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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group of the LCCC1848 | Patients in the control arm will receive standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| none (observational study) | Other | This is an observational study and does not include intervention delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 first, third, fourth, fifth, sixth, and seventh cycle of treatment (baseline, about day 60, 90, 120, 150, and 180) |
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[Patient]
Inclusion Criteria:
Exclusion Criteria:
[Caregiver]
Inclusion criteria:
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Patients aged 60 years or older, diagnosed with AML, received HMA+VEN treatment, and participated in the NCT04570709 study.
Caregivers identified by eligible patients.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Lineberger Comprehenisive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Processing speed and executive function as assessed by Trial Making Test | Include both trails A and B. | 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. | 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. | 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. | 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. | at the first, fourth, and seventh cycle of treatment (baseline, about day 90 and 180) |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |