Clinical trial NCT03322059: Evaluating Whether Charity Incentives Motive Cancer Survivors to Increase Physical Activity
Official title: Randomized Trial of Charity-based Incentives to Increase Physical Activity Among Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Physical Activity
Incentives
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Daily steps
timeFrame: 12 weeks - change from baseline to 12 weeks
Secondary outcomes:
measure: Participant retention
timeFrame: 12 weeks
measure: Intervention Reach
timeFrame: Baseline
measure: Step goal adherence
timeFrame: 1-12 weeks
measure: Daily Steps
timeFrame: baseline to 12 weeks
measure: Sleep
timeFrame: baseline to 12 weeks
measure: Sedentary time
timeFrame: Change from baseline to 12 weeks
measure: Standing time
timeFrame: Change from baseline to 12 weeks
measure: Stepping time
timeFrame: Change from baseline to 12 weeks
measure: Moderate-vigorous intensity physical activity (MVPA) time
timeFrame: Change from baseline to 12 weeks
measure: Sedentary breaks/patterns
timeFrame: Change from baseline to 12 weeks
measure: Fatigue
timeFrame: Change from baseline to 12 weeks
measure: Physical Function
timeFrame: Change from baseline to 12 weeks
measure: Depression
timeFrame: Change from baseline to 12 weeks
measure: Attitudes Toward Charitable Giving
timeFrame: Change from baseline to 12 weeks
measure: Behavioral Regulation in Exercise Questionnaire
timeFrame: Change from baseline to 12 weeks
measure: Barriers Self-efficacy Scale
timeFrame: Change from baseline to 12 weeks
measure: Physical Activity Enjoyment
timeFrame: Change from baseline to 12 weeks
measure: Pittsburg Sleep Quality Questionnaire
timeFrame: Change from baseline to 12 weeks
measure: Exercise Self-efficacy Scale
timeFrame: Change from baseline to 12 weeks
measure: Intervention Maintenance
timeFrame: 12-18 weeks
measure: Duration wore Fitbit
timeFrame: 12-18 weeks
measure: Exercise outcome expectations
timeFrame: Change from baseline to 12 weeks
measure: Sleep disturbance
timeFrame: Change from baseline to 12 weeks
measure: Exercise Goal Setting
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: California Polytechnic State University
state: California
Study officials:
References:
citation: Keadle SK, Meuter L, Phelan S, Phillips SM. Charity-based incentives motivate young adult cancer survivors to increase physical activity: a pilot randomized clinical trial. J Behav Med. 2021 Oct;44(5):682-693. doi: 10.1007/s10865-021-00218-w. Epub 2021 Apr 7.