MM-CARE: Cardiovascular Risk Assessment in Adults With Multiple Myeloma (MM-CARE)
A Pilot Feasibility Study of Oncology-Embedded Versus Primary Care-Directed Cardiovascular Risk Assessment in Adults With Multiple Myeloma Starting a New Line of Therapy
People with multiple myeloma may have health conditions or receive treatments that increase their risk of heart and blood-vessel problems. This pilot study will evaluate whether a structured heart-health assessment can be completed successfully and on time when adults with multiple myeloma start a new line of treatment.
Participants who do not require urgent treatment in the hospital will be assigned by chance to receive the assessment from either an internal medicine clinician working with the oncology team or their primary care provider. Participants who require urgent inpatient treatment will receive the oncology-embedded assessment during their hospital stay.
Researchers expect that both approaches will be practical, but the approaches may differ in how often and how quickly the assessments are completed. The study will also collect information about care recommendations, quality of life, physical activity, diet, usual-care blood test and electrocardiogram results, and heart-related health events. Because this is a small pilot study, it is not designed to determine whether one approach provides better health outcomes than the other.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
MM-CARE is a prospective, pragmatic, open-label, randomized pilot feasibility study evaluating two approaches to cardiovascular risk assessment for adults with multiple myeloma who are starting a new line of systemic therapy.
After informed consent, eligibility confirmation, and completion of baseline study assessments, participants who do not require urgent inpatient treatment will be randomized 1:1 to the oncology-embedded pathway or the primary care provider (PCP)-directed pathway. Randomization will be stratified according to whether the participant's PCP practices within the University of Vermont Health Network. Participants and clinicians will know the assigned pathway.
Participants assigned to the oncology-embedded pathway will receive a focused cardiovascular risk-assessment visit with an internal medicine clinician who works with the oncology team. The assessment may be conducted in person or by secure video and will include review of cardiovascular history, symptoms, family history, medications, vital signs, relevant laboratory and electrocardiogram results, physical activity, diet, tobacco use, and medication adherence. The clinician may provide counseling or recommend additional clinical evaluation, referrals, or medications based on the participant's individual needs. Clinical follow-up will occur at approximately Months 3, 6, and 12.
For participants assigned to the PCP-directed pathway, the study team will send the participant's PCP a structured letter within five business days after randomization. The letter will request a focused cardiovascular risk assessment and will include relevant clinical information and available laboratory and electrocardiogram results. The PCP will be asked to complete the assessment as soon as feasible, preferably within 30 days after treatment initiation and no later than six months after treatment initiation. The study team will track whether the assessment occurred and collect information about recommendations, medication changes, and referrals.
Participants who are hospitalized because of a multiple myeloma-related emergency and must begin a new line of therapy in the hospital will enter a separate nonrandomized urgent-treatment cohort. These participants will receive the oncology-embedded cardiovascular assessment during the qualifying hospitalization and will be analyzed separately from the randomized groups.
The study does not require a specific cardiovascular medicine, test, referral, diet, exercise plan, or change to multiple myeloma treatment. All clinical decisions will be made by the participant and the responsible clinicians. Multiple myeloma treatment may begin before or after the cardiovascular assessment and will not be delayed to complete study activities.
Study assessments will occur at baseline and approximately Months 3, 6, and 12. Participants will complete questionnaires about physical function, quality of life, physical activity, diet, the perceived helpfulness of the cardiovascular assessment, and whether they followed recommendations. The study team will also review relevant medical information and available results from blood tests and electrocardiograms performed as part of usual clinical care. Participants may separately agree to provide an additional 10 mL blood sample at each of these four time points for storage and future research.
Active study participation will continue through Month 12. At Month 24, the study team will conduct a medical-record review for cardiovascular events, hospitalizations, new cardiovascular diagnoses, deaths, and cardiovascular-related changes or interruptions to multiple myeloma treatment. No participant visit or additional procedure is required at Month 24.
