Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-29 @ 9:10 AM
Study NCT ID:
NCT03372356
Status:
UNKNOWN
Last Update Posted:
2017-12-13
First Post:
2017-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychosocial Screening for Neuroendocrine Tumor Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], 'ancestors': [{'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': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2020-08-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-10', 'studyFirstSubmitDate': '2017-12-10', 'studyFirstSubmitQcDate': '2017-12-10', 'lastUpdatePostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DT', 'timeFrame': 'every 3 month until 24 month', 'description': 'Distress Thermometer'}], 'secondaryOutcomes': [{'measure': 'HADS', 'timeFrame': 'every 3 month until 24 month', 'description': 'Hospital Anxiety and Depression Scale'}, {'measure': 'SPBS', 'timeFrame': 'every 3 month until 24 month', 'description': 'Self-Perceived Burden Scale'}, {'measure': 'CD-RISC', 'timeFrame': 'every 3 month until 24 month', 'description': 'Connor-Davidson Resilience Scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DT', 'HADS', 'SPBS', 'CD-RISC', 'Psychosocial Screening'], 'conditions': ['Neuroendocrine Tumors']}, 'descriptionModule': {'briefSummary': 'This is a psychosocial screening application to usual care in a cohort of neuroendocrine tumor patients. The application involves monitoring using the NCCN Distress Thermometer(DT), Hospital Anxiety and Depression Scale(HADS), Self-Perceived Burden Scale(SPBS) and Connor-Davidson Resilience Scale(CD-RISC). These assessments will be completed at baseline, 3 months, 6 months, 12 months and 24 months. Patients will have the option of filling out questionnaires more frequently if desired.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%)', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. sign written informed consent form;\n2. age ≥ 18 years;\n3. pathologically confirmed well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%);\n\nExclusion Criteria:\n\n1. \\<18 years;\n2. Neuroendocrine carcinoma;\n3. History of psychiatric or psychologic illness;\n4. History of previous cancers or cancer distress;\n5. Patients with central nervous system(CNS) disorder；\n6. Severe, uncontrolled medical condition that would affect patients' compliance;"}, 'identificationModule': {'nctId': 'NCT03372356', 'briefTitle': 'Psychosocial Screening for Neuroendocrine Tumor Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Psychosocial Screening for Neuroendocrine Tumor Patients', 'orgStudyIdInfo': {'id': 'PSNET'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neuroendocrine tumors', 'description': 'Patients with neuroendocrine tumors will be given access to an application that monitors distress, anxiety, depression, self-perceived burden, and resilience at regular intervals for 3 months lasting for 24 months.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shen Lin, Professor', 'role': 'CONTACT', 'email': 'Linshenpku@163.com', 'phone': '010-88196561'}, {'name': 'Shen Lin, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital', 'investigatorFullName': 'Shen Lin', 'investigatorAffiliation': 'Peking University'}}}}