Improving Physical Activity in Young Adult Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT03233581|
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : May 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity Quality of Life||Behavioral: Fitbit + Facebook + Coaching Group Behavioral: Fitbit only||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Improving Physical Activity in Young Adult Cancer Survivors|
|Actual Study Start Date :||September 12, 2017|
|Actual Primary Completion Date :||May 6, 2018|
|Actual Study Completion Date :||May 22, 2018|
Experimental: Fitbit + Facebook + Health Coaching
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
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.
Active Comparator: Usual care control with Fitbit only
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
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.
- Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers) [ Time Frame: up to week 12 ]
- Post-intervention health related quality of life (measured by questionnaire) [ Time Frame: up to week 12 ]
- Self-determination theory constructs (measured by the Behavioral Regulation in Exercise Questionnaire 2) [ Time Frame: up to week 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233581
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Seattle Children's Research Institute|
|Seattle, Washington, United States, 98145-5005|