Acute Myeloid Leukemia
Conditions
Keywords
Cognitive function
Brief summary
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
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.
Interventions
OTHERnone (observational study)
This is an observational study and does not include intervention delivery.
Sponsors
American Cancer Society, Inc.
UNC Lineberger Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\[Patient\] 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive effort as assessed by Borg CR 10 | at the second cycle of treatment (about day 30) | Range from 0-10, maximum. The higher the score, the much the cognitive effort. |
| Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function | 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. |
| Processing speed and executive function as assessed by Trial Making Test | at the second cycle of treatment (about day 30) | Include both trails A and B. |
| Memory and verbal learning as assessed by Hopkins Verbal Learning Test-revised (HVLT-R) | at the second cycle of treatment (about day 30) | Include total recall and delayed recall. |
| Speeded lexical fluency as assessed by Delis-Kaplan Executive Function System (D-KEFS) letter fluency | 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 | at the second cycle of treatment (about day 30) | Include forward and backward assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | Include both trails A and B. |
| 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) | Include total recall and delayed recall. |
| 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) | Include three initial alphabet letter for each assessment. |
| 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) | Include forward and backward assessment. |
| Cognitive effort as assessed by Borg CR 10 | at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180) | Range from 0-10, maximum. The higher the score, the much the cognitive effort. |
Countries
United States
Outcome results
None listed