Chemotherapy-related Cognitive Impairment and Acute Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

Chemotherapy-related Cognitive Impairment in Adults With Acute Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644419
• Other study ID #: LCCC2045
• Status: Completed
• Start date: November 3, 2020
• Est. completion date: May 3, 2023

Study information

• Verified date: May 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 3, 2023
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

[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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Chemotherapy-Related Cognitive Impairment
• Cognitive Dysfunction
• Leukemia

Intervention

Other:
• none (observational study)
This is an observational study and does not include intervention delivery.

Locations

Country	Name	City	State
United States	University of North Carolina Lineberger Comprehenisive Cancer Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)