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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exercise group | Experimental | 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. |
|
| usual-care group | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise and dietary education | Other |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective sleep quality | using Pittsburgh Sleep Quality Index | baseline |
| Subjective sleep quality | using Pittsburgh Sleep Quality Index |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence status | Recurrence status was assessed through chart review. | Third month (T2), sixth month (T3), twelfth month (T4), twenty-fourth month (T5), and thirty-sixth month (T6). |
| Nutritional status |
Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Hui-Mei Chen, PhD | National Taipei University of Nursing and Health Sciences | Principal Investigator |
| YU-CHUNG WU, M.D. | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taipei University of Nursing and Health Sciences | Taipei | 112 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40312569 | Derived | Chen HM, Huang CS, Wu YC, Chien LI, Hsu PK. The effects of a 3-month walking and dietary education program on the quality of life of patients with esophageal cancer: a 1-year follow-up randomized controlled trial. Support Care Cancer. 2025 May 1;33(5):441. doi: 10.1007/s00520-025-09489-4. | |
| 33813524 | Derived |
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|
| weekly telephone consultations concerning exercise and diet. | Other | 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. |
|
| 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 |
| 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\ | baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited |
Nutritional status, including body weight, Body Mass Index (BMI), and serum albumin level, was assessed through chart review. However, patients will not be required to return to the hospital for blood tests; only existing blood test reports available in the medical records will be retrieved.
| Baseline (T1), third month (T2), sixth month (T3), twelfth month (T4), twenty-fourth month (T5), and thirty-sixth month (T6) |
| Survival status | Survival status was assessed through chart review. | Third month (T2), sixth month (T3), twelfth month (T4), twenty-fourth month (T5), and thirty-sixth month (T6). |
| Chen HM, Lin YY, Wu YC, Huang CS, Hsu PK, Chien LI, Lin YJ, Huang HL. Effects of Rehabilitation Program on Quality of Life, Sleep, Rest-Activity Rhythms, Anxiety, and Depression of Patients With Esophageal Cancer: A Pilot Randomized Controlled Trial. Cancer Nurs. 2022 Mar-Apr 01;45(2):E582-E593. doi: 10.1097/NCC.0000000000000953. |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D015596 | Nutrition Assessment |
| D004032 | Diet |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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