An interventional study of Experimental and Control in Cancer, Physical Activity and Incentives, sponsored by California Polytechnic State University-San Luis Obispo. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by California Polytechnic State University-San Luis Obispo · Not applicable, Interventional, and Prevention
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.
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).
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →California Polytechnic State University-San Luis Obispo is the lead sponsor of 29 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Also known as: 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).
Also known as: Fitbit-only
Daily steps
Daily steps as measured by activPAL
Time frame: 12 weeks - change from baseline to 12 weeks
Participant retention
Proportion of participants retained of those randomized
Time frame: 12 weeks
Intervention Reach
Proportion of individuals who agree to participate of those who express an interest in participation
Time frame: Baseline
Step goal adherence
Proportion of weeks meeting physical activity goal as measured by fitbit
Time frame: 1-12 weeks
Daily Steps
Daily Steps as Measured by Fitbit
Time frame: baseline to 12 weeks
Sleep
Sleep as Measured by Fitbit
Time frame: baseline to 12 weeks
Sedentary time
Sedentary time as Measured by activPAL activity monitor
Time frame: Change from baseline to 12 weeks
Standing time
Standing time as Measured by activPAL
Time frame: Change from baseline to 12 weeks
Stepping time
Stepping time as Measured by activPAL
Time frame: Change from baseline to 12 weeks
Moderate-vigorous intensity physical activity (MVPA) time
MVPA time as Measured by activPAL
Time frame: Change from baseline to 12 weeks
Sedentary breaks/patterns
Sedentary breaks/patterns as Measured by activPAL
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Change from baseline to 12 weeks
Pittsburg Sleep Quality Questionnaire
Pittsburg Sleep Quality Questionnaire. Total score. Greater than 5 indicated poor sleep quality.
Time frame: 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
Time frame: Change from baseline to 12 weeks
Intervention Maintenance
% of weeks adhered to step goal as measured by fitbit during 6-week follow-up period
Time frame: 12-18 weeks
Duration wore Fitbit
Duration wore Fitbit during during 6-week follow-up period
Time frame: 12-18 weeks
Exercise outcome expectations
Multidimensional Outcome Expectations for Exercise Scale. Total score (range 15-75), higher score means more multidimensional outcome expectations.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to 12 weeks
Ran from Nov 2017 to primary completion in Dec 2018, 13 months.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 13 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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California Polytechnic State University-San Luis Obispo