Improving Physical Activity in Young Adult Cancer Survivors

Study Overview
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Brief Summary
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The Primary Goal is to conduct a 12 week pilot randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mobile health (mHealth) app. The target population will be cancer survivors 18-39 years old recruited from the Seattle Cancer Care Alliance. For the intervention group, peer influences will be engaged via a private, social network (e.g. a Facebook group) customized for survivors. Measurements will be completed (1) at baseline, prior to randomization, and (2) during the final week of the intervention period (follow-up measure). This pilot study will provide initial proof of concept and allow for further customization of the intervention for cancer survivors in anticipation of a future, larger proposal to study physical activity and related outcomes over a multi-year period. Besides conducting exploratory analyses of primary and secondary outcomes for this pilot RCT, we also specify feasibility criteria including: (1) recruiting 50 cancer survivors ages 18-39 years and between 1.0-5.0 years from the completion of active cancer therapy, (2) intervention participants wear the Fitbit Flex on the majority of all intervention days during the 12-week intervention period, and (3) ≥75% of all participants complete online questionnaire data collection at Time 1 and Time 2.

Official Title
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Improving Physical Activity in Young Adult Cancer Survivors

Conditions
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Physical Activity, Quality of Life

Intervention / Treatment
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* Behavioral: Fitbit + Facebook + Coaching Group
* Behavioral: Fitbit only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Does not meet recommended guidelines for physical activity (PA,150 min of moderate activity or 75 min of vigorous activity) Currently between 1.0-5.0 years from the completion of active cancer therapy Able to read and speak English Have a smart phone (or can borrow a study-provided iPod Touch) and willing to use it for the mobile app and Facebook group Exclusion Criteria: Pregnant or planning on becoming pregnant in the next year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fitbit + Facebook + Health Coaching<br>Participants will use the Fitbit device and join the Facebook group. They will also receive brief weekly health coaching from a research staff. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide them with support. | Behavioral: Fitbit + Facebook + Coaching Group<br>* Participants will use the FitBit device to track their physical activity (PA). Participants will receive and post messages and receive badges on the Facebook group. Weekly a research staff member will call them to provide brief health coaching. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide support.<br>|
| Active Comparator: Usual care control with Fitbit only<br>Participants will be loaned a Fitbit device only. They will not join the Facebook group nor receive health coaching. They will not select an adult family member or friend to receive a Fitbit device to provide them with support. | Behavioral: Fitbit only<br>* Participants will receive a Fitbit device only, and will not receive health coaching, join the Facebook group, or select an adult family member or friend to receive a Fitbit to provide them with support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers) |  | up to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-intervention health related quality of life (measured by questionnaire) |  | up to week 12 | 
| Self-determination theory constructs (measured by the Behavioral Regulation in Exercise Questionnaire 2) |  | up to week 12 |