Effectiveness of a Rehabilitation Program in Improving Quality of Life in Patients With Esophageal Cancer

Study Overview
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Brief Summary
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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: The quality of life in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month. The quality of sleep in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month. The emotional distress in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month. The circadian rhythms in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.

Detailed Description
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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.

Official Title
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Effectiveness of a Rehabilitation Program in Improving Sleep Quality, Emotional Distress, Circadian Rhythms, and Quality of Life in Patients With Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Other: exercise and dietary education
* Other: weekly telephone consultations concerning exercise and diet.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with esophageal cancer who were aged ≥20 years, could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise group<br>The rehabilitation program was composed of two parts: an exercise program and a diet-teaching program. The exercise program was a 12-week home-based program that comprised moderate-intensity brisk walking for 40 min per session, with 3 sessions per week; in addition, weekly exercise counseling was provided through telephone. The diet teaching program was provided to the patients by using a diet booklet at baseline (same timing as the exercise program), and its contents were used to instruct the patients regarding dietary principles to be followed. | Other: exercise and dietary education<br>* 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. Diet-teaching program (using dietary education booklet).<br>Other: weekly telephone consultations concerning exercise and diet.<br>* 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.<br>|
| No Intervention: usual-care group<br>The control group (CG) received usual care, whereas a nurse, the manager for esophageal cancer treatment, provided routine care, conducted follow-ups, and offered information on esophageal cancer to the experimental group (EG). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (EORTC QLQ-C30 ) | using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life. | baseline | 
| Quality of life (EORTC QLQ-C30 ) | using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 36th month after recruited | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sleep quality | using Pittsburgh Sleep Quality Index | baseline | 
| Subjective sleep quality | using Pittsburgh Sleep Quality Index | 3rd month after recruited | 
| Subjective sleep quality | using Pittsburgh Sleep Quality Index | 6th month after recruited | 
| Subjective sleep quality | using Pittsburgh Sleep Quality Index | 12th month after recruited | 
| Subjective sleep quality | using Pittsburgh Sleep Quality Index | 24th month after recruited | 
| Subjective sleep quality | using Pittsburgh Sleep Quality Index | 36th month after recruited | 
| Objective sleep quality | using Actigraph for measure Objective sleep quality | baseline | 
| Objective sleep quality | using Actigraph for measure Objective sleep quality | 3rd month after recruited | 
| Objective sleep quality | using Actigraph for measure Objective sleep quality | 6th month after recruited | 
| Objective sleep quality | using Actigraph for measure Objective sleep quality | 12th month after recruited | 
| Objective sleep quality | using Actigraph for measure Objective sleep quality | 24th month after recruited | 
| Objective sleep quality | using Actigraph for measure Objective sleep quality | 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. | 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. | baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited |