Chemotherapy-related Cognitive Impairment and Acute Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Chemotherapy-related Cognitive Impairment in Adults With Acute Leukemia

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Other: none (observational study)


Participation Criteria
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Eligibility Criteria
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[Patient] Inclusion Criteria: ≥ 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) Exclusion Criteria: referred to hospice care [Caregiver] Inclusion criteria: identified by patient as a caregiver ≥18 years of age speak and read English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group of the LCCC1848<br>Patients in the control arm will receive standard of care. | Other: none (observational study)<br>* This is an observational study and does not include intervention delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function | 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. | at the second cycle of treatment (about day 30) | 
| Processing speed and executive function as assessed by Trial Making Test | Include both trails A and B. | at the second cycle of treatment (about day 30) | 
| Memory and verbal learning as assessed by Hopkins Verbal Learning Test-revised (HVLT-R) | Include total recall and delayed recall. | at the second cycle of treatment (about day 30) | 
| Speeded lexical fluency as assessed by Delis-Kaplan Executive Function System (D-KEFS) letter fluency | Include three initial alphabet letter for each assessment. | at the second cycle of treatment (about day 30) | 
| Attention and working memory as assessed by Wechsler Adult Intelligence Scale (WAIS)-digit span | Include forward and backward assessment. | at the second cycle of treatment (about day 30) | 
| Cognitive effort as assessed by Borg CR 10 | Range from 0-10, maximum. The higher the score, the much the cognitive effort. | at the second cycle of treatment (about day 30) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function | 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. | 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 | Include both trails A and B. | at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180) | 
| Memory and verbal learning as assessed by Hopkins Verbal Learning Test-revised (HVLT-R) | Include total recall and delayed recall. | 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 | Include three initial alphabet letter for each assessment. | 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 | Include forward and backward assessment. | at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180) | 
| Cognitive effort as assessed by Borg CR 10 | Range from 0-10, maximum. The higher the score, the much the cognitive effort. | at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive function