Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
CANTAB
3 other identifiers
observational
1,432
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Longer than P75 for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedStudy Start
First participant enrolled
July 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 24, 2026
April 1, 2026
15.1 years
June 23, 2011
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
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
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
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
8 and/or 10 years post-chemotherapy
- +2 more secondary outcomes
Other Outcomes (1)
correlation of cognitive function with TNF alpha pathway biomarkers
change from pre to post chemotherapy and six month follow up
Study Arms (3)
subjects with breast cancer
subjects with lymphoma
subjects without cancer
Eligibility Criteria
During enrollment, the groups will be balanced on age and gender. Controls of the same age and gender as the subject receiving chemotherapy will be enrolled at the same time.
You may qualify if:
- 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
- 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
- +1 more criteria
You may not qualify if:
- 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
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Delaware/Christiana Care NCORP
Newark, Delaware, 19713, United States
Delaware/Christiana Care NCORP (CHRISTIANA)
Newark, Delaware, 19718, United States
Heartland
Decatur, Illinois, 62526, United States
Kansas City Clinical Oncology Program
Prairie Village, Kansas, 66208, United States
Wichita NCORP
Wichita, Kansas, 67214, United States
Wichita
Wichita, Kansas, 67214, United States
Gulf South MU-NCORP
New Orleans, Louisiana, 70112, United States
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, 49503, United States
CRCWM
Grand Rapids, Michigan, 49503, United States
Metro Minnesota NCORP
Minneapolis, Minnesota, 55426, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Nevada
Las Vegas, Nevada, 89106, United States
Hem Onc CNY
East Syracuse, New York, 13057, United States
Kansas City
Rochester, New York, 14642, United States
University of Rochester Cancer Center
Rochester, New York, 14642, United States
Novant Health Cancer Institute - Kernersville
Winston-Salem, North Carolina, 27103, United States
Southeast Clinical Oncology Research Program
Winston-Salem, North Carolina, 27104, United States
Columbus NCORP
Columbus, Ohio, 43215, United States
Columbus
Columbus, Ohio, 43215, United States
Dayton Community Oncology Program
Dayton, Ohio, 45420, United States
Dayton
Dayton, Ohio, 45459, United States
Pacific Cancer Research Consortium Ncorp
Portland, Oregon, 97213, United States
PCRC
Portland, Oregon, 97213, United States
NCORP of the Carolinas
Greenville, South Carolina, 29605, United States
Upstate Carolina
Spartanburg, South Carolina, 29303, United States
Northwest (Virginia Mason)
Seattle, Washington, 98101, United States
Wisconsin NCORP
Marshfield, Wisconsin, 54449, United States
Aurora NCORP
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
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.
PMID: 35678881DERIVEDGilmore 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.
PMID: 33546731DERIVED
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michelle C. Janelsins, PhD
University of Rochester
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery, Radiation Oncology, and Neuroscience
Study Record Dates
First Submitted
June 23, 2011
First Posted
June 27, 2011
Study Start
July 14, 2011
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04