Effects of Bright-light Exposure Combined With Specific Exercise Training (BEST) Program on Sleep-Wake Rhythm, Physical and Psychological Symptoms, and Quality of Life of Patients With Thoracic Cancer: A Series Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Sleep-wake rhythm
研究概览
简要总结
This study plans to investigate the effectiveness of six-week light exposure combined with an exercise training program on improving sleep-wake rhythm, physical and mental symptoms, quality of life, one-year recurrence rate, and one-year survival rate of patients with lung and esophageal cancer.
详细描述
This study plans to investigate the effectiveness of six-week light exposure combined with an exercise training program on improving sleep-wake rhythm, physical and mental symptoms, quality of life, one-year recurrence rate, and one-year survival rate of patients with lung and esophageal cancer.
Two groups, parallel, randomly assigned clinical trials, long-term follow-up, repeated measurement (pre-test, 6th week, 12th week, 6th month, 12th month, five times in total), and a design of single center recruitment. The experimental group receiving an intervention comprised six weeks of light exposure combined with exercise training. The active control group receiving six weeks of stretching exercise. With a double-blind study design of participant blind and outcomes assessor blind, subjects were recruited from the thoracic surgery clinic and thoracic surgery ward of a medical center in northern Taiwan.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed primary lung cancer or esophageal cancer, from the first stage to the third stage.
- •At least 20 years of age.
- •Able to communicate in Mandarin Chinese or Taiwanese.
- •Literate and free from cognitive disabilities.
- •The attending physician agrees to participate in the study.
- •Those who can connect to the Internet with mobile devices such as computers, mobile phones, and tablets, or those whose family members can assist in the operation.
- •Those with Karnofsky Performance Scale (KPS) greater than or equal to 70 points.
- •Those who are hospitalized for lung cancer or esophageal cancer lesion resection.
排除标准
- •Congestive heart failure.
- •Orthopedic diseases of the lower extremities that limit one's walking ability.
研究组 & 干预措施
Experimental group
The rehabilitation program is composed of two parts: six-week bright-light exposure program and an exercise program.
干预措施: Daylight exposure combine walking (Behavioral)
Active control group
The active control group receives six weeks of a stretching exercise.
干预措施: Stretching exercise (Behavioral)
结局指标
主要结局
Sleep-wake rhythm
时间窗: Change from baseline sleep-wake rhythm at 12th month
Using Actigraph to measure sleep-wake rhythm. The parameter including 24-h correlation coefficient(r24), in bed less than out of bed dichotomy index (I \< O), midline estimating statistic of rhythm (MESOR), and amplitude…etc.
Sleep-wake rhythm
时间窗: Baseline
Using Actigraph to measure sleep-wake rhythm. The parameter including 24-h correlation coefficient(r24), in bed less than out of bed dichotomy index (I \< O), midline estimating statistic of rhythm (MESOR), and amplitude…etc.
Sleep-wake rhythm
时间窗: Change from baseline sleep-wake rhythm at 6th week
Using Actigraph to measure sleep-wake rhythm. The parameter including 24-h correlation coefficient(r24), in bed less than out of bed dichotomy index (I \< O), midline estimating statistic of rhythm (MESOR), and amplitude…etc.
Sleep-wake rhythm
时间窗: Change from baseline sleep-wake rhythm at 12th week
Using Actigraph to measure sleep-wake rhythm. The parameter including 24-h correlation coefficient(r24), in bed less than out of bed dichotomy index (I \< O), midline estimating statistic of rhythm (MESOR), and amplitude…etc.
Sleep-wake rhythm
时间窗: Change from baseline sleep-wake rhythm at 6th month
Using Actigraph to measure sleep-wake rhythm. The parameter including 24-h correlation coefficient(r24), in bed less than out of bed dichotomy index (I \< O), midline estimating statistic of rhythm (MESOR), and amplitude…etc.
次要结局
- Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)(Change from baseline anxiety and depression at 12th month)
- Objective sleep quality: total sleep time(Change from baseline total sleep time at 12th month)
- Objective sleep quality: wake after sleep onset(Change from baseline wake after sleep onset at 12th month)
- Recurrent rate(12th month after recruitment)
- Survival rate(12th month after recruitment)
- Objective sleep quality: sleep efficiency(Change from baseline sleep efficiency at 12th month)
- Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)(Change from baseline sleep-wake rhythm at 12th month)
- Objective sleep quality: sleep onset latency(Change from baseline sleep onset latency at 12th month)
- Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)(Change from baseline quality of life at 12th month)
- Objective sleep quality: sleep onset latency(Change from baseline sleep onset latency at 6th week)
- Objective sleep quality: sleep onset latency(Change from baseline sleep onset latency at 12th week)
- Objective sleep quality: sleep onset latency(Change from baseline sleep onset latency at 6th month)
- Objective sleep quality: sleep efficiency(Baseline)
- Objective sleep quality: sleep efficiency(Change from baseline sleep efficiency at 6th week)
- Objective sleep quality: sleep efficiency(Change from baseline sleep efficiency at 12th week)
- Objective sleep quality: sleep efficiency(Change from baseline sleep efficiency at 6th month)
- Objective sleep quality: wake after sleep onset(Baseline)
- Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)(Baseline)
- Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)(Change from baseline sleep-wake rhythm at 6th week)
- Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)(Change from baseline sleep-wake rhythm at 12th week)
- Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)(Change from baseline sleep-wake rhythm at 6th month)
- Objective sleep quality: total sleep time(Baseline)
- Objective sleep quality: total sleep time(Change from baseline total sleep time at 6th week)
- Objective sleep quality: total sleep time(Change from baseline total sleep time at 12th week)
- Objective sleep quality: total sleep time(Change from baseline total sleep time at 6th month)
- Objective sleep quality: sleep onset latency(Baseline)
- Objective sleep quality: wake after sleep onset(Change from baseline wake after sleep onset at 6th week)
- Objective sleep quality: wake after sleep onset(Change from baseline wake after sleep onset at 12th week)
- Objective sleep quality: wake after sleep onset(Change from baseline wake after sleep onset at 6th month)
- Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)(Baseline)
- Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)(Change from baseline anxiety and depression at 6th week)
- Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)(Change from baseline anxiety and depression at 12th week)
- Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)(Change from baseline anxiety and depression at 6th month)
- Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)(Baseline)
- Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)(Change from baseline quality of life at 6th week)
- Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)(Change from baseline quality of life at 12th week)
- Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)(Change from baseline quality of life at 6th month)