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| ID | Type | Description | Link |
|---|---|---|---|
| CA166210 | Other Grant/Funding Number | NIH/NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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] |
| Change in Daily Steps From Baseline 24 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexi A. Wright, MD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33637350 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Participants who initially consented to the study | Posted | Count of Participants | Participants | 1 year pilot |
|
Adverse events were collected on an ongoing basis throughout the course of the study, Day 1-182.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexi Wright, MD, MPH | Dana-Farber Cancer Institute | 617-632-2334 | alexi_wright@dfci.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2018 | Jun 14, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 20, 2018 | Jun 14, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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| 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. |
|
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] |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital status | Count of Participants | Participants |
|
| International Federation of Gynecology and Obstetrics (FIGO) stage | FIGO Stages range from I through IV. Median overall survival is greatest in early stage disease (IC and II) and worse is stage III-IV. Staging is determined using criteria such as the size of the tumor, if the cancer has spread to nearby lymph nodes, and if the cancer has spread to distant sites or organs. | Count of Participants | Participants |
|
| Histology | Count of Participants | Participants |
|
| ECOG PS | Eastern Cooperative Oncology Group Performance Status 0: Fully active; no performance restrictions.
ECOG of 0 are considered to have fewer restrictions in their activities compared with those with an ECOG 1 or 2 | Count of Participants | Participants |
|
| Time from treatment completion to intervention enrollment, days | Mean | Standard Deviation | days |
|
| Baseline daily steps | Mean | Standard Deviation | steps |
|
| Teammate | Self-selected family member or friend to participate as support partner | Count of Participants | Participants |
|
|
|
| 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) | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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 | Posted | Mean | Standard Deviation | steps | 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 | Posted | Mean | Standard Deviation | steps | 24 weeks [from end to baseline (day 15) to day 182] |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001519 | Behavior |