Integrating Touchscreen-based Geriatric Assessment and Frailty Screening for Adults With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Feasibility, usability, and acceptability of a tablet-based modified geriatric assessment using online questionnaires.
研究概览
简要总结
The overarching objective of this study is to evaluate the feasibility, usability, and acceptability of an abbreviated, tablet-based geriatric assessment in a population of older adults with multiple myeloma.
详细描述
With rapid advances in research, clinicians are challenged to remain current on evolving treatment and supportive care guidelines for the management of Multiple Myeloma, particularly in older adults who present with various degrees of vulnerability to treatment complications. The global population is rapidly growing, and the number of people >80 years is expected to quadruple between 2000 and 2050. According to the International Myeloma Working Group (IMWG), more than 60% of multiple myeloma (MM) diagnoses and nearly 75% of deaths occur in patients over 65 years of age.1 Older patients experience more toxicity, especially with multidrug combinations, and historical treatment approaches for older adults with MM have included dose reductions or avoidance of treatment based on age and performance status alone, despite the poor predictive value of these variables for patient outcomes. Recent studies conclude that while chronological age is an important consideration when making treatment decisions for hematologic malignancies, functional status is more predictive of treatment outcomes. Thus it is important to factor variables beyond age into treatment for the older adult MM patient population, including functional and physical performance and comorbidity.
The Comprehensive Geriatric Assessment (CGA) is a global health evaluation of older adults that extends beyond a disease-focused evaluation in order to identify unrecognized issues amendable to interventions that may prevent future problems.4 The CGA has been used to predict toxicity and survival in patients using the domains of comorbidities, function, cognition, polypharmacy, social support, and depression and/or psychological distress. Most of the studies are in patients with solid tumors and not those with hematologic malignancies. However, there is evidence to support the use of the CGA to predict risk for adverse events and prognosis.
A modified Geriatric Assessment (mGA) tool that utilized age, functional status as determined by assessment of activities of daily living (ADLs) and instrumental activities of daily living (IADLs), plus comorbidity status was used to develop the Palumbo Frailty Index (FI). Frailty is a state of cumulative decline in many physiological systems that results in the diminished resistance to stressors. The FI categorizes patients into groups of fit, intermediate fit, and frail. In a retrospective analysis of data in 867 older adults with MM, toxicity, treatment discontinuation, and survival rates were correlated with the FI. To date, no studies have investigated the prospective ability of the Palumbo frailty index to predict toxicity and treatment outcomes in older adults with MM.
As a result of this retrospective validation work, fit/frailty status can be evaluated for usefulness in the clinical setting by gathering information from a mGA and providing the data to the care provider to guide treatment decisions. The use of decision aids for care and treatment decisions is rapidly growing, given that such aids have been shown to reduce decisional conflict, improve patient-clinician communication, improve the alignment of values and choice, and reduce the use of low value interventions. Use of decision aids is of growing interest as we shift to value-based cancer care models. Value-based cancer care models require the engagement of patients to better understand patient goals and ensure patients are counseled on the risks and benefits of various treatment options.
For older patients, GAs are not routinely performed because they are complex and time-consuming, the optimal tools for administering the GA accurately and efficiently have not been established, many clinicians lack knowledge about how to incorporate GA into decision-making and care of older adults, and integration of a GA into a Health Information System platform has not been adequately studied for feasibility and usage. Hurria and colleagues developed the Cancer Specific Geriatric Assessment (CSGA), a shorter assessment that specifically captures data from seven domains (functional status, comorbid medical conditions, psychological state, cognition, nutritional status, social support, and medications). This CSGA assessment took an average time of 27 minutes to complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years of age or older
- •Diagnosis of multiple myeloma
- •Newly diagnoses or needing a new line of therapy and have not yet made a treatment decision
- •Must be able to understand English
排除标准
- •Any patient who cannot understand written or spoken English
- •Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C, and D)
研究组 & 干预措施
Care planning platform usage
This intervention will focus on the use of the Carevive care planning software for multiple myeloma patients age 65 and older who are at a treatment decision-making timepoint.
干预措施: Carevive CPS (Behavioral)
结局指标
主要结局
Feasibility, usability, and acceptability of a tablet-based modified geriatric assessment using online questionnaires.
时间窗: Years 1-2
This study will evaluate the feasibility, usability, and acceptability of a tablet-based modified geriatric assessment completed by patients and presented to clinicians at a treatment decision-making visit for older adults with multiple myeloma. Data from multiple qualitative online questionnaires will be aggregated together to arrive at one reported value, utility of a tablet-based modified geriatric assessment.
Physician use and perceived utility of the modified geriatric assessment
时间窗: Years 1-2
This still will examine the physician use and perceived utility of the modified geriatric assessment including the use and utility of the mCGA to facilitate treatment decision-making.
次要结局
- Description of treatment decision making patterns chosen by hematologists managing older patients with multiple myeloma(Years 1-2)
- Description of rates of CTCAE Grade 3-5 toxicities in older adults with MM who receive treatment following a treatment decision making visit at which an mCGA is completed(Years 1-2)
- Description of the relationship between the mCGA and toxicity in older adults with MM over 3 months of chemotherapy(Years 1-2)
- Description of the relationship between the mCGA and dose modification and/or treatment discontinuation in older adults with MM over 3 months of chemotherapy.(Years 1-2)
