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

• ClinicalTrials.gov Identifier: NCT03364673
• Recruitment Status: Completed
• First Posted: December 6, 2017
• Results First Posted: September 17, 2021
• Last Update Posted: October 13, 2023
• Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Alexi A. Wright, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: October 17, 2017
• First Posted Date: December 6, 2017
• Results First Submitted Date: June 28, 2021
• Results First Posted Date: September 17, 2021
• Last Update Posted Date: October 13, 2023
• Actual Study Start Date: July 20, 2018
• Actual Primary Completion Date: October 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 23, 2021)

• Feasibility of the Accelerometer + Social Support + Gamification [ Time Frame: 1 year pilot ]
  Feasibility will be defined as ≥60% of patients who participate in the pilot study complete the 24-week intervention
• Acceptability [ Time Frame: 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 [ Time Frame: 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.

Original Primary Outcome Measures (submitted: December 5, 2017)

• Feasibility of the accelerometer + social support + gamification [ Time Frame: 1 year pilot ]
  ≥60% of patients who participate in the pilot study complete the 24-week intervention
• To compare the change in daily steps baseline to the 14-week intervention period by study arm [ Time Frame: 14 weeks ]

Current Secondary Outcome Measures (submitted: August 23, 2021)

• Change in Daily Steps From Baseline to 12 Weeks [ Time Frame: 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
• Change in Daily Steps From Baseline 24 Weeks [ Time Frame: 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

Original Secondary Outcome Measures (submitted: December 5, 2017)

• To compare the change in daily steps from baseline to 26 weeks by study arm [ Time Frame: 26 weeks ]
• Compare the change in quality of life (EuroQol EQ-5D index) by study arm [ Time Frame: 26 weeks ]
• Compare the change in mental health outcomes (HADS) by study arm [ Time Frame: 26 weeks ]
• Compare health care utilization (number of emergency department visits and hospitalizations) by study arm [ Time Frame: 26 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Ovarian Cancer

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.

Study Arms

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.

Interventions:

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

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 23, 2021): 29
• Original Estimated Enrollment (submitted: December 5, 2017): 148
• Actual Study Completion Date: December 5, 2020
• Actual Primary Completion Date: October 31, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03364673
• Other Study ID Numbers: 17-361; CA166210 ( Other Grant/Funding Number: NIH/NCI )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Alexi A. Wright, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Alexi A. Wright, Dana-Farber Cancer Institute, Prinicipal Investigator
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Alexi A. Wright, MD, MPH; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: October 2023