Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-03-01 @ 12:50 PM
Study NCT ID:
NCT01208532
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2010-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation Study of the Korean Version of the EORTC QLQ-HDC29
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-21', 'studyFirstSubmitDate': '2010-09-23', 'studyFirstSubmitQcDate': '2010-09-23', 'lastUpdatePostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability and validity of the Korean version of the EORTC HDC-29', 'timeFrame': "at the patient's hospitalization (before the SCT) and the outpatient clinic (three, six, and 12 months after their SCT)", 'description': "Relaibility; Cronbach's alpha coefficient is used to evaluate the internal consistency.\n\nValidity; Persons's correlation coefficient is used to examine the correlation between similar dimensions of the different questionnaires."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Quality of Life After Stem Cell Transplantation']}, 'referencesModule': {'references': [{'pmid': '17081744', 'type': 'BACKGROUND', 'citation': 'Velikova G, Weis J, Hjermstad MJ, Kopp M, Morris P, Watson M, Sezer O; EORTC Quality of Life Group. The EORTC QLQ-HDC29: a supplementary module assessing the quality of life during and after high-dose chemotherapy and stem cell transplantation. Eur J Cancer. 2007 Jan;43(1):87-94. doi: 10.1016/j.ejca.2006.09.004. Epub 2006 Nov 1.'}, {'pmid': '15129896', 'type': 'BACKGROUND', 'citation': 'Yun YH, Park YS, Lee ES, Bang SM, Heo DS, Park SY, You CH, West K. Validation of the Korean version of the EORTC QLQ-C30. Qual Life Res. 2004 May;13(4):863-8. doi: 10.1023/B:QURE.0000021692.81214.70.'}, {'pmid': '15240928', 'type': 'BACKGROUND', 'citation': 'Han CW, Lee EJ, Iwaya T, Kataoka H, Kohzuki M. Development of the Korean version of Short-Form 36-Item Health Survey: health related QOL of healthy elderly people and elderly patients in Korea. Tohoku J Exp Med. 2004 Jul;203(3):189-94. doi: 10.1620/tjem.203.189.'}, {'pmid': '16547794', 'type': 'BACKGROUND', 'citation': 'Yoo H, Lee K, Lee J, Eremenco S, Choi S, Kim H, Lee J. Korean translation and validity of FACT-BMT version 4 and the quality of life in allogeneic bone marrow transplantation patients. Qual Life Res. 2006 Apr;15(3):559-64. doi: 10.1007/s11136-005-1769-3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the reliability and validity of the Korean version of the European Organization for Research and Treatment of Cancer High-dose Chemotherapy module (EORTC HDC-29).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are diagnosed with hematologic malignancies and who are planned to recieve high-dose chemotherapy followed by allo or auto stem cell transplantation in Seoul National University Hospital, Korea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are aged more than 18 years\n* Patients who are diagnosed with hematologic malignancies and who are planned to receive high-dose chemotherapy followed by allogeneic or autologous stem cell transplantation (SCT)\n* Patients who agree with the informed consent\n\nExclusion Criteria:\n\n* Patients who are unable to complete the questionnaire due to the serious physical or psychological morbidity'}, 'identificationModule': {'nctId': 'NCT01208532', 'briefTitle': 'Validation Study of the Korean Version of the EORTC QLQ-HDC29', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Quality of Life in Patients With Stem Cell Transplant After High Dose Chemotherapy: Validation Study of the Korean Version of the EORTC QLQ-HDC29', 'orgStudyIdInfo': {'id': 'HDC29_Kor'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sung-Soo Yoon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Jung Mi Oh, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'College of Pharmacy, Seoul National University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sung-Soo Yoon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}