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

This study has suspended participant recruitment.
(We are in the process of determining whether we need more participants or not.)
Sponsor:
Collaborator:
MHE Coalition
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00474448
First received: May 15, 2007
Last updated: February 27, 2014
Last verified: February 2014
  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. The investigators hypothesize that there are a wide range of quality of life experiences for patients with this syndrome.


Condition
Exostoses, Multiple Hereditary

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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • SF-36 score for adults and CHQ PF-50 for children [ Time Frame: No time frame ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2007
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
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, which will be used to develop the disease-specific quality of life (QOL) score. All participants will complete 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.), which 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 reapplied 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 readminister this survey, in conjunction with the SF-36 or CHQ PF, and 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
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: NCT00474448

Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
MHE Coalition
Investigators
Principal Investigator: Christine Alvarez, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00474448     History of Changes
Other Study ID Numbers: H07-00457
Study First Received: May 15, 2007
Last Updated: February 27, 2014
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

Additional relevant MeSH terms:
Exostoses
Osteophyte
Osteochondroma
Exostoses, Multiple Hereditary
Osteochondromatosis
Hyperostosis
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Osteochondrodysplasias
Bone Diseases, Developmental
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 18, 2014