The primary purpose of this pilot study is to evaluate whether the cardiovascular assessment pathways can be implemented and completed within the planned timeframe. The study is not designed or statistically powered to establish that one pathway produces better clinical outcomes than the other. Findings will be used to inform the design of a larger future study.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Mansour Gergi, MD
- Telefonszám: 802-656-2021
- E-mail: mansour.gergi@med.uvm.edu
Tanulmányi helyek
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Vermont
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Burlington, Vermont, Egyesült Államok, 05401
- University of Vermont Medical Center
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Kapcsolatba lépni:
- Mansour Gergi, MD
- Telefonszám: 802-656-2021
- E-mail: mansour.gergi@med.uvm.edu
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
- Confirmed diagnosis of multiple myeloma.
- Age 18 years or older.
- Preparing to begin a new line of systemic multiple myeloma treatment in the newly diagnosed or relapsed or refractory setting.
- Planned ongoing oncology care with anticipated clinical visits sufficient to coordinate study assessments at Months 3, 6, and 12.
- For participants eligible for randomization, an established primary care provider who can be identified at enrollment and contacted by the study team if the participant is assigned to the primary care provider-directed pathway.
- Ability to understand the study and willingness to provide written informed consent.
Exclusion Criteria:
- An acute cardiovascular condition requiring emergency evaluation or specialty cardiology management rather than routine cardiovascular risk assessment, as determined by the treating clinician.
- Any condition that, in the investigator's judgment, would prevent meaningful participation in the study intervention or required assessments.
- Hospitalization or an urgent need to begin multiple myeloma treatment is not an exclusion.
Participants meeting the urgent-treatment criteria may enroll in the separate nonrandomized urgent-treatment cohort.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egészségügyi szolgáltatások kutatása
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: Oncology-Embedded Cardiovascular Assessment
Participants receive a focused cardiovascular risk assessment from an internal medicine clinician who works with the oncology team.
The assessment may occur in person or by secure video and includes review of cardiovascular history, symptoms, family history, medications, vital signs, relevant laboratory and electrocardiogram results, physical activity, diet, tobacco use, and medication adherence.
The clinician may provide counseling or recommend clinically appropriate testing, referrals, or medications.
Clinical follow-up occurs at approximately Months 3, 6, and 12.
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A focused cardiovascular risk assessment is provided by an internal medicine clinician who works with the oncology team.
The assessment may occur in person or by secure video.
The clinician reviews cardiovascular history, symptoms, family history, medications, vital signs, relevant laboratory and electrocardiogram results, physical activity, diet, tobacco use, and medication adherence.
The clinician may provide counseling or recommend clinically appropriate testing, referrals, or medications.
Clinical follow-up occurs at approximately Months 3, 6, and 12.
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Aktív összehasonlító: Primary Care Provider-Directed Cardiovascular Assessment
Within five business days after randomization, the study team sends the participant's primary care provider a structured letter requesting a focused cardiovascular risk assessment.
Relevant clinical information and available laboratory and electrocardiogram results are provided.
The assessment is requested as soon as feasible, preferably within 30 days after treatment initiation and no later than six months after treatment initiation.
The primary care provider determines the appropriate counseling, testing, referrals, or medications.
The study team tracks completion of the assessment and related recommendations.
|
Within five business days after randomization, the study team sends the participant's primary care provider a structured letter requesting a focused cardiovascular risk assessment.
The communication includes relevant clinical information and available laboratory and electrocardiogram results.
The assessment is requested as soon as feasible, preferably within 30 days after treatment initiation and no later than six months after treatment initiation.
The primary care provider determines the appropriate counseling, testing, referrals, or medications.
The study team tracks assessment completion and related recommendations.
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Kísérleti: Urgent-Treatment Oncology-Embedded Assessment
Participants who are hospitalized because of a multiple myeloma-related emergency and must begin a new line of therapy in the hospital enter this nonrandomized cohort.
Participants receive the oncology-embedded cardiovascular risk assessment during the qualifying hospitalization.
Multiple myeloma treatment is not delayed to complete the assessment.
Participants in this cohort are analyzed separately from participants in the two randomized arms.
|
A focused cardiovascular risk assessment is provided by an internal medicine clinician who works with the oncology team.
The assessment may occur in person or by secure video.
The clinician reviews cardiovascular history, symptoms, family history, medications, vital signs, relevant laboratory and electrocardiogram results, physical activity, diet, tobacco use, and medication adherence.
The clinician may provide counseling or recommend clinically appropriate testing, referrals, or medications.
Clinical follow-up occurs at approximately Months 3, 6, and 12.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Proportion of Eligible Patients Who Enroll
Időkeret: During the study recruitment period, up to 24 months
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Number of eligible patients who provide informed consent and enroll divided by the total number of eligible patients approached, multiplied by 100.
The proportion will be reported with a 95% confidence interval.
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During the study recruitment period, up to 24 months
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Proportion of Participants Completing the Cardiovascular Assessment Before Treatment
Időkeret: From study enrollment through the first dose of the new systemic multiple myeloma treatment line
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Number of participants whose assigned cardiovascular risk-assessment visit is documented as completed on or before the first dose of the new systemic multiple myeloma treatment line, divided by the number assigned to the pathway, multiplied by 100.
Results will be summarized by study arm with 95% confidence intervals.
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From study enrollment through the first dose of the new systemic multiple myeloma treatment line
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Proportion of Participants Completing the Cardiovascular Assessment Within 6 Months
Időkeret: From treatment initiation through 6 months after treatment initiation
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Number of participants whose assigned cardiovascular risk-assessment visit is documented as completed within six months after starting the new systemic multiple myeloma treatment line, divided by the number assigned to the pathway, multiplied by 100.
Results will be summarized by study arm with 95% confidence intervals.
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From treatment initiation through 6 months after treatment initiation
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Uptake and Adherence to Cardiovascular Medication Recommendations
Időkeret: Assessed at Months 3, 6, and 12 after the baseline study visit
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Among participants who receive a cardiovascular medication recommendation, the percentage who initiate or continue the recommended medication and report adherence.
Medication initiation, continuation, discontinuation, and adherence will be summarized separately by study arm and assessment time point.
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Assessed at Months 3, 6, and 12 after the baseline study visit
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Uptake and Adherence to Lifestyle Recommendations
Időkeret: Assessed at Months 3, 6, and 12 after the baseline study visit
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Among participants who receive a physical activity or dietary recommendation, the percentage who report following the recommendation.
Physical activity and dietary recommendations will be summarized separately by study arm and assessment time point.
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Assessed at Months 3, 6, and 12 after the baseline study visit
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Completion of the PCP-Directed Cardiovascular Assessment by PCP Affiliation
Időkeret: From treatment initiation through 6 months after treatment initiation
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Among participants assigned to the PCP-directed pathway, the percentage who complete the assigned cardiovascular risk-assessment visit will be summarized separately for participants with a UVM Health Network-affiliated PCP and participants with a non-UVM Health Network-affiliated PCP.
Completion requires documentation that the PCP reviewed cardiovascular risk and provided an assessment or recommendations.
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From treatment initiation through 6 months after treatment initiation
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Change From Baseline in PROMIS Physical Function Short Form 6b Score
Időkeret: Baseline and Months 3, 6, and 12
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Physical function is measured using the 6-item Patient-Reported Outcomes Measurement Information System Physical Function Short Form 6b.
Items are scored from 1 to 5, with raw scores ranging from 6 to 30.
Raw scores are converted to standardized T-scores according to PROMIS scoring procedures.
Higher scores indicate better physical function.
Change from baseline will be summarized at each follow-up time point and compared between the randomized arms.
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Baseline and Months 3, 6, and 12
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Cumulative Incidence of Composite Cardiovascular Events
Időkeret: From baseline through Month 24
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The percentage of participants who experience at least one of the following events will be estimated: myocardial infarction, ischemic stroke, peripheral arterial thrombotic event, new-onset heart failure or hospitalization for heart failure, new clinically significant arrhythmia, or cardiovascular-related death.
The composite endpoint and its individual components will be summarized by randomized arm and for the urgent-treatment cohort.
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From baseline through Month 24
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Érrendszeri betegségek
- Szív-és érrendszeri betegségek
- Neoplazmák
- Immunrendszeri betegségek
- Neoplazmák szövettani típus szerint
- Hematológiai betegségek
- Limfoproliferatív rendellenességek
- Immunproliferatív rendellenességek
- Neoplazmák, plazmasejt
- Hemostatikus rendellenességek
- Paraproteinémiák
- Vérfehérje rendellenességek
- Hemorrhagiás rendellenességek
- Hemikus és nyirokbetegségek
- Myeloma multiplex
Egyéb vizsgálati azonosító számok
- STUDY00004410/UVMCC2608
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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