Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
NCT ID: NCT01382082
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
1432 participants
OBSERVATIONAL
2011-07-14
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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subjects with breast cancer
No interventions assigned to this group
subjects with lymphoma
No interventions assigned to this group
subjects without cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
* 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
* Must not have dementia or any severe neurodegenerative disease that would prohibit the ability to complete cognitive testing.
* Must not be colorblind
21 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Rochester NCORP Research Base
OTHER
Responsible Party
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Michelle Janelsins, PhD, MPH
Professor of Surgery, Radiation Oncology, and Neuroscience
Principal Investigators
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Michelle C. Janelsins, PhD
Role: STUDY_CHAIR
University of Rochester
Locations
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Delaware/Christiana Care NCORP
Newark, Delaware, United States
Delaware/Christiana Care NCORP (CHRISTIANA)
Newark, Delaware, United States
Heartland
Decatur, Illinois, United States
Kansas City Clinical Oncology Program
Prairie Village, Kansas, United States
Wichita NCORP
Wichita, Kansas, United States
Wichita
Wichita, Kansas, United States
Gulf South MU-NCORP
New Orleans, Louisiana, United States
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, United States
CRCWM
Grand Rapids, Michigan, United States
Metro Minnesota NCORP
Minneapolis, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Nevada
Las Vegas, Nevada, United States
Hem Onc CNY
East Syracuse, New York, United States
Kansas City
Rochester, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Novant Health Cancer Institute - Kernersville
Winston-Salem, North Carolina, United States
Southeast Clinical Oncology Research Program
Winston-Salem, North Carolina, United States
Columbus NCORP
Columbus, Ohio, United States
Columbus
Columbus, Ohio, United States
Dayton Community Oncology Program
Dayton, Ohio, United States
Dayton
Dayton, Ohio, United States
Pacific Cancer Research Consortium Ncorp
Portland, Oregon, United States
PCRC
Portland, Oregon, United States
NCORP of the Carolinas
Greenville, South Carolina, United States
Upstate Carolina
Spartanburg, South Carolina, United States
Northwest (Virginia Mason)
Seattle, Washington, United States
Wisconsin NCORP
Marshfield, Wisconsin, United States
Aurora NCORP
Milwaukee, Wisconsin, United States
Countries
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References
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Kleckner AS, Kleckner IR, Culakova E, Shayne M, Belcher EK, Gudina AT, Williams AM, Onitilo AA, Hopkins JO, Gross H, Mustian KM, Peppone LJ, Janelsins MC. The association between cancer-related fatigue and diabetes from pre-chemotherapy to 6 months post-chemotherapy. Support Care Cancer. 2022 Sep;30(9):7655-7663. doi: 10.1007/s00520-022-07189-x. Epub 2022 Jun 9.
Gilmore N, Mohile S, Lei L, Culakova E, Mohamed M, Magnuson A, Loh KP, Maggiore R, Belcher E, Conlin A, Weiselberg L, Ontko M, Janelsins M. The longitudinal relationship between immune cell profiles and frailty in patients with breast cancer receiving chemotherapy. Breast Cancer Res. 2021 Feb 5;23(1):19. doi: 10.1186/s13058-021-01388-w.
Other Identifiers
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