Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-04 @ 2:23 PM
Study NCT ID:
NCT01866969
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2013-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life in Caregivers of Hospitalized Older Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-05-29', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caregiver burden and caregiver quality of life as measured by the Caregiver Quality of Life-Cancer Index', 'timeFrame': 'Up to 1 year', 'description': 'Univariate analyses will be performed to test differences in the Caregiver Quality of Life-Cancer Index (CQOLC) total score and score of each domain (burden, distinctiveness, positive adaption, and financial concern) across categorical variables (analysis of variance \\[ANOVA\\]), and simple linear regression will be used to test association of CQOLC total score with continuous and categorical variables.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hematopoietic/Lymphoid Cancer', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies quality of life in caregivers of hospitalized older patients with cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Identify patient and caregiver factors associated with increased caregiver burden and decreased quality of life in caregivers of older adults with cancer.\n\nSECONDARY OBJECTIVES:\n\nI. Determine characteristics of informal caregivers of older adults with cancer admitted to hospital.\n\nII. Determine type and amount of care informal caregivers provide for older adults with cancer admitted to hospital.\n\nIII. Determine quality of life in informal caregivers of older adults with cancer admitted to hospital.\n\nIV. Identify caregiver needs, both informational and resource related. V. Explore the association between re-admission to the hospital within 30 days and caregiver burden.\n\nVI. Explore whether feedback of information attained from the assessment of the caregiver influences services implemented by the health care team.\n\nVII. Determine reasons for non-participation.\n\nOUTLINE:\n\nCaregivers complete a questionnaire about their sociodemographics, physical health, social supports, social activity, mental health and caregiver burden. They will also provide an assessment of the person they care for.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PATIENT: Age \\>= 65 years old\n* PATIENT: Diagnosis of cancer (solid or hematologic malignancy)\n* PATIENT: Be able to provide informed consent\n* PATIENT: Unplanned admission to hospital\n* CAREGIVER: Primary caregiver (person who provides all of the majority of the unpaid care for the care recipient)\n* CAREGIVER: Be able to provide informed consent\n\nExclusion Criteria:\n\n* PATIENT: Planned admission to hospital for treatment (chemotherapy, transplant)\n* CAREGIVER: Not fluent in English (because not all questionnaires have been validated in other languages)\n* CAREGIVER: Paid and trained to care for the patient'}, 'identificationModule': {'nctId': 'NCT01866969', 'briefTitle': 'Quality of Life in Caregivers of Hospitalized Older Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Physical, Emotional and Social Stressors and Their Impact on Quality of Life of Caregivers of Hospitalized Older Adults With Cancer', 'orgStudyIdInfo': {'id': '13158'}, 'secondaryIdInfos': [{'id': 'NCI-2013-01068', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '13158', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (quality of life questionnaire)', 'description': 'Caregivers complete a self-administered questionnaire about factors associated with increased caregiver burden and decreased quality of life.', 'interventionNames': ['Other: questionnaire administration', 'Procedure: quality-of-life assessment']}], 'interventions': [{'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (quality of life questionnaire)']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (quality of life questionnaire)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Arti Hurria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}