Improving Physical Activity in Young Adult Cancer Survivors

Quality of Life Clinical Trial

Official title:

Improving Physical Activity in Young Adult Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233581
• Other study ID #: Fitbit YA 9865
• Status: Completed
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: May 22, 2018

Study information

• Verified date: May 2018
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 22, 2018
• Est. primary completion date: May 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity
• Quality of Life

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Seattle Children's Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers)		up to week 12
Secondary	Post-intervention health related quality of life (measured by questionnaire)		up to week 12
Secondary	Self-determination theory constructs (measured by the Behavioral Regulation in Exercise Questionnaire 2)		up to week 12