Clinical trial · Observational
Older Breast Cancer Patients: Risk for Cognitive Decline
Older Breast Cancer Patients: Risk for Cognitive Decline. The Thinking and Living With Cancer (TLC) Study
NCT03451383CI-TRIAL-00087030TLCrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
The goal of this study is to evaluate the impact of systemic therapy on cognition in older breast cancer patients, explore change in APE, LM and Cognition domains, measure associations between cognitive decline and QOL, and describe how genetic polymorphisms, inflammatory biomarkers, sleep and physical measures moderate cognitive outcomes. This study is being done nationally, with recruiting sites at Georgetown University, Montgomery General Hospital, Virginia Cancer Specialists, Washington Hospital Center, Reston Breast Care Specialists, Memorial Sloan-Kettering, Moffitt Cancer Center, City of Hope National Medical Center, Hackensack University Medical Center, Indiana University and University of California, Los Angeles.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Age-related Cognitive Decline | — | UNRESOLVED | — |
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cognitive Decline | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Breast Cancer Case
- description
- Women age 60+ with a newly diagnosed breast adenocarcinoma staged 0-3.
- label
- Non-Cancer Controls
- description
- Women age 60+ with no diagnosis of breast cancer.
Primary outcomes (3)
- measure
- Change in Attention, Processing Speed, Executive Function (APE) Domain
- timeFrame
- Baseline and annually up to 5 years
- description
- Using neuropsychological tests: NAB Digits Forward and Backward, Trailmaking A and B, Digit Symbol Subtest-Wechsler Adult, The Timed Instrumental Activities of Daily Living, Controlled Oral Word Association Test, NAB Driving Scenes and NAB Figure Drawing. These measures are aggregated to arrive at one reported value. The individual tests are first selected via factor analysis, then the selected raw scores are standardized to baseline controls by age and education group. The final domain score is calculated by averaging available individual z-standardized test scores.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
- Maximum age
- 105 Years
Show eligibility criteria text
Inclusion Criteria: For cancer patients, eligibility includes: * being female * Age 60+ at diagnosis of a new primary histological confirmed adenocarcinoma breast cancer * AJCC stages 0-3 or planning neoadjuvant therapy * In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent * If currently taking psychoactive medications (including, but not limited to anticonvulsants, antidepressants, and anxiolytics), dose must have been stable at least two months prior to enrollment. * Participant report of no previous or current chemotherapy or hormonal treatment use (anastrazole, exemestane, etc.) This does not include hormonal replacement therapy, synthetic thyroid hormones, etc. For controls, eligibility includes: * being female * Age 60+ * In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent * If currently taking psychoactive medications (including, but not limited to anticonvulsants, antidepressants, and anxiolytics), dose must have been stable at least two months prior to enrollment. Exclusion: We apply the same exclusion criteria for patients and controls. * Participant report of a history of formal diagnosis of neurological problems (i.e. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, brain tumors, etc.) * Participant report of surgery on the brain for any reason (cancerous or non-cancerous tumors, subdural hematomas, AV malformations, increased intracranial pressure, etc.) * Participant report of a history of stroke (with the exception of TIA if ≥1 year ago) * Participant report of HIV/AIDS * Participant report of moderate to severe head trauma (loss of consciousness \> 60 min or with evidence of structural brain changes on imaging) * History of major psychiatric disorder (DSM-IV Axis 1) (i.e. major depressive disorder (untreated or poorly treated), bipolar disorders, schizophrenia, or substance abuse disorders (self-reported and/or stated in medical record). * Participant report of a history of prior breast or other cancer with the exception of non-melanoma skin cancer. An exception for cases only: women who completed treatment for a previous cancer at least 5 years ago and have not undergone any chemotherapy or hormonal therapy. This previous cancer cannot be breast cancer. * Participant report of previous or current chemotherapy or hormonal therapy use * Participant use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for Lupus. * Visual or hearing impairment that would preclude ability to complete interviews or neuropsychological testing, such as significant macular degeneration or being unable to correct hearing with hearing aides * Non-English speaking * To participate in the optional neuroimaging portion of the study: Participant cannot be claustrophobic Participant cannot have a pacemaker, aneurysm clip or other implants that are not MRI safe Participant cannot have any type of implanted electrical device
References
Publications (6)
- DERIVEDArtese AL, Zhou X, Tometich DB, Small BJ, Ahles TA, Ahn J, Bethea TN, Breen EC, Cohen HJ, Extermann M, Graham D, Isaacs C, Jim HSL, McDonald BC, Nakamura ZM, Patel SK, Rentscher KE, Root JC, Saykin AJ, Van Dyk K, Zhai W, Carroll JE, Mandelblatt J. Physical activity and cognition: longitudinal findings from the Thinking and Living with Cancer Study. J Natl Cancer Inst. 2024 Dec 1;116(12):2009-2021. doi: 10.1093/jnci/djae182. PMID 39107910
- DERIVEDMcDonald BC, Van Dyk K, Deardorff RL, Bailey JN, Zhai W, Carroll JE, Root JC, Ahles TA, Mandelblatt JS, Saykin AJ. Multimodal MRI examination of structural and functional brain changes in older women with breast cancer in the first year of antiestrogen hormonal therapy. Breast Cancer Res Treat. 2022 Jul;194(1):113-126. doi: 10.1007/s10549-022-06597-1. Epub 2022 Apr 27. PMID 35476252
- DERIVEDBethea TN, Zhai W, Zhou X, Ahles TA, Ahn J, Cohen HJ, Dilawari AA, Graham DMA, Jim HSL, McDonald BC, Nakamura ZM, Patel SK, Rentscher KE, Root J, Saykin AJ, Small BJ, Van Dyk KM, Mandelblatt JS, Carroll JE. Associations between longitudinal changes in sleep disturbance and depressive and anxiety symptoms during the COVID-19 virus pandemic among older women with and without breast cancer in the thinking and living with breast cancer study. Cancer Med. 2022 Sep;11(17):3352-3363. doi: 10.1002/cam4.4682. Epub 2022 Mar 22. PMID 35315588
- DERIVEDDilawari A, Rentscher KE, Zhai W, Zhou X, Ahles TA, Ahn J, Bethea TN, Carroll JE, Cohen HJ, Graham DA, Jim HSL, McDonald B, Nakamura ZM, Patel SK, Root JC, Small BJ, Saykin AJ, Tometich D, Van Dyk K, Mandelblatt JS; Thinking and Living with Cancer Study. Medical care disruptions during the first six months of the COVID-19 pandemic: the experience of older breast cancer survivors. Breast Cancer Res Treat. 2021 Nov;190(2):287-293. doi: 10.1007/s10549-021-06362-w. Epub 2021 Sep 13. PMID 34515905
- DERIVEDCarroll JE, Small BJ, Tometich DB, Zhai W, Zhou X, Luta G, Ahles TA, Saykin AJ, Nudelman KNH, Clapp JD, Jim HS, Jacobsen PB, Hurria A, Graham D, McDonald BC, Denduluri N, Extermann M, Isaacs C, Dilawari AA, Root J, Stern RA, Mandelblatt JS; Thinking and Living With Cancer Study. Sleep disturbance and neurocognitive outcomes in older patients with breast cancer: Interaction with genotype. Cancer. 2019 Dec 15;125(24):4516-4524. doi: 10.1002/cncr.32489. Epub 2019 Sep 25.