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

Primary Purpose

Lung Neoplasm, Esophageal Neoplasms

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Daylight exposure combine walking
Stretching exercise
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Neoplasm

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group

    Active control group

    Arm Description

    The rehabilitation program is composed of two parts: six-week bright-light exposure program and an exercise program.

    The active control group receives six weeks of a stretching exercise.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    Objective sleep quality: total sleep time
    Using actigraph to measure total sleep time (min/night)
    Objective sleep quality: total sleep time
    Using actigraph to measure total sleep time (min/night)
    Objective sleep quality: total sleep time
    Using actigraph to measure total sleep time (min/night)
    Objective sleep quality: total sleep time
    Using actigraph to measure total sleep time (min/night)
    Objective sleep quality: total sleep time
    Using actigraph to measure total sleep time (min/night)
    Objective sleep quality: sleep onset latency
    Using actigraph to measure sleep onset latency (min/night)
    Objective sleep quality: sleep onset latency
    Using actigraph to measure sleep onset latency (min/night)
    Objective sleep quality: sleep onset latency
    Using actigraph to measure sleep onset latency (min/night)
    Objective sleep quality: sleep onset latency
    Using actigraph to measure sleep onset latency (min/night)
    Objective sleep quality: sleep onset latency
    Using actigraph to measure sleep onset latency (min/night)
    Objective sleep quality: sleep efficiency
    Using actigraph to measure sleep efficiency (percentage)
    Objective sleep quality: sleep efficiency
    Using actigraph to measure sleep efficiency (percentage)
    Objective sleep quality: sleep efficiency
    Using actigraph to measure sleep efficiency (percentage)
    Objective sleep quality: sleep efficiency
    Using actigraph to measure sleep efficiency (percentage)
    Objective sleep quality: sleep efficiency
    Using actigraph to measure sleep efficiency (percentage)
    Objective sleep quality: wake after sleep onset
    Using actigraph to measure wake after sleep onset (min/night)
    Objective sleep quality: wake after sleep onset
    Using actigraph to measure wake after sleep onset (min/night)
    Objective sleep quality: wake after sleep onset
    Using actigraph to measure wake after sleep onset (min/night)
    Objective sleep quality: wake after sleep onset
    Using actigraph to measure wake after sleep onset (min/night)
    Objective sleep quality: wake after sleep onset
    Using actigraph to measure wake after sleep onset (min/night)
    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.
    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.
    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.
    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.
    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.
    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).
    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).
    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).
    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).
    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).
    Recurrent rate
    Chart review to determine whether cancer has recurred for participant one year after diagnosis.
    Survival rate
    Chart review to determine whether participant survived one year after diagnosis.

    Full Information

    First Posted
    May 1, 2023
    Last Updated
    May 31, 2023
    Sponsor
    Taipei Veterans General Hospital, Taiwan
    Collaborators
    National Taipei University of Nursing and Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05875870
    Brief Title
    Effects of Bright-light Exposure Combined With Specific Exercise Training (BEST) Program in Patients With Cancer
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 30, 2023 (Anticipated)
    Primary Completion Date
    May 15, 2028 (Anticipated)
    Study Completion Date
    May 15, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Veterans General Hospital, Taiwan
    Collaborators
    National Taipei University of Nursing and Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Neoplasm, Esophageal Neoplasms

