Improving Physical Activity in Young Adult Cancer Survivors

NCT03233581 | Completed

• 1 other identifier: Fitbit YA 9865
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Physical Activity; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers)

  up to week 12

Secondary Outcomes (2)

• Post-intervention health related quality of life (measured by questionnaire)

  up to week 12

• Self-determination theory constructs (measured by the Behavioral Regulation in Exercise Questionnaire 2)

  up to week 12

Study Arms (2)

Fitbit + Facebook + Health Coaching

EXPERIMENTAL

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.

Behavioral: Fitbit + Facebook + Coaching Group

Usual care control with Fitbit only

ACTIVE COMPARATOR

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.

Behavioral: Fitbit only

Interventions

Fitbit + Facebook + Coaching Group 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.

Fitbit + Facebook + Health Coaching

Fitbit only 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.

Usual care control with Fitbit only

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or planning on becoming pregnant in the next year

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Fred Hutchinson Cancer Center: collaborator

Study Sites (2)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Seattle Children's Research Institute

Seattle, Washington, 98145-5005, United States

Location

Related Publications (2)

• 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.

  PMID: 34677081 DERIVED

• 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.

  PMID: 31928489 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

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: Investigator and Associate Professor of Pediatrics

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 28, 2017
• Study Start: September 12, 2017
• Primary Completion: May 6, 2018
• Study Completion: May 22, 2018
• Last Updated: May 25, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)