Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-related Cognitive Impairment (CRCI)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 36
研究概览
简要总结
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For all participants:
- •Able to provide informed consent.
- •Visual acuity sufficient to be able to read the consent form with corrective lenses.
- •Over 18 years of age.
- •English- or French-speaking.
- •For patients only:
- •Initial diagnosis of breast cancer stage I-IIIA and scheduled chemotherapy
- •First-time cancer diagnosis.
- •ECOG performance < 2
- •Receiving curative intent chemotherapy: either Adriamycin/Cyclophosphamide for 4 cycles followed by weekly Taxol for 12 cycles or Taxotere/Cyclophosphamide for 4 cycles
排除标准
- •For all participants:
- •Evidence or medical history of neurological/psychiatric issues known to affect movements and oculomotor control.
- •Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
- •Diagnosis of macular edema or other pre-existing ocular conditions that would prevent participants from performing the eye movement assessments.
- •Previous history of cancer or chemotherapy
- •Distant metastases
- •Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment.
- •Diagnosis of a substance abuse disorder.
- •Recreational drug use (e.g., alcohol, marijuana) is a potential exclusion criterion that will be determined on an individual basis as per the discretion of the research team. All recreational drug use will be documented.
研究组 & 干预措施
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
干预措施: Eye-Tracking (Device)
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.
干预措施: Eye-Tracking (Device)
结局指标
主要结局
Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 36
时间窗: Baseline and 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.
次要结局
- Change from Baseline in The Controlled Oral Word Association Test (COWAT) scores at Month 36(Baseline and Month 36)
- Change from Baseline in The Hopkins Verbal Learning Test-Revised (HVLT-R) scores at Month 36(Baseline and Month 36)
- Change from Baseline in The Trail Making Test (TMT) Parts A & B scores at Month 36(Baseline and Month 36)