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

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875870
• Other study ID #: 2023-04-003B
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: May 15, 2028

Study information

• Verified date: February 2024
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Hui-Mei Chen, PhD
• Phone: 886-2-28227101
• Email: alice[@]ntunhs.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Lung Neoplasm
• Lung Neoplasms
• Neoplasms

Intervention

Behavioral:
• Daylight exposure combine walking
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.
• Stretching exercise
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).

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei city	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

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

Outcome

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

External Links

•   Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable