Assessment and Treatment of Cognitive Deficits in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Examine the effectiveness of a cognitive rehabilitation program for improving executive function (EF) deficits for preventing or lessening EF impairments in women with Breast Cancer
研究概览
简要总结
RATIONALE: Breast cancer and its treatment may cause changes in a patient's ability to think, learn, and remember. Gathering information about a woman's genes, brain function, and personal history may help doctors learn more about the disease and plan the best treatment.
PURPOSE:
- To determine changes in brain function that occur following breast cancer chemotherapy.
- To gain further understanding of the individual differences in brain function changes and recovery based on demographic, medical and treatment variables.
详细描述
This study aims to determine some of the genetic, neurobiologic and demographic factors that are associated with cognitive outcome following breast cancer (BC). Additionally, it aims to test novel behavioral interventions designed to improve executive function skills following BC treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •3.1.1 Primary, non-metastatic breast cancer
- •3.1.2 Newly diagnosed patients who have not yet begun treatment.
- •3.1.4 Female participants age 40-65 years of all ethnicities who speak fluent English will be recruited.
- •3.1.5 There are no life expectancy restrictions.
- •3.1.6 Karnofsky Performance Status 70% minimum. ECOG will not be employed.
- •3.1.7 There are no requirements for marrow function. The brain must be free from gross neuropathology and metastases in order to participate.
- •3.1.8 Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •3.2.1 History of cognitive, psychiatric or medical conditions prior or unrelated to cancer diagnosis and/or known to significantly impact assessments (e.g. premature birth, developmental delays, learning disabilities, severe psychiatric conditions, brain injury, stroke). Non-English speaking. Major sensory impairment (e.g. hearing loss, blindness) that would render assessments invalid. MRI contraindications (e.g. metallic implants or devices). Distant metastases. See also section 4.2.
- •3.2.2 Participants currently involved in studies specifically aimed at improving cognitive symptoms will be excluded.
- •3.2.3 Participants with significant co-morbid diseases known to significant impact neuropsychological function such as Alzheimer's or Parkinson's will be excluded.
- •3.2.4 There are no known risks for allergic reactions to any of the study procedures.
- •3.2.5 Participants taking certain medications that affect neuropsychological and/or brain function including Haldol, Aricept, Ritalin, etc. will be excluded. Most anti-depressants are acceptable. Some anti-anxiety medications may not be. Each case will be individually reviewed.
- •3.2.6 There are no other agent-specific exclusion criteria.
- •3.2.7 Pregnant individuals will be excluded as this is a contraindication for the 3 Tesla research MRI scanner employed by this study but not because of the treatment programs per se. Nursing individuals can enroll.
- •3.2.8 Patients who are HIV positive will be excluded given the known effects of this condition on cognitive function which would confound the effects of anti-cancer treatments on cognitive outcome.
研究组 & 干预措施
Cognitive Rehabilitation (Breast Cancer(BC) with chemotherapy)
Cognitive rehabilitation is a very low-risk method of treatment for cognitive deficits that involves restoring impaired function and/or training the individual to compensate for the area of deficit. Subjects will complete a curriculum of cognitive exercises 30 minutes per day, 5 days per week for 6-weeks.
干预措施: Cognitive Rehabilitation (Behavioral)
Active Neurofeedback (BC pre-chemotherapy)
In active Neurofeedback session subjects will be trained to increase brain activation in regions associated with executive function (EF) function deficits (as determined by neuroimaging measures) by viewing their own brain activation in real-time. The "dose" will be 2-3 sessions, each lasting approximately 30 minutes.
干预措施: Active Neurofeedback Training (Behavioral)
Neurofeedback placebo (Sham) (BC pre-chemotherapy)
Neurofeedback training: 2-3, 30 min training sessions. For the sham placebo group, fabricated real-time data will be provided to the subject as feedback information hence enabling the subject to view information identical to experimental subjects but without accurate data pertaining to their own brain activation. The technician will be blinded to the subject's treatment condition assignment.
干预措施: Neurofeedback Training (placebo / Sham) (Behavioral)
结局指标
主要结局
Examine the effectiveness of a cognitive rehabilitation program for improving executive function (EF) deficits for preventing or lessening EF impairments in women with Breast Cancer
时间窗: 6 weeks
Evaluation of efficacy of executive function (EF) will be done via Neuropsychological and Neuroimaging (using functional MRI) assessments. Measurements of executive function, memory, processing speed, attention, visual-spatial processing and language will be compared before and after 6 weeks of cognitive rehabilitation program. Neuropsychological assessment and neuroimaging assessment changes will be compared from baseline to post-assessment in the intervention groups. Mixed effects approach and reliable change index (RCI) will be used as a supplementary analysis to determine the change in cognitive testing scores from pre- to post-intervention.Specific neuroimaging data (e.g. prefrontal cortex volumes, hippocampal metabolite levels, whole brain white matter fractional anisotropy) will be correlated with neuropsychological testing scores.
次要结局
- Examine the effectiveness of neurofeedback training program for preventing or reducing cognitive deficits in women with Breast Cancer(up to 6 months)
- Evaluate diurnal cortisol levels on executive function outcome in women with Breast cancer(2 days)
研究者
Oxana Palesh
Assistant Professor of Psychiatry and Behavioral Sciences
Stanford University