Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-03-04 @ 7:06 PM
Study NCT ID:
NCT00508235
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2007-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Friendships in Children With Neurofibromatosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017253', 'term': 'Neurofibromatoses'}], 'ancestors': [{'id': 'D009455', 'term': 'Neurofibroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-31', 'studyFirstSubmitDate': '2007-07-26', 'studyFirstSubmitQcDate': '2007-07-26', 'lastUpdatePostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease severity scale and Friendship Quality Questionnaire (FQQ)', 'timeFrame': 'Questionnaire completion by patient and chart review by doctor for disease severity scoring.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neurofibromatosis', 'Quality of Friendships', 'Disease Severity', 'Questionnaire', 'NF-1'], 'conditions': ['Neurofibromatosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'UT MD Anderson Cancer Center website'}]}, 'descriptionModule': {'briefSummary': '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.\n\nSpecific Aims:\n\n1. 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.\n2. 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.', 'detailedDescription': "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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants with Neurofibromatosis, type 1 (NF-1) between the ages of 8 and 18 years old.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) 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.\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT00508235', 'briefTitle': 'Quality of Friendships in Children With Neurofibromatosis', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Quality of Friendships in Children With Neurofibromatosis: Relationship to Disease Severity', 'orgStudyIdInfo': {'id': '2004-0791'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Quality of Friendships', 'description': 'Patients with Neurofibromatosis, type 1 (NF-1) between the ages of 8 and 18 years old.', 'interventionNames': ['Behavioral: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['Survey'], 'description': "Questionnaire about the patient's relationship with their best friend.", 'armGroupLabels': ['Quality of Friendships']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'U.T.M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Bartlett D. Moore, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}