Clinical trial NCT03233581: Improving Physical Activity in Young Adult Cancer Survivors
Official title: Improving Physical Activity in Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Quality of Life
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Fred Hutchinson Cancer Center
First posted: 2017-07-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers)
timeFrame: up to week 12
Secondary outcomes:
measure: Post-intervention health related quality of life (measured by questionnaire)
timeFrame: up to week 12
measure: Self-determination theory constructs (measured by the Behavioral Regulation in Exercise Questionnaire 2)
timeFrame: up to week 12
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
References:
citation: 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.
citation: 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.