Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy at Pre-Treatment, Post-Treatment, at Six Month Follow-Up, and Long-Term Follow-Ups
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,432
- 试验地点
- 29
- 主要终点
- Short-term memory
研究概览
简要总结
Cognitive impairments in cancer patients represent an important clinical problem. Studies to date estimating prevalence of difficulties in memory, executive function, and attention deficits have been limited by small sample sizes and many have lacked healthy control groups. More information is needed on promising biomarkers and allelic variants that may help to determine the etiology of impairment, identify those most vulnerable to impairment, and develop interventions for these difficulties.
This is a longitudinal observational study of cognitive function in breast cancer and lymphoma patients receiving chemotherapy to better understand the prevalence of cognitive difficulties (i.e., problems with memory, executive function, and attention) in these populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects Receiving Chemotherapy:
- •Have a diagnosis of invasive breast cancer (stage I-IIIC) or intermediate or high-grade* lymphoma (*defined by the treating physician)
- •Be scheduled to begin a course of chemotherapy
- •Oral chemotherapy is acceptable
- •Previous or concurrent treatment with hormones or biological response modifiers is acceptable. (Subjects receiving biological response modifiers only are not eligible).
- •Be chemotherapy naïve
- •Life expectancy greater than 10 months
- •Be able to speak and read English
- •Give written informed consent
- •Inclusion Criteria, Controls:
- •Must be the same gender as the subject receiving chemotherapy
- •Must be within 5 years of the age of the subject receiving chemotherapy
- •Life expectancy greater than 10 months
- •Be able to speak and read English
- •Give written informed consent
- •Must be willing to participate in the study for the entire period
- •Inclusion Criteria, Long-Term Followup Study:
- •Must be a subject who had breast cancer, or control who was paired with that subject with breast cancer, who provided CANTAB data at any time-point during assessments 1 through 3.
排除标准
- •Subjects Receiving Chemotherapy:
- •Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness
- •Must not be diagnosed with a neurodegenerative disease
- •Must not have primary central nervous system (CNS) disease
- •Must not have received chemotherapy in the past
- •Must not be scheduled to receive concurrent radiation treatment
- •Must not have metastatic disease (subjects with breast cancer)
- •Must not be pregnant
- •Must not be colorblind
- •Exclusion Criteria, Controls:
- •Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness
- •Must not be diagnosed with a neurodegenerative disease
- •Must not have primary CNS disease
- •Must not have been diagnosed with cancer or previously have received chemotherapy
- •Must not be pregnant or plan on becoming pregnant during the study period
- •Must not be colorblind
- •Exclusion Criteria, Long-Term Followup Study:
- •Must not have dementia or any severe neurodegenerative disease that would prohibit the ability to complete cognitive testing.
- •Must not be colorblind
研究组 & 干预措施
subjects with lymphoma
subjects without cancer
subjects with breast cancer
结局指标
主要结局
Short-term memory
时间窗: Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls
Change in Short-term visual memory will be assessed by the computerized Delayed Matching to Sample (DMS) task.
次要结局
- short term memory(8 and/or 10 years post-chemotherapy)
- Attention impairment(Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls)
- Executive function impairment(Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls)
- Self-report score(8 and/or 10 years post-chemotherapy)
- attention(8 and/or 10 years post-chemotherapy)
- Verbal recognition memory impairment(Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls)
- Self-report score(Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls)
研究者
Michelle Janelsins, PhD, MPH
Professor of Surgery, Radiation Oncology, and Neuroscience
University of Rochester NCORP Research Base