- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07842679
Cognitive Impairment in Older Adults With Hematologic Malignancies
Prevalence of Cognitive Impairment and Its Association With Activities of Daily Living Among Older Adults With Hematologic Malignancies Receiving Chemotherapy
This cross-sectional study aims to determine the prevalence of cognitive impairment and evaluate its relationship with activities of daily living among older adults with hematologic malignancies receiving chemotherapy.
Study Overview
Status
Detailed Description
Cognitive impairment is common among older adults with cancer and may affect treatment adherence and independence. This observational study will include adults aged 65 years or older with confirmed hematologic malignancies who are currently receiving chemotherapy.
Participants will undergo cognitive assessment using the Montreal Cognitive Assessment (MoCA) and functional assessment using the Katz Index of Activities of Daily Living (ADL) and Lawton Instrumental Activities of Daily Living (IADL).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kholoud K Fawzy, Resident
- Phone Number: 01009850621
- Email: khloud.18313604@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Older adults aged 65 years or older with confirmed hematologic malignancies receiving chemotherapy at Assiut University Hospitals.
Description
Inclusion Criteria:
- - Age 65 years or older
- Confirmed diagnosis of hematologic malignancy
- Currently receiving chemotherapy
- Able to communicate and participate in cognitive assessment
- Written informed consent
Exclusion Criteria:
- - Previously diagnosed dementia before the diagnosis of malignancy
- Delirium at the time of assessment
- Severe visual or hearing impairment interfering with cognitive testing
- History of major neurological disorders affecting cognition
- Severe psychiatric illness affecting cognitive assessment
- Critically ill patients unable to complete study assessment
Study Plan
How is the study designed?
Design Details
- Observational Models: CASE_ONLY
- Time Perspectives: CROSS_SECTIONAL
Cohorts and Interventions
Group / Cohort |
|---|
|
Single cohort: Older adults with hematologic malignancies
Adults aged 65 years or older with hematologic malignancies receiving chemotherapy who will undergo cognitive and functional assessment. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of cognitive impairment
Time Frame: Baseline
|
Proportion of participants with cognitive impairment defined as a Montreal Cognitive Assessment (MoCA) score less than 26. |
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean MoCA score
Time Frame: Baseline
|
Mean Montreal Cognitive Assessment (MoCA) score (range 0-30, higher scores indicate better cognition).. |
Baseline
|
|
Mean Katz ADL score
Time Frame: Baseline
|
Mean Katz Index of Independence in Activities of Daily Living score (range 0-6, higher scores indicate greater independence). |
Baseline
|
|
Mean Lawton IADL score
Time Frame: Baseline
|
Mean Lawton Instrumental Activities of Daily Living score (range 0-8, higher scores indicate greater independence) |
Baseline
|
|
Proportion with impaired activities of daily living
Time Frame: Baseline
|
Proportion of participants with impaired Katz ADL score. |
Baseline
|
|
Proportion with impaired instrumental activities of daily living
Time Frame: Baseline
|
Proportion of participants with impaired Lawton IADL score. |
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Soher M kasem, prof, Internal Medicine Department, Assiut University Hospitals
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cognitive-Hematology-Assiut-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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