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
This trial accepts healthy volunteersQualifiers
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 population
Women age 60+ with a newly diagnosed breast adenocarcinoma staged 0-3 and matched controls.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,700 Participants
are grouped into 2 trial groupsGroup A: Breast Cancer Case
Group B: Non-Cancer Controls
Trial outcomes
Primary outcomes
1
Change in Attention, Processing Speed, Executive Function (APE) Domain
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.
Time frame
Baseline and annually up to 5 years2
Change in Learning and Memory (LM) Domain
Using neuropsychological tests: Logical Memory I and II (Wechsler Memory Scale), NAB List Learning (Immediate Recall, Short Delay Recall, Long Delay). 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.
Time frame
Baseline and annually up to 5 years3
Change in Cognition Domain
Using assessment: FACT-Cog and PCI Sub-scale. The measures are aggregated to arrive at one reported value. Change in cognition is calculated based on the official FACT-Cog scoring manual. The total score is calculated by summing the available items among all 37 items when no more than 30 items are missing. The PCI subscale score is calculated by summing the available items among all 18 items when no more than 8 items are missing.
Time frame
Baseline and annually up to 5 yearsSecondary outcomes
1
Change in Quality of Life
Using Functional Assessment of Cancer Therapy-Breast quality of life measure (FACT-B)
Time frame
Baseline and annually up to 5 years2
Change in Quality of Life
Using Medical Outcome Study measure (MOS)
Time frame
Baseline and annually up to 5 years3
Change in Quality of Life
Using Short Form Health Survey measure (SF-12)
Time frame
Baseline and annually up to 5 years4
Change in cancer-related symptoms (including fatigue, sleep, pain, anxiety and depression)
Using survey data
Time frame
Baseline and annually up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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