Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-27 @ 8:48 AM
Study NCT ID:
NCT03161535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-28
First Post:
2017-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Rehabilitation Program in Improving Quality of Life in Patients With Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D015596', 'term': 'Nutrition Assessment'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2017-05-18', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Recurrence status', 'timeFrame': 'Third month (T2), sixth month (T3), twelfth month (T4), twenty-fourth month (T5), and thirty-sixth month (T6).', 'description': 'Recurrence status was assessed through chart review.'}, {'measure': 'Nutritional status', 'timeFrame': 'Baseline (T1), third month (T2), sixth month (T3), twelfth month (T4), twenty-fourth month (T5), and thirty-sixth month (T6)', 'description': '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.'}, {'measure': 'Survival status', 'timeFrame': 'Third month (T2), sixth month (T3), twelfth month (T4), twenty-fourth month (T5), and thirty-sixth month (T6).', 'description': 'Survival status was assessed through chart review.'}], 'primaryOutcomes': [{'measure': 'Quality of life (EORTC QLQ-C30 )', 'timeFrame': 'baseline', 'description': 'using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.'}, {'measure': 'Quality of life (EORTC QLQ-C30 )', 'timeFrame': '3rd month after recruited', 'description': 'using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.'}, {'measure': 'Quality of life (EORTC QLQ-C30 )', 'timeFrame': '6th month after recruited', 'description': 'using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.'}, {'measure': 'Quality of life (EORTC QLQ-C30 )', 'timeFrame': '12th month after recruited', 'description': 'using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.'}, {'measure': 'Quality of life (EORTC QLQ-C30 )', 'timeFrame': '24th month after recruited', 'description': 'using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.'}, {'measure': 'Quality of life (EORTC QLQ-C30 )', 'timeFrame': '36th month after recruited', 'description': 'using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.'}, {'measure': 'Quality of life (EORTC QLQ-OES 18 )', 'timeFrame': 'baseline', 'description': 'using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.'}, {'measure': 'Quality of life (EORTC QLQ-OES 18 )', 'timeFrame': '3rd month after recruited', 'description': 'using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.'}, {'measure': 'Quality of life (EORTC QLQ-OES 18 )', 'timeFrame': '6th month after recruited', 'description': 'using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.'}, {'measure': 'Quality of life (EORTC QLQ-OES 18 )', 'timeFrame': '12th month after recruited', 'description': 'using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.'}, {'measure': 'Quality of life (EORTC QLQ-OES 18 )', 'timeFrame': '24th month after recruited', 'description': 'using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.'}, {'measure': 'Quality of life (EORTC QLQ-OES 18 )', 'timeFrame': '36th month after recruited', 'description': 'using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.'}], 'secondaryOutcomes': [{'measure': 'Subjective sleep quality', 'timeFrame': 'baseline', 'description': 'using Pittsburgh Sleep Quality Index'}, {'measure': 'Subjective sleep quality', 'timeFrame': '3rd month after recruited', 'description': 'using Pittsburgh Sleep Quality Index'}, {'measure': 'Subjective sleep quality', 'timeFrame': '6th month after recruited', 'description': 'using Pittsburgh Sleep Quality Index'}, {'measure': 'Subjective sleep quality', 'timeFrame': '12th month after recruited', 'description': 'using Pittsburgh Sleep Quality Index'}, {'measure': 'Subjective sleep quality', 'timeFrame': '24th month after recruited', 'description': 'using Pittsburgh Sleep Quality Index'}, {'measure': 'Subjective sleep quality', 'timeFrame': '36th month after recruited', 'description': 'using Pittsburgh Sleep Quality Index'}, {'measure': 'Objective sleep quality', 'timeFrame': 'baseline', 'description': 'using Actigraph for measure Objective sleep quality'}, {'measure': 'Objective sleep quality', 'timeFrame': '3rd month after recruited', 'description': 'using Actigraph for measure Objective sleep quality'}, {'measure': 'Objective sleep quality', 'timeFrame': '6th month after recruited', 'description': 'using Actigraph for measure Objective sleep quality'}, {'measure': 'Objective sleep quality', 'timeFrame': '12th month after recruited', 'description': 'using Actigraph for measure Objective sleep quality'}, {'measure': 'Objective sleep quality', 'timeFrame': '24th month after recruited', 'description': 'using Actigraph for measure Objective sleep quality'}, {'measure': 'Objective sleep quality', 'timeFrame': '36th month after recruited', 'description': 'using Actigraph for measure Objective sleep quality'}, {'measure': 'Emotional distress', 'timeFrame': 'baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited', 'description': '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.'}, {'measure': 'Circadian rhythms', 'timeFrame': 'baseline, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited', 'description': 'Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I\\<O) collection from actigraphy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '40312569', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33813524', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nHypothesis:\n\n1. The quality of life in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.\n2. The quality of sleep in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.\n3. The emotional distress in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.\n4. The circadian rhythms in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with esophageal cancer who were aged ≥20 years, could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03161535', 'briefTitle': 'Effectiveness of a Rehabilitation Program in Improving Quality of Life in Patients With Esophageal Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Effectiveness of a Rehabilitation Program in Improving Sleep Quality, Emotional Distress, Circadian Rhythms, and Quality of Life in Patients With Esophageal Cancer', 'orgStudyIdInfo': {'id': '2017-04-001A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exercise group', 'description': '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.', 'interventionNames': ['Other: exercise and dietary education', 'Other: weekly telephone consultations concerning exercise and diet.']}, {'type': 'NO_INTERVENTION', 'label': 'usual-care group', 'description': '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).'}], 'interventions': [{'name': 'exercise and dietary education', 'type': 'OTHER', 'description': "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.\n2. Diet-teaching program (using dietary education booklet).", 'armGroupLabels': ['exercise group']}, {'name': 'weekly telephone consultations concerning exercise and diet.', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taipei University of Nursing and Health Sciences', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Hui-Mei Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taipei University of Nursing and Health Sciences'}, {'name': 'YU-CHUNG WU, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Veterans General Hospital, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}