Lung NeoplasmNCT05875870
Effects of Bright-light Exposure Combined With Specific Exercise Training (BEST) Program in Patients With Cancer
A study testing Daylight exposure combine walking and Stretching exercise in people with Lung Neoplasm and Esophageal Neoplasms, run by Taipei Veterans General Hospital, Taiwan at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Neoplasm, Esophageal Neoplasms
- What is being tested?
- Daylight exposure combine walking and Stretching exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesTaiwan
- Study dates
- 24 Jul 2023to 15 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Congestive heart failure.
- Orthopedic diseases of the lower extremities that limit one's walking ability.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Hui-Mei Chen, PhD, 886-2-28227101ext3139, alice@ntunhs.edu.tw
Hui-Mei Chen, PhD
- Recruiting
Taipei Veterans General Hospital
Taipei City, Taipei, 112
Hui-Mei Chen, PhD, 886-2-28227101 ext. 3139, alice@ntunhs.edu.tw
Hui-Mei Chen, PhD
About this study
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.
Read the detailed 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.
- Conditions
- Lung Neoplasm, Esophageal Neoplasms
- Being tested
- Daylight exposure combine walking, Stretching exercise
- Medical subject headings
- Lung Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daylight exposure combine walkingBehavioural
- 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 exerciseBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The rehabilitation program is composed of two parts: six-week bright-light exposure program and an exercise program. Receives: Behavioral: Daylight exposure combine walking |
| Active control group | Active comparator | The active control group receives six weeks of a stretching exercise. Receives: Behavioral: Stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline sleep-wake rhythm at 12th month
Secondary outcomes (37)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline sleep-wake rhythm at 12th month
Objective sleep quality: total sleep time
Using actigraph to measure total sleep time (min/night)
Measured: Baseline
Objective sleep quality: total sleep time
Using actigraph to measure total sleep time (min/night)
Measured: Change from baseline total sleep time at 6th week
Objective sleep quality: total sleep time
Using actigraph to measure total sleep time (min/night)
Measured: Change from baseline total sleep time at 12th week
Objective sleep quality: total sleep time
Using actigraph to measure total sleep time (min/night)
Measured: Change from baseline total sleep time at 6th month
Objective sleep quality: total sleep time
Using actigraph to measure total sleep time (min/night)
Measured: Change from baseline total sleep time at 12th month
Objective sleep quality: sleep onset latency
Using actigraph to measure sleep onset latency (min/night)
Measured: Baseline
Objective sleep quality: sleep onset latency
Using actigraph to measure sleep onset latency (min/night)
Measured: Change from baseline sleep onset latency at 6th week
Objective sleep quality: sleep onset latency
Using actigraph to measure sleep onset latency (min/night)
Measured: Change from baseline sleep onset latency at 12th week
Objective sleep quality: sleep onset latency
Using actigraph to measure sleep onset latency (min/night)
Measured: Change from baseline sleep onset latency at 6th month
Objective sleep quality: sleep onset latency
Using actigraph to measure sleep onset latency (min/night)
Measured: Change from baseline sleep onset latency at 12th month
Objective sleep quality: sleep efficiency
Using actigraph to measure sleep efficiency (percentage)
Measured: Baseline
Objective sleep quality: sleep efficiency
Using actigraph to measure sleep efficiency (percentage)
Measured: Change from baseline sleep efficiency at 6th week
Objective sleep quality: sleep efficiency
Using actigraph to measure sleep efficiency (percentage)
Measured: Change from baseline sleep efficiency at 12th week
Objective sleep quality: sleep efficiency
Using actigraph to measure sleep efficiency (percentage)
Measured: Change from baseline sleep efficiency at 6th month
Objective sleep quality: sleep efficiency
Using actigraph to measure sleep efficiency (percentage)
Measured: 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)
Measured: Baseline
Objective sleep quality: wake after sleep onset
Using actigraph to measure wake after sleep onset (min/night)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 12th month after recruitment
Survival rate
Chart review to determine whether participant survived one year after diagnosis.
Measured: 12th month after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start24 Jul 2023
- Primary completion15 May 2028 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Responsible party
- Sponsor
- Investigators
- Hui-Mei Chen, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875870
- Sponsor's protocol ID
- 2023-04-003B
- Status last verified
- Feb 2026
- First submitted
- 1 May 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available from the corresponding author upon reasonable request.
Publications
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.
PubMed 31626055Chen 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. doi: 10.1111/ecc.13233. Epub 2020 Feb 25.
PubMed 32100388Chen 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. 2024 Mar-Apr 01;47(2):112-120. doi: 10.1097/NCC.0000000000001188. Epub 2023 Jan 14.
PubMed 36728167Chen 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. Cancer Nurs. 2022 Mar-Apr 01;45(2):E582-E593. doi: 10.1097/NCC.0000000000000953.
PubMed 33813524Chen 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/bjc.2014.612. Epub 2014 Dec 9.
PubMed 25490525Chen 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.
PubMed 27811855Chen 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.
PubMed 24945266
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05875870
- Acronym / sponsor ID
- 2023-04-003B
- Conditions
- Lung Neoplasm, Esophageal Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Daylight exposure combine walkingThe rehabilitation program is composed of two parts: six-week bright-light exposure program and an exercise program. |
| Active control group | Active comparator | Behavioral: Stretching exerciseThe active control group receives six weeks of a stretching exercise. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- Congestive heart failure.
- Orthopedic diseases of the lower extremities that limit one's walking ability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daylight exposure combine walking1. 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. | Behavioural | Experimental group |
| Stretching exerciseThe 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). | Behavioural | Active control group |
Primary outcome
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.
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.
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.
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.
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.
37 secondary outcomes
Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
Time frame: Baseline
Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
Time frame: Change from baseline sleep-wake rhythm at 6th week
Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
Time frame: Change from baseline sleep-wake rhythm at 12th week
Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
Time frame: Change from baseline sleep-wake rhythm at 6th month
Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
Time frame: Change from baseline sleep-wake rhythm at 12th month
Objective sleep quality: total sleep time
Time frame: Baseline
Objective sleep quality: total sleep time
Time frame: Change from baseline total sleep time at 6th week
Objective sleep quality: total sleep time
Time frame: Change from baseline total sleep time at 12th week
Objective sleep quality: total sleep time
Time frame: Change from baseline total sleep time at 6th month
Objective sleep quality: total sleep time
Time frame: Change from baseline total sleep time at 12th month
Objective sleep quality: sleep onset latency
Time frame: Baseline
Objective sleep quality: sleep onset latency
Time frame: Change from baseline sleep onset latency at 6th week
Objective sleep quality: sleep onset latency
Time frame: Change from baseline sleep onset latency at 12th week
Objective sleep quality: sleep onset latency
Time frame: Change from baseline sleep onset latency at 6th month
Objective sleep quality: sleep onset latency
Time frame: Change from baseline sleep onset latency at 12th month
Objective sleep quality: sleep efficiency
Time frame: Baseline
Objective sleep quality: sleep efficiency
Time frame: Change from baseline sleep efficiency at 6th week
Objective sleep quality: sleep efficiency
Time frame: Change from baseline sleep efficiency at 12th week
Objective sleep quality: sleep efficiency
Time frame: Change from baseline sleep efficiency at 6th month
Objective sleep quality: sleep efficiency
Time frame: Change from baseline sleep efficiency at 12th month
Objective sleep quality: wake after sleep onset
Time frame: Baseline
Objective sleep quality: wake after sleep onset
Time frame: Change from baseline wake after sleep onset at 6th week
Objective sleep quality: wake after sleep onset
Time frame: Change from baseline wake after sleep onset at 12th week
Objective sleep quality: wake after sleep onset
Time frame: Change from baseline wake after sleep onset at 6th month
Objective sleep quality: wake after sleep onset
Time frame: Change from baseline wake after sleep onset at 12th month
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
Time frame: Baseline
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
Time frame: Change from baseline anxiety and depression at 6th week
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
Time frame: Change from baseline anxiety and depression at 12th week
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
Time frame: Change from baseline anxiety and depression at 6th month
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
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)
Time frame: Baseline
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
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
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
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
Recurrent rate
Time frame: 12th month after recruitment
Survival rate
Time frame: 12th month after recruitment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 31626055Campbell 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.
- Results publication: PubMed 32100388Chen 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. doi: 10.1111/ecc.13233. Epub 2020 Feb 25.
- Results publication: PubMed 36728167Chen 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. 2024 Mar-Apr 01;47(2):112-120. doi: 10.1097/NCC.0000000000001188. Epub 2023 Jan 14.
- Results publication: PubMed 33813524Chen 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. Cancer Nurs. 2022 Mar-Apr 01;45(2):E582-E593. doi: 10.1097/NCC.0000000000000953.
- Results publication: PubMed 25490525Chen 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/bjc.2014.612. Epub 2014 Dec 9.
- Results publication: PubMed 27811855Chen 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.
- Results publication: PubMed 24945266Chen 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.
- Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary RoundtableLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui-Mei Chen, PhD principal investigator
National Taipei University of Nursing and Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daylight exposure combine walking and Stretching exercise in people with Lung Neoplasm and Esophageal Neoplasms, run by Taipei Veterans General Hospital, Taiwan at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Mei Chen, PhD (886-2-28227101 ext. 3139, alice@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep-wake rhythm (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05875870, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.