Improving Physical Activity in Young Adult Cancer Survivors

NCT ID: NCT03233581

Last Updated: 2018-05-25

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-12

Study Completion Date

2018-05-22

Brief Summary

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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.

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 + 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.

Group Type EXPERIMENTAL

Fitbit + Facebook + Coaching Group

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Fitbit only

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fred Hutchinson Cancer Center

OTHER

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jason Mendoza

Investigator and Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Seattle Children's Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Johnson AM, Baker KS, Haviland MJ, Syrjala KL, Abbey-Lambertz M, Chow EJ, Mendoza JA. A Pilot Randomized Controlled Trial of a Fitbit- and Facebook-Based Physical Activity Intervention for Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2022 Aug;11(4):379-388. doi: 10.1089/jayao.2021.0056. Epub 2021 Oct 22.

Reference Type DERIVED
PMID: 34677081 (View on PubMed)

Miropolsky EM, Scott Baker K, Abbey-Lambertz M, Syrjala K, Chow EJ, Ceballos R, Mendoza JA. Participant Perceptions on a Fitbit and Facebook Intervention for Young Adult Cancer Survivors: A Qualitative Study. J Adolesc Young Adult Oncol. 2020 Jun;9(3):410-417. doi: 10.1089/jayao.2019.0072. Epub 2020 Jan 13.

Reference Type DERIVED
PMID: 31928489 (View on PubMed)

Other Identifiers

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Fitbit YA 9865

Identifier Type: -

Identifier Source: org_study_id

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