Clinical trial NCT01208532: Validation Study of the Korean Version of the EORTC QLQ-HDC29
Official title: Quality of Life in Patients With Stem Cell Transplant After High Dose Chemotherapy: Validation Study of the Korean Version of the EORTC QLQ-HDC29
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life After Stem Cell Transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-09-24
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Patients who are aged more than 18 years
* 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)
* Patients who agree with the informed consent

Exclusion Criteria:

* Patients who are unable to complete the questionnaire due to the serious physical or psychological morbidity

Primary outcomes:
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)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sung-Soo Yoon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: College of Pharmacy, Seoul National University
name: Jung Mi Oh, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.