Effects of Bright-light Exposure Combined With Specific Exercise Training (BEST) Program in Patients With Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Lung Neoplasm, Esophageal Neoplasms

Intervention / Treatment
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* Behavioral: Daylight exposure combine walking
* Behavioral: Stretching exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Congestive heart failure. Orthopedic diseases of the lower extremities that limit one's walking ability.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>The rehabilitation program is composed of two parts: six-week bright-light exposure program and an exercise program. | Behavioral: Daylight exposure combine walking<br>* Out-door of bright-light exposure in the morning (36 min/day, 7 times/week) for six weeks. 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. Weekly exercise consultation via communication software (LINE App). Teaching strategy includes one-on one instruction (hard-copy of teaching manual), video, and webpage.<br>|
| Active Comparator: Active control group<br>The active control group receives six weeks of a stretching exercise. | Behavioral: Stretching exercise<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Change from baseline sleep-wake rhythm at 12th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Change from baseline sleep-wake rhythm at 12th month | 
| Objective sleep quality: total sleep time | Using actigraph to measure total sleep time (min/night) | Baseline | 
| Objective sleep quality: total sleep time | Using actigraph to measure total sleep time (min/night) | Change from baseline total sleep time at 6th week | 
| Objective sleep quality: total sleep time | Using actigraph to measure total sleep time (min/night) | Change from baseline total sleep time at 12th week | 
| Objective sleep quality: total sleep time | Using actigraph to measure total sleep time (min/night) | Change from baseline total sleep time at 6th month | 
| Objective sleep quality: total sleep time | Using actigraph to measure total sleep time (min/night) | Change from baseline total sleep time at 12th month | 
| Objective sleep quality: sleep onset latency | Using actigraph to measure sleep onset latency (min/night) | Baseline | 
| Objective sleep quality: sleep onset latency | Using actigraph to measure sleep onset latency (min/night) | Change from baseline sleep onset latency at 6th week | 
| Objective sleep quality: sleep onset latency | Using actigraph to measure sleep onset latency (min/night) | Change from baseline sleep onset latency at 12th week | 
| Objective sleep quality: sleep onset latency | Using actigraph to measure sleep onset latency (min/night) | Change from baseline sleep onset latency at 6th month | 
| Objective sleep quality: sleep onset latency | Using actigraph to measure sleep onset latency (min/night) | Change from baseline sleep onset latency at 12th month | 
| Objective sleep quality: sleep efficiency | Using actigraph to measure sleep efficiency (percentage) | Baseline | 
| Objective sleep quality: sleep efficiency | Using actigraph to measure sleep efficiency (percentage) | Change from baseline sleep efficiency at 6th week | 
| Objective sleep quality: sleep efficiency | Using actigraph to measure sleep efficiency (percentage) | Change from baseline sleep efficiency at 12th week | 
| Objective sleep quality: sleep efficiency | Using actigraph to measure sleep efficiency (percentage) | Change from baseline sleep efficiency at 6th month | 
| Objective sleep quality: sleep efficiency | Using actigraph to measure sleep efficiency (percentage) | 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) | Baseline | 
| Objective sleep quality: wake after sleep onset | Using actigraph to measure wake after sleep onset (min/night) | 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) | 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) | 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) | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | 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. | 12th month after recruitment | 
| Survival rate | Chart review to determine whether participant survived one year after diagnosis. | 12th month after recruitment |