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Trial Title:
Effects of Bright-light Exposure Combined With Specific Exercise Training (BEST) Program in Patients With Cancer
NCT ID:
NCT05875870
Condition:
Lung Neoplasm
Esophageal Neoplasms
Conditions: Official terms:
Neoplasms
Lung Neoplasms
Esophageal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Daylight exposure combine walking
Description:
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.
Arm group label:
Experimental group
Intervention type:
Behavioral
Intervention name:
Stretching exercise
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).
Arm group label:
Active control group
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.
Criteria for 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.
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei city
Zip:
112
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Hui-Mei Chen, PhD
Phone:
886-2-28227101
Phone ext:
3139
Email:
alice@ntunhs.edu.tw
Investigator:
Last name:
Hui-Mei Chen, PhD
Email:
Principal Investigator
Start date:
July 24, 2023
Completion date:
May 15, 2028
Lead sponsor:
Agency:
Taipei Veterans General Hospital, Taiwan
Agency class:
Other
Collaborator:
Agency:
National Taipei University of Nursing and Health Sciences
Agency class:
Other
Source:
Taipei Veterans General Hospital, Taiwan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05875870
https://pubmed.ncbi.nlm.nih.gov/31626055/
