Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT06948305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-29
First Post:
2025-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Effectiveness of the Mobile Instant Messaging Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Supportive Care Needs -Partners & Caregivers 45, SCNS-P&C45', 'timeFrame': 'Post-intervention assessments will be conducted at 1 month, 3 months, and 6 months after the intervention.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecological Cancer']}, 'descriptionModule': {'briefSummary': 'This study explores the caregiving needs of male spouses and develops an instant messaging software intervention to provide effective support. The goal is to help male spouses better adjust to their caregiving roles, reduce psychological stress and emotional distress, and improve overall health.\n\nA randomized controlled trial will be conducted to evaluate the effectiveness of the mobile instant messaging intervention, analyzing its impact on reducing psychological distress and improving the quality of life of male spouses.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 or older, with a diagnosis of gynecological cancer (including cancers of the cervix, endometrium, fallopian tubes, ovaries, uterus, or vagina), and whose spouse has not been diagnosed with any other type of cancer;\n2. The spouse has undergone cancer treatment, including surgery, chemotherapy, or radiotherapy;\n3. Clear consciousness and ability to communicate in Mandarin or Taiwanese;\n4. Willingness to participate in the study after being informed of the study purpose and procedures.\n\nExclusion Criteria:\n\nIndividuals with psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT06948305', 'briefTitle': 'Evaluate the Effectiveness of the Mobile Instant Messaging Intervention', 'organization': {'class': 'OTHER', 'fullName': 'National Taipei University of Nursing and Health Sciences'}, 'officialTitle': 'Exploring the Care Needs of Spouses of Gynecological Cancer Patients and Evaluating the Development of Care Plans', 'orgStudyIdInfo': {'id': 'NTUNHS-2025-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'instant messaging software', 'interventionNames': ['Behavioral: instant messaging software']}, {'type': 'NO_INTERVENTION', 'label': '"Control Group"'}], 'interventions': [{'name': 'instant messaging software', 'type': 'BEHAVIORAL', 'description': 'instant messaging software', 'armGroupLabels': ['instant messaging software']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111', 'city': 'Taipei', 'country': 'Taiwan', 'contacts': [{'name': 'Ya-Hui Tseng, PhD', 'role': 'CONTACT', 'email': 'yhtseng@ntunhs.edu.tw', 'phone': '886-2-2822-7101 Ext. 3196'}], 'facility': 'Shin Kong Memorial Wu Ho-Su Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Hung-Ru Lin, PhD', 'role': 'CONTACT', 'email': 'hungru@ntunhs.edu.tw', 'phone': '886-2-2822-7101 Ext. 3197'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taipei University of Nursing and Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished Professor & Dean, College of Nursing', 'investigatorFullName': 'Hung-Ru Lin, PhD, RN', 'investigatorAffiliation': 'National Taipei University of Nursing and Health Sciences'}}}}