Clinical trial NCT05875870: 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
Overall status: RECRUITING
Phase: NA
Conditions: Lung Neoplasm
Esophageal Neoplasms
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: National Taipei University of Nursing and Health Sciences
First posted: 2023-05-25
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with newly diagnosed primary lung cancer or esophageal cancer, from the first stage to the third stage.
2. At least 20 years of age.
3. Able to communicate in Mandarin Chinese or Taiwanese.
4. Literate and free from cognitive disabilities.
5. The attending physician agrees to participate in the study.
6. 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.
7. Those with Karnofsky Performance Scale (KPS) greater than or equal to 70 points.
8. Those who are hospitalized for lung cancer or esophageal cancer lesion resection.

Exclusion Criteria:

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

Primary outcomes:
measure: Sleep-wake rhythm
timeFrame: Baseline
measure: Sleep-wake rhythm
timeFrame: Change from baseline sleep-wake rhythm at 6th week
measure: Sleep-wake rhythm
timeFrame: Change from baseline sleep-wake rhythm at 12th week
measure: Sleep-wake rhythm
timeFrame: Change from baseline sleep-wake rhythm at 6th month
measure: Sleep-wake rhythm
timeFrame: Change from baseline sleep-wake rhythm at 12th month
Secondary outcomes:
measure: Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
timeFrame: Baseline
measure: Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
timeFrame: Change from baseline sleep-wake rhythm at 6th week
measure: Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
timeFrame: Change from baseline sleep-wake rhythm at 12th week
measure: Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
timeFrame: Change from baseline sleep-wake rhythm at 6th month
measure: Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)
timeFrame: Change from baseline sleep-wake rhythm at 12th month
measure: Objective sleep quality: total sleep time
timeFrame: Baseline
measure: Objective sleep quality: total sleep time
timeFrame: Change from baseline total sleep time at 6th week
measure: Objective sleep quality: total sleep time
timeFrame: Change from baseline total sleep time at 12th week
measure: Objective sleep quality: total sleep time
timeFrame: Change from baseline total sleep time at 6th month
measure: Objective sleep quality: total sleep time
timeFrame: Change from baseline total sleep time at 12th month
measure: Objective sleep quality: sleep onset latency
timeFrame: Baseline
measure: Objective sleep quality: sleep onset latency
timeFrame: Change from baseline sleep onset latency at 6th week
measure: Objective sleep quality: sleep onset latency
timeFrame: Change from baseline sleep onset latency at 12th week
measure: Objective sleep quality: sleep onset latency
timeFrame: Change from baseline sleep onset latency at 6th month
measure: Objective sleep quality: sleep onset latency
timeFrame: Change from baseline sleep onset latency at 12th month
measure: Objective sleep quality: sleep efficiency
timeFrame: Baseline
measure: Objective sleep quality: sleep efficiency
timeFrame: Change from baseline sleep efficiency at 6th week
measure: Objective sleep quality: sleep efficiency
timeFrame: Change from baseline sleep efficiency at 12th week
measure: Objective sleep quality: sleep efficiency
timeFrame: Change from baseline sleep efficiency at 6th month
measure: Objective sleep quality: sleep efficiency
timeFrame: Change from baseline sleep efficiency at 12th month
measure: Objective sleep quality: wake after sleep onset
timeFrame: Baseline
measure: Objective sleep quality: wake after sleep onset
timeFrame: Change from baseline wake after sleep onset at 6th week
measure: Objective sleep quality: wake after sleep onset
timeFrame: Change from baseline wake after sleep onset at 12th week
measure: Objective sleep quality: wake after sleep onset
timeFrame: Change from baseline wake after sleep onset at 6th month
measure: Objective sleep quality: wake after sleep onset
timeFrame: Change from baseline wake after sleep onset at 12th month
measure: Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
timeFrame: Baseline
measure: Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
timeFrame: Change from baseline anxiety and depression at 6th week
measure: Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
timeFrame: Change from baseline anxiety and depression at 12th week
measure: Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
timeFrame: Change from baseline anxiety and depression at 6th month
measure: Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
timeFrame: Change from baseline anxiety and depression at 12th month
measure: Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
timeFrame: Baseline
measure: Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
timeFrame: Change from baseline quality of life at 6th week
measure: Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
timeFrame: Change from baseline quality of life at 12th week
measure: Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
timeFrame: Change from baseline quality of life at 6th month
measure: Quality of life (European Organization for Research and Treatment of cancer quality of life questionnaire)
timeFrame: Change from baseline quality of life at 12th month
measure: Recurrent rate
timeFrame: 12th month after recruitment
measure: Survival rate
timeFrame: 12th month after recruitment
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: Taipei Veterans General Hospital
state: Taipei
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Hui-Mei Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.