Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-02 @ 11:57 AM
Study NCT ID:
NCT01073735
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2010-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Needs of Childhood Cancer Survivors: The Unreported Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-08', 'studyFirstSubmitDate': '2010-02-22', 'studyFirstSubmitQcDate': '2010-02-22', 'lastUpdatePostDateStruct': {'date': '2012-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examine the construct validity, internal consistency, item-response performance, and short-term stability of a health-related needs assessment self-report instrument for adult childhood cancer survivors.', 'timeFrame': 'July 2011'}], 'secondaryOutcomes': [{'measure': 'Inform future sample stratification by over-sampling minority and rural-dwelling survivors to enhance the heterogeneity of the respondent pool.', 'timeFrame': 'July 2011'}, {'measure': 'Describe the met and unmet needs of childhood cancer survivors and their important covariates in a large, stratified random sample of childhood cancer survivors.', 'timeFrame': 'July 2011'}, {'measure': 'Evaluate the sample selection methods, length of time to complete recruitment, and response rates in the study sample.', 'timeFrame': 'July 2011'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Needs assessment', 'Health-related needs', 'Childhood cancer survivors'], 'conditions': ['Childhood Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}]}, 'descriptionModule': {'briefSummary': "This feasibility study will determine the psychometric adequacy of a newly developed instrument - Childhood Cancer Survivor Study Needs Assessment Questionnaire (CCSS-NAQ). Additionally, the study will explore the feasibility of selected study methods -- sample selection, length of time to complete recruitment, and response rates - in order to inform a larger national periodic survey of adult survivors' health related needs", 'detailedDescription': 'This study will focus on the following primary and secondary objectives:\n\n1. Examine the construct validity, short-term stability, internal consistency and item-response performance of a health-related needs assessment self-report instrument for adult childhood cancer survivors\n2. Inform future sample stratification by over-sampling minority and rural-dwelling survivors to enhance the heterogeneity of the respondent pool;\n3. Describe the met and unmet health-related needs and their covariates in a large, stratified, random sample of childhood cancer survivors;\n4. Evaluate the sample selection methods, length of time to complete recruitment, and response rates in the study sample.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The study sample will be recruited from long-term childhood cancer survivors who are currently participating in the CCSS and whose pediatric malignancy was not treated at St. Jude Children's Research Hospital", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Living CCSS participant\n2. Age 25 years or older on December 31, 2009\n3. History of successful independent (non-surrogate) response to previous CCSS surveys (Flesch-Kincaid reading level for non-medical items established at 4th-6th grade).\n\nExclusion Criteria:\n\nReceived treatment for pediatric malignancy at St. Jude Children's Research Hospital."}, 'identificationModule': {'nctId': 'NCT01073735', 'briefTitle': 'Investigating the Needs of Childhood Cancer Survivors: The Unreported Experience', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Investigating the Needs of Childhood Cancer Survivors: The Unreported Experience', 'orgStudyIdInfo': {'id': 'INSURE'}, 'secondaryIdInfos': [{'id': 'R21CA142921', 'link': 'https://reporter.nih.gov/quickSearch/R21CA142921', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer Survivors', 'description': 'Examine the construct validity, short-term stability, internal consistency and item-response performance of a health-related needs assessment self-report instrument for adult childhood cancer survivors.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Cheryl Cox, RN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}