mHealth Intervention to Promote Cancer Survivors' Physical Activity
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedOctober 13, 2016
October 1, 2016
1 year
June 8, 2015
October 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Post-intervention physical activity (measured by accelerometers)
up to week 10
Secondary Outcomes (1)
Post-intervention health related quality of life (measured by questionnaire)
up to week 10
Study Arms (2)
Fitbit + Facebook
EXPERIMENTALParticipants will use the Fitbit device and join the Facebook group.
Usual care control
NO INTERVENTIONNo intervention provided.
Interventions
Participants will use the FitBit device to track their physical activity
Participants will receive and post messages and receive badges on the Facebook group
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- currently or previously used a wearable physical activity sensing device to improve physical activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seattle Children's Research Institute
Seattle, Washington, 98145-5005, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 8, 2015
First Posted
June 11, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
October 13, 2016
Record last verified: 2016-10