Actively Recruiting

Age: 60Years - 105Years
FEMALE
Healthy Volunteers
ID03451383

Older Breast Cancer Patients: Risk for Cognitive Decline. The Thinking and Living With Cancer (TLC) Study

Led by Georgetown University · Updated on 2025-03-11

1700

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

G

Georgetown University

Lead Sponsor

M

Memorial Sloan Kettering Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how systemic therapy affects cognitive function in older women with breast cancer. This study focuses on women aged 60 and older, aiming to evaluate changes in attention, processing speed, executive function, learning, memory, and overall cognition over five years. The study also explores connections between cognitive decline and quality of life, and examines how genetic factors, inflammation, sleep, and physical health influence cognitive outcomes in this population. The study involves two groups: women aged 60 and above newly diagnosed with breast adenocarcinoma (stages 0-3 or planning neoadjuvant therapy) and a control group of women without breast cancer. Participants undergo baseline neuropsychological testing before any systemic treatment or at enrollment for controls. Follow-up assessments, including physical tests, blood or saliva samples for genetic and biomarker analysis, sleep monitoring, and optional neuroimaging, take place annually for up to five years. Participants complete questionnaires about cognitive function, sleep, quality of life, and daily activities. Physical performance tests like grip strength and walking speed are conducted. Clinical data are collected from medical records. The primary outcomes measure changes in cognitive domains annually. Secondary outcomes include quality of life changes, cancer-related symptoms, aging biomarkers, and sleep patterns. The study lasts up to five years with ongoing evaluations to understand how systemic therapy impacts cognition and overall well-being in older breast cancer patients.

CONDITIONS

Brief Title

Older Breast Cancer Patients: Risk for Cognitive Decline

Who Can Participate

Age: 60Years - 105Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female gender
  • Age 60 years or older at diagnosis or enrollment
  • Newly diagnosed primary breast adenocarcinoma cancer staged 0 to 3 or planning neoadjuvant therapy (for cancer patients)
  • Able to communicate well in English verbally and in writing
  • Stable dose of psychoactive medications for at least two months prior to enrollment
  • No previous or current chemotherapy or hormonal treatment use (except hormonal replacement or synthetic thyroid hormones)
  • Non-cancer controls must be female, 60 years or older, able to communicate in English, and stable on psychoactive medications if applicable
Not Eligible

You will not qualify if you...

  • History of neurological diseases such as Alzheimer's, Parkinson's, multiple sclerosis, dementia, seizure disorders, or brain tumors
  • History of brain surgery for any reason
  • History of stroke except TIA more than 1 year ago
  • HIV/AIDS diagnosis
  • Moderate to severe head trauma with loss of consciousness over 60 minutes or structural brain changes
  • Major untreated or poorly treated psychiatric disorders including major depression, bipolar disorder, schizophrenia, or substance abuse
  • History of prior breast or other cancers except non-melanoma skin cancer; for cancer patients, previous cancer treatment must be completed at least 5 years ago with no chemotherapy or hormonal therapy
  • Previous or current chemotherapy or hormonal therapy use
  • Use of methotrexate, rituximab, or cyclophosphamide for autoimmune diseases
  • Visual or hearing impairments preventing completion of assessments
  • Non-English speaking
  • For optional neuroimaging: claustrophobia, MRI-incompatible implants or devices

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At enrollment

Participants complete baseline neuropsychological tests, surveys, physical measurements, blood or saliva collection, sleep monitoring, and optional neuroimaging to assess cognitive function and related biomarkers.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants undergo annual follow-up assessments including neuropsychological testing, surveys, physical measurements, blood or saliva collection, sleep monitoring, and optional neuroimaging for up to 5 years to monitor changes in cognition and quality of life.

Annual visits (in-person)

Trial Site Locations

Total: 1 location

1

Georgetown University

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

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Research Team

J

Jeanne Mandelblatt

M

Meghan Mihalache

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Multimodal MRI examination of structural and functional brain changes in older women with breast cancer in the first year of antiestrogen hormonal therapy.

Brenna C McDonald, Kathleen Van Dyk, Rachael L Deardorff...

https://pubmed.ncbi.nlm.nih.gov/35476252

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.

Traci N Bethea, Wanting Zhai, Xingtao Zhou...

https://pubmed.ncbi.nlm.nih.gov/35315588

Medical care disruptions during the first six months of the COVID-19 pandemic: the experience of older breast cancer survivors.

A Dilawari, K E Rentscher, W Zhai...

https://pubmed.ncbi.nlm.nih.gov/34515905

Sleep disturbance and neurocognitive outcomes in older patients with breast cancer: Interaction with genotype.

Judith E Carroll, Brent J Small, Danielle B Tometich...

https://pubmed.ncbi.nlm.nih.gov/31553501

Pretreatment Psychoneurological Symptoms and Their Association With Longitudinal Cognitive Function and Quality of Life in Older Breast Cancer Survivors.

Danielle B Tometich, Brent J Small, Judith E Carroll...

https://pubmed.ncbi.nlm.nih.gov/30472317