Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
- Conditions
- Breast CancerLymphoma
- Registration Number
- NCT01382082
- Lead Sponsor
- University of Rochester NCORP Research Base
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1432
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.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Short-term memory 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.
- Secondary Outcome Measures
Name Time Method short term memory 8 and/or 10 years post-chemotherapy Delayed match to sample score
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 Change in attention will be assessed by the computerized Rapid Visual Information Processing (RVP) task.
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 Change in Executive function will be assessed by the computerized One Touch Stockings of Cambridge (OTS) planning task.
Self-report score 8 and/or 10 years post-chemotherapy FACT-Cog
attention 8 and/or 10 years post-chemotherapy Rapid Visual Processing speed score
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 Change in Memory (verbal) will be assessed by the computerized Verbal Recognition Memory (VRM) Task.
Trial Locations
- Locations (29)
Nevada
🇺🇸Las Vegas, Nevada, United States
Northwest (Virginia Mason)
🇺🇸Seattle, Washington, United States
Metro Minnesota NCORP
🇺🇸Minneapolis, Minnesota, United States
Pacific Cancer Research Consortium Ncorp
🇺🇸Portland, Oregon, United States
PCRC
🇺🇸Portland, Oregon, United States
Aurora NCORP
🇺🇸Milwaukee, Wisconsin, United States
Novant Health Cancer Institute - Kernersville
🇺🇸Winston-Salem, North Carolina, United States
Southeast Clinical Oncology Research Program
🇺🇸Winston-Salem, North Carolina, United States
Heartland
🇺🇸Decatur, Illinois, United States
Hem Onc CNY
🇺🇸East Syracuse, New York, United States
Columbus
🇺🇸Columbus, Ohio, United States
Columbus NCORP
🇺🇸Columbus, Ohio, United States
Wisconsin NCORP
🇺🇸Marshfield, Wisconsin, United States
Dayton
🇺🇸Dayton, Ohio, United States
Metro Minnesota Community Oncology Research Consortium
🇺🇸Saint Louis Park, Minnesota, United States
Delaware/Christiana Care NCORP
🇺🇸Newark, Delaware, United States
Wichita
🇺🇸Wichita, Kansas, United States
Cancer Research Consortium of West Michigan
🇺🇸Grand Rapids, Michigan, United States
Kansas City
🇺🇸Rochester, New York, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Delaware/Christiana Care NCORP (CHRISTIANA)
🇺🇸Newark, Delaware, United States
Wichita NCORP
🇺🇸Wichita, Kansas, United States
Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
CRCWM
🇺🇸Grand Rapids, Michigan, United States
Dayton Community Oncology Program
🇺🇸Dayton, Ohio, United States
NCORP of the Carolinas
🇺🇸Greenville, South Carolina, United States
Kansas City Clinical Oncology Program
🇺🇸Prairie Village, Kansas, United States
Gulf South MU-NCORP
🇺🇸New Orleans, Louisiana, United States