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OpenTrials
Completed

NCT Number: NCT03233581

Improving Physical Activity in Young Adult Cancer Survivors

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: up to week 12

Secondary outcomes

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

    Time frame: up to week 12

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

    Time frame: up to week 12

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Fred Hutchinson Cancer Center

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 28, 2017
Registry last updated
May 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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