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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01208532
First Posted: September 24, 2010
Last Update Posted: April 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sung-Soo Yoon, Seoul National University Hospital
  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 Sung-Soo Yoon, 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) ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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