Improving Physical Activity in Young Adult Cancer Survivors

May 23, 2018 updated by: Jason Mendoza, Seattle Children's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98145-5005
        • Seattle Children's Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Collaborators

Fred Hutchinson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2017

Primary Completion (Actual)

May 6, 2018

Study Completion (Actual)

May 22, 2018

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (Actual)

July 28, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Fitbit YA 9865

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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