Esophageal Neoplasms Clinical Trial
Official title:
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.
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | May 15, 2028 |
Est. primary completion date | May 15, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: 1. Patients with newly diagnosed primary lung cancer or esophageal cancer, from the first stage to the third stage. 2. At least 20 years of age. 3. Able to communicate in Mandarin Chinese or Taiwanese. 4. Literate and free from cognitive disabilities. 5. The attending physician agrees to participate in the study. 6. 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. 7. Those with Karnofsky Performance Scale (KPS) greater than or equal to 70 points. 8. Those who are hospitalized for lung cancer or esophageal cancer lesion resection. Exclusion Criteria: 1. Congestive heart failure. 2. Orthopedic diseases of the lower extremities that limit one's walking ability. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Veterans General Hospital | Taipei city | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan | National Taipei University of Nursing and Health Sciences |
Taiwan,
Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116. — View Citation
Chen HM, Cheung DST, Lin YY, Wu YC, Liu CY, Lin KC, Lin YJ, Lin CC. Relationships of exercise timing with sleep, fatigue and rest-activity rhythms of lung cancer patients in Taiwan: An exploratory study. Eur J Cancer Care (Engl). 2020 Jul;29(4):e13233. do — View Citation
Chen HM, Lee MC, Tian JY, Dai MF, Wu YC, Huang CS, Hsu PK, Duong LT. Relationships Among Physical Activity, Daylight Exposure, and Rest-Activity Circadian Rhythm in Patients With Esophageal and Gastric Cancer: An Exploratory Study. Cancer Nurs. 2023 Jan 1 — View Citation
Chen HM, Lin YY, Wu YC, Huang CS, Hsu PK, Chien LI, Lin YJ, Huang HL. Effects of Rehabilitation Program on Quality of Life, Sleep, Rest-Activity Rhythms, Anxiety, and Depression of Patients With Esophageal Cancer: A Pilot Randomized Controlled Trial. Canc — View Citation
Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Effect of walking on circadian rhythms and sleep quality of patients with lung cancer: a randomised controlled trial. Br J Cancer. 2016 Nov 22;115(11):1304-1312. doi: 10.1038/bjc.2016.356. Epub 2016 Nov 3. — View Citation
Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Randomised controlled trial on the effectiveness of home-based walking exercise on anxiety, depression and cancer-related symptoms in patients with lung cancer. Br J Cancer. 2015 Feb 3;112(3):438-45. doi: 10.1038/b — View Citation
Chen HM, Wu YC, Tsai CM, Tzeng JI, Lin CC. Relationships of Circadian Rhythms and Physical Activity With Objective Sleep Parameters in Lung Cancer Patients. Cancer Nurs. 2015 May-Jun;38(3):215-23. doi: 10.1097/NCC.0000000000000163. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Objective sleep quality: total sleep time | Using actigraph to measure total sleep time (min/night) | Baseline | |
Secondary | Objective sleep quality: total sleep time | Using actigraph to measure total sleep time (min/night) | Change from baseline total sleep time at 6th week | |
Secondary | Objective sleep quality: total sleep time | Using actigraph to measure total sleep time (min/night) | Change from baseline total sleep time at 12th week | |
Secondary | Objective sleep quality: total sleep time | Using actigraph to measure total sleep time (min/night) | Change from baseline total sleep time at 6th month | |
Secondary | Objective sleep quality: total sleep time | Using actigraph to measure total sleep time (min/night) | Change from baseline total sleep time at 12th month | |
Secondary | Objective sleep quality: sleep onset latency | Using actigraph to measure sleep onset latency (min/night) | Baseline | |
Secondary | Objective sleep quality: sleep onset latency | Using actigraph to measure sleep onset latency (min/night) | Change from baseline sleep onset latency at 6th week | |
Secondary | Objective sleep quality: sleep onset latency | Using actigraph to measure sleep onset latency (min/night) | Change from baseline sleep onset latency at 12th week | |
Secondary | Objective sleep quality: sleep onset latency | Using actigraph to measure sleep onset latency (min/night) | Change from baseline sleep onset latency at 6th month | |
Secondary | Objective sleep quality: sleep onset latency | Using actigraph to measure sleep onset latency (min/night) | Change from baseline sleep onset latency at 12th month | |
Secondary | Objective sleep quality: sleep efficiency | Using actigraph to measure sleep efficiency (percentage) | Baseline | |
Secondary | Objective sleep quality: sleep efficiency | Using actigraph to measure sleep efficiency (percentage) | Change from baseline sleep efficiency at 6th week | |
Secondary | Objective sleep quality: sleep efficiency | Using actigraph to measure sleep efficiency (percentage) | Change from baseline sleep efficiency at 12th week | |
Secondary | Objective sleep quality: sleep efficiency | Using actigraph to measure sleep efficiency (percentage) | Change from baseline sleep efficiency at 6th month | |
Secondary | Objective sleep quality: sleep efficiency | Using actigraph to measure sleep efficiency (percentage) | Change from baseline sleep efficiency at 12th month | |
Secondary | Objective sleep quality: wake after sleep onset | Using actigraph to measure wake after sleep onset (min/night) | Baseline | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Recurrent rate | Chart review to determine whether cancer has recurred for participant one year after diagnosis. | 12th month after recruitment | |
Secondary | Survival rate | Chart review to determine whether participant survived one year after diagnosis. | 12th month after recruitment |
Status | Clinical Trial | Phase | |
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