Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-26 @ 3:18 AM
Study NCT ID:
NCT03173833
Status:
UNKNOWN
Last Update Posted:
2017-06-02
First Post:
2017-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fulfilling Care Needs of Adolescents With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 720}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-31', 'studyFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2017-05-31', 'lastUpdatePostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Distress Scale', 'timeFrame': '2 weeks'}, {'measure': 'Beck Youth Inventories second edition', 'timeFrame': '2 weeks'}, {'measure': 'Posttraumatic Growth Index', 'timeFrame': '2 weeks'}, {'measure': 'Resilience Scale', 'timeFrame': '2 weeks'}, {'measure': 'Care demand scale', 'timeFrame': '2 weeks'}, {'measure': 'Pediatric Quality of Life', 'timeFrame': '2 weeks'}, {'measure': 'Acceptability if E-scale', 'timeFrame': '2 weeks'}, {'measure': 'Usability scale', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer patients, quality of life'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of phase 1 of this study is to develop a care need scale (CNS) for adolescents with cancer. The aim of phase 2 is to examine the mediating role of care needs between physical and psychosocial dysfunction and QoL, and to explore the recovery trajectory and its predictors regarding the care needs, physical and psychosocial factors, and the QoL of adolescents with cancer at the first, second, and third 3-month periods after initiating on-treatment and off-treatment. The aim of phase 3 is to examine the effectiveness of the computerized assessment with graphic outcome (CAGO) for fulfilling the care needs of adolescents with cancer, its acceptability for adolescents with cancer, and its usability for clinicians in pediatric oncology units.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The inclusion criteria for adolescents with cancer are\n\n1. 13-20 years of age\n2. previously or currently treated for cancer\n3. able to communicate in Chinese\n4. able to comprehend the study information'}, 'identificationModule': {'nctId': 'NCT03173833', 'briefTitle': 'Fulfilling Care Needs of Adolescents With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Fulfilling Care Needs of Adolescents With Cancer', 'orgStudyIdInfo': {'id': '201612238RINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants will not receive the outcome of their questionnaire in the form of computerized assessment with graphic outcome (CAGO) after the first time they fill in the questionnaire. And they will be able to discuss their care needs with their health care practitioners.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Participants will receive the outcome of their questionnaire in the form of computerized assessment with graphic outcome (CAGO) every time after the first time they fill in the questionnaire.\n\nAnd they will be able to discuss their care needs with their health care practitioners.', 'interventionNames': ['Other: CAGO questionnaire outcome']}], 'interventions': [{'name': 'CAGO questionnaire outcome', 'type': 'OTHER', 'otherNames': ['computer assessment with graphic outcome (CAGO)'], 'description': 'Every time when cancer patients fulfill the following questionnaires, SDS, PTGI, CNS, PedsQL, the outcome of the questionnaires will be provided to the experimental group of the participants by using a computer assessment with graphic outcome.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'test3', 'city': 'Test1', 'state': 'Test2', 'country': 'Taiwan', 'contacts': [{'name': 'SHIANN-TARNG JOU', 'role': 'CONTACT', 'email': 'stjou4@gmail.com', 'phone': '02-23123456', 'phoneExt': '71716'}], 'facility': 'National Taiwan University Hospital'}], 'centralContacts': [{'name': 'Wei-Wen Wu', 'role': 'CONTACT', 'email': 'weiwen@ntu.edu.tw', 'phone': '2312-3456', 'phoneExt': '88422'}], 'overallOfficials': [{'name': 'SHIANN-TARNG LOU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital Department of Pediatrics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}