Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 7:57 PM
Study NCT ID:
NCT01546233
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2012-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multidisciplinary Education in Lung Cancer Patients Who Receiving Chemotherapy Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-04', 'studyFirstSubmitDate': '2012-03-01', 'studyFirstSubmitQcDate': '2012-03-06', 'lastUpdatePostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure fatigue by questionnaires', 'timeFrame': 'August 2011 to august 2012 (up to 1 year)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung cancer', 'Chemotherapy', 'Multidisciplinary self care programme', 'Fatigue'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the fatigue in lung cancer patients receiving chemotherapy treatment, between the education programme in self-care a multidisciplinary with the group who received standard care.', 'detailedDescription': 'Educate of self-care by Oncology nurses to relieve and prevent the fatigue of cancer chemotherapy, and provide the manual to read at home, take about 15 minutes. By using home exercise program, 30 minutes of physical education. Teaching and demonstration exercises of the muscles to breath and conservation of energy during exercise and record the exercise/walking diary, the nutritional education nutrition counseling, psychiatric assessment,self-care prevention of depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fatigue Lung Cancer Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 45-65 years.\n2. Has been diagnosed lung cancer stages 3-4 must be chemotherapy is platinum-based, and had received chemotherapy for at least one time, must be in the range of 2-4 cycles of chemotherapy.\n3. Performance status: ECOG 0-1\n4. No problem hearing it.\n5. Read and write Thai.\n6. Be willing to cooperate in research. And signed a joint research\n\nExclusion Criteria:\n\n1. The complications include: high fever, severe nausea and vomiting.\n2. Injection drug use in diabetes treatment.\n3. Ischemic heart disease with heart arrhythmia and the drug continuously.\n4. Is unable to daily living. Caused by defects in movement, and severe osteoarthritis, muscle atrophy, paralysis or walking flat less than 10 meters.'}, 'identificationModule': {'nctId': 'NCT01546233', 'briefTitle': 'Multidisciplinary Education in Lung Cancer Patients Who Receiving Chemotherapy Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Department of Medical Services Ministry of Public Health of Thailand'}, 'officialTitle': 'Outcome of Multidisciplinary Education Programme in Self-care in Fatigue Lung Cancer Patients Who Receiving Chemotherapy Treatment', 'orgStudyIdInfo': {'id': 'RajavithiMultidisciplinary01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'multidisiplinary self care program', 'description': 'Patient with Lung cancer will be participated in group education with multidisiplinary self care program', 'interventionNames': ['Behavioral: multidisciplinary education programme']}, {'label': 'Conventional education', 'description': 'Lung cancer patient will be received standard education', 'interventionNames': ['Behavioral: standard education']}], 'interventions': [{'name': 'multidisciplinary education programme', 'type': 'BEHAVIORAL', 'otherNames': ['multidisciplinary self care education programm'], 'description': 'Educate of self-care by Oncology nurses to relieve and prevent the fatigue of cancer chemotherapy, and provide the manual to read at home, take about 15 minutes. By using home exercise program, 30 minutes of physical education. Teaching and demonstration exercises of the muscles to breath and conservation of energy during exercise and record the exercise/walking diary, the nutritional education nutrition counseling, psychiatric assessment,self-care prevention of depression.', 'armGroupLabels': ['multidisiplinary self care program']}, {'name': 'standard education', 'type': 'BEHAVIORAL', 'otherNames': ['standard education before and after chemotherapy'], 'description': 'standard education before and after chemotherapy', 'armGroupLabels': ['Conventional education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Chemotherapy Unit, Rajavithi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Kotchukorn Wnagnum, Msc (nurse)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medical Services Ministry of Public Health of Thailand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '๋Journal of the medical association of Thailand'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Medical Services Ministry of Public Health of Thailand', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}