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The Health Related Quality of Life in Patients With Hereditary Multiple Exostoses

This study is currently recruiting participants.
Verified by University of British Columbia, May 2008

Sponsors and Collaborators: University of British Columbia
MHE Coalition
Information provided by: University of British Columbia
ClinicalTrials.gov Identifier: NCT00474448
  Purpose

The purpose of this study is to assess the health related quality of life of subjects who have Hereditary Multiple Exostoses and to develop a disease specific quality of life survey. Our hypothesis is that there is a wide range of quality of life experience for patients with this syndrome.


Condition
Exostoses, Multiple Hereditary

Genetics Home Reference related topics:   hereditary multiple exostoses    Melnick-Needles syndrome   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Other
Official Title:   The Health Related Quality of Life in Patients With Hereditary Multiple Exostoses

Further study details as provided by University of British Columbia:

Estimated Enrollment:   200
Study Start Date:   May 2007
Estimated Study Completion Date:   May 2008

Detailed Description:

At the time of recruitment, subjects will be asked to indicate whether they would like to participate in a one-time survey or are willing to participate in the initial survey plus two additional questionnaire administrations thereafter that will be used to develop the disease-specific quality of life (QOL) score. All participants will fill out either the SF-36 survey (for adult HME subjects) or the CHQ PF (for parents of children with HME), as applicable, in addition to a blank form with categorical subheadings (such as recreation, social function, etc.) that they will use to address any issues not covered in the standardized questionnaire. Standardized questionnaires will be scored and analyzed. The items listed on the second form will be compiled and re-applied to subjects that indicated interest in extended participation in survey completion. Subjects will be asked to determine which items apply to them and to rank these applicable items in order of importance. The results from this will be used to develop a 30 question, disease-specific questionnaire. The final step will be to re-administer this survey, in conjunction with the SF-36 or CHQ PF, and then follow up in two weeks with a second administration of the aforementioned surveys in order to test the variability and validity of the disease specific health related quality of life score.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

Adult patients or parents of child patients in British Columbia.


Criteria

Inclusion Criteria:

  • Must be diagnosed with Hereditary Multiple Exostoses
  • Adult patients or parents of child patients
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474448

Contacts
Contact: Harpreet Chhina     604-875-2000 ext 6008     hchhina@cw.bc.ca    

Locations
Canada, British Columbia
BC Children's Hospital     Recruiting
      Vancouver, British Columbia, Canada, V6H 3V4
      Contact: Harpreet Chhina     604-875-2000 ext 6008     hchhina@cw.bc.ca    

Sponsors and Collaborators
University of British Columbia
MHE Coalition

Investigators
Principal Investigator:     Christine Alvarez, MD     University of British Columbia    
  More Information


Responsible Party:   University of British Columbia ( Dr. Christine Alvarez )
Study ID Numbers:   H07-00457
First Received:   May 15, 2007
Last Updated:   May 26, 2008
ClinicalTrials.gov Identifier:   NCT00474448
Health Authority:   Canada: Health Canada

Keywords provided by University of British Columbia:
Hereditary Multiple Exostoses  
Survey  
Quality of Life  
Hereditary Multiple Exostoses,
also known as Multiple Hereditary Exostoses,
also known as Hereditary Multiple Osteochondromas

Study placed in the following topic categories:
Exostoses, multiple
Osteochondrodysplasias
Quality of Life
Exostoses, Multiple Hereditary
Exostoses
Bone Diseases
Neoplasms, Connective and Soft Tissue
Neoplastic Syndromes, Hereditary
Musculoskeletal Diseases
Genetic Diseases, Inborn
Bone Diseases, Developmental
Multiple hereditary exostoses
Osteochondromatosis

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Osteochondroma
Hyperostosis
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on October 10, 2008




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