Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-06 @ 12:29 AM
Study NCT ID:
NCT05845294
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2023-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Effect of Short-term Structured Psychological Care in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2023-04-13', 'studyFirstSubmitQcDate': '2023-04-25', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale', 'timeFrame': '1 month', 'description': 'Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale'}, {'measure': 'Anxiety of patients was assessed by the Social Impact Scale', 'timeFrame': '1 month', 'description': 'Anxiety of patients was assessed by the Social Impact Scale'}, {'measure': 'Anxiety of patients was assessed by Hospital Anxiety and Depression Scale', 'timeFrame': '1 month', 'description': 'Anxiety of patients was assessed by Hospital Anxiety and Depression Scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The study explored the effects of short-term structured psychological care on the level of postoperative psychological resilience, stigma, anxiety and depression in patients with colorectal cancer colostomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. voluntary participation in the study and ability to cooperate with treatment and care;\n2. patients who were to undergo enterostomy;\n3. age ≥18 years;\n4. consciousness (being able to complete the questionnaire alone or able to answer the questions correctly);\n5. social impact scale (SIS) score ≥24.\n\nExclusion Criteria:\n\n1. Critically ill and unable to cooperate with the study;\n2. Impaired cognitive function that affects communication;\n3. Patients with other organic diseases in combination.'}, 'identificationModule': {'nctId': 'NCT05845294', 'briefTitle': 'A Study of the Effect of Short-term Structured Psychological Care in Patients', 'organization': {'class': 'OTHER', 'fullName': 'Zunyi Medical College'}, 'officialTitle': 'A Study of the Effect of Short-term Structured Psychological Care on the Level of Postoperative Stigma in Patients With Colorectal Cancer', 'orgStudyIdInfo': {'id': 'Zunyi002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Procedure: Routine Care']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'interventionNames': ['Procedure: Short-term structured psychological Care']}], 'interventions': [{'name': 'Routine Care', 'type': 'PROCEDURE', 'description': 'Routine care for patients undergoing colorectal cancer stoma', 'armGroupLabels': ['Control group']}, {'name': 'Short-term structured psychological Care', 'type': 'PROCEDURE', 'description': 'Short-term structured psychological care for colorectal cancer stoma patients based on conventional care', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '563000', 'city': 'Zunyi', 'state': 'Guizhou', 'country': 'China', 'facility': 'Zunyi Medical College', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zunyi Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Xu Ren', 'investigatorAffiliation': 'Zunyi Medical College'}}}}