Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT06992167
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2025-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Caregiver Depression in a Low-Resource Setting: Socio-Demographic Predictors of Major Depressive Disorder Among Family Caregivers of Breast Cancer Patients in Pakistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 402}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-24', 'studyFirstSubmitDate': '2025-05-17', 'studyFirstSubmitQcDate': '2025-05-24', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of depression among caregivers of breast cancer patients', 'timeFrame': 'At a single time point during caregiver recruitment (cross-sectional assessment within 6 months of study initiation)', 'description': 'Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated screening tool. The PHQ-9 consists of 9 items, each scored from 0 (not at all) to 3 (nearly every day), for a total score range of 0 to 27. Higher scores indicate worse depressive symptoms. Depression severity will be categorized as follows:\n\n0-4: Minimal\n\n5-9: Mild\n\n10-14: Moderate\n\n15-19: Moderately Severe\n\n20-27: Severe\n\nThe proportion of caregivers falling into each category will be reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder (MDD)']}, 'descriptionModule': {'briefSummary': 'This cross-sectional study aims to assess the prevalence of depression among primary caregivers of breast cancer patients within low-resource country like Pakistan. Caregiving for individuals with breast cancer can be physically and emotionally demanding, often leading to psychological distress, including depression. However, there is limited data from low- and middle-income countries, including Pakistan, where caregivers may face additional socioeconomic and systemic burdens. This study seeks to quantify the burden of depression in this population and explore associated sociodemographic and caregiving-related factors. Findings will help inform psychosocial support strategies and interventions to improve caregiver well-being in resource-constrained environments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of primary caregivers of breast cancer patients receiving treatment in public or private healthcare facilities in low-resource settings of Pakistan. Caregivers include family members or individuals who are directly involved in providing physical, emotional, or financial support to the patient.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Primary caregiver of a patient diagnosed with breast cancer at any stage\n2. Male or female caregiver\n3. Aged 15 years or older\n4. Providing physical, emotional, or financial support to the patient\n5. Willing to give informed consent\n\nExclusion Criteria:\n\n1. Paid caregivers (professional or hired help)\n2. Age under 15 years\n3. Unwilling to provide consent or participate in the study\n4. Incomplete or missing essential data required for analysis'}, 'identificationModule': {'nctId': 'NCT06992167', 'briefTitle': 'Caregiver Depression in a Low-Resource Setting: Socio-Demographic Predictors of Major Depressive Disorder Among Family Caregivers of Breast Cancer Patients in Pakistan', 'organization': {'class': 'OTHER', 'fullName': 'Rahmah Health Foundation'}, 'officialTitle': 'Caregiver Depression in a Low-Resource Setting: Socio-Demographic Predictors of Major Depressive Disorder Among Family Caregivers of Breast Cancer Patients in Pakistan', 'orgStudyIdInfo': {'id': 'RHF-04-2024'}}, 'contactsLocationsModule': {'locations': [{'city': 'Abbottabad', 'state': 'Pubjab', 'country': 'Pakistan', 'facility': 'Ayub Teaching Hospital', 'geoPoint': {'lat': 34.1463, 'lon': 73.21168}}, {'city': 'Multan', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Nishtar Medical University and Hospital', 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}, {'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Jinnah Postgraduate Medical Center', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'city': 'Rawalpindi', 'country': 'Pakistan', 'facility': 'Benazir Bhutto Hospital', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rahmah Health Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Muhammad Usman Hashmi', 'investigatorAffiliation': 'Rahmah Health Foundation'}}}}