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NCT Number: NCT05875870

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

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Key information

Conditions

Lung Neoplasm Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Veterans General Hospital, Taipei City, Taipei, Taiwan

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About this 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Daylight exposure combine walking

Behavioral
  • 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

Behavioral

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).

Primary outcomes

  1. Sleep-wake rhythm

    Time frame: 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.

  2. Sleep-wake rhythm

    Time frame: 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.

  3. Sleep-wake rhythm

    Time frame: 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.

  4. Sleep-wake rhythm

    Time frame: 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.

  5. Sleep-wake rhythm

    Time frame: 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.

Secondary outcomes

  1. Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

    Time frame: Baseline

    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.

  2. Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

    Time frame: Change from baseline sleep-wake rhythm at 6th week

    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.

  3. Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

    Time frame: Change from baseline sleep-wake rhythm at 12th week

    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.

  4. Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

    Time frame: Change from baseline sleep-wake rhythm at 6th month

    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.

  5. Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

    Time frame: Change from baseline sleep-wake rhythm at 12th month

    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.

  6. Objective sleep quality: total sleep time

    Time frame: Baseline

    Using actigraph to measure total sleep time (min/night)

  7. Objective sleep quality: total sleep time

    Time frame: Change from baseline total sleep time at 6th week

    Using actigraph to measure total sleep time (min/night)

  8. Objective sleep quality: total sleep time

    Time frame: Change from baseline total sleep time at 12th week

    Using actigraph to measure total sleep time (min/night)

  9. Objective sleep quality: total sleep time

    Time frame: Change from baseline total sleep time at 6th month

    Using actigraph to measure total sleep time (min/night)

  10. Objective sleep quality: total sleep time

    Time frame: Change from baseline total sleep time at 12th month

    Using actigraph to measure total sleep time (min/night)

  11. Objective sleep quality: sleep onset latency

    Time frame: Baseline

    Using actigraph to measure sleep onset latency (min/night)

  12. Objective sleep quality: sleep onset latency

    Time frame: Change from baseline sleep onset latency at 6th week

    Using actigraph to measure sleep onset latency (min/night)

  13. Objective sleep quality: sleep onset latency

    Time frame: Change from baseline sleep onset latency at 12th week

    Using actigraph to measure sleep onset latency (min/night)

  14. Objective sleep quality: sleep onset latency

    Time frame: Change from baseline sleep onset latency at 6th month

    Using actigraph to measure sleep onset latency (min/night)

  15. Objective sleep quality: sleep onset latency

    Time frame: Change from baseline sleep onset latency at 12th month

    Using actigraph to measure sleep onset latency (min/night)

  16. Objective sleep quality: sleep efficiency

    Time frame: Baseline

    Using actigraph to measure sleep efficiency (percentage)

  17. Objective sleep quality: sleep efficiency

    Time frame: Change from baseline sleep efficiency at 6th week

    Using actigraph to measure sleep efficiency (percentage)

  18. Objective sleep quality: sleep efficiency

    Time frame: Change from baseline sleep efficiency at 12th week

    Using actigraph to measure sleep efficiency (percentage)

  19. Objective sleep quality: sleep efficiency

    Time frame: Change from baseline sleep efficiency at 6th month

    Using actigraph to measure sleep efficiency (percentage)

  20. Objective sleep quality: sleep efficiency

    Time frame: Change from baseline sleep efficiency at 12th month

    Using actigraph to measure sleep efficiency (percentage)

  21. Objective sleep quality: wake after sleep onset

    Time frame: Baseline

    Using actigraph to measure wake after sleep onset (min/night)

  22. Objective sleep quality: wake after sleep onset

    Time frame: Change from baseline wake after sleep onset at 6th week

    Using actigraph to measure wake after sleep onset (min/night)

  23. Objective sleep quality: wake after sleep onset

    Time frame: Change from baseline wake after sleep onset at 12th week

    Using actigraph to measure wake after sleep onset (min/night)

  24. Objective sleep quality: wake after sleep onset

    Time frame: Change from baseline wake after sleep onset at 6th month

    Using actigraph to measure wake after sleep onset (min/night)

  25. Objective sleep quality: wake after sleep onset

    Time frame: Change from baseline wake after sleep onset at 12th month

    Using actigraph to measure wake after sleep onset (min/night)

  26. Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)

    Time frame: Baseline

    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.

  27. Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)

    Time frame: Change from baseline anxiety and depression at 6th week

    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.

  28. Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)

    Time frame: Change from baseline anxiety and depression at 12th week

    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.

  29. Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)

    Time frame: Change from baseline anxiety and depression at 6th month

    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.

  30. Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)

    Time frame: Change from baseline anxiety and depression at 12th month

    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.

  31. Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)

    Time frame: Baseline

    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).

  32. Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)

    Time frame: Change from baseline quality of life at 6th week

    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).

  33. Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)

    Time frame: Change from baseline quality of life at 12th week

    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).

  34. Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)

    Time frame: Change from baseline quality of life at 6th month

    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).

  35. Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)

    Time frame: Change from baseline quality of life at 12th month

    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).

  36. Recurrent rate

    Time frame: 12th month after recruitment

    Chart review to determine whether cancer has recurred for participant one year after diagnosis.

  37. Survival rate

    Time frame: 12th month after recruitment

    Chart review to determine whether participant survived one year after diagnosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Mei Chen, PhD

CONTACT

[email protected]

886-2-28227101 ext. 3139

Mei-Fen Dai, MSN

CONTACT

[email protected]

886-2-28757154

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Collaborators

  • National Taipei University of Nursing and Health Sciences

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 25, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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