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Completed

NCT Number: NCT03322059

Evaluating Whether Charity Incentives Motive Cancer Survivors to Increase Physical Activity

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.

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Key information

Conditions

Cancer Behavior Incentives Motor Activity Neoplasms Physical Activity

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Polytechnic State University

San Luis Obispo, California, 94307, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental

Behavioral

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.

Other names: Fitbit+incentives

Control

Behavioral

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).

Other names: Fitbit-only

Primary outcomes

  1. Daily steps

    Time frame: 12 weeks - change from baseline to 12 weeks

    Daily steps as measured by activPAL

Secondary outcomes

  1. Participant retention

    Time frame: 12 weeks

    Proportion of participants retained of those randomized

  2. Intervention Reach

    Time frame: Baseline

    Proportion of individuals who agree to participate of those who express an interest in participation

  3. Step goal adherence

    Time frame: 1-12 weeks

    Proportion of weeks meeting physical activity goal as measured by fitbit

  4. Daily Steps

    Time frame: baseline to 12 weeks

    Daily Steps as Measured by Fitbit

  5. Sleep

    Time frame: baseline to 12 weeks

    Sleep as Measured by Fitbit

  6. Sedentary time

    Time frame: Change from baseline to 12 weeks

    Sedentary time as Measured by activPAL activity monitor

  7. Standing time

    Time frame: Change from baseline to 12 weeks

    Standing time as Measured by activPAL

  8. Stepping time

    Time frame: Change from baseline to 12 weeks

    Stepping time as Measured by activPAL

  9. Moderate-vigorous intensity physical activity (MVPA) time

    Time frame: Change from baseline to 12 weeks

    MVPA time as Measured by activPAL

  10. Sedentary breaks/patterns

    Time frame: Change from baseline to 12 weeks

    Sedentary breaks/patterns as Measured by activPAL

  11. Fatigue

    Time frame: Change from baseline to 12 weeks

    Patient-Reported Outcomes Measurement Information System Fatigue Short Form 8a (Total Score range 8-40). higher score is more fatigue.

  12. Physical Function

    Time frame: Change from baseline to 12 weeks

    Patient-Reported Outcomes Measurement Information System Physical Function Short Form 20a. Total score (range 20-100). Higher score is worse physical function

  13. Depression

    Time frame: Change from baseline to 12 weeks

    Patient-Reported Outcomes Measurement Information System Depression Short Form 8a. Total score range 8-40. Higher score is more depressed.

  14. Attitudes Toward Charitable Giving

    Time frame: Change from baseline to 12 weeks

    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

  15. Behavioral Regulation in Exercise Questionnaire

    Time frame: Change from baseline to 12 weeks

    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.

  16. Barriers Self-efficacy Scale

    Time frame: Change from baseline to 12 weeks

    Barriers Self-efficacy Scale. 15 items, total score range 0-1500. Higher indicated more self-efficacy

  17. Physical Activity Enjoyment

    Time frame: Change from baseline to 12 weeks

    Physical Activity Enjoyment Scale. 18-item scale with 7-point bipolar rating. Total score range 18-126. Higher scores reflect greater levels of enjoyment.

  18. Pittsburg Sleep Quality Questionnaire

    Time frame: Change from baseline to 12 weeks

    Pittsburg Sleep Quality Questionnaire. Total score. Greater than 5 indicated poor sleep quality.

  19. Exercise Self-efficacy Scale

    Time frame: Change from baseline to 12 weeks

    Exercise Self-efficacy Scale. 6 items total score. Range 0-600, higher is more self-efficacy

  20. Intervention Maintenance

    Time frame: 12-18 weeks

    % of weeks adhered to step goal as measured by fitbit during 6-week follow-up period

  21. Duration wore Fitbit

    Time frame: 12-18 weeks

    Duration wore Fitbit during during 6-week follow-up period

  22. Exercise outcome expectations

    Time frame: Change from baseline to 12 weeks

    Multidimensional Outcome Expectations for Exercise Scale. Total score (range 15-75), higher score means more multidimensional outcome expectations.

  23. Sleep disturbance

    Time frame: Change from baseline to 12 weeks

    Patient-Reported Outcomes Measurement Information System Sleep Disturbance Form. Total score range 8-40. Higher score is more disturbance.

  24. Exercise Goal Setting

    Time frame: Change from baseline to 12 weeks

    10-item total score. Ranged from 10 to 50, higher score means more goal setting. Exercise Goal-Setting Scale.

Sponsors and collaborators

Lead sponsor

California Polytechnic State University-San Luis Obispo

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 26, 2017
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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