Older Breast Cancer Patients: Risk for Cognitive Decline
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age60-105
SponsorGeorgetown University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
1,700 Participants
are grouped into 2 trial groupsSponsors and collaborators
Georgetown University
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborator
Indiana University
Collaborator
H. Lee Moffitt Cancer Center and Research Institute
Collaborator
City of Hope Medical Center
Collaborator
Hackensack Meridian Health
Collaborator
Source ClinicalTrials.gov