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

NCT05276622 | Terminated DMC

• 2 other identifiers: LCCC21211R03AG074030-01
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Newly diagnosed multiple myeloma; Physical Function; Cognitive Function; Quality of Life; Geriatric Assessments; Care partners

Outcome Measures

Primary Outcomes (6)

• Trajectories of cognitive functions NIHTB-CB

  Standardized National Institutes of Health Toolbox Cognition Battery (objective) (NIHTB-CB) will be used for the measure of cognitive function. The NIHTB-CB contains 7 computer-based instruments assessing 5 cognitive sub-domains: Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory. The Composite Score is calculated using all subsets. Higher score =better level of cognitive functions.

  Up to 6 months

• Trajectories of cognitive functions PROMIS

  Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Cognitive function 8a (subjective) scores will be combined for an overall measure of cognitive function. PROMIS Short Form v2.0- Cognitive function 8a is a participant reported measure of cognitive function. There are 8 questions, with a possible raw score of 8 to 40, then converted into a T-score for each participant. T-scores lower below 50 indicate a lower than average cognitive performance.

  Up to 6 months

• Trajectories of HRQoL cognitive functions

  The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) will be used to measure the changes in quality of life. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.

  Up to 6 months

• Trajectories of physical function measured by ADLs

  The physical function will be measured using participant-reported activities of daily living (ADLs) as bath, dress, toilet, transfer bed to chair, maintain continence and feed. The score ranges from 0-6 with an increasing score indicating loss of independence/function.

  Up to 6 months

• Trajectories of physical function measured by IADLS

  The physical function will be measured using Older Americans Resources and Services (OARS) instrumental activities of daily living (IADLS). Participants are asked to self-report their ability to engage in the following activities of daily living: bathe, dress, feed, toilet, maintain continence, transfer from bed to chair, use the telephone, shop, prepare food, housekeeping, laundry, take medications, manage finances, use transportation. The score ranges from 0-8 with an increasing score indicating loss of independence/function.

  Up to 6 months

• Trajectories of physical function measured by Gait speed

  The physical function will be measured using gait speed. Gait speed is measured by having participants walk at their normal pace at a distance of 4 meters. The slower the gait speed the more likely an individual is likely to be impaired functionally.

  Up to 6 months

Secondary Outcomes (4)

• Predictors of changes in cognitive function

  Up to 6 months

• Predictors of changes in physical function

  Up to 6 months

• Predictors of changes in quality of life

  Up to 6 months

• Gain a complete understanding of the challenges patients and care partners living with multiple myeloma face

  Up to 6 months

Study Arms (2)

Subjects with newly diagnosed multiple myeloma

Forty subjects with newly diagnosed multiple myeloma.

Other: Comprehensive Geriatric Assessment

Care partners of the subjects with newly diagnosed multiple myeloma

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

Other: Qualitative patient-care partner interviews; Other: Surveys on well-being and function

Interventions

Comprehensive Geriatric Assessment OTHER

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)

Subjects with newly diagnosed multiple myeloma

Qualitative patient-care partner interviews OTHER

Semi-structured Interviews: Baseline and again at 3 months.

Care partners of the subjects with newly diagnosed multiple myeloma

Surveys on well-being and function OTHER

Care partner's Surveys on well-being and function: Baseline and again at 3 months

Care partners of the subjects with newly diagnosed multiple myeloma

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged ≥55
• 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.
• Starting systemic treatment.
• Able to understand and speak in English.
• Able to provide informed consent to participate.
• Aged ≥18.
• Able to understand and speak in English.
• Able to provide informed consent to participate.
• Be a care partner for a patient with multiple myeloma and is also enrolled in the assessment portion of this study.
• Willing and able to participate in semi-structured interviews.

You may not qualify if:

• Dementia altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Geriatric Assessment; Functional Status

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Shakira Grant, MBBS

  Lineberger CCC, Center for Aging and Health, The University of North Carolina Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 11, 2022
• Study Start: February 8, 2022
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)