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临床试验/NCT03233581
NCT03233581已完成不适用

Improving Physical Activity in Young Adult Cancer Survivors

Seattle Children's Hospital4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
4
主要终点
Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Pregnant or planning on becoming pregnant in the next year

研究组 & 干预措施

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.

干预措施: Fitbit + Facebook + Coaching Group (Behavioral)

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.

干预措施: Fitbit only (Behavioral)

结局指标

主要结局

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

时间窗: up to week 12

次要结局

  • Self-determination theory constructs (measured by the Behavioral Regulation in Exercise Questionnaire 2)(up to week 12)
  • Post-intervention health related quality of life (measured by questionnaire)(up to week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason Mendoza

Investigator and Associate Professor of Pediatrics

Seattle Children's Hospital

研究点 (4)

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