跳至主要内容
临床试验/NCT05556928
NCT05556928招募中不适用

Cancer and Aging Resilience Evaluation in Older Adults With Hematologic Malignancies: The CARE-Heme Registry

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2020年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
Create the CARE-Heme Registry

研究概览

简要总结

The primary purpose of this protocol is to create a registry of older (≥50 years old) patients with Hematologic Malignancies. Our main objectives include: To understand the prevalence of frailty and geriatric impairments among patients aged ≥50y and above diagnosed with a hematologic malignancy at UAB and to gather information that would lend support for future research in this vulnerable population.

详细描述

All participants will be invited to participate in a patient reported geriatric assessment questionnaire as well as an objective physical function testing. This includes the Short Physical Performance Battery (SPPB) that evaluates lower extremity performance and muscle strength assessment via hand grip dynamometer. Participants will also complete a 12 item modified version of PRO-CTCAE. This will be administered by trained research staff at the time of study enrollment. Repeat CARE instruments (Follow-up GA questionnaire and Physical Function test) will be administered after the baseline visit to measure changes in patient reported outcomes at 3 months, 6 months, and one year. A one-time blood or saliva sample will be requested and obtained at baseline or a follow-up visit.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients are ≥50 years of age.
  • Patients have a biopsy proven diagnosis of Hematologic Malignancy (Multiple Myeloma, AL Amyloidosis, Waldenstrom's Macrogloblunemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Myelodysplastic syndromes, Myeloproliferative Neoplasm, Acute/Chronic Myeloid Leukemia, Acute/Chronic Lymphoid Leukemia).
  • Patients have appointments at UAB including if they are an inpatient or other clinic locations.

排除标准

  • Individuals who are <50 years old.
  • Patients who do not read and/or speak English will not be eligible for this study as many of the questionnaires are not validated in other languages. No exclusions will be made based on gender, ethnicity or race.

结局指标

主要结局

Create the CARE-Heme Registry

时间窗: 5 years

To establish and maintain a well-annotated registry (to be called the 'CARE-Heme' Registry) of adults ≥50 years of age with a hematologic malignancy to improve our understanding of this vulnerable population.

次要结局

  • To administer a patient reported geriatric assessment and a brief objective physical assessment.(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noha Mohamed Sharafeldin

Principal Investigator

University of Alabama at Birmingham

研究点 (1)

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