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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Proportion of Eligible Patients Who Enroll
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Proportion of Eligible Patients Who Enroll
时间窗: During the study recruitment period, up to 24 months
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.
Proportion of Participants Completing the Cardiovascular Assessment Before Treatment
时间窗: From study enrollment through the first dose of the new systemic multiple myeloma treatment line
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.
Proportion of Participants Completing the Cardiovascular Assessment Within 6 Months
时间窗: From treatment initiation through 6 months after treatment initiation
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.
Uptake and Adherence to Cardiovascular Medication Recommendations
时间窗: Assessed at Months 3, 6, and 12 after the baseline study visit
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.
Uptake and Adherence to Lifestyle Recommendations
时间窗: Assessed at Months 3, 6, and 12 after the baseline study visit
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.
次要结局
- Completion of the PCP-Directed Cardiovascular Assessment by PCP Affiliation(From treatment initiation through 6 months after treatment initiation)
- Change From Baseline in PROMIS Physical Function Short Form 6b Score(Baseline and Months 3, 6, and 12)
- Cumulative Incidence of Composite Cardiovascular Events(From baseline through Month 24)
研究者
Mansour Gergi
Assistant Professor of Medicine
University of Vermont Medical Center