CancerNCT03322059
Evaluating Whether Charity Incentives Motive Cancer Survivors to Increase Physical Activity
A study testing Experimental in people with Cancer and Physical Activity, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Physical Activity, Incentives
- What is being tested?
- Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
California Polytechnic State University
San Luis Obispo, California, 94307
About this study
Official title: 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.
Read the 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).
- Conditions
- Cancer, Physical Activity, Incentives
- Being tested
- Experimental, Control
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalBehavioural
Also called Fitbit+incentives
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.
ControlBehavioural
Also called Fitbit-only
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).
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Behavioral: Control |
| Intervention | Experimental | 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. Receives: Behavioral: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily steps
Daily steps as measured by activPAL
Measured: 12 weeks - change from baseline to 12 weeks
Secondary outcomes (24)
Participant retention
Proportion of participants retained of those randomized
Measured: 12 weeks
Intervention Reach
Proportion of individuals who agree to participate of those who express an interest in participation
Measured: Baseline
Step goal adherence
Proportion of weeks meeting physical activity goal as measured by fitbit
Measured: 1-12 weeks
Daily Steps
Daily Steps as Measured by Fitbit
Measured: baseline to 12 weeks
Sleep
Sleep as Measured by Fitbit
Measured: baseline to 12 weeks
Sedentary time
Sedentary time as Measured by activPAL activity monitor
Measured: Change from baseline to 12 weeks
Standing time
Standing time as Measured by activPAL
Measured: Change from baseline to 12 weeks
Stepping time
Stepping time as Measured by activPAL
Measured: Change from baseline to 12 weeks
Moderate-vigorous intensity physical activity (MVPA) time
MVPA time as Measured by activPAL
Measured: Change from baseline to 12 weeks
Sedentary breaks/patterns
Sedentary breaks/patterns as Measured by activPAL
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Change from baseline to 12 weeks
Pittsburg Sleep Quality Questionnaire
Pittsburg Sleep Quality Questionnaire. Total score. Greater than 5 indicated poor sleep quality.
Measured: 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
Measured: Change from baseline to 12 weeks
Intervention Maintenance
% of weeks adhered to step goal as measured by fitbit during 6-week follow-up period
Measured: 12-18 weeks
Duration wore Fitbit
Duration wore Fitbit during during 6-week follow-up period
Measured: 12-18 weeks
Exercise outcome expectations
Multidimensional Outcome Expectations for Exercise Scale. Total score (range 15-75), higher score means more multidimensional outcome expectations.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Nov 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah K Keadle, California Polytechnic State University-San Luis Obispo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322059
- Sponsor's protocol ID
- RSCA111
- Status last verified
- Jul 2019
- First submitted
- 13 Oct 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33825070
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Charity-based Incentives to Increase Physical Activity Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT03322059
- Acronym / sponsor ID
- RSCA111
- Conditions
- Cancer, Physical Activity, Incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlThe 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. |
| Intervention | Experimental | Behavioral: ExperimentalThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalAlso: Fitbit+incentivesParticipants 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. | Behavioural | Intervention |
| ControlAlso: Fitbit-onlyParticipants 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). | Behavioural | Control |
Primary outcome
Daily steps
Time frame: 12 weeks - change from baseline to 12 weeks
Daily steps as measured by activPAL
24 secondary outcomes
Participant retention
Time frame: 12 weeks
Intervention Reach
Time frame: Baseline
Step goal adherence
Time frame: 1-12 weeks
Daily Steps
Time frame: baseline to 12 weeks
Sleep
Time frame: baseline to 12 weeks
Sedentary time
Time frame: Change from baseline to 12 weeks
Standing time
Time frame: Change from baseline to 12 weeks
Stepping time
Time frame: Change from baseline to 12 weeks
Moderate-vigorous intensity physical activity (MVPA) time
Time frame: Change from baseline to 12 weeks
Sedentary breaks/patterns
Time frame: Change from baseline to 12 weeks
Fatigue
Time frame: Change from baseline to 12 weeks
Physical Function
Time frame: Change from baseline to 12 weeks
Depression
Time frame: Change from baseline to 12 weeks
Attitudes Toward Charitable Giving
Time frame: Change from baseline to 12 weeks
Behavioral Regulation in Exercise Questionnaire
Time frame: Change from baseline to 12 weeks
Barriers Self-efficacy Scale
Time frame: Change from baseline to 12 weeks
Physical Activity Enjoyment
Time frame: Change from baseline to 12 weeks
Pittsburg Sleep Quality Questionnaire
Time frame: Change from baseline to 12 weeks
Exercise Self-efficacy Scale
Time frame: Change from baseline to 12 weeks
Intervention Maintenance
Time frame: 12-18 weeks
Duration wore Fitbit
Time frame: 12-18 weeks
Exercise outcome expectations
Time frame: Change from baseline to 12 weeks
Sleep disturbance
Time frame: Change from baseline to 12 weeks
Exercise Goal Setting
Time frame: Change from baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Derived from this study: PubMed 33825070Keadle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Cancer and Physical Activity, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily steps (time frame: 12 weeks - change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03322059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.