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

Multiple Myeloma Clinical Trial

— PaCE-MM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05276622
• Other study ID #: LCCC2121
• Secondary ID: 1R03AG074030-01
• Status: Terminated
• Start date: February 8, 2022
• Est. completion date: October 3, 2023

Study information

• Verified date: October 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: October 3, 2023
• Est. primary completion date: October 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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)
• 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

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Predictors of changes in cognitive function	Multivariable regression modelling will be used to examine whether or not the following participant-reported socio-demographics factors (age, race, sex, education, income, community social vulnerability) and geriatric conditions (medical comorbidities, depression, anxiety, lack of social support) can predict those most likely to experience changes in cognitive function over a 6- month period.	Up to 6 months
Secondary	Predictors of changes in physical function	Multivariable regression modelling will be used to examine whether or not the following participant-reported socio-demographics factors (age, race, sex, education, income, community social vulnerability) and geriatric conditions (medical comorbidities, depression, anxiety, lack of social support) can predict those most likely to experience changes in physical function (ADLS, IADLS, gait speed) over a 6-month period.	Up to 6 months
Secondary	Predictors of changes in quality of life	Multivariable regression modeling will be used to examine whether or not the following participant-reported socio-demographics factors (age, race, sex, education, income, community social vulnerability) and geriatric conditions (medical comorbidities, depression, anxiety, lack of social support) can predict those most likely to experience changes in quality of life level based on the European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) scores, over 6- month period. Higher score=better level of physical functioning.	Up to 6 months
Secondary	Gain a complete understanding of the challenges patients and care partners living with multiple myeloma face	Multiple myeloma and its associated treatments shape functional capacity, quality of life, and the overall illness experience in adults with multiple myeloma and their care partners will be evaluated using semi-structured interviews. Furthermore, changes between baseline, and at 3 months after treatment starts will be compared.	Up to 6 months

External Links

•   Center for Aging and Health Clinical Trials, The University of North Carolina Chapel Hill
•   University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials