Clinical trial NCT04644419: Chemotherapy-related Cognitive Impairment and Acute Leukemia
Official title: Chemotherapy-related Cognitive Impairment in Adults With Acute Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Keywords: Cognitive function
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2020-11-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 60 years or older, diagnosed with AML, received HMA+VEN treatment, and participated in the NCT04570709 study.

Caregivers identified by eligible patients.

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.

Eligibility 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

Primary outcomes:
measure: Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function
timeFrame: at the second cycle of treatment (about day 30)
measure: Processing speed and executive function as assessed by Trial Making Test
timeFrame: at the second cycle of treatment (about day 30)
measure: Memory and verbal learning as assessed by Hopkins Verbal Learning Test-revised (HVLT-R)
timeFrame: at the second cycle of treatment (about day 30)
measure: Speeded lexical fluency as assessed by Delis-Kaplan Executive Function System (D-KEFS) letter fluency
timeFrame: at the second cycle of treatment (about day 30)
measure: Attention and working memory as assessed by Wechsler Adult Intelligence Scale (WAIS)-digit span
timeFrame: at the second cycle of treatment (about day 30)
measure: Cognitive effort as assessed by Borg CR 10
timeFrame: at the second cycle of treatment (about day 30)
Secondary outcomes:
measure: Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function
timeFrame: at the first, third, fourth, fifth, sixth, and seventh cycle of treatment (baseline, about day 60, 90, 120, 150, and 180)
measure: Processing speed and executive function as assessed by Trial Making Test
timeFrame: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)
measure: Memory and verbal learning as assessed by Hopkins Verbal Learning Test-revised (HVLT-R)
timeFrame: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)
measure: Speeded lexical fluency as assessed by Delis-Kaplan Executive Function System (D-KEFS) letter fluency
timeFrame: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)
measure: Attention and working memory as assessed by Wechsler Adult Intelligence Scale (WAIS)-digit span
timeFrame: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)
measure: Cognitive effort as assessed by Borg CR 10
timeFrame: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Lineberger Comprehenisive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ya-Ning Chan, MSN, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Ashley L Bryant, PhD, RN
role: STUDY_CHAIR
References: