Clinical and Patient Reported Outcomes for Individuals with Relapsed/Refractory Multiple Myeloma Treated with Isatuximab: Real-World Insights from Patient Reported, Wearable, and Qualitative Data in the Context of Digital Health Coaching
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Change in Patient's Qualitative Assessment of Treatment Real World version (PQAT-RW)
研究概览
简要总结
This descriptive study aims to evaluate the experience of adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc through collection of quantitative, qualitative and wearable data. Fifty adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc will be enrolled across 2 sites, The University of California San Francisco and The University of Texas MD Anderson Cancer Center. Consented participants will be enrolled in a 3-month digital health coaching program through which electronic patient reported outcomes and wearable activity data will be collected. Outcomes include treatment experience, quality of life, financial toxicity, treatment adherence, symptom burden and health self-efficacy. These will be captured by patient reported outcome measures including the Patient's Qualitative Assessment of Treatment- Real World (PQAT-RW), Patient Global Impression of Change/Severity (PGIC/S), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20), and the European QoL-5 Dimensions (EQ5D), Cancer Behavior Inventory-Brief Form (CBI-B), Center for Adherence Support Evaluation (CASE) Medication Adherence Index, Comprehensive Score for Financial Toxicity (COST) Instrument.
Clinical data, including treatment history, healthcare utilization, and co-morbidities, as well as demographic data will be collected via the electronic health record from each clinical site. This data will be complemented by qualitative data from a selected cohort of study participants with a focus on treatment experience ranging from infusion burden, toxicity management, to overall quality of life. Evaluation of this data in combination will be used to better understand the treatment experience of individuals on standard of care isatuximab-irfc specifically, and with relapsed or refractory multiple myeloma generally, contributing to an existing gap in the literature regarding patient reported outcomes from diverse data sources. Outcomes will be analyzed with attention to the relationship between social determinants of health, including race, ethnicity, and geographic location, and treatment experience as reflected in both the qualitative and quantitative data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age 18 or older
- •Diagnosis of relapsed/refractory multiple myeloma corresponding to the Food and Drug Administration (FDA) package insert for isatuximab-irfc (Sarclisa®).
- •Confirmed or planned treatment with intravenous isatuximab-irfc for relapsed/refractory multiple myeloma as standard-of-care therapy. Concurrent therapy with other agents (e.g., pomalidomide) is allowed.
- •Access to and willingness to use a smartphone or other device through which they can send and receive text messages, emails and/or access a mobile application.
- •Willingness to wear and have data collected by a Fitbit
- •Ability to engage in physical activity as evidenced by an Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 2
排除标准
- •Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
- •Individuals for whom there is documentation of inability to provide consent in the medical record.
- •Individuals receiving isatuximab-irfc subcutaneously
结局指标
主要结局
Change in Patient's Qualitative Assessment of Treatment Real World version (PQAT-RW)
时间窗: Change in baseline perception of treatment experience at 3 months
A 6-item survey assessing experience of a drug during clinical trial. The instrument consists of 3-free text and 3 scaled responses assessing the perceived benefits and disadvantages of received treatment and willingness to continue on drug after the study.
Qualitative Interview
时间窗: Within the last month of study participation
A one time interview will be conducted to learn more about the experience of individuals related to their diagnosis, treatment, symptoms, side effects and overall care experience.
次要结局
- Change in Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20)(Change in baseline perception of treatment experience at 3 months)
- Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)(Change in baseline perception of treatment experience at 3 months)
- Change in European QoL-5 Dimensions (EQ5D)(Change in baseline perception of treatment experience at 3 months)
- Change in Cancer Behavior Inventory-Brief Form (CBI-B)(Change in baseline perception of treatment experience at 3 months)
- Change in Patient Global Impression of Severity (PGIS) Scale(Change in baseline perception of treatment experience at 3 months)
- Change in Patient Global Impression of Change (PGIC) Scale(Change in baseline perception of treatment experience at 3 months)
- Change in Center for Adherence Support Evaluation (CASE) Medication Adherence Index(Change in baseline perception of treatment experience at 3 months)
- Change in Comprehensive Score for Financial Toxicity (COST) Instrument(Change in baseline perception of treatment experience at 3 months)