Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer

Study Overview
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Brief Summary
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This research study will test whether using wearable fitness trackers with a social incentive, delivered through a game-based mobile health intervention, increases physical activity and quality of life in ovarian cancer survivors.

Detailed Description
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Nearly 50% of ovarian cancer survivors experience poor quality of life, fatigue, and anxiety after completing surgery and chemotherapy to treat their disease. Moreover, many ovarian cancer survivors become deconditioned during treatment; 40% report significant drops in activity during the year after diagnosis, and only 20% meet the recommended guidelines for physical activity. Interventional exercise studies are urgently needed to determine whether increasing physical activity improves outcomes in ovarian cancer survivors. In other cancers, physical activity improves quality of life and mental health, while reducing the risk of cancer recurrence and death. To date, however, most studies have focused on patients with curable breast and prostate cancers. The effects of physical activity on understudied populations, including ovarian cancer survivors, are unknown. Furthermore, although ovarian cancer survivors report an interest in participating in home-based walking programs, few formal programs exist. Stepping into Survivorship is a single-arm study designed to test the effectiveness of a wearable fitness tracker with a game-based mobile health intervention that leverages social support to increase physical activity in ovarian cancer survivors. At the start of the study all participants will track their daily step counts using a wearable fitness tracker (e.g. Fitbit) to determine how many steps they walk in an average day. Next, they will set an increased step-goal and receive daily, individualized feedback based upon their performance. Participants will also choose a team partner (i.e. family or friend) to receive a wearable fitness tracker and together they will track their steps, earning non-financial micro-incentives (e.g. points, levels, badges) when they achieve their collaborative goals. This game-based mobile health intervention is designed to enhance collaboration, accountability, peer support, and ultimately physical activity among ovarian cancer survivors and their friends/family members. This research is being done to improve participants' quality of life. The investigators hope that the use of wearable fitness trackers with a game-based mobile health intervention will help participants increase their physical activity and improve quality of life.

Official Title
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Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Other: Fitness Tracker
* Other: Social Incentive (Way to Health)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be eligible if they have newly diagnosed ovarian cancer Are ≤6 months of completing chemotherapy Read English Do not have cognitive, visual, or orthopedic impairments that would preclude participation Plan to continue treatment at Dana-Farber Cancer Institute Exclusion Criteria: Participants will be excluded if they are already participating in an mHealth intervention Are unable to ambulate Do not have a smartphone to transmit data from the wearable tracker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fitness Tracker + Social Incentive Intervention<br>Participants will enroll with a teammate (i.e. family or friend) and collaborate together. Teams will set a daily step goal, receive daily feedback on whether they achieved their goal, and receive a social incentive intervention. | Other: Fitness Tracker<br>* Fitness trackers (e.g. Fitbit) are accelerometers that are worn on the wrist and tracks users' heart rate continuously in addition to steps, distance, calories, and active minutes<br>Other: Social Incentive (Way to Health)<br>* The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial randomization and enrollment processes, messaging (text, e-mail or voice), self-administered surveys, automatic transfers of financial incentives, and secure data capture for research purposes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the Accelerometer + Social Support + Gamification | Feasibility will be defined as ≥60% of patients who participate in the pilot study complete the 24-week intervention | 1 year pilot | 
| Acceptability | Study burden: To what extent do you agree or disagree with: Participating in this study placed a substantial burden on me. (Options: strongly agree, agree, neutral, disagree, strongly disagree) | 24 weeks | 
| Perceived Effectiveness | To what extent do you agree or disagree with the following statements: Participating in this study motivated me to increase my activity levels. Response options: strongly disagree, disagree, neutral, agree, strongly agree. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Daily Steps From Baseline to 12 Weeks | To compare the change in daily steps from end of baseline to 12 weeks (after the end of baseline) to estimate outcome parameters for future study | 12 weeks [from end of baseline (day 15) to day 98] | 
| Change in Daily Steps From Baseline 24 Weeks | To compare the change in daily steps from end of baseline to 24 weeks (after the end of baseline) to estimate outcome parameters for future study | 24 weeks [from end to baseline (day 15) to day 182] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cancer, Physical Activity, Mobile Health, Fitness Tracker, Survivorship, Quality of Life