This study will investigate the effectiveness of a rehabilitation program in improving sleep quality, emotional distress, circadian rhythms, and quality of life in patients with esophageal cancer in Taiwan. Hypothesis: 1. The quality of life in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month. 2. The quality of sleep in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month. 3. The emotional distress in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month. 4. The circadian rhythms in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.
This study will investigate the effectiveness of a rehabilitation program in improving sleep quality, emotional distress, circadian rhythms, and quality of life in patients with esophageal cancer in Taiwan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
85
1. A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a week, was administered along with weekly exercise counseling. After collecting pretrial measurements, we explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. The detailed instructions, provided at the hospital clinics, included the determination of activity intensity, demonstration of pulse measurement, criteria for scores of 6-20 on the Borg's rating of perceived exertion (RPE), prevention of exercise-related injuries, and conditions necessitating termination of an exercise session. Participants were instructed that the exercises would be effective only if they reached 60%-80% of the target heart rate, as determined by the Karvonen method, and 13-15 on the RPE. 2. Diet-teaching program (using dietary education booklet).
For each participant, we discussed exercise regimen-related issues and diet weekly through the telephone. For instance, we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects.
National Taipei University of Nursing and Health Sciences
Taipei, Taiwan
Quality of life (EORTC QLQ-C30 )
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Time frame: baseline
Quality of life (EORTC QLQ-C30 )
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Time frame: 3rd month after recruited
Quality of life (EORTC QLQ-C30 )
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Time frame: 6th month after recruited
Quality of life (EORTC QLQ-C30 )
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Time frame: 12th month after recruited
Quality of life (EORTC QLQ-C30 )
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Time frame: 24th month after recruited
Quality of life (EORTC QLQ-C30 )
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Time frame: 36th month after recruited
Quality of life (EORTC QLQ-OES 18 )
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Time frame: baseline
Quality of life (EORTC QLQ-OES 18 )
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Time frame: 3rd month after recruited
Quality of life (EORTC QLQ-OES 18 )
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Time frame: 6th month after recruited
Quality of life (EORTC QLQ-OES 18 )
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Time frame: 12th month after recruited
Quality of life (EORTC QLQ-OES 18 )
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Time frame: 24th month after recruited
Quality of life (EORTC QLQ-OES 18 )
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Time frame: 36th month after recruited
Subjective sleep quality
using Pittsburgh Sleep Quality Index
Time frame: baseline
Subjective sleep quality
using Pittsburgh Sleep Quality Index
Time frame: 3rd month after recruited
Subjective sleep quality
using Pittsburgh Sleep Quality Index
Time frame: 6th month after recruited
Subjective sleep quality
using Pittsburgh Sleep Quality Index
Time frame: 12th month after recruited
Subjective sleep quality
using Pittsburgh Sleep Quality Index
Time frame: 24th month after recruited
Subjective sleep quality
using Pittsburgh Sleep Quality Index
Time frame: 36th month after recruited
Objective sleep quality
using Actigraph for measure Objective sleep quality
Time frame: baseline
Objective sleep quality
using Actigraph for measure Objective sleep quality
Time frame: 3rd month after recruited
Objective sleep quality
using Actigraph for measure Objective sleep quality
Time frame: 6th month after recruited
Objective sleep quality
using Actigraph for measure Objective sleep quality
Time frame: 12th month after recruited
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Objective sleep quality
using Actigraph for measure Objective sleep quality
Time frame: 24th month after recruited
Objective sleep quality
using Actigraph for measure Objective sleep quality
Time frame: 36th month after recruited
Emotional distress
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Time frame: baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited
Circadian rhythms
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I\<O) collection from actigraphy.
Time frame: baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited