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

April 21, 2015 updated by: Sung-Soo Yoon, Seoul National University Hospital

Quality of Life in Patients With Stem Cell Transplant After High Dose Chemotherapy: Validation Study of the Korean Version of the EORTC QLQ-HDC29

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the patient's hospitalization (before the SCT) and the outpatient clinic (three, six, and 12 months after their SCT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jung Mi Oh, Pharm.D., College of Pharmacy, Seoul National University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria

September 23, 2010

First Posted (Estimate)

September 24, 2010

Study Record Updates

Last Update Posted (Estimate)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • HDC29_Kor

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life After Stem Cell Transplantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe