Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03364673|
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : February 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Other: Fitness Tracker Other: Social Incentive (Way to Health)||Not Applicable|
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.
Randomized trials of interventions 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 randomized clinical trial designed to test the effectiveness of wearable fitness trackers with or without 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 randomized to the game-based intervention 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 or without a game-based mobile health intervention will help participants increase their physical activity and improve quality of life.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer|
|Actual Study Start Date :||July 20, 2018|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: Fitness Tracker + Social Incentive Intervention
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
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
Other: Social Incentive (Way to Health)
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.
- Feasibility of the accelerometer + social support + gamification [ Time Frame: 1 year pilot ]≥60% of patients who participate in the pilot study complete the 26-week intervention
- Acceptability [ Time Frame: 26 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)
- To compare the change in daily steps from baseline to 14 weeks to estimate outcome parameters for future study [ Time Frame: 14 weeks ]
- To compare the change in daily steps from baseline 26 weeks to estimate outcome parameters for future study [ Time Frame: 26 weeks ]
- Perceived effectiveness [ Time Frame: 26 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364673
|Contact: Embree Thompsonfirstname.lastname@example.org|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Elizabeth Schrier 617-582-7396 email@example.com|
|Principal Investigator: Alexi A. Wright, MD MPH|
|Principal Investigator:||Alexi A. Wright, MD MPH||Dana-Farber Cancer Institute|