Rehabilitation Management for Patients With Multiple Myeloma: a Retrospective Observational Study on Bone Fragility and Rehabilitation Needs in This Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Number of patients who experienced a Skeletal-Related Event (SRE) in the first 2 years from MM diagnosis
研究概览
简要总结
Multiple myeloma (MM) is the second most common blood cancer. Bone involvement is very common in these patients: it is estimated that between 80% and 90% will develop bone lesions during the course of the disease. This represents a potential risk of fragility and pain, significantly impacting the patient's functional status and therefore worsening their quality of life. [1] The presence of bone lesions also represents a risk for the development of Skeletal-Related Events (SREs), which can include: pathological fractures, vertebral compression that causes spinal cord compression, and the need for surgery or radiotherapy to treat the bone lesions. It is important to monitor and manage SREs as they are associated with increased mortality.
With the improvement of treatments and increased survival rates, more and more patients require rehabilitation management, which includes therapeutic education, the prescription of orthoses/aids, and specific rehabilitation programs to address fatigue or cope with major events such as SREs. Also frequently needed are guidelines regarding safe physical activity and support for returning to work or resuming satisfying social participation.
In many MM patients, bone involvement represents a challenge for the rehabilitation specialist, who must be able to perform an accurate assessment of the risks and benefits of treatment to avoid exposing the patient to unnecessary risks or complications. Managing the patient within a multidisciplinary team of specialists can improve the accuracy of the overall assessment and therapeutic recommendations. The aim of our study is to retrospectively analyze patients with a new diagnosis of MM who were managed by the Hematology Department in 2019, 2020, and 2021, in order to describe and evaluate any SREs, as well as some clinical and rehabilitation data.
详细描述
Multiple myeloma (MM) is the second most common hematologic malignancy and is characterized by the proliferation of malignant plasma cells within the bone marrow. Bone disease represents one of the most frequent clinical manifestations of MM, affecting approximately 80-90% of patients during the course of the disease. Osteolytic lesions are associated with pain, skeletal fragility, impaired mobility, reduced functional independence, and deterioration in quality of life.
Bone involvement increases the risk of skeletal-related events (SREs), including pathological fractures, vertebral compression resulting in spinal cord compression, and the need for surgery or radiotherapy to treat bone lesions. These events are associated with increased healthcare utilization, reduced functional outcomes, and poorer survival, highlighting the importance of their early identification and appropriate multidisciplinary management.
The improvement in therapeutic strategies has substantially increased the survival of patients with MM, making rehabilitation an increasingly important component of comprehensive patient care. Rehabilitation interventions may include therapeutic education, prescription of orthotic devices and assistive technologies, individualized exercise and rehabilitation programs to address fatigue and functional impairment, recommendations regarding safe physical activity, and support for returning to work and social participation. Because of the high risk of skeletal complications, rehabilitation planning requires careful assessment of the balance between potential benefits and risks. A multidisciplinary approach involving hematologists, rehabilitation specialists, and other healthcare professionals may optimize clinical decision-making and improve patient management.
This retrospective observational study aims to evaluate the occurrence of skeletal-related events in patients with newly diagnosed MM managed by the Hematology Department between January 2019 and December 2021. The study will also describe the clinical characteristics, bone involvement, rehabilitation needs, rehabilitation interventions, and functional outcomes of this patient population, providing real-world data that may support the optimization of multidisciplinary care pathways for patients with MM.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •New Diagnosis of Multiple Myeloma in 2019,2020 or 2021
- •Older then 18 years
排除标准
- •Absence of even one inclusion criterion
研究组 & 干预措施
Patients with a new diagnosis of Multiple Myeloma
who were managed by the Hematology Department in 2019, 2020, and 2021
结局指标
主要结局
Number of patients who experienced a Skeletal-Related Event (SRE) in the first 2 years from MM diagnosis
时间窗: SREs will be detected in the period including 60 days before MM diagnosis to 24 months after diagnosis
The Presence of SREs (pathological fractures, radiation to bone, bone surgery or spinal cord compression) will be recorded from clinical databases for each patient, considering the period including 60 days before MM diagnosis to 24 months after diagnosis.
Number pf patients who underwent Hospitalization due to SREs
时间窗: between 60 days before MM diagnosis and 24 months after MM diagnosis
Record if the patient was hospitalized due to complications from SREs, considering this timeframe: between 60 days before MM diagnosis and 24 months after MM diagnosis.
Number of patients reporting a pathological fracture, number of patients who needed radiation to bone, number of patients who underwent bone surgery, number of patients with spinal cord compression.
时间窗: between 60 days before MM diagnosis and 24 months after MM diagnosis
SREs are classified it as: * pathological fractures * spinal cord compression * surgical stabilization of bone * radiotherapy on bone This outcome will record how many patients experienced each of these SREs, in different moments of MM timeline. We will specify if it is a: * baseline SREs if patients experienced it within 60 days before MM diagnosis to 60 days after MM diagnosis * early SREs if patients experienced it in the period included within 2 months after MM diagnosis up to 12 months * late SREs if patients experienced it in the period included within 12 months after MM diagnosis up to 24 months
次要结局
- Number of patients with bone involvement at MM diagnosis(between 60 days before MM diagnosis and 60 days after MM diagnosis)
- Number of patients needing aids or orthoses(between 60 days before MM diagnosis and 24 months after MM diagnosis)
- Number of patients who underwent therapy with zoledronic acid or other Bone Modifying Agents (BMAs)(between 60 days before MM diagnosis and 24 months after MM diagnosis)
- Number of patients who received a Multiple Myeloma Multidisciplinary Team evaluation(period including 60 days before MM diagnosis and 24 months after diagnosis)
- Number pf patients who suffered pain and its location(between 60 days before MM diagnosis and 60 days after MM diagnosis)
- Number of patient who received a physiatric consultation(period including 60 days before MM diagnosis and 24 months after diagnosis)
- Number of patients who received a Rehabilitation intervention(period including 60 days before MM diagnosis and 24 months after diagnosis)