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

Not Applicable
Active, not recruiting
Conditions
Esophageal Cancer
Registration Number
NCT03161535
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
85
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Quality of life (EORTC QLQ-OES 18 )36th month after recruited

using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.

Quality of life (EORTC QLQ-C30 )36th month after recruited

using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.

Secondary Outcome Measures
NameTimeMethod
Subjective sleep quality36th month after recruited

using Pittsburgh Sleep Quality Index

Objective sleep quality36th month after recruited

using Actigraph for measure Objective sleep quality

Circadian rhythmsbaseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited

Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I\<O) collection from actigraphy.

Emotional distressbaseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited

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.

Trial Locations

Locations (1)

National Taipei University of Nursing and Health Sciences

🇨🇳

Taipei, Taiwan

National Taipei University of Nursing and Health Sciences
🇨🇳Taipei, Taiwan
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