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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Cancer

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings