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

NCT05875870 | Recruiting

• 1 other identifier: 2023-04-003B
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Neoplasm; Esophageal Neoplasms

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Change from baseline sleep-wake rhythm at 12th month

Secondary Outcomes (37)

• Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

  Baseline

• Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

  Change from baseline sleep-wake rhythm at 6th week

• Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

  Change from baseline sleep-wake rhythm at 12th week

• Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

  Change from baseline sleep-wake rhythm at 6th month

• Subjective sleep quality (Pittsburgh Sleep Quality Index, PSQI)

  Change from baseline sleep-wake rhythm at 12th month

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Behavioral: Daylight exposure combine walking

Active control group

ACTIVE COMPARATOR

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

Behavioral: Stretching exercise

Interventions

Daylight exposure combine walking BEHAVIORAL

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 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.

Experimental group

Stretching exercise BEHAVIORAL

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).

Active control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: collaborator
• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (2)

Taipei Veterans General Hospital

Taipei City, Taipei, 112, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Related Links

• Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable

MeSH Terms

Conditions

Lung Neoplasms; Esophageal Neoplasms

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hui-Mei Chen, PhD

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Mei Chen, PhD

CONTACT

886-2-28227101; alice@ntunhs.edu.tw

Mei-Fen Dai, MSN

CONTACT

886-2-28757154; mfdai@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 25, 2023
• Study Start: July 24, 2023
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)