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

Not Applicable

Completed

Conditions: Ovarian Cancer

Interventions: Other: Fitness Tracker
Other: Social Incentive (Way to Health)

Registration Number: NCT03364673

Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 29

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fitness Tracker + Social Incentive Intervention	Fitness Tracker	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.
Fitness Tracker + Social Incentive Intervention	Social Incentive (Way to Health)	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of the Accelerometer + Social Support + Gamification	1 year pilot	Feasibility will be defined as ≥60% of patients who participate in the pilot study complete the 24-week intervention
Acceptability	24 weeks	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)
Perceived Effectiveness	24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Daily Steps From Baseline 24 Weeks	24 weeks [from end to baseline (day 15) to day 182]	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
Change in Daily Steps From Baseline to 12 Weeks	12 weeks [from end of baseline (day 15) to day 98]	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