Quality of Friendships in Children With Neurofibromatosis

Neurofibromatosis Clinical Trial

Official title:

Quality of Friendships in Children With Neurofibromatosis: Relationship to Disease Severity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508235
• Other study ID #: 2004-0791
• Status: Completed
• Phase: N/A
• First received: July 26, 2007
• Last updated: July 31, 2012
• Start date: December 2004
• Est. completion date: July 2009

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The aim of this study is to determine if children with a higher disease severity have lower quality friendships than children who are less severely affected and children who are unaffected. Researchers will test the hypothesis that the quality of friendships is inversely related to their disease severity.

Specific Aims:

1. To use the FQQ to determine if the quality of friendships in children with NF1 is lower than the quality of friendships in unaffected children.

2. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

1) 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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis

Intervention

Behavioral:
• Questionnaire
Questionnaire about the patient's relationship with their best friend.

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease severity scale and Friendship Quality Questionnaire (FQQ)		Questionnaire completion by patient and chart review by doctor for disease severity scoring.	No

External Links

•   UT MD Anderson Cancer Center website