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NCT Number: NCT04644419

Chemotherapy-related Cognitive Impairment and 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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina Lineberger Comprehenisive Cancer Center

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

[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

Treatment and study plan

None (Observational study)

Other

This is an observational study and does not include intervention delivery.

Primary outcomes

  1. Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function

    Time frame: 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.

  2. Processing speed and executive function as assessed by Trial Making Test

    Time frame: at the second cycle of treatment (about day 30)

    Include both trails A and B.

  3. Memory and verbal learning as assessed by Hopkins Verbal Learning Test-revised (HVLT-R)

    Time frame: at the second cycle of treatment (about day 30)

    Include total recall and delayed recall.

  4. Speeded lexical fluency as assessed by Delis-Kaplan Executive Function System (D-KEFS) letter fluency

    Time frame: at the second cycle of treatment (about day 30)

    Include three initial alphabet letter for each assessment.

  5. Attention and working memory as assessed by Wechsler Adult Intelligence Scale (WAIS)-digit span

    Time frame: at the second cycle of treatment (about day 30)

    Include forward and backward assessment.

  6. Cognitive effort as assessed by Borg CR 10

    Time frame: at the second cycle of treatment (about day 30)

    Range from 0-10, maximum. The higher the score, the much the cognitive effort.

Secondary outcomes

  1. Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function

    Time frame: 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.

  2. Processing speed and executive function as assessed by Trial Making Test

    Time frame: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)

    Include both trails A and B.

  3. Memory and verbal learning as assessed by Hopkins Verbal Learning Test-revised (HVLT-R)

    Time frame: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)

    Include total recall and delayed recall.

  4. Speeded lexical fluency as assessed by Delis-Kaplan Executive Function System (D-KEFS) letter fluency

    Time frame: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)

    Include three initial alphabet letter for each assessment.

  5. Attention and working memory as assessed by Wechsler Adult Intelligence Scale (WAIS)-digit span

    Time frame: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)

    Include forward and backward assessment.

  6. Cognitive effort as assessed by Borg CR 10

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Chemotherapy-related Cognitive Impairment in Adults With Acute Leukemia

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Nov 25, 2020
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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