by 1=not at all likely to recommend to others and 7=extremely likely | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Symptom Burden | sum of severities of the core patient-reported symptoms from the MD Anderson Symptom Inventory, including fatigue, insomnia, pain, appetite loss, dyspnea (shortness of breath), cognitive problems, nausea, distress, and sensory neuropathy. A higher score indicates higher symptom burden | 6 weeks | 
| Cumulative Symptom Burden | sum of severities of the core patient-reported symptoms from the MD Anderson Symptom Inventory, including fatigue, insomnia, pain, appetite loss, dyspnea (shortness of breath), cognitive problems, nausea, distress, and sensory neuropathy. A higher score indicates higher symptom burden | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile health, mhealth, exercise, nutrition, behavior change