Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-01 @ 12:22 AM
Study NCT ID:
NCT01525251
Status:
UNKNOWN
Last Update Posted:
2012-02-02
First Post:
2012-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurse Case Manager Model on Neuroblastoma Caregiver's Uncertainty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009447', 'term': 'Neuroblastoma'}], 'ancestors': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'lastUpdateSubmitDate': '2012-02-01', 'studyFirstSubmitDate': '2012-01-30', 'studyFirstSubmitQcDate': '2012-02-01', 'lastUpdatePostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['primary caregiver', 'neuroblastoma', 'support group', 'posttraumatic stress', 'uncertainty'], 'conditions': ['Neuroblastoma']}, 'descriptionModule': {'briefSummary': "Clinical Problem and Significance: The incidence of neuroblastoma is about 30 cases a year in Taiwan. The five-year survival rate of neuroblastom is near 50% in Taiwan. Compared to the survival rate in Western countries, the treatment in Taiwan needs more efforts to improve. According to the report from the Childhood Cancer Foundation ROC, several children with neuroblastoma did not complete their treatment and or not received the protocol. In addition to the efforts in improving protocol, the reasons for those who drop-out and do not receive complete treatment need the investigators more attention to think of.\n\nPurpose of Study: The main purpose is to evaluate the effects of nurse case manager model on caregivers' adaptation of disease uncertainty about then child with neuroblastorna.\n\nMethods: A longitudinal and prospective design will be used to perform this study. Questionnaire survey and chart review will be the means of data collection for the part of quantative analysis. The qualitative method , semi-structural interview , also will be used to collect data regarding caregiver's perception of social support and adaptation at the same time of self-report of questionnaires survey .There are five points of time to collect data: Baseline (A), 3 months(B) , 6 months(C), 9 months(D),1 year(E) and 1.5 year(F) after eligible subjects agree to participate in the study.\n\nSubjects: The study will use a convenience sample. Once the caregiver's child is on has been diagnosed with neuroblastoma will be recruited in this study.\n\nInstruments: Three Chinese versions of Mishel Uncertainty in Illness-Parent Form , the self-reported socio-demographic questionnaire will be used to collect data. Process recording will be typed once finishing interview for further analysis.\n\nData Analysis: Quantitative data will be analyzed using SPSS 15.0 statistical software. The data will be analyzed using descriptive statistics and inferred statistics. Content analysis and theme formation will be categorized to assist the interpretation of quantitative results.\n\nImplication: The findings of this study will be expected of the effects of nurse care manager model on children with newoblastoma cancer survivors."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Caregiver of Neuroblastoma Childern', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Care giver of Neuroblastoma Children\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT01525251', 'acronym': 'NCMM', 'briefTitle': "Nurse Case Manager Model on Neuroblastoma Caregiver's Uncertainty", 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': "The Effect of Nurse Case Manager Model on Caregiver's Adaptation of Disease Uncertainty About Their Child With Neuroblastoma", 'orgStudyIdInfo': {'id': '200907067R'}}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ya-Ling Lee, RN,DNSc', 'role': 'CONTACT', 'email': 'yallee@ntu.edu.tw', 'phone': '+886-02-23123456', 'phoneExt': '88422'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Ya-Ling Lee, RN,DNSc', 'role': 'CONTACT', 'email': 'yallee@ntu.edu.tw', 'phone': '+886-2-23123456', 'phoneExt': '88422'}, {'name': 'Hsiao-Ling Chen, RN,GC,MS', 'role': 'CONTACT', 'email': 'hsaolene@gmail.com', 'phone': '+886-2-23123456', 'phoneExt': '88422'}], 'overallOfficials': [{'name': 'Ya-Ling Lee, RN,DNSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}, {'name': 'National Taiwan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'National Taiwan University Hospital', 'investigatorAffiliation': 'National Taiwan University Hospital'}}}}