Evaluating Whether Charity Incentives Motive Cancer Survivors to Increase Physical Activity

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Cancer, Physical Activity, Incentives

Intervention / Treatment
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* Behavioral: Experimental
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 18 years and <50 y, with diagnosed Adolescent or Young Adult cancer (diagnosed between 15-39y of age); ≥ 6 months post-cancer treatment English speaking Participate in <60 minutes of MVPA/week Own a smartphone Have access to computer Participants must also pass a physical activity readiness questionnaire or receive medical clearance from their primary care physician or oncologist. Exclusion Criteria: Joint, cardiovascular, or respiratory problem(s) precluding physical activity Metastatic disease Planned elective surgery or pregnancy during intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery). Already using a wearable device >5 days per week

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Participants will receive a weekly email with a step goal that will increase 10% beyond the previous weeks values. | Behavioral: Control<br>* 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).<br>* Other names: Fitbit-only;|
| Experimental: Intervention<br>The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Participants will receive a weekly email with a step goal that will increase 10% beyond the previous weeks values. Participants will be in the form of a charitable donation in their name to a cancer charity. | Behavioral: Experimental<br>* 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.<br>* Other names: Fitbit+incentives;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily steps | Daily steps as measured by activPAL | 12 weeks - change from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant retention | Proportion of participants retained of those randomized | 12 weeks | 
| Intervention Reach | Proportion of individuals who agree to participate of those who express an interest in participation | Baseline | 
| Step goal adherence | Proportion of weeks meeting physical activity goal as measured by fitbit | 1-12 weeks | 
| Daily Steps | Daily Steps as Measured by Fitbit | baseline to 12 weeks | 
| Sleep | Sleep as Measured by Fitbit | baseline to 12 weeks | 
| Sedentary time | Sedentary time as Measured by activPAL activity monitor | Change from baseline to 12 weeks | 
| Standing time | Standing time as Measured by activPAL | Change from baseline to 12 weeks | 
| Stepping time | Stepping time as Measured by activPAL | Change from baseline to 12 weeks | 
| Moderate-vigorous intensity physical activity (MVPA) time | MVPA time as Measured by activPAL | Change from baseline to 12 weeks | 
| Sedentary breaks/patterns | Sedentary breaks/patterns as Measured by activPAL | Change from baseline to 12 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Pittsburg Sleep Quality Questionnaire | Pittsburg Sleep Quality Questionnaire. Total score. Greater than 5 indicated poor sleep quality. | Change from baseline to 12 weeks | 
| 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 | 
| Intervention Maintenance | % of weeks adhered to step goal as measured by fitbit during 6-week follow-up period | 12-18 weeks | 
| Duration wore Fitbit | Duration wore Fitbit during during 6-week follow-up period | 12-18 weeks | 
| 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 | 
| 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 | 
| 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 |