Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitness Tracker
Social Incentive (Way to Health)
Sponsored by
About this trial
This is an interventional supportive care trial for Ovarian Cancer focused on measuring Ovarian Cancer, Physical Activity, Mobile Health, Fitness Tracker, Survivorship, Quality of Life
Eligibility Criteria
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
Sites / Locations
- Dana Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fitness Tracker + Social Incentive Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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)
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.
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT03364673
First Posted
October 17, 2017
Last Updated
October 7, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03364673
Brief Title
Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer
Official Title
Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
December 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian Cancer, Physical Activity, Mobile Health, Fitness Tracker, Survivorship, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fitness Tracker + Social Incentive Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fitness Tracker
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Social Incentive (Way to Health)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the Accelerometer + Social Support + Gamification
Description
Feasibility will be defined as ≥60% of patients who participate in the pilot study complete the 24-week intervention
Time Frame
1 year pilot
Title
Acceptability
Description
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)
Time Frame
24 weeks
Title
Perceived Effectiveness
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in Daily Steps From Baseline to 12 Weeks
Description
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
Time Frame
12 weeks [from end of baseline (day 15) to day 98]
Title
Change in Daily Steps From Baseline 24 Weeks
Description
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
Time Frame
24 weeks [from end to baseline (day 15) to day 182]
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexi A. Wright, MD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33637350
Citation
Schrier E, Xiong N, Thompson E, Poort H, Schumer S, Liu JF, Krasner C, Campos SM, Horowitz NS, Feltmate C, Konstantinopoulos PA, Dinardo MM, Tayob N, Matulonis UA, Patel M, Wright AA. Stepping into survivorship pilot study: Harnessing mobile health and principles of behavioral economics to increase physical activity in ovarian cancer survivors. Gynecol Oncol. 2021 May;161(2):581-586. doi: 10.1016/j.ygyno.2021.02.023. Epub 2021 Feb 23.
Results Reference
background
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Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer
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