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临床试验/NCT03454568
NCT03454568已完成不适用

Measuring Cognition, Physical Function, and Quality of Life After Hematopoietic Cell Transplantation in Adults >/= 60 Years: A Feasibility Study

University of Nebraska1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Assess differences with cognitive function in older patients undergoing allogeneic or autologous stem cell transplant at 4 timepoints.

研究概览

简要总结

This study will examine how adults ≥ 60 years old thinking and memory abilities are affected by stem cell transplant; whether these changes affect day-to-day activities and quality of life and how thinking and memory abilities are affected by genetics, depression, anxiety and physical function. Genetics and other factors may affect the brain's chemicals or structure, and may increase risk for negative effects on thinking and memory.

详细描述

In this study, the investigators are looking to understand: 1) how adults ≥ 60 years old thinking and memory abilities are affected by stem cell transplant; 2) whether these changes affect day-to-day activities and quality of life; and 3) how thinking and memory abilities are affected by genetics, depression, anxiety and physical function. Genetics and other factors may affect the brain's chemicals or structure, and may increase risk for negative effects on thinking and memory. Participants will undergo neurocognitive testing along with the collection of a saliva sample and completing a battery of questionnaires and assessments.

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
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 60-85
  • Diagnosed with a hematological malignancy
  • Is considering an autologous or allogeneic stem cell transplant OR has undergone stem cell transplant in the past 12 months and seen by the PI for pre-transplant evaluation.
  • Is able to read, write, speak, and understand English

排除标准

  • As per self report or medical record, history of central nervous system involvement and/or history of cranial irradiation or intrathecal chemotherapy except for patients with history of prophylactic intrathecal chemotherapy.
  • As per self report or medical record, history of stroke, head injury, neurosurgery, seizure disorder, or demyelinating disorder.
  • As per self report or medical record, history of substance use disorder.
  • As per self report or in the judgement of the consenting professional, uncorrected vision loss.
  • As per self report or medical record, primary psychiatric disorder necessitating inpatient treatment in the last 12 months.
  • As per self report or medical record, history of allogeneic and or autologous stem cell transplant.

结局指标

主要结局

Assess differences with cognitive function in older patients undergoing allogeneic or autologous stem cell transplant at 4 timepoints.

时间窗: Before transplant; Post Transplant at 100 days, 6 months, and 12 months

Cognition will be measured using a neuropsychological battery.

次要结局

  • Assess activity engagement of older patients undergoing allogeneic and autologous transplant at 4 timepoints.(Before transplant; Post Transplant at 100 days, 6 months, and 12 months)
  • Assess quality of life of of older patients undergoing allogeneic and autologous transplant at 4 timepoints.(Before transplant; Post Transplant at 100 days, 6 months, and 12 months)
  • Describe genetic variations in genes potentially involved in cognitive function and cancer treatment.(1 time collection: Before transplant)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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