Chemotherapy-related Cognitive Impairment in Adults With Acute Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Processing speed and executive function as assessed by Trial Making Test
研究概览
简要总结
This is an ancillary study of an intervention study (NCT04570709). The parent study is a single institution, feasibility trial of 20 (10 control and 10 intervention) patients with the primary objective of assessing feasibility, acceptability, and change in pre and post measures of symptoms, function, and quality of life by administering the Palliative and Collaborative Care InTervention (PACT). We will further assess cognitive function in the patients who participate in the control of the parent study.
详细描述
The study objective is to observe patient-reported and researcher-assessed cognitive function in adults with acute myeloid leukemia with chemotherapy treatment. We will assess cognitive function using a battery of neuropsychological assessments, patient-reported questionnaire, and semi-structured interviews among participants in control group only. The group assignment will be conducted through parent study (NCT04570709). Participating in this study will not affect participants' group assignment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 60 years of age
- •diagnosis of AML
- •Receive 1) low-dose cytarabine or hypomethylating agent (HMA) in combination with Venetoclax chemotherapy OR 2) low-dose cytarabine or hypomethylating agent (HMA) in combination with Venetoclax chemotherapy and any investigational drugs
- •have caregiver(s) willing to participate
- •participate in the parent study (PACT study, NCT04570709)
排除标准
- •referred to hospice care
- •[Caregiver]
- •Inclusion criteria:
- •identified by patient as a caregiver
- •≥18 years of age
- •speak and read English
结局指标
主要结局
Processing speed and executive function as assessed by Trial Making Test
时间窗: at the second cycle of treatment (about day 30)
Include both trails A and B.
Cognitive effort as assessed by Borg CR 10
时间窗: at the second cycle of treatment (about day 30)
Range from 0-10, maximum. The higher the score, the much the cognitive effort.
Speeded lexical fluency as assessed by Delis-Kaplan Executive Function System (D-KEFS) letter fluency
时间窗: at the second cycle of treatment (about day 30)
Include three initial alphabet letter for each assessment.
Attention and working memory as assessed by Wechsler Adult Intelligence Scale (WAIS)-digit span
时间窗: at the second cycle of treatment (about day 30)
Include forward and backward assessment.
Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function
时间窗: at the second cycle of treatment (about day 30)
The questionnaire consists of 4 domains, including perceived cognitive impairments, comments from others, perceived cognitive abilities, and impact of quality of life. The higher the score, the better the cognitive function.
Memory and verbal learning as assessed by Hopkins Verbal Learning Test-revised (HVLT-R)
时间窗: at the second cycle of treatment (about day 30)
Include total recall and delayed recall.
次要结局
- Memory and verbal learning as assessed by Hopkins Verbal Learning Test-revised (HVLT-R)(at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180))
- Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function(at the first, third, fourth, fifth, sixth, and seventh cycle of treatment (baseline, about day 60, 90, 120, 150, and 180))
- Processing speed and executive function as assessed by Trial Making Test(at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180))
- Speeded lexical fluency as assessed by Delis-Kaplan Executive Function System (D-KEFS) letter fluency(at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180))
- Attention and working memory as assessed by Wechsler Adult Intelligence Scale (WAIS)-digit span(at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180))
- Cognitive effort as assessed by Borg CR 10(at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180))