Quality of Friendships in Children With Neurofibromatosis - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00508235

Purpose

Primary Objectives:

To use the Friendship Quality Questionnaire (FQQ) to determine if the quality of friendships in children with Neurofibromatosis Type 1 (NF1) is lower than the quality of friendships in unaffected children.
To use a disease severity scale and the FQQ to determine if children who are less severely affected have higher friendship qualities than children who are more severely affected.

Condition	Intervention
Neurofibromatosis	Behavioral: Questionnaire

Genetics Home Reference related topics: familial encephalopathy with neuroserpin inclusion bodies neurofibromatosis type 1 neurofibromatosis type 2

MedlinePlus related topics: Cancer Neurofibromatosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Quality of Friendships in Children With Neurofibromatosis: Relationship to Disease Severity

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To find out if children with neurofibromatosis who have higher disease severity also have lower quality friendships than children who are less severely affected and children who are unaffected by the disease. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	December 2004
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with Neurofibromatosis, type 1 (NF-1) between the ages of 8 and 18 years old.	Behavioral: Questionnaire Questionnaire about the patient's relationship with their best friend.

Detailed Description:

You (your) child will be asked to complete a short questionnaire (40 questions) about their relationship with their best friend. Doctors will review your (child's) medical chart to find out how severe the disease is, so that this may be compared to the answers you have (your child has) given on the friendship questionnaire.

This is an investigational study. About 90-100 children and adolescents with NF-1 will be asked to take part in this study. All will be enrolled at M.D. Anderson.

Eligibility

Ages Eligible for Study:	8 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Study participants with Neurofibromatosis, type 1 (NF-1) between the ages of 8 and 18 years old.

Criteria

Inclusion Criteria:

Patients with a clinical diagnosis of neurofibromatosis, type 1 (NF-1) who are between the ages of 8 and 18 years will be eligible.
Patients must be English or Spanish speaking (test instrument will be translated into Spanish), and be able to read.

Exclusion Criteria: None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508235

Contacts

Contact: Bartlett D. Moore, PhD

713-792-2454

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Bartlett D. Moore, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Bartlett D. Moore, PhD

U.T.M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Bartlett D. Moore, PhD/Professor )
Study ID Numbers:	2004-0791
Study First Received:	July 26, 2007
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00508235
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Neurofibromatosis
Quality of Friendships
Disease Severity
Questionnaire
Survey

Study placed in the following topic categories:

Heredodegenerative Disorders, Nervous System
Neoplastic Syndromes, Hereditary
Neuromuscular Diseases
Genetic Diseases, Inborn
Neurofibroma
Peripheral Nervous System Diseases

Neurofibromatoses
Neurodegenerative Diseases
Neurofibromatosis type 1
Nerve Sheath Neoplasms
Neurofibromatosis 1
Neurocutaneous Syndromes

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 16, 2009