Acute Myeloid LeukemiaNCT04644419
Chemotherapy-related Cognitive Impairment and Acute Leukemia
An observational study of Acute Myeloid Leukemia, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- none (observational study)
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2020to 3 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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
Who cannot join
- referred to hospice care
- [Caregiver]
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Lineberger Comprehenisive Cancer Center
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- none (observational study)
- Keywords
- Cognitive function
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none (observational study)Other
This is an observational study and does not include intervention delivery.
| Study group | Role | What they receive |
|---|---|---|
| Control group of the LCCC1848 | Patients in the control arm will receive standard of care. Receives: Other: none (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at the second cycle of treatment (about day 30)
Secondary 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.
Measured: 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
Include both trails A and B.
Measured: 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)
Include total recall and delayed recall.
Measured: 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
Include three initial alphabet letter for each assessment.
Measured: 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
Include forward and backward assessment.
Measured: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)
Cognitive effort as assessed by Borg CR 10
Range from 0-10, maximum. The higher the score, the much the cognitive effort.
Measured: at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start3 Nov 2020
- Primary completion15 Oct 2022
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Ya-Ning Chan, MSN, RN, Principal investigator, University of North Carolina, Chapel HillAshley L Bryant, PhD, RN, Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644419
- Sponsor's protocol ID
- LCCC2045
- Status last verified
- May 2023
- First submitted
- 19 Nov 2020
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy-related Cognitive Impairment in Adults With Acute Leukemia
- ClinicalTrials.gov ID
- NCT04644419
- Acronym / sponsor ID
- LCCC2045
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Cognitive function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control group of the LCCC1848 | – | Other: none (observational study)Patients in the control arm will receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- ≥ 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)
Key exclusion criteria (2 listed)
- referred to hospice care
- [Caregiver]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| none (observational study)This is an observational study and does not include intervention delivery. | Other | Control group of the LCCC1848 |
Primary outcome
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.
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.
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.
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.
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.
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.
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ya-Ning Chan, MSN, RN principal investigator
University of North Carolina, Chapel Hill
Ashley L Bryant, PhD, RN study chair
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function as assessed by Functional Assessment of Cancer Therapy - Cognitive Function (time frame: at the second cycle of treatment (about day 30)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.