Effects of Bright-light Exposure Combined With Specific Exercise Training (BEST) Program in Patients With Cancer
- Conditions
- Esophageal NeoplasmsLung Neoplasm
- Interventions
- Behavioral: Daylight exposure combine walkingBehavioral: Stretching exercise
- Registration Number
- NCT05875870
- Lead Sponsor
- Taipei Veterans General Hospital, Taiwan
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- Congestive heart failure.
- Orthopedic diseases of the lower extremities that limit one's walking ability.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Daylight exposure combine walking The rehabilitation program is composed of two parts: six-week bright-light exposure program and an exercise program. Active control group Stretching exercise The active control group receives six weeks of a stretching exercise.
- Primary Outcome Measures
Name Time Method Sleep-wake rhythm 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 Outcome Measures
Name Time Method Anxiety and depression (Hospital Anxiety and Depression Scale, HADS) 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.
Objective sleep quality: total sleep time Change from baseline total sleep time at 12th month Using actigraph to measure total sleep time (min/night)
Objective sleep quality: wake after sleep onset Change from baseline wake after sleep onset at 12th month Using actigraph to measure wake after sleep onset (min/night)
Recurrent rate 12th month after recruitment Chart review to determine whether cancer has recurred for participant one year after diagnosis.
Survival rate 12th month after recruitment Chart review to determine whether participant survived one year after diagnosis.
Objective sleep quality: sleep efficiency Change from baseline sleep efficiency at 12th month Using actigraph to measure sleep efficiency (percentage)
Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI) 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.Objective sleep quality: sleep onset latency Change from baseline sleep onset latency at 12th month Using actigraph to measure sleep onset latency (min/night)
Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire) 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).
Trial Locations
- Locations (1)
Taipei Veterans General Hospital
🇨🇳Taipei city, Taipei, Taiwan