Chemotherapy-related Cognitive Impairment and Acute Leukemia
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Other: none (observational study)
- Registration Number
- NCT04644419
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- ≥ 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)
- referred to hospice care
[Caregiver]
Inclusion criteria:
- identified by patient as a caregiver
- ≥18 years of age
- speak and read English
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control group of the LCCC1848 none (observational study) Patients in the control arm will receive standard of care.
- Primary Outcome Measures
Name Time Method Processing speed and executive function as assessed by Trial Making Test at the second cycle of treatment (about day 30) Include both trails A and B.
Cognitive effort as assessed by Borg CR 10 at the second cycle of treatment (about day 30) Range from 0-10, maximum. The higher the score, the much the cognitive effort.
Speeded lexical fluency as assessed by Delis-Kaplan Executive Function System (D-KEFS) letter fluency at the second cycle of treatment (about day 30) Include three initial alphabet letter for each assessment.
Attention and working memory as assessed by Wechsler Adult Intelligence Scale (WAIS)-digit span at the second cycle of treatment (about day 30) Include forward and backward assessment.
Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function 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.
Memory and verbal learning as assessed by Hopkins Verbal Learning Test-revised (HVLT-R) at the second cycle of treatment (about day 30) Include total recall and delayed recall.
- Secondary Outcome Measures
Name Time Method 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) Include total recall and delayed recall.
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) 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.
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) Include both trails A and B.
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) Include three initial alphabet letter for each assessment.
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) Include forward and backward assessment.
Cognitive effort as assessed by Borg CR 10 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.
Trial Locations
- Locations (1)
University of North Carolina Lineberger Comprehenisive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States