Improving Physical Activity in Young Adult Cancer Survivors

Not Applicable

Completed

• Conditions: Quality of Life; Physical Activity
• Interventions: Behavioral: Fitbit only; Behavioral: Fitbit + Facebook + Coaching Group

• Registration Number: NCT03233581
• Lead Sponsor: Seattle Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-28
• Study Start: 2017-09-12
• Status Verified: 2018-05
• Primary Completion: 2018-05-06
• Study Completion: 2018-05-22
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care control with Fitbit only	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.
Fitbit + Facebook + Health Coaching	Fitbit + Facebook + Coaching Group	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.

Primary Outcome Measures

Name	Time	Method
Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers)	up to week 12

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

Seattle Children's Research Institute; 🇺🇸 Seattle, Washington, United States