Evaluating Whether Charity Incentives Motive Cancer Survivors to Increase Physical Activity

Cancer Clinical Trial

Official title:

Randomized Trial of Charity-based Incentives to Increase Physical Activity Among Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322059
• Other study ID #: RSCA111
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: July 2019
• Source: California Polytechnic State University-San Luis Obispo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose to examine whether linking daily activity with charity-based incentives motivates cancer survivors to initiate and maintain physical activity. Linking daily physical activity goals with a cancer specific charity incentive may provide a uniquely salient motivator that promotes increased physical activity among cancer survivors. The investigators will examine whether using activity monitors in combination with charitable incentives leads to greater increases in physical activity compared to activity monitors alone. Target participants includes cancer survivors who are not already active. Physical activity (e.g., steps per day, time in moderate-intensity activity) will be examined at baseline and following a 12-week intervention period using an activPAL accelerometer. After the baseline assessment, both groups will receive a fitbit monitor and informational material designed to increase physical activity. Participants in the fitbit+charity group will have donations made in their name to a cancer charity if they meet daily step goals. Physical activity levels will be monitored using the fitbit device for 6-weeks following the formal intervention period.

Description:

The study is a Randomized Controlled Trial (RCT) of a 12-week physical activity intervention. Fifty cancer survivors will be recruited and allocated to one of two research arms: Fitbit+Only Group or Fitbit+Charity Incentives Group. Participants in both intervention arms will be asked to track their physical activities using Fitbit One, an activity monitor that monitors steps and physical activity and will receive basic educational materials about increasing physical activity. Those in the Fitbit+charity incentives Group will raise money for cancer charities if they meet weekly step targets.

The key outcome variable of the RCT is steps as measured by an activPAL accelerometer. Data will be collected at baseline and 12-weeks. Fitbit data will also be collected for the duration of the 12-week intervention and for 6-weeks following the end of the intervention period to have an initial examination of behavior change maintenance (total 18-weeks).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Adults = 18 years and <50 y, with diagnosed Adolescent or Young Adult cancer (diagnosed between 15-39y of age);

2. = 6 months post-cancer treatment

3. English speaking

4. Participate in <60 minutes of MVPA/week

5. Own a smartphone

6. Have access to computer

7. Participants must also pass a physical activity readiness questionnaire or receive medical clearance from their primary care physician or oncologist.

Exclusion Criteria:

1. Joint, cardiovascular, or respiratory problem(s) precluding physical activity

2. Metastatic disease

3. Planned elective surgery or pregnancy during intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).

4. Already using a wearable device >5 days per week

Related Conditions & MeSH terms

• Cancer
• Incentives
• Physical Activity

Intervention

Behavioral:
• Experimental
Participants will receive a fitbit and lifestyle counseling to increase steps. Weekly newsletter for first 6 weeks, bi-weekly for remaining weeks with behavioral content designed to increase physical activity (e.g., barriers, SMART goals). They will also receive a donation to a cancer charity of their choice if they meet daily step goals.
• Control
Participants will receive a fitbit and lifestyle counseling to increase steps. Weekly newsletter for first 6 weeks, bi-weekly for remaining weeks with behavioral content designed to increase physical activity (e.g., barriers, SMART goals).

Locations

Country	Name	City	State
United States	California Polytechnic State University	San Luis Obispo	California

Sponsors (1)

Lead Sponsor	Collaborator
California Polytechnic State University-San Luis Obispo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily steps	Daily steps as measured by activPAL	12 weeks - change from baseline to 12 weeks
Secondary	Participant retention	Proportion of participants retained of those randomized	12 weeks
Secondary	Intervention Reach	Proportion of individuals who agree to participate of those who express an interest in participation	Baseline
Secondary	Step goal adherence	Proportion of weeks meeting physical activity goal as measured by fitbit	1-12 weeks
Secondary	Daily Steps	Daily Steps as Measured by Fitbit	baseline to 12 weeks
Secondary	Sleep	Sleep as Measured by Fitbit	baseline to 12 weeks
Secondary	Sedentary time	Sedentary time as Measured by activPAL activity monitor	Change from baseline to 12 weeks
Secondary	Standing time	Standing time as Measured by activPAL	Change from baseline to 12 weeks
Secondary	Stepping time	Stepping time as Measured by activPAL	Change from baseline to 12 weeks
Secondary	Moderate-vigorous intensity physical activity (MVPA) time	MVPA time as Measured by activPAL	Change from baseline to 12 weeks
Secondary	Sedentary breaks/patterns	Sedentary breaks/patterns as Measured by activPAL	Change from baseline to 12 weeks
Secondary	Fatigue	Patient-Reported Outcomes Measurement Information System Fatigue Short Form 8a (Total Score range 8-40). higher score is more fatigue.	Change from baseline to 12 weeks
Secondary	Physical Function	Patient-Reported Outcomes Measurement Information System Physical Function Short Form 20a. Total score (range 20-100). Higher score is worse physical function	Change from baseline to 12 weeks
Secondary	Depression	Patient-Reported Outcomes Measurement Information System Depression Short Form 8a. Total score range 8-40. Higher score is more depressed.	Change from baseline to 12 weeks
Secondary	Attitudes Toward Charitable Giving	Attitudes Toward Charitable Giving Scale. Total of 20 questions with scores from 1-5, there are five domains higher score is more of a particular attitude. 1.) Inefficiency of Charitable Giving 2.) Efficiency of Charitable Giving 3.) Cynical Giving 4.) Altruistic Giving 5.) Purpose of Charity	Change from baseline to 12 weeks
Secondary	Behavioral Regulation in Exercise Questionnaire	Behavioral Regulation in Exercise Questionnaire -3. Contains 6 subscales Amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, intrinsic regulation, each range from 0-16, higher values indicate more motivation in that domain.	Change from baseline to 12 weeks
Secondary	Barriers Self-efficacy Scale	Barriers Self-efficacy Scale. 15 items, total score range 0-1500. Higher indicated more self-efficacy	Change from baseline to 12 weeks
Secondary	Physical Activity Enjoyment	Physical Activity Enjoyment Scale. 18-item scale with 7-point bipolar rating. Total score range 18-126. Higher scores reflect greater levels of enjoyment.	Change from baseline to 12 weeks
Secondary	Pittsburg Sleep Quality Questionnaire	Pittsburg Sleep Quality Questionnaire. Total score. Greater than 5 indicated poor sleep quality.	Change from baseline to 12 weeks
Secondary	Exercise Self-efficacy Scale	Exercise Self-efficacy Scale. 6 items total score. Range 0-600, higher is more self-efficacy	Change from baseline to 12 weeks
Secondary	Intervention Maintenance	% of weeks adhered to step goal as measured by fitbit during 6-week follow-up period	12-18 weeks
Secondary	Duration wore Fitbit	Duration wore Fitbit during during 6-week follow-up period	12-18 weeks
Secondary	Exercise outcome expectations	Multidimensional Outcome Expectations for Exercise Scale. Total score (range 15-75), higher score means more multidimensional outcome expectations.	Change from baseline to 12 weeks
Secondary	Sleep disturbance	Patient-Reported Outcomes Measurement Information System Sleep Disturbance Form. Total score range 8-40. Higher score is more disturbance.	Change from baseline to 12 weeks
Secondary	Exercise Goal Setting	10-item total score. Ranged from 10 to 50, higher score means more goal setting. Exercise Goal-Setting Scale.	Change from baseline to 12 weeks