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    The rehabilitation program is composed of two parts: six-week bright-light exposure program and an exercise program.
    Arm Title
    Active control group
    Arm Type
    Active Comparator
    Arm Description
    The active control group receives six weeks of a stretching exercise.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Daylight exposure combine walking
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Stretching exercise
    Intervention Description
    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 Outcome Measure Information:
    Title
    Sleep-wake rhythm
    Description
    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.
    Time Frame
    Baseline
    Title
    Sleep-wake rhythm
    Description
    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.
    Time Frame
    Change from baseline sleep-wake rhythm at 6th week
    Title
    Sleep-wake rhythm
    Description
    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.
    Time Frame
    Change from baseline sleep-wake rhythm at 12th week
    Title
    Sleep-wake rhythm
    Description
    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.
    Time Frame
    Change from baseline sleep-wake rhythm at 6th month
    Title
    Sleep-wake rhythm
    Description
    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.
    Time Frame
    Change from baseline sleep-wake rhythm at 12th month
    Secondary Outcome Measure Information:
    Title
    Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
    Description
    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.
    Time Frame
    Baseline
    Title
    Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
    Description
    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.
    Time Frame
    Change from baseline sleep-wake rhythm at 6th week
    Title
    Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
    Description
    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.
    Time Frame
    Change from baseline sleep-wake rhythm at 12th week
    Title
    Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
    Description
    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.
    Time Frame
    Change from baseline sleep-wake rhythm at 6th month
    Title
    Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
    Description
    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.
    Time Frame
    Change from baseline sleep-wake rhythm at 12th month
    Title
    Objective sleep quality: total sleep time
    Description
    Using actigraph to measure total sleep time (min/night)
    Time Frame
    Baseline
    Title
    Objective sleep quality: total sleep time
    Description
    Using actigraph to measure total sleep time (min/night)
    Time Frame
    Change from baseline total sleep time at 6th week
    Title
    Objective sleep quality: total sleep time
    Description
    Using actigraph to measure total sleep time (min/night)
    Time Frame
    Change from baseline total sleep time at 12th week
    Title
    Objective sleep quality: total sleep time
    Description
    Using actigraph to measure total sleep time (min/night)
    Time Frame
    Change from baseline total sleep time at 6th month
    Title
    Objective sleep quality: total sleep time
    Description
    Using actigraph to measure total sleep time (min/night)
    Time Frame
    Change from baseline total sleep time at 12th month
    Title
    Objective sleep quality: sleep onset latency
    Description
    Using actigraph to measure sleep onset latency (min/night)
    Time Frame
    Baseline
    Title
    Objective sleep quality: sleep onset latency
    Description
    Using actigraph to measure sleep onset latency (min/night)
    Time Frame
    Change from baseline sleep onset latency at 6th week
    Title
    Objective sleep quality: sleep onset latency
    Description
    Using actigraph to measure sleep onset latency (min/night)
    Time Frame
    Change from baseline sleep onset latency at 12th week
    Title
    Objective sleep quality: sleep onset latency
    Description
    Using actigraph to measure sleep onset latency (min/night)
    Time Frame
    Change from baseline sleep onset latency at 6th month
    Title
    Objective sleep quality: sleep onset latency
    Description
    Using actigraph to measure sleep onset latency (min/night)
    Time Frame
    Change from baseline sleep onset latency at 12th month
    Title
    Objective sleep quality: sleep efficiency
    Description
    Using actigraph to measure sleep efficiency (percentage)
    Time Frame
    Baseline
    Title
    Objective sleep quality: sleep efficiency
    Description
    Using actigraph to measure sleep efficiency (percentage)
    Time Frame
    Change from baseline sleep efficiency at 6th week
    Title
    Objective sleep quality: sleep efficiency
    Description
    Using actigraph to measure sleep efficiency (percentage)
    Time Frame
    Change from baseline sleep efficiency at 12th week
    Title
    Objective sleep quality: sleep efficiency
    Description
    Using actigraph to measure sleep efficiency (percentage)
    Time Frame
    Change from baseline sleep efficiency at 6th month
    Title
    Objective sleep quality: sleep efficiency
    Description
    Using actigraph to measure sleep efficiency (percentage)
    Time Frame
    Change from baseline sleep efficiency at 12th month
    Title
    Objective sleep quality: wake after sleep onset
    Description
    Using actigraph to measure wake after sleep onset (min/night)
    Time Frame
    Baseline
    Title
    Objective sleep quality: wake after sleep onset
    Description
    Using actigraph to measure wake after sleep onset (min/night)
    Time Frame
    Change from baseline wake after sleep onset at 6th week
    Title
    Objective sleep quality: wake after sleep onset
    Description
    Using actigraph to measure wake after sleep onset (min/night)
    Time Frame
    Change from baseline wake after sleep onset at 12th week
    Title
    Objective sleep quality: wake after sleep onset
    Description
    Using actigraph to measure wake after sleep onset (min/night)
    Time Frame
    Change from baseline wake after sleep onset at 6th month
    Title
    Objective sleep quality: wake after sleep onset
    Description
    Using actigraph to measure wake after sleep onset (min/night)
    Time Frame
    Change from baseline wake after sleep onset at 12th month
    Title
    Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
    Description
    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.
    Time Frame
    Baseline
    Title
    Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
    Description
    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.
    Time Frame
    Change from baseline anxiety and depression at 6th week
    Title
    Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
    Description
    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.
    Time Frame
    Change from baseline anxiety and depression at 12th week
    Title
    Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
    Description
    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.
    Time Frame
    Change from baseline anxiety and depression at 6th month
    Title
    Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
    Description
    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.
    Time Frame
    Change from baseline anxiety and depression at 12th month
    Title
    Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
    Description
    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).
    Time Frame
    Baseline
    Title
    Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
    Description
    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).
    Time Frame
    Change from baseline quality of life at 6th week
    Title
    Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
    Description
    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).
    Time Frame
    Change from baseline quality of life at 12th week
    Title
    Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
    Description
    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).
    Time Frame
    Change from baseline quality of life at 6th month
    Title
    Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
    Description
    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).
    Time Frame
    Change from baseline quality of life at 12th month
    Title
    Recurrent rate
    Description
    Chart review to determine whether cancer has recurred for participant one year after diagnosis.
    Time Frame
    12th month after recruitment
    Title
    Survival rate
    Description
    Chart review to determine whether participant survived one year after diagnosis.
    Time Frame
    12th month after recruitment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hui-Mei Chen, PhD
    Phone
    886-2-28227101
    Ext
    3139
    Email
    alice@ntunhs.edu.tw
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mei-Fen Dai, MSN
    Phone
    886-2-28757154
    Email
    mfdai@vghtpe.gov.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hui-Mei Chen, PhD
    Organizational Affiliation
    National Taipei University of Nursing and Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data are available from the corresponding author upon reasonable request.
    Citations:
    PubMed Identifier
    31626055
    Citation
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    https://pubmed.ncbi.nlm.nih.gov/31626055/
    Description
    Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable

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

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