Clinical trial NCT05276622: Patient and Care Partner Experiences Living With Multiple Myeloma (PaCE-MM)
Official title: Patient and Care Partner Experiences Living With Multiple Myeloma (PaCE-MM)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Myeloma
Keywords: Newly diagnosed multiple myeloma
Physical Function
Cognitive Function
Quality of Life
Geriatric Assessments
Care partners
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-03-11
Enrollment: 64
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study has two different population groups: A. Forty subjects with newly diagnosed multiple myeloma did not receive treatment yet., B. Thirty care partners of the subjects with newly diagnosed multiple myeloma did not receive treatment yet.

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: Trajectories of cognitive functions NIHTB-CB
timeFrame: Up to 6 months
measure: Trajectories of cognitive functions PROMIS
timeFrame: Up to 6 months
measure: Trajectories of HRQoL cognitive functions
timeFrame: Up to 6 months
measure: Trajectories of physical function measured by ADLs
timeFrame: Up to 6 months
measure: Trajectories of physical function measured by IADLS
timeFrame: Up to 6 months
measure: Trajectories of physical function measured by Gait speed
timeFrame: Up to 6 months
Secondary outcomes:
measure: Predictors of changes in cognitive function
timeFrame: Up to 6 months
measure: Predictors of changes in physical function
timeFrame: Up to 6 months
measure: Predictors of changes in quality of life
timeFrame: Up to 6 months
measure: Gain a complete understanding of the challenges patients and care partners living with multiple myeloma face
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Lineberger CCC, Center for Aging and Health, The University of North Carolina Chapel Hill
name: Shakira Grant, MBBS
role: PRINCIPAL_INVESTIGATOR
References: