Trial Outcomes & Findings for Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer (NCT NCT03364673)
NCT ID: NCT03364673
Last Updated: 2023-10-13
Results Overview
Feasibility will be defined as ≥60% of patients who participate in the pilot study complete the 24-week intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
1 year pilot
Results posted on
2023-10-13
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Injury unrelated to study
|
3
|
Baseline Characteristics
Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Fitness Tracker + Social Incentive Intervention
n=24 Participants
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.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
|
Marital status
Married, partnered
|
18 Participants
n=5 Participants
|
|
Marital status
Single
|
4 Participants
n=5 Participants
|
|
Marital status
Widowed, separated
|
2 Participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) stage
IC
|
5 Participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) stage
II
|
1 Participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) stage
III
|
1 Participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) stage
IIIB
|
3 Participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) stage
IIIC
|
6 Participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) stage
IVA
|
3 Participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) stage
IVB
|
5 Participants
n=5 Participants
|
|
Histology
Serous
|
19 Participants
n=5 Participants
|
|
Histology
Endometrioid
|
3 Participants
n=5 Participants
|
|
Histology
Carcinosarcoma
|
1 Participants
n=5 Participants
|
|
Histology
Clear cell
|
1 Participants
n=5 Participants
|
|
ECOG PS
0
|
5 Participants
n=5 Participants
|
|
ECOG PS
1
|
15 Participants
n=5 Participants
|
|
ECOG PS
2
|
4 Participants
n=5 Participants
|
|
Time from treatment completion to intervention enrollment, days
|
45 days
STANDARD_DEVIATION 35 • n=5 Participants
|
|
Baseline daily steps
|
6210 steps
STANDARD_DEVIATION 3328 • n=5 Participants
|
|
Teammate
Spouse, partner
|
11 Participants
n=5 Participants
|
|
Teammate
Sibling
|
4 Participants
n=5 Participants
|
|
Teammate
Parent
|
3 Participants
n=5 Participants
|
|
Teammate
Child
|
2 Participants
n=5 Participants
|
|
Teammate
Other
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year pilotPopulation: Participants who initially consented to the study
Feasibility will be defined as ≥60% of patients who participate in the pilot study complete the 24-week intervention
Outcome measures
| Measure |
Fitness Tracker + Social Incentive Intervention
n=29 Participants
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.
|
|---|---|
|
Feasibility of the Accelerometer + Social Support + Gamification
Completed intervention and follow-up period
|
24 Participants
|
|
Feasibility of the Accelerometer + Social Support + Gamification
Did not complete intervention and follow-up period
|
5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksStudy 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)
Outcome measures
| Measure |
Fitness Tracker + Social Incentive Intervention
n=24 Participants
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.
|
|---|---|
|
Acceptability
Participants indicate that the study was burdensome
|
1 Participants
|
|
Acceptability
Participants did not indicate that the study was burdensome
|
23 Participants
|
PRIMARY outcome
Timeframe: 24 weeksTo 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.
Outcome measures
| Measure |
Fitness Tracker + Social Incentive Intervention
n=24 Participants
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.
|
|---|---|
|
Perceived Effectiveness
"strongly agree" or "agree"
|
21 Participants
|
|
Perceived Effectiveness
"strongly disagree", "disagree", or "neutral"
|
3 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Fitness Tracker + Social Incentive Intervention
n=24 Participants
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.
|
|---|---|
|
Change in Daily Steps From Baseline to 12 Weeks
Baseline (Day 1-14)
|
6210.7 steps
Standard Deviation 3328.1
|
|
Change in Daily Steps From Baseline to 12 Weeks
Intervention (Day 15-98)
|
7643.0 steps
Standard Deviation 3610.9
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Fitness Tracker + Social Incentive Intervention
n=24 Participants
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.
|
|---|---|
|
Change in Daily Steps From Baseline 24 Weeks
Baseline (Day 1-15)
|
6210.7 steps
Standard Deviation 3328.1
|
|
Change in Daily Steps From Baseline 24 Weeks
Follow-up (Day 98-182)
|
6435.1 steps
Standard Deviation 3550.6
|
Adverse Events
Fitness Tracker + Social Incentive Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place