Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-02 @ 8:38 PM
Study NCT ID:
NCT03069105
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2017-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploratory Study of Caregiver Burden Among Family Caregivers of Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2017-02-23', 'studyFirstSubmitQcDate': '2017-02-27', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Caregiver Burden Score [Caregiver Reaction Assessment (CRA)]', 'timeFrame': '1 year', 'description': 'Relation between caregiver burden subscale scores and caregiver resilience, social support, and coping'}], 'secondaryOutcomes': [{'measure': 'Changes in Anxiety and Depression Score [Hospital Anxiety and Depression Scale (HADS)]', 'timeFrame': '1 year', 'description': 'Relation between caregiver anxiety and depression score and caregiver resilience, social support, and coping'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caregivers', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '28189161', 'type': 'BACKGROUND', 'citation': 'Saria MG, Nyamathi A, Phillips LR, Stanton AL, Evangelista L, Kesari S, Maliski S. The Hidden Morbidity of Cancer: Burden in Caregivers of Patients with Brain Metastases. Nurs Clin North Am. 2017 Mar;52(1):159-178. doi: 10.1016/j.cnur.2016.10.002.'}, {'pmid': '27921222', 'type': 'BACKGROUND', 'citation': 'Saria MG, Courchesne N, Evangelista L, Carter J, MacManus DA, Gorman MK, Nyamathi AM, Phillips LR, Piccioni D, Kesari S, Maliski S. Cognitive dysfunction in patients with brain metastases: influences on caregiver resilience and coping. Support Care Cancer. 2017 Apr;25(4):1247-1256. doi: 10.1007/s00520-016-3517-3. Epub 2016 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'This study will look at caregiver burden and the coping behavior of caregivers of patients with cancer. Through this study, the investigators will identify the relationship between cognitive dysfunction (measured as a proxy rating by the caregiver), resilience, social support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression among family caregivers of patients with cancer.', 'detailedDescription': 'The goal of this study is to explore caregiver burden and the coping behavior of caregivers of patients with cancer. It has been documented that non-professional caregivers and long-term care providers to patients with cancer receive little preparation, information, or support to perform their vital role. Through this study, the investigators will identify the relationship between cognitive dysfunction, resilience, social support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression among family caregivers of patients with cancer. The findings of this study will direct future intervention studies to reduce caregiver burden and improve outcomes for the many individuals caring for family members with cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The sample for this study will consist of caregivers of persons with cancer. A convenience sampling will be used to enroll eligible caregivers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Self-identified primary caregiver of patients with cancer\n* Co-residence with the patient\n* Providing a minimum of 4 hours of direct care for at least 3 days per week\n* Able to speak, read, and understand English\n* Willing to participate in completion of surveys\n\nExclusion Criteria:\n\n* Professional or paid caregivers'}, 'identificationModule': {'nctId': 'NCT03069105', 'briefTitle': 'An Exploratory Study of Caregiver Burden Among Family Caregivers of Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': "Saint John's Cancer Institute"}, 'officialTitle': 'An Exploratory Study of Caregiver Burden Among Family Caregivers of Cancer Patients', 'orgStudyIdInfo': {'id': 'JWCI-16-1201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Family caregivers', 'description': 'The sample for this study will consist of caregivers of patients with cancer. Eligible subjects who agrees to participate in the research study and sign the consent form will participate by completing paper and pencil or electronic questionnaires.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Participants will complete paper and pencil or electronic questionnaires at the cancer center or in the privacy of their own homes.', 'armGroupLabels': ['Family caregivers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Saint Joseph Medical Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Providence Holy Cross Medical Center', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': "John Wayne Cancer Institute at Providence Saint John's Health Center", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '98052', 'city': 'Redmond', 'state': 'Washington', 'country': 'United States', 'facility': 'EndBrainCancer Initiative/Chris Elliott Fund', 'geoPoint': {'lat': 47.67399, 'lon': -122.12151}}], 'overallOfficials': [{'name': 'Santosh Kesari, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Saint John's Cancer Institute"}, {'name': 'Marlon G Saria, PhD RN FAAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "John Wayne Cancer Institute at Providence Saint John's Health Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Saint John's Cancer Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Marlon Garzo Saria', 'investigatorAffiliation': "Saint John's Cancer Institute"}}}}