Chemotherapy-related Cognitive Impairment and Acute Leukemia

NCT04644419 | Completed

• 1 other identifier: LCCC2045
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia

Keywords

Cognitive function

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (6)

• Cognitive function as assessed by Functional Assessment of Cancer Therapy - 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

  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)

  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

  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

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

Study Arms (1)

Control group of the LCCC1848

Patients in the control arm will receive standard of care.

Other: none (observational study)

Interventions

none (observational study) OTHER

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

Control group of the LCCC1848

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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)

You may not qualify if:

• referred to hospice care
• \[Caregiver\]
• identified by patient as a caregiver
• ≥18 years of age
• speak and read English

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

University of North Carolina Lineberger Comprehenisive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Ya-Ning Chan, MSN, RN

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Ashley L Bryant, PhD, RN

  University of North Carolina, Chapel Hill

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: November 3, 2020
• Primary Completion: October 15, 2022
• Study Completion: May 3, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

US (1)