Physical Activity, Quality of Life
Conditions
Brief summary
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.
Interventions
BEHAVIORALFitbit + Facebook + Coaching Group
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.
BEHAVIORALFitbit only
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.
Sponsors
Fred Hutchinson Cancer Center
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers) | up to week 12 |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed