Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-28 @ 5:53 PM
Study NCT ID:
NCT03641820
Status:
UNKNOWN
Last Update Posted:
2018-08-22
First Post:
2018-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Dysfunction in Patients With Cancer Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 928}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2018-08-20', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Cancer-related cognitive dysfunction patient with pain', 'timeFrame': '6 months', 'description': 'Statistical analysis was performed SPSS 21.0. The t test was used for comparison between groups, and the X2 test was used for the count data. The logistic regression model was used for multivariate analysis. The regression coefficient, P value and OR value were calculated by age, ethnicity, education level, treatment plan and income as covariates.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'To investigate the occurrence of cognitive dysfunction in cancer patients with pain in China.Analysis of patients with different cancer pain, different analgesic drugs and different treatments are associated with the severity of cognitive dysfunction, to provide relevant evidence for the next screening, prediction, prevention and treatment. In order to achieve the purpose of improving the quality of life of cancer patients.', 'detailedDescription': 'Cross-sectional survey in patients with cancer pain is used in the outpatient clinics and wards of five cancer hospitals in China.\n\nThis study is to survey the incidence of cognitive dysfunction in Chinese cancer patients, and the related factors of cognitive dysfunction, demographic characteristics (economic situation, education, gender, age), disease status (tumor type, staging) ), analgesic treatment (NRS score, with or without analgesic drugs, analgesic drug name, dose), anti-tumor treatment (with or without anti-tumor treatment, surgery, radiotherapy, chemotherapy, time interval from last treatment, chemotherapy drugs) and so on.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Malignant tumor patient with pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malignant tumor patient with pain are confirmed by histopathology or cytology (NRS score ≥ 1);\n* Understand Chinese through verbal and written communication, read and write Chinese, numbers, and complete questionnaire surveys;\n* Male or female, age 18-75 years old;\n* ECOG 0-2, expected to survive for more than 3 months;\n* no obvious dysfunction of heart, lung, liver, kidney, blood system (≤I degree);\n* patients voluntarily sign informed consent\n\nExclusion Criteria:\n\n* Pregnant women and lactating women.\n* Also participate in clinical trials of drugs that have not been approved for marketing.\n* Patients with depression (evaluated by the Hamilton Depression Scale).\n* Active bleeding or bleeding tendency.\n* Serious or uncontrolled medical conditions and infected people.\n* Patients with structural heart disease, such as coronary heart disease, unstable angina, especially patients with congestive heart failure and atrial fibrillation, atrial flutter history, and patients with hypertension, hypercoagulable state and severe cerebrovascular disease.\n* History of thromboembolic disease; long-term oral administration of aspirin and other anticoagulants.\n* Preventive Whole Brain Irradiation (PCI).\n* Bone marrow invasion or bone marrow metastasis.\n* Patients with severe or uncontrollable mental illness.'}, 'identificationModule': {'nctId': 'NCT03641820', 'briefTitle': 'Cognitive Dysfunction in Patients With Cancer Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'Correlative Factors of Cognitive Dysfunction in Patients With Cancer Pain: a Cross-sectional Study From China', 'orgStudyIdInfo': {'id': 'FJZL20180407'}}, 'contactsLocationsModule': {'locations': [{'zip': '350014', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'huiyu luo', 'role': 'CONTACT', 'email': '13799365820@163.com', 'phone': '13799365820'}], 'facility': 'Department of Nursing, Fujian Provincial Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'huiyu luo', 'role': 'CONTACT', 'email': '13799365820@163.com', 'phone': '13799365820'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}