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

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Daylight exposure combine walking
  1. 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
• Поведенческое Stretching exercise
  The stretching exercise includes two movements for the upper body and two movements for the lower body, 10 minutes each time, three times a week, for 6 weeks. The researcher will explain to the participants about how to perform the stretching exercise, according to an instruction manual (hardcopy) for the exercise regimen. A video is shown to the participants (the content same as hardcopy of education manual).

Первичные конечные точки

• Sleep-wake rhythm [Срок оценки: Baseline]
• Sleep-wake rhythm [Срок оценки: Change from baseline sleep-wake rhythm at 6th week]
• Sleep-wake rhythm [Срок оценки: Change from baseline sleep-wake rhythm at 12th week]
• Sleep-wake rhythm [Срок оценки: Change from baseline sleep-wake rhythm at 6th month]
• Sleep-wake rhythm [Срок оценки: Change from baseline sleep-wake rhythm at 12th month]

Вторичные конечные точки (12)

• Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI) [Срок оценки: Baseline]
• Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI) [Срок оценки: Change from baseline sleep-wake rhythm at 6th week]
• Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI) [Срок оценки: Change from baseline sleep-wake rhythm at 12th week]
• Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI) [Срок оценки: Change from baseline sleep-wake rhythm at 6th month]
• Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI) [Срок оценки: Change from baseline sleep-wake rhythm at 12th month]
• Objective sleep quality: total sleep time [Срок оценки: Baseline]
• Objective sleep quality: total sleep time [Срок оценки: Change from baseline total sleep time at 6th week]
• Objective sleep quality: total sleep time [Срок оценки: Change from baseline total sleep time at 12th week]
• Objective sleep quality: total sleep time [Срок оценки: Change from baseline total sleep time at 6th month]
• Objective sleep quality: total sleep time [Срок оценки: Change from baseline total sleep time at 12th month]
• Objective sleep quality: sleep onset latency [Срок оценки: Baseline]
• Objective sleep quality: sleep onset latency [Срок оценки: Change from baseline sleep onset latency at 6th week]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Congestive heart failure.
• Orthopedic diseases of the lower extremities that limit one's walking ability.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 2 центра

• Taipei Veterans General Hospital — Taipei City
• Taipei Medical University Hospital — Taipei

Публикации

• 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. PMID 31626055
• Chen HM, Cheung DST, Lin YY, Wu YC, Liu CY, Lin KC, Lin YJ, Lin CC. Relationships of exercise timing with sleep, fatigue and rest-activity rhythms of lung cancer patients in Taiwan: An exploratory study. Eur J Cancer Care (Engl). 2020 Jul;29(4):e13233. doi: 10.1111/ecc.13233. Epub 2020 Feb 25. PMID 32100388
• Chen HM, Lee MC, Tian JY, Dai MF, Wu YC, Huang CS, Hsu PK, Duong LT. Relationships Among Physical Activity, Daylight Exposure, and Rest-Activity Circadian Rhythm in Patients With Esophageal and Gastric Cancer: An Exploratory Study. Cancer Nurs. 2024 Mar-Apr 01;47(2):112-120. doi: 10.1097/NCC.0000000000001188. Epub 2023 Jan 14. PMID 36728167
• Chen HM, Lin YY, Wu YC, Huang CS, Hsu PK, Chien LI, Lin YJ, Huang HL. Effects of Rehabilitation Program on Quality of Life, Sleep, Rest-Activity Rhythms, Anxiety, and Depression of Patients With Esophageal Cancer: A Pilot Randomized Controlled Trial. Cancer Nurs. 2022 Mar-Apr 01;45(2):E582-E593. doi: 10.1097/NCC.0000000000000953. PMID 33813524
• Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Randomised controlled trial on the effectiveness of home-based walking exercise on anxiety, depression and cancer-related symptoms in patients with lung cancer. Br J Cancer. 2015 Feb 3;112(3):438-45. doi: 10.1038/bjc.2014.612. Epub 2014 Dec 9. PMID 25490525
• Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Effect of walking on circadian rhythms and sleep quality of patients with lung cancer: a randomised controlled trial. Br J Cancer. 2016 Nov 22;115(11):1304-1312. doi: 10.1038/bjc.2016.356. Epub 2016 Nov 3. PMID 27811855
• Chen HM, Wu YC, Tsai CM, Tzeng JI, Lin CC. Relationships of Circadian Rhythms and Physical Activity With Objective Sleep Parameters in Lung Cancer Patients. Cancer Nurs. 2015 May-Jun;38(3):215-23. doi: 10.1097/NCC.0000000000000163. PMID 24945266

Идентификаторы

NCT: NCT05875870 · 2023-04-003B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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