Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05620420
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2022-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicenter Cross-sectional Study on Mental Health of Patients With Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D000071896', 'term': 'Medically Unexplained Symptoms'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 501}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-24', 'studyFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2022-11-16', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morbidity of psychological distress in patients with multiple myeloma.', 'timeFrame': 'Baseline (the time when the patient is enrolled to the study)', 'description': 'The total score of DT scale ≥4 points is defined as obviously psychological distress.'}], 'secondaryOutcomes': [{'measure': 'morbidity of anxiety in patients with multiple myeloma.', 'timeFrame': 'Baseline (the time when the patient is enrolled to the study)', 'description': 'GAD-7 scale is applied to assess the anxiety of the patient'}, {'measure': 'morbidity of insomnia in patients with multiple myeloma.', 'timeFrame': 'Baseline (the time when the patient is enrolled to the study)', 'description': 'PSQI scale is applied to assess the insomnia of the patient'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple myeloma', 'mental health'], 'conditions': ['Psychological Distress', 'Insomnia', 'Somatic Symptoms']}, 'descriptionModule': {'briefSummary': 'Multiple myeloma patients with normal ability of communication and understanding will be enrolled. DT, GAD-7, PHQ-15 and PSQI scales are designed to assess the mental health status of the patients. Demographic and disease data of patients will be collected as well. The main aim is to explore the factors affecting the mental health of myeloma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients will be recruited form 14 medical centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with symptomatic multiple myeloma were diagnosed according to the criteria of Chinese multiple myeloma diagnosis and treatment guidelines (revised in 2022).\n2. Age ≥18 years, with junior high school education or above. Patients have normal ability of communication and understanding.\n3. Informed consent has been signed.\n\nExclusion Criteria:\n\n1. Who has kinship with other enrolled patients.\n2. Life expectancy of\\< 6 months.'}, 'identificationModule': {'nctId': 'NCT05620420', 'briefTitle': 'A Multicenter Cross-sectional Study on Mental Health of Patients With Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'A Multicenter Cross-sectional Study on Mental Health of Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': 'LY2022-068-A'}}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'shanghai Jiaotong University School of Medicine, Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jian Hou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}