Chemotherapy-related Cognitive Impairment and Acute Leukemia

NCT ID: NCT04644419

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-03

Study Completion Date

2023-05-03

Brief Summary

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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

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group of the LCCC1848

Patients in the control arm will receive standard of care.

none (observational study)

Intervention Type OTHER

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

Interventions

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none (observational study)

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

Intervention Type OTHER

Eligibility Criteria

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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)


* identified by patient as a caregiver
* ≥18 years of age
* speak and read English

Exclusion Criteria

* referred to hospice care

\[Caregiver\]
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ya-Ning Chan, MSN, RN

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Ashley L Bryant, PhD, RN

Role: STUDY_CHAIR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina Lineberger Comprehenisive Cancer Center

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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LCCC2045

Identifier Type: -

Identifier Source: org_study_id

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