Effectiveness of a Rehabilitation Program in Improving Quality of Life in Patients With Esophageal Cancer
- Conditions
- Esophageal Cancer
- Interventions
- Other: exercise and dietary educationOther: weekly telephone consultations concerning exercise and diet.
- 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
- Patients with esophageal cancer who were aged ≥20 years, could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description exercise group weekly telephone consultations concerning exercise and diet. 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. exercise group exercise and dietary education 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Subjective sleep quality 36th month after recruited using Pittsburgh Sleep Quality Index
Objective sleep quality 36th month after recruited using Actigraph for measure Objective sleep quality
Circadian rhythms baseline, 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 distress baseline, 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