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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 60
Maximum Age: 105
Healthy Volunteers: t
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⁃ For cancer patients, eligibility includes:

• 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

• 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.

• 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.

⁃ For controls, eligibility includes:

• being female

• Age 60+

• 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

• 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.

Locations
United States
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Contact Information
Primary
Jeanne Mandelblatt
mandelbj@georgetown.edu
2026870801
Backup
Meghan Mihalache
mem323@georgetown.edu
2026878247
Time Frame
Start Date: 2010-08-01
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 1700
Treatments
Breast Cancer Case
Women age 60+ with a newly diagnosed breast adenocarcinoma staged 0-3.
Non-Cancer Controls
Women age 60+ with no diagnosis of breast cancer.
Related Therapeutic Areas
Sponsors
Collaborators: Indiana University, Memorial Sloan Kettering Cancer Center, Hackensack Meridian