mHealth Intervention to Promote Cancer Survivors' Physical Activity

Quality of Life Clinical Trial

Official title:

mHealth Intervention to Promote Cancer Survivors' Physical Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469727
• Other study ID #: 15563
• Status: Completed
• Phase: N/A
• First received: June 8, 2015
• Last updated: October 12, 2016
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Physical Activity
• Quality of Life

Intervention

Behavioral:
• Fitbit
Participants will use the FitBit device to track their physical activity
• Facebook group
Participants will receive and post messages and receive badges on the Facebook group

Locations

Country	Name	City	State
United States	Seattle Children's Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-intervention physical activity (measured by accelerometers)		up to week 10	No
Secondary	Post-intervention health related quality of life (measured by questionnaire)		up to week 10	No