Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT02166866
Status:
COMPLETED
Last Update Posted:
2018-06-29
First Post:
2014-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Cancer Caregiver Interventions to Improve Quality of Life and Prevent Burnout
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-28', 'studyFirstSubmitDate': '2014-06-06', 'studyFirstSubmitQcDate': '2014-06-16', 'lastUpdatePostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'calculate the average number of caregivers participating in each offered web-based session', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Cancer Care Recipient']}, 'referencesModule': {'references': [{'pmid': '34842060', 'type': 'DERIVED', 'citation': 'Lapid MI, Atherton PJ, Kung S, Clark MM, Sloan JA, Whitford KJ, Hubbard JM, Gentry MT, Miller JJ, Rummans TA. A feasibility study of virtual group therapy to improve quality of life of cancer caregivers. J Psychosoc Oncol. 2022;40(6):854-867. doi: 10.1080/07347332.2021.2000550. Epub 2021 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'This study defines cancer caregivers as unpaid individuals who provide physical, practical, and/or emotional care and support to the cancer patient in the home setting. They may participate in this study if care recipients and the caregiver are both adults (18 years or older), with the patient having been diagnosed with cancer.The 8 intervention sessions will target the five domains of Quality Of Life (emotional, physical, social, cognitive, and spiritual well-being), be provided in group settings, and be delivered in two 45-minute sessions each week over a 4-week period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Caregivers will be recruited through the Mayo Clinic inpatient and outpatient services, including but not limited to referrals from staff of the Divisions of Medical Oncology, Hematology, and Radiation Oncology and other clinics in the outpatient setting, and Divisions of HospitalMedicine, Hospice and Palliative Medicine, and other inpatient services in the hospital setting. This population was chosen as they are likely to experience caregiver-related distress for which the intervention will be beneficial.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide written informed consent.\n* Ability to speak, read, write and understand English language\n* Has cancer caregiver status defined as an unpaid individual who provides physical, practical, and/or emotional care and support to a cancer care recipient in the home or other healthcare setting.\n* Has a care recipient:\n\n * ≥ 18 years of age who\n * has a malignancy (either solid tumor or hematologic) diagnosis.\n * who has signed a research authorization form\n * who is undergoing or in the last 6 months has undergone cancer treatment\n* Ability to use and access to a computer, tablet or other device with internet access and video capabilities\n\nExclusion Criteria:\n\n* Diagnosis within the past 12 months of active substance abuse (alcohol or drugs)\n* Diagnosis within the past 12 months of active mental health condition that has required psychiatric hospitalization\n* Diagnosis within the past 12 months of suicidal thoughts or attempt\n* Care recipient is currently participating in another psychosocial clinical trial'}, 'identificationModule': {'nctId': 'NCT02166866', 'briefTitle': 'Phase I/II Cancer Caregiver Interventions to Improve Quality of Life and Prevent Burnout', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'orgStudyIdInfo': {'id': 'MC1295'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental arm', 'interventionNames': ['Other: Quality of Life Questionairre and Education']}], 'interventions': [{'name': 'Quality of Life Questionairre and Education', 'type': 'OTHER', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}