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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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care |
| Condition |
Ovarian Cancer |
| Interventions |
Other: Fitness Tracker Other: Social Incentive (Way to Health) |
| Enrollment | 29 |
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Fitness Tracker + Social Incentive Intervention |
|---|---|
 Arm/Group Description |
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. |
| Period Title: Overall Study | |
| Started | 29 |
| Completed | 24 |
| Not Completed | 5 |
| Reason Not Completed | |
| Withdrawal by Subject | 2 |
| Injury unrelated to study | 3 |
| Arm/Group Title | Fitness Tracker + Social Incentive Intervention | |
|---|---|---|
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Arm/Group Description |
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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| Overall Number of Baseline Participants | 24 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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| Number Analyzed | 24 participants | |
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63
(37 to 79)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 24 participants | |
| Female |
24 100.0%
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| Male |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 24 participants | |
| American Indian or Alaska Native |
0 0.0%
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| Asian |
1 4.2%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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| Black or African American |
0 0.0%
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| White |
23 95.8%
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| More than one race |
0 0.0%
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| Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 24 participants |
| 24 | ||
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Marital status
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 24 participants | |
| Married, partnered |
18 75.0%
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| Single |
4 16.7%
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| Widowed, separated |
2 8.3%
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International Federation of Gynecology and Obstetrics (FIGO) stage
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 24 participants | |
| IC |
5 20.8%
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| II |
1 4.2%
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| III |
1 4.2%
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| IIIB |
3 12.5%
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| IIIC |
6 25.0%
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| IVA |
3 12.5%
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| IVB |
5 20.8%
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[1]
Measure Description:
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. |
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Histology
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 24 participants | |
| Serous |
19 79.2%
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| Endometrioid |
3 12.5%
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| Carcinosarcoma |
1 4.2%
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| Clear cell |
1 4.2%
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ECOG PS
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 24 participants | |
| 0 |
5 20.8%
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| 1 |
15 62.5%
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| 2 |
4 16.7%
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[1]
Measure Description:
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 |
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Time from treatment completion to intervention enrollment, days
Mean (Standard Deviation) Unit of measure: Days |
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| Number Analyzed | 24 participants | |
| 45 (35) | ||
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Baseline daily steps
Mean (Standard Deviation) Unit of measure: Steps |
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| Number Analyzed | 24 participants | |
| 6210 (3328) | ||
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Teammate
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 24 participants | |
| Spouse, partner |
11 45.8%
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| Sibling |
4 16.7%
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| Parent |
3 12.5%
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| Child |
2 8.3%
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| Other |
4 16.7%
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[1]
Measure Description: Self-selected family member or friend to participate as support partner
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- 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).
| Name/Title: | Alexi Wright, MD, MPH |
| Organization: | Dana-Farber Cancer Institute |
| Phone: | 617-632-2334 |
| EMail: | alexi_wright@dfci.harvard.edu |
| Responsible Party: | Alexi A. Wright, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT03364673 |
| Other Study ID Numbers: |
17-361 CA166210 ( Other Grant/Funding Number: NIH/NCI ) |
| First Submitted: | October 17, 2017 |
| First Posted: | December 6, 2017 |
| Results First Submitted: | June 28, 2021 |
| Results First Posted: | September 17, 2021 |
| Last Update Posted: | October 13, 2023 |