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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
200
1. Out-door of bright-light exposure in the morning (36 min/day, 7 times/week) for six weeks. 2. Tailored to the individual patient with moderate intensity of walking (3 sessions/week) for six weeks. Duration of each session depends on one-on-one exercise consultation via communication software (LINE App). The duration of walking in week 1 is 15 minutes, then increasing 5 minutes each week if the patient has tolerance. If the patient cannot tolerate the duration, the coach will instruct to keep the same duration for the following week. Basically, the goal of duration in week six is 40 minutes. 3. Weekly exercise consultation via communication software (LINE App). 4. Teaching strategy includes one-on one instruction (hard-copy of teaching manual), video, and webpage.
The stretching exercise includes two movements for the upper body and two movements for the lower body, 10 minutes each time, three times a week, for 6 weeks. The researcher will explain to the participants about how to perform the stretching exercise, according to an instruction manual (hardcopy) for the exercise regimen. A video is shown to the participants (the content same as hardcopy of education manual).
Taipei Veterans General Hospital
Taipei City, Taipei, Taiwan
RECRUITINGTaipei Medical University Hospital
Taipei, Taiwan
RECRUITINGSleep-wake rhythm
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.
Time frame: Baseline
Sleep-wake rhythm
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.
Time frame: Change from baseline sleep-wake rhythm at 6th week
Sleep-wake rhythm
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.
Time frame: Change from baseline sleep-wake rhythm at 12th week
Sleep-wake rhythm
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.
Time frame: Change from baseline sleep-wake rhythm at 6th month
Sleep-wake rhythm
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.
Time frame: Change from baseline sleep-wake rhythm at 12th month
Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor.
Time frame: Baseline
Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor.
Time frame: Change from baseline sleep-wake rhythm at 6th week
Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor.
Time frame: Change from baseline sleep-wake rhythm at 12th week
Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor.
Time frame: Change from baseline sleep-wake rhythm at 6th month
Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
The scale consists of 19 questions covering collective sleep quality, sleep latency, total sleep hours, sleep habits, sleep disturbance, use of sleeping drugs, and daytime functioning. The PSQI score is calculated from the above seven facets. The score of each facet was 0-3 points, and the total score was 0-21 points. A score greater than 5 indicates that the total quality of sleep is poor.
Time frame: Change from baseline sleep-wake rhythm at 12th month
Objective sleep quality: total sleep time
Using actigraph to measure total sleep time (min/night)
Time frame: Baseline
Objective sleep quality: total sleep time
Using actigraph to measure total sleep time (min/night)
Time frame: Change from baseline total sleep time at 6th week
Objective sleep quality: total sleep time
Using actigraph to measure total sleep time (min/night)
Time frame: Change from baseline total sleep time at 12th week
Objective sleep quality: total sleep time
Using actigraph to measure total sleep time (min/night)
Time frame: Change from baseline total sleep time at 6th month
Objective sleep quality: total sleep time
Using actigraph to measure total sleep time (min/night)
Time frame: Change from baseline total sleep time at 12th month
Objective sleep quality: sleep onset latency
Using actigraph to measure sleep onset latency (min/night)
Time frame: Baseline
Objective sleep quality: sleep onset latency
Using actigraph to measure sleep onset latency (min/night)
Time frame: Change from baseline sleep onset latency at 6th week
Objective sleep quality: sleep onset latency
Using actigraph to measure sleep onset latency (min/night)
Time frame: Change from baseline sleep onset latency at 12th week
Objective sleep quality: sleep onset latency
Using actigraph to measure sleep onset latency (min/night)
Time frame: Change from baseline sleep onset latency at 6th month
Objective sleep quality: sleep onset latency
Using actigraph to measure sleep onset latency (min/night)
Time frame: Change from baseline sleep onset latency at 12th month
Objective sleep quality: sleep efficiency
Using actigraph to measure sleep efficiency (percentage)
Time frame: Baseline
Objective sleep quality: sleep efficiency
Using actigraph to measure sleep efficiency (percentage)
Time frame: Change from baseline sleep efficiency at 6th week
Objective sleep quality: sleep efficiency
Using actigraph to measure sleep efficiency (percentage)
Time frame: Change from baseline sleep efficiency at 12th week
Objective sleep quality: sleep efficiency
Using actigraph to measure sleep efficiency (percentage)
Time frame: Change from baseline sleep efficiency at 6th month
Objective sleep quality: sleep efficiency
Using actigraph to measure sleep efficiency (percentage)
Time frame: Change from baseline sleep efficiency at 12th month
Objective sleep quality: wake after sleep onset
Using actigraph to measure wake after sleep onset (min/night)
Time frame: Baseline
Objective sleep quality: wake after sleep onset
Using actigraph to measure wake after sleep onset (min/night)
Time frame: Change from baseline wake after sleep onset at 6th week
Objective sleep quality: wake after sleep onset
Using actigraph to measure wake after sleep onset (min/night)
Time frame: Change from baseline wake after sleep onset at 12th week
Objective sleep quality: wake after sleep onset
Using actigraph to measure wake after sleep onset (min/night)
Time frame: Change from baseline wake after sleep onset at 6th month
Objective sleep quality: wake after sleep onset
Using actigraph to measure wake after sleep onset (min/night)
Time frame: Change from baseline wake after sleep onset at 12th month
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
The scale consists of seven items each for anxiety and depression. Each item of the anxiety subscale (HADS-A) and the depression subscale (HADS-D) was scored on a 4-point scale from 0 (not at all) to 3 (very much so). Higher scores indicated higher anxiety or depression levels.
Time frame: Baseline
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
The scale consists of seven items each for anxiety and depression. Each item of the anxiety subscale (HADS-A) and the depression subscale (HADS-D) was scored on a 4-point scale from 0 (not at all) to 3 (very much so). Higher scores indicated higher anxiety or depression levels.
Time frame: Change from baseline anxiety and depression at 6th week
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
The scale consists of seven items each for anxiety and depression. Each item of the anxiety subscale (HADS-A) and the depression subscale (HADS-D) was scored on a 4-point scale from 0 (not at all) to 3 (very much so). Higher scores indicated higher anxiety or depression levels.
Time frame: Change from baseline anxiety and depression at 12th week
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
The scale consists of seven items each for anxiety and depression. Each item of the anxiety subscale (HADS-A) and the depression subscale (HADS-D) was scored on a 4-point scale from 0 (not at all) to 3 (very much so). Higher scores indicated higher anxiety or depression levels.
Time frame: Change from baseline anxiety and depression at 6th month
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
The scale consists of seven items each for anxiety and depression. Each item of the anxiety subscale (HADS-A) and the depression subscale (HADS-D) was scored on a 4-point scale from 0 (not at all) to 3 (very much so). Higher scores indicated higher anxiety or depression levels.
Time frame: Change from baseline anxiety and depression at 12th month
Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each).
Time frame: Baseline
Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each).
Time frame: Change from baseline quality of life at 6th week
Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each).
Time frame: Change from baseline quality of life at 12th week
Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each).
Time frame: Change from baseline quality of life at 6th month
Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each).
Time frame: Change from baseline quality of life at 12th month
Recurrent rate
Chart review to determine whether cancer has recurred for participant one year after diagnosis.
Time frame: 12th month after recruitment
Survival rate
Chart review to determine whether participant survived one year after diagnosis.
Time frame: 12th month after recruitment