Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer
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| ClinicalTrials.gov Identifier: NCT03364673 |
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Recruitment Status :
Completed
First Posted : December 6, 2017
Results First Posted : September 17, 2021
Last Update Posted : October 13, 2023
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| 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.
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 (Clinical Trial) |
| Actual Enrollment : | 29 participants |
| Allocation: | N/A |
| 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 |
| Actual Primary Completion Date : | October 31, 2019 |
| Actual Study Completion Date : | December 5, 2020 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 ]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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
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
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Alexi A. Wright, MD, MPH | Dana-Farber Cancer Institute |
Documents provided by Alexi A. Wright, MD, Dana-Farber Cancer Institute:
| Responsible Party: | Alexi A. Wright, MD, Prinicipal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT03364673 |
| Other Study ID Numbers: |
17-361 CA166210 ( Other Grant/Funding Number: NIH/NCI ) |
| First Posted: | December 6, 2017 Key Record Dates |
| Results First Posted: | September 17, 2021 |
| Last Update Posted: | October 13, 2023 |
| Last Verified: | October 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Ovarian Cancer Physical Activity Mobile Health |
Fitness Tracker Survivorship Quality of Life |
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial 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 Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |