Multiple MyelomaPaCE-MMNCT05276622
Patient and Care Partner Experiences Living With Multiple Myeloma (PaCE-MM)
An observational study of Multiple Myeloma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Comprehensive Geriatric Assessment, Qualitative patient-care partner interviews and Surveys on well-being and function
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to 3 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
About this study
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.
Read the 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
- Conditions
- Multiple Myeloma
- Being tested
- Comprehensive Geriatric Assessment, Qualitative patient-care partner interviews, Surveys on well-being and function
- Keywords
- Newly diagnosed multiple myeloma, Physical Function, Cognitive Function, Quality of Life, Geriatric Assessments, Care partners
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric AssessmentOther
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 interviewsOther
Semi-structured Interviews: Baseline and again at 3 months.
Surveys on well-being and functionOther
Care partner's Surveys on well-being and function: Baseline and again at 3 months
| Study group | Role | What they receive |
|---|---|---|
| Subjects with newly diagnosed multiple myeloma | Forty subjects with newly diagnosed multiple myeloma. Receives: 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. Receives: Other: Qualitative patient-care partner interviews; Other: Surveys on well-being and function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Secondary outcomes (4)
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start8 Feb 2022
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
Why it stopped: Investigator left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Shakira Grant, MBBS, Principal investigator, Lineberger CCC, Center for Aging and Health, The University of North Carolina Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276622
- Sponsor's protocol ID
- LCCC2121
- Other IDs
- 1R03AG074030-01
- Acronym
- PaCE-MM
- Status last verified
- Dec 2024
- First submitted
- 26 Jan 2022
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Care Partner Experiences Living With Multiple Myeloma (PaCE-MM)
- ClinicalTrials.gov ID
- NCT05276622
- Acronym / sponsor ID
- PaCE-MM / LCCC2121
- Conditions
- Multiple Myeloma
- Keywords
- Newly diagnosed multiple myeloma, Physical Function, Cognitive Function, Quality of Life, Geriatric Assessments, Care partners
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator left the institution.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with newly diagnosed multiple myeloma | – | Other: Comprehensive Geriatric AssessmentForty subjects with newly diagnosed multiple myeloma. |
| Care partners of the subjects with newly diagnosed multiple myeloma | – | Other: Qualitative patient-care partner interviews, Other: Surveys on well-being and functionThirty care partners of the subjects with newly diagnosed multiple myeloma. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Geriatric AssessmentA 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) | Other | Subjects with newly diagnosed multiple myeloma |
| Qualitative patient-care partner interviewsSemi-structured Interviews: Baseline and again at 3 months. | Other | Care partners of the subjects with newly diagnosed multiple myeloma |
| Surveys on well-being and functionCare partner's Surveys on well-being and function: Baseline and again at 3 months | Other | Care partners of the subjects with newly diagnosed multiple myeloma |
Primary outcome
Trajectories of cognitive functions NIHTB-CB
Time frame: 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 cognitive functions PROMIS
Time frame: 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
Time frame: 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 ADLs
Time frame: 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 physical function measured by IADLS
Time frame: 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.
Trajectories of physical function measured by Gait speed
Time frame: 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.
4 secondary outcomes
Predictors of changes in cognitive function
Time frame: Up to 6 months
Predictors of changes in physical function
Time frame: Up to 6 months
Predictors of changes in quality of life
Time frame: Up to 6 months
Gain a complete understanding of the challenges patients and care partners living with multiple myeloma face
Time frame: Up to 6 months
Results and safety
The study was stopped early (reason given: Investigator left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shakira Grant, MBBS principal investigator
Lineberger CCC, Center for Aging and Health, The University of North Carolina Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator left the institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trajectories of cognitive functions NIHTB-CB (time frame: Up to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.