RECRUITING

Older Breast Cancer Patients: Risk for Cognitive Decline

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Conditions

Cancer, BreastAge-related Cognitive DeclineCognitive Declinebreast cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2010-08-01
Study Completion:2023-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03451383

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 105 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * being female
  2. * Age 60+ at diagnosis of a new primary histological confirmed adenocarcinoma breast cancer
  3. * AJCC stages 0-3 or planning neoadjuvant therapy
  4. * 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
  5. * 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.
  6. * 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.
  7. * being female
  8. * Age 60+
  9. * 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
  10. * 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.
  11. * 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.)
  12. * Participant report of surgery on the brain for any reason (cancerous or non-cancerous tumors, subdural hematomas, AV malformations, increased intracranial pressure, etc.)
  13. * Participant report of a history of stroke (with the exception of TIA if ≥1 year ago)
  14. * Participant report of HIV/AIDS
  15. * Participant report of moderate to severe head trauma (loss of consciousness \> 60 min or with evidence of structural brain changes on imaging)
  16. * 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).
  17. * 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.
  18. * Participant report of previous or current chemotherapy or hormonal therapy use
  19. * Participant use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for Lupus.
  20. * 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
  21. * Non-English speaking
  22. * To participate in the optional neuroimaging portion of the study:
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Jeanne Mandelblatt
CONTACT
2026870801
mandelbj@georgetown.edu
Meghan Mihalache
CONTACT
2026878247
mem323@georgetown.edu

Principal Investigator

Jeanne Mandelblatt
PRINCIPAL_INVESTIGATOR
Lombardi Comprehensive Cancer Center

Study Locations (Sites)

Georgetown University
Washington, District of Columbia, 20007
United States

Collaborators and Investigators

Sponsor: Georgetown University

  • Jeanne Mandelblatt, PRINCIPAL_INVESTIGATOR, Lombardi Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2010-08-01
Study Completion Date2023-12-31

Study Record Updates

Study Start Date2010-08-01
Study Completion Date2023-12-31

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • cognitive decline

Additional Relevant MeSH Terms

  • Cancer, Breast
  • Age-related Cognitive Decline
  • Cognitive Decline