Tele-rehabilitation Following Curative Intent Therapy of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Difference in change in accelerometry-measured physical activity between baseline and week 12
研究概览
简要总结
This is a pilot randomized study to investigate the feasibility, acceptability, safety, and effects of a novel tele-rehabilitation intervention for stage I-IIIA lung cancer survivors following curative intent therapy.
The specific aims and hypotheses are:
Specific Aim 1: Conduct a pilot, phase IIb, parallel randomized (1:1) study to investigate the feasibility, acceptability, and safety of inspiratory muscle training and behavioral support to promote walking in tele-rehabilitation with stage I-IIIA lung cancer survivors following curative intent therapy (N=40).
Hypothesis 1a: ≥ 20% eligible patients will enroll; ≥75% of participants will achieve ≥75% adherence to the tele-rehabilitation program.
Hypothesis 1b: ≥75% of participants will perceive tele-rehabilitation as acceptable (Telemedicine Satisfaction and Usefulness Questionnaire ≥4). There will be 0 intervention adverse events.
Specific Aim 2: Explore the effects of the tele-rehabilitation program (N=40).
Hypothesis 2: At 12 weeks, participants in the tele-rehabilitation (experimental) arm, compared to education only (control) arm, will have a trend of greater improvements in outcomes, including:
- accelerometry-measured physical activity (primary outcome); and
- functional capacity, self-reported physical activity, control of dyspnea and anxiety symptoms, sleep quality, and quality of life (secondary outcomes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of stage I-IIIA lung cancer;
- •completed curative intent therapy (i.e., lung cancer resection surgery, definitive radiation, or concurrent chemoradiation) within 1-6 months;
- •access to a mobile phone or personal computer with internet access;
- •willingness to wear activity trackers
排除标准
- •dementia (or cognitive impairment identified by chart review) resulting in inability to follow directions or provide written informed consent;
- •acute myocardial infarction, ventricular tachycardia, ventricular fibrillation, acute cerebrovascular event, or acute asthma exacerbation in past 2 months;
- •spontaneous pneumothorax in past 12 months;
- •Parkinson's disease;
- •multiple sclerosis;
- •amyotrophic lateral sclerosis;
- •additional movement/gait disorders that may be identified by chart review
结局指标
主要结局
Difference in change in accelerometry-measured physical activity between baseline and week 12
时间窗: Baseline, mid study (week 6), and end of study (week 12).
Physical activity will be measured by the activPAL4 device (PAL Technologies, Ltd).
次要结局
- Difference in change in self-reported physical activity between baseline and week 12(Baseline, mid study (week 6), and end of study (week 12))
- Difference in change in sleep quality between baseline and week 12(Baseline, mid study (week 6), and end of study (week 12))
- Difference in change in functional capacity between baseline and week 12(Baseline, mid study (week 6), and end of study (week 12))
- Difference in change in quality of life between baseline and week 12(Baseline, mid study (week 6), and end of study (week 12))
- Difference in change in control of dyspnea between baseline and week 12(Baseline, mid study (week 6), and end of study (week 12))
- Difference in change in anxiety symptoms between baseline and week 12(Baseline, mid study (week 6), and end of study (week 12))