Chemotherapy-related Cognitive Impairment and Acute Leukemia

Chemotherapy-related Cognitive Impairment in Adults With Acute Leukemia

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: none (observational 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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Lineberger Comprehenisive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

[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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group of the LCCC1848; Patients in the control arm will receive standard of care.	Other: none (observational study); This is an observational study and does not include intervention delivery.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Ya-Ning Chan, MSN, RN, University of North Carolina, Chapel Hill; Study Chair: Ashley L Bryant, PhD, RN, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Actual): October 15, 2022
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Cognitive function
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Neoplasms by Histologic Type; Neoplasms; Neurocognitive Disorders; Cognition Disorders; Drug-Related Side Effects and Adverse Reactions; Leukemia; Cognitive Dysfunction; Chemotherapy-Related Cognitive Impairment
• Other Study ID Numbers: LCCC2045

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No