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

UNC Lineberger Comprehensive Cancer Center

Status: Terminated

Conditions: Multiple Myeloma

Treatments: Other: Qualitative patient-care partner interviews; Other: Surveys on well-being and function; Other: Comprehensive Geriatric Assessment

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05276622

LCCC2121

1R03AG074030-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 64 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Patients must meet the following inclusion criteria to participate in this study:

1. Aged ≥55
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.

Care Partners must meet the following inclusion criteria to participate in this study

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

1. All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study: Inability to read and speak English.
2. Dementia altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

Trial design

64 participants in 2 patient groups

Subjects with newly diagnosed multiple myeloma

Description:

Forty subjects with newly diagnosed multiple myeloma.

Treatment:

Other: Comprehensive Geriatric Assessment

Care partners of the subjects with newly diagnosed multiple myeloma

Description:

Thirty care partners of the subjects with newly diagnosed multiple myeloma.

Treatment:

Other: Surveys on well-being and function

Other: Qualitative patient-care partner interviews