Patient and Care Partner Experiences Living With Multiple Myeloma (PaCE-MM)
NCT ID: NCT05276622
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
64 participants
OBSERVATIONAL
2022-02-08
2023-10-03
Brief Summary
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Detailed Description
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Patients will complete baseline geriatric assessments and a 30-45-minute cognitive test, and both will be reassessed in 3 months intervals. The geriatric assessment is primarily patient-reported surveys and involves a multi-domain evaluation of a patient's functional status (i.e., their ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medications, and nutritional status. Care Partners will be asked to complete baseline surveys that will also assess their well-being and ability to function at home.
To provide a more comprehensive understanding of the myeloma-related experiences a subset of patients and their care partners will be asked to participate in a baseline interview repeated over time to understand how the disease and its treatments shape the experiences.
Duration of Subject Participation: 6 months
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects with newly diagnosed multiple myeloma
Forty subjects with newly diagnosed multiple myeloma.
Comprehensive Geriatric Assessment
A modified Cancer and Aging Research Group (CARG) Geriatric Assessment that includes validated measures of 7 geriatric domains: functional status, comorbidity, cognition, psychological state, social activity, and support, nutritional status, and medications will be performed at baseline (pre-treatment), every 3 months for a total of 3 assessments. The modified comprehensive Geriatric Assessment includes patient-reported surveys and research staff assessments.
Cognitive Testing: The National Institutes of Health Toolbox Cognition Battery (objective) and PROMIS Short Form v2.0 - Cognitive function 8a (subjective)
Care partners of the subjects with newly diagnosed multiple myeloma
Thirty care partners of the subjects with newly diagnosed multiple myeloma.
Qualitative patient-care partner interviews
Semi-structured Interviews: Baseline and again at 3 months.
Surveys on well-being and function
Care partner's Surveys on well-being and function: Baseline and again at 3 months
Interventions
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Comprehensive Geriatric Assessment
A modified Cancer and Aging Research Group (CARG) Geriatric Assessment that includes validated measures of 7 geriatric domains: functional status, comorbidity, cognition, psychological state, social activity, and support, nutritional status, and medications will be performed at baseline (pre-treatment), every 3 months for a total of 3 assessments. The modified comprehensive Geriatric Assessment includes patient-reported surveys and research staff assessments.
Cognitive Testing: The National Institutes of Health Toolbox Cognition Battery (objective) and PROMIS Short Form v2.0 - Cognitive function 8a (subjective)
Qualitative patient-care partner interviews
Semi-structured Interviews: Baseline and again at 3 months.
Surveys on well-being and function
Care partner's Surveys on well-being and function: Baseline and again at 3 months
Eligibility Criteria
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Inclusion Criteria
2. New myeloma diagnosis as defined by the International Myeloma Working Group, does not have another non-myeloma plasma cell disorder such as POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma cell disorder, skin changes) or amyloidosis.
3. Starting systemic treatment.
4. Able to understand and speak in English.
5. Able to provide informed consent to participate.
1. Aged ≥18.
2. Able to understand and speak in English.
3. Able to provide informed consent to participate.
4. Be a care partner for a patient with multiple myeloma and is also enrolled in the assessment portion of this study.
5. Willing and able to participate in semi-structured interviews.
Exclusion Criteria
55 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Shakira Grant, MBBS
Role: PRINCIPAL_INVESTIGATOR
Lineberger CCC, Center for Aging and Health, The University of North Carolina Chapel Hill
Locations
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Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Countries
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Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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LCCC2121
Identifier Type: -
Identifier Source: org_study_id