Improving Physical Activity in Young Adult Cancer Survivors
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
- 是
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
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
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
Jason Mendoza
Investigator and Associate Professor of Pediatrics
Seattle Children's Hospital
