Strides For Life I: A Randomized Controlled Trial of Induction of Positive Affect to Increase Physical Activity in Early Stage Lung Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Kilocalories/week assessed by 6-minute walk test
研究概览
简要总结
This randomized controlled trial will evaluate, among 54 stage early stage lung cancer patients, whether a behavioral intervention versus an educational Control group results in improved function at 6-months.
详细描述
This is a two arm randomized controlled trial that will evaluate, among 54 stage 1 non-small cell lung cancer patients, whether induction of positive affect vs. an educational Control group, results in improved function as assessed by the 6-minute Walk Test. Our primary outcome will be a within-patient change in the 6-Minute Walk Test at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-small cell lung cancer (Stage 1)
排除标准
- •Cognitive impairment
- •Inability to walk
- •< 12 month anticipated survival
- •enrollment in other behavioral programs
- •lack of medical approval to participate
- •substance/alcohol dependence or participation in a substance abuse treatment program within 12 months
- •major psychiatric illness.
研究组 & 干预措施
Physical activity plus positive affect
Subjects will be randomized to a physical activity goal and the positive affect component
干预措施: Physical activity plus positive affect (Behavioral)
Physical activity plus education
Subjects will be randomized to a physical activity goal and education
干预措施: Physical activity plus education (Behavioral)
结局指标
主要结局
Kilocalories/week assessed by 6-minute walk test
时间窗: 1 month to 6 months
次要结局
- Functional Assessment of Cancer Therapy- Lung (FACT-L14)(1 month to 6 months)
- Maximal Oxygen Consumption (VO2 max)(1 month to 6 months)
- Forced expiratory volume (FEV1)(1 month to 6 months)
- Activity expenditure (assessed by the Fit Bit Zip accelerometer)(1 month to 6 months)