Working... Menu

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

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. Identifier: NCT00474448
Recruitment Status : Completed
First Posted : May 17, 2007
Last Update Posted : August 3, 2015
MHE Coalition
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
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 or disease
Exostoses, Multiple Hereditary

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Official Title: The Health-Related Quality of Life in Patients With Hereditary Multiple Exostoses
Study Start Date : May 2007
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Primary Outcome Measures :
  1. SF-36 score for adults and CHQ PF-50 for children [ Time Frame: No time frame ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients or parents of child patients in British Columbia.

Inclusion Criteria:

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

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 identifier (NCT number): NCT00474448

Layout table for location information
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
MHE Coalition
Layout table for investigator information
Principal Investigator: Christine Alvarez, MD University of British Columbia

Layout table for additonal information
Responsible Party: University of British Columbia Identifier: NCT00474448     History of Changes
Other Study ID Numbers: H07-00457
First Posted: May 17, 2007    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: July 2015

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

Additional relevant MeSH terms:
Layout table for MeSH terms
Exostoses, Multiple Hereditary
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Bone Diseases, Developmental
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn