NCT05276622

Patient and Care Partner Experiences Living With Multiple Myeloma (PaCE-MM)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

This research study is explore the impact over time of multiple myeloma and its associated treatments on the physical and cognitive function and quality of life of patients and their care partners and how these impacts affect the overall illness experience.

Detailed description

This study aims to identify the factors, for example, age, race, sex, education, household income, clinical or other geriatric conditions such as depression, anxiety, or lack of social support that can predict those most likely to experience changes in physical and cognitive function and quality of life. Furthermore, patients and care partners experienced challenges, because of multiple myeloma and its associated treatments, will be studied using semi-structured interviews. 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

• Multiple Myeloma

Interventions

Type	Name	Description
OTHER	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)
OTHER	Qualitative patient-care partner interviews	Semi-structured Interviews: Baseline and again at 3 months.
OTHER	Surveys on well-being and function	Care partner's Surveys on well-being and function: Baseline and again at 3 months

Timeline

• Start date: 2022-02-08
• Primary completion: 2023-10-03
• Completion: 2023-10-03
• First posted: 2022-03-11
• Last updated: 2024-12-12

Locations

1 site across 1 country: United States