Acute Myeloid Leukemia Clinical Trial

Chemotherapy-related Cognitive Impairment and Acute Leukemia

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.

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Full 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.

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Eligibility Criteria

[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 is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

25

Study ID:

NCT04644419

Recruitment Status:

Completed

Sponsor:

UNC Lineberger Comprehensive Cancer Center

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There is 1 Location for this study

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

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Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

25

Study ID:

NCT04644419

Recruitment Status:

Completed

Sponsor:


UNC Lineberger Comprehensive Cancer Center

How clear is this clinincal trial information?

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