Patient and Care Partner Experiences Living With Multiple Myeloma (PaCE-MM)
- Conditions
- Multiple Myeloma
- Interventions
- Other: Comprehensive Geriatric AssessmentOther: Qualitative patient-care partner interviewsOther: Surveys on well-being and function
- Registration Number
- NCT05276622
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 64
Patients must meet the following inclusion criteria to participate in this study:
- 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.
Care Partners must meet the following inclusion criteria to participate in this study
- 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.
- All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study: Inability to read and speak English.
- Dementia altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Care partners of the subjects with newly diagnosed multiple myeloma Surveys on well-being and function Thirty care partners of the subjects with newly diagnosed multiple myeloma. Subjects with newly diagnosed multiple myeloma Comprehensive Geriatric Assessment Forty subjects with newly diagnosed multiple myeloma. Care partners of the subjects with newly diagnosed multiple myeloma Qualitative patient-care partner interviews Thirty care partners of the subjects with newly diagnosed multiple myeloma.
- Primary Outcome Measures
Name Time Method Trajectories of physical function measured by ADLs Up to 6 months 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.
Trajectories of cognitive functions NIHTB-CB Up to 6 months 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.
Trajectories of physical function measured by Gait speed Up to 6 months 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.
Trajectories of cognitive functions PROMIS Up to 6 months 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.
Trajectories of HRQoL cognitive functions Up to 6 months 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.
Trajectories of physical function measured by IADLS Up to 6 months 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.
- Secondary Outcome Measures
Name Time Method Predictors of changes in cognitive function Up to 6 months 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.
Gain a complete understanding of the challenges patients and care partners living with multiple myeloma face Up to 6 months 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.
Predictors of changes in physical function Up to 6 months 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.
Predictors of changes in quality of life Up to 6 months 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.
Trial Locations
- Locations (1)
Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States