Evaluating Whether Charity Incentives Motive Cancer Survivors to Increase Physical Activity

July 22, 2019 updated by: Sarah K Keadle, California Polytechnic State University-San Luis Obispo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Luis Obispo, California, United States, 94307
        • California Polytechnic State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control

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
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
Experimental: Intervention

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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Polytechnic State University-San Luis Obispo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (Actual)

October 26, 2017

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • RSCA111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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