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/Actively Recruiting
Led by Georgetown University · Updated on 2025-03-11
1700
Participants Needed
1
Research Sites
N/A
Total Duration
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
Older Breast Cancer Patients: Risk for Cognitive Decline
J
Jeanne Mandelblatt
M
Meghan Mihalache
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Georgetown University
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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)
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/35476252/Georgetown University
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborating Sponsor