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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03364673
• Other study ID #: 17-361
• Secondary ID: CA166210
• Status: Completed
• Phase: N/A
• Start date: July 20, 2018
• Est. completion date: December 5, 2020

Study information

• Verified date: October 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 5, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

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
• 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.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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]
Secondary	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]