Chemotherapy-related Cognitive Impairment and Acute Leukemia

May 4, 2023 updated by: UNC Lineberger Comprehensive Cancer Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at the second cycle of treatment (about day 30)
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.
at the second cycle of treatment (about day 30)
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.
at the second cycle of treatment (about day 30)
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.
at the second cycle of treatment (about day 30)
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.
at the second cycle of treatment (about day 30)
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.
at the second cycle of treatment (about day 30)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)
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)
Time Frame: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)
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
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.
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
Time Frame: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)
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
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.
at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UNC Lineberger Comprehensive Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Cancer Society, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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