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

NCT03364673 | Completed Results DMC

• 2 other identifiers: 17-361CA166210
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Physical Activity; Mobile Health; Fitness Tracker; Survivorship; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Change in Daily Steps From Baseline to 12 Weeks

  12 weeks [from end of baseline (day 15) to day 98]

• Change in Daily Steps From Baseline 24 Weeks

  24 weeks [from end to baseline (day 15) to day 182]

Study Arms (1)

Fitness Tracker + Social Incentive Intervention

EXPERIMENTAL

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; Other: Social Incentive (Way to Health)

Interventions

Fitness Tracker OTHER

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

Fitness Tracker + Social Incentive Intervention

Social Incentive (Way to Health) OTHER

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.

Fitness Tracker + Social Incentive Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related 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.

  PMID: 33637350 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Motor Activity

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Limitations and Caveats

* Single-arm pilot study without a control group * Participants were recruited from a single academic center, were required to have a smartphone, and needed to be able to identify a teammate. This may have resulted in the selection of a more affluent, educated, and socially-connected population than is representative of ovarian cancer survivors nationwide. * We did not specifically measure other types of activity not captured by Fitbits (e.g., swimming or biking).

Results Point of Contact

• Title: Alexi Wright, MD, MPH
• Organization: Dana-Farber Cancer Institute

alexi_wright@dfci.harvard.edu

617-632-2334

Study Officials

• Alexi A. Wright, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: December 6, 2017
• Study Start: July 20, 2018
• Primary Completion: October 31, 2019
• Study Completion: December 5, 2020
• Last Updated: October 13, 2023
• Results First Posted: September 17, 2021

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)