mHealth Intervention to Promote Cancer Survivors' Physical Activity

The Primary Goal is to conduct a 5-10 week randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mHealth app. The target population will be childhood cancer survivors 14-18 years old recruited from Seattle Children's Hospital. 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 study will provide initial proof of concept and allow for further customization of the intervention for childhood cancer survivors in anticipation of a future, larger proposal to study physical activity and related outcomes over a multi-year period.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Physical Activity
• Intervention / Treatment: Behavioral: Fitbit; Behavioral: Facebook group

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98145-5005
      • Seattle Children's Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• in remission for childhood cancer and previously treated for childhood cancer at Seattle Children's Hospital
• ≥1-year post-cancer therapy
• ambulatory without any known medical contraindications to participation
• able to complete surveys in English
• agree to install and share data from the FitBit smart phone app with the investigators

Exclusion Criteria:

• currently or previously used a wearable physical activity sensing device to improve physical activity

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fitbit + Facebook; Participants will use the Fitbit device and join the Facebook group.	Behavioral: Fitbit; Participants will use the FitBit device to track their physical activity; Behavioral: Facebook group; Participants will receive and post messages and receive badges on the Facebook group
No Intervention: Usual care control; No intervention provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-intervention physical activity (measured by accelerometers)	up to week 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Post-intervention health related quality of life (measured by questionnaire)	up to week 10

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 9, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 15563