Quality of Friendships in Children With Neurofibromatosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00508235
First received: July 26, 2007
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.

Condition Intervention
Neurofibromatosis
Behavioral: Questionnaire

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disease severity scale and Friendship Quality Questionnaire (FQQ) [ Time Frame: Questionnaire completion by patient and chart review by doctor for disease severity scoring. ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: December 2004
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Quality of Friendships
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.
Other Name: Survey

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:

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:

  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: NCT00508235

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Bartlett D. Moore, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508235     History of Changes
Other Study ID Numbers: 2004-0791
Study First Received: July 26, 2007
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Neurofibromatosis
Quality of Friendships
Disease Severity
Questionnaire
NF-1

Additional relevant MeSH terms:
Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 29, 2014