Validation Study of the Korean Version of the EORTC QLQ-HDC29

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sung-Soo Yoon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01208532
First received: September 23, 2010
Last updated: April 21, 2015
Last verified: April 2015
  Purpose

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).


Condition
Quality of Life After Stem Cell Transplantation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Reliability and validity of the Korean version of the EORTC HDC-29 [ Time Frame: at the patient's hospitalization (before the SCT) and the outpatient clinic (three, six, and 12 months after their SCT) ] [ Designated as safety issue: No ]

    Relaibility; Cronbach's alpha coefficient is used to evaluate the internal consistency.

    Validity; Persons's correlation coefficient is used to examine the correlation between similar dimensions of the different questionnaires.



Enrollment: 226
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208532

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Sung-Soo Yoon, MD, PhD Seoul National University Hospital
Principal Investigator: Jung Mi Oh, Pharm.D. College of Pharmacy, Seoul National University