Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer, Lymphoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| subjects with breast cancer<br> | |
| subjects with lymphoma<br> | |
| subjects without cancer<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term memory | Change in Short-term visual memory will be assessed by the computerized Delayed Matching to Sample (DMS) task. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention impairment | Change in attention will be assessed by the computerized Rapid Visual Information Processing (RVP) task. | 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 | 
| Verbal recognition memory impairment | Change in Memory (verbal) will be assessed by the computerized Verbal Recognition Memory (VRM) Task. | 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 | Change in Executive function will be assessed by the computerized One Touch Stockings of Cambridge (OTS) planning task. | 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 | FACT-Cog change 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 | 
| short term memory | Delayed match to sample score | 8 years post chemotherapy | 
| attention | Rapid Visual Processing speed score | 8 years post chemotherapy | 
| Self-report score | FACT-Cog | 8 years post-chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive function, memory, attention, breast cancer, lymphoma