Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not enough personnel
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.
This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by the Cancer-related cognitive impairment (CRCI) and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of the Cancer-related cognitive impairment (CRCI) and associated cognitive changes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer patients (stages I-IIIA) | 200 patients with an initial diagnosis of breast cancer stages I-IIIA and scheduled chemotherapy, fulfilling the eligibility criteria |
| |
| healthy control | Group of 30 healthy control participants, matched for age and sex, with no evidence or history of significant neurodegenerative disorder affecting brain function. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye-Tracking | Device | Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 36 | The SDMT is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Scoring involves summing the number of correct substitutions within the 90 second interval. | Baseline and Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in The Controlled Oral Word Association Test (COWAT) scores at Month 36 | The Controlled Oral Word Association Test from the Halstead-Reitan Neuropsychological Battery is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). | Baseline and Month 36 |
Not provided
Inclusion Criteria:
For all participants:
For patients only:
Exclusion Criteria:
For all participants:
Not provided
Not provided
Not provided
Data will be obtained from 200 patients with an initial diagnosis of breast cancer stages I-IIIA and scheduled chemotherapy, fulfilling the eligibility criteria. Data will also be acquired from a group of 30 healthy control participants. Groups will be matched for age and sex.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Center-Cedar Cancer Center | Montreal | Quebec | H4A 3J1 | Canada |
Not provided
| ID | Term |
|---|---|
| D000084542 | Eye-Tracking Technology |
| ID | Term |
|---|---|
| D053483 | Eye Movement Measurements |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
| Change from Baseline in The Trail Making Test (TMT) Parts A & B scores at Month 36 | The Trail Making Test (TMT) is a neuropsychological test that provides information on visual search, scanning, speed of processing, mental flexibility and executive functions. The TMT consists of two parts. TMT-A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-B except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task. | Baseline and Month 36 |
| Change from Baseline in The Hopkins Verbal Learning Test-Revised (HVLT-R) scores at Month 36 | The Hopkins Verbal Learning Test (HVLT-R) is a neuropsychological test that provides information on verbal learning and memory. The assessment consists of memorization of a list of words to test the ability to recall immediately after memorization (immediate recall) and after a 20-minute delay (delayed recall). | Baseline and Month 36 |
| D004568 | Electrodiagnosis |