mHealth Intervention to Promote Cancer Survivors' Physical Activity

NCT ID: NCT02469727

Last Updated: 2016-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Physical Activity Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Fitbit + Facebook

Participants will use the Fitbit device and join the Facebook group.

Group Type EXPERIMENTAL

Fitbit

Intervention Type BEHAVIORAL

Participants will use the FitBit device to track their physical activity

Facebook group

Intervention Type BEHAVIORAL

Participants will receive and post messages and receive badges on the Facebook group

Usual care control

No intervention provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fitbit

Participants will use the FitBit device to track their physical activity

Intervention Type BEHAVIORAL

Facebook group

Participants will receive and post messages and receive badges on the Facebook group

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jason Mendoza

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seattle Children's Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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15563

Identifier Type: -

Identifier Source: org_study_id

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