NCT03619083进行中（未招募）不适用
Assessment of Sensory Gating, Attention, and Executive Control in Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- congnitive changes in patients
研究概览
简要总结
This study is being done to find out if a new series of evaluations called the SAE (Sensory-Attention-Executive) Battery can help researchers learn more about how cancer treatment does or does not change the way the brain processes/filters information, emotions, attention span, and behavior by comparing the results of the SAE Battery with traditional evaluations like questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For Patients:
- •As per medical record or self-report, female
- •As per medical record or self-report, age 40-75 at diagnosis of a new primary histological confirmed adenocarcinoma breast cancer
- •As per medical record or self-report, AJCC stages 0-3 breast cancer
- •As per medical record or self-report, post-surgery for current breast cancer diagnosis (surgery includes cryosurgery/cryotherapy)
- •Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)
- •As per medical record or self-report, if currently taking psychoactive medications (excluding gabapentin and including but not limited to antidepressants and anxiolytics) on a daily basis, dose must have been stable at least two months prior to enrollment.
- •English fluent (as per self-report, fluency of "well" or "very well", and having a reasonable comprehension of the study conversation in the opinion of the research staff)**
- •For Healthy Controls:
- •As per medical record or self-report, female
- •As per medical record or self-report, age 40-75
- •As per medical record or self-report, if currently taking psychoactive medications (including but not limited to antidepressants and anxiolytics), dose must have been stable at least two months prior to enrollment.
- •As per self report, no history of cancer except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma and, at the discretion of the PI, early stage secondary cancer diagnoses treated only with surgery
- •Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)
- •English fluent (as per self-report, fluency of "well" or "very well", and having a reasonable comprehension of the study conversation in the opinion of the research staff)**
排除标准
- •For All Participants:
- •As per medical record or self-report, diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.)
- •As per medical record or self report, history of stroke or head injury resulting in a structural lesion on neuropsych imaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation
- •As per medical record or self report, a diagnosis of a Schizophrenia Spectrum Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and Attenuated Psychotic Disorder.
- •As per medical record or self-report, visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aides)
- •As per medical record or self-report, use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for Lupus.
- •As per medical record or self-report, history of treatment using radiation, chemotherapy, and/or Tamoxifen or Aromatase-inhibitors
- •For Patients only:
- •As per medical record or self-report, history of another type of cancer or prior breast cancer diagnosis except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma and, at the discretion of the PI, early stage secondary cancer diagnoses treated only with surgery
- •As per medical record or self-report, disease recurrence. ** Language verification: For both patients and controls, prior to enrollment, all will be asked the following two questions by an RSA to verify English fluency necessary for participation in the study:
- •How well do you speak English? (must respond "Well" or "Very well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
- •What is your preferred language for healthcare? (must respond English)
研究组 & 干预措施
Breast cancer patients treated with chemotherapy
干预措施: SAE battery (Other)
Breast cancer patients treated with chemotherapy
干预措施: Assessments (Behavioral)
patients not exposed to chemotherapy
干预措施: SAE battery (Other)
patients not exposed to chemotherapy
干预措施: Assessments (Behavioral)
healthy controls
干预措施: SAE battery (Other)
healthy controls
干预措施: Assessments (Behavioral)
结局指标
主要结局
congnitive changes in patients
时间窗: 3 years
using the Sensory-Attention-Executive Battery
次要结局
未报告次要终点
研究者
研究点 (1)
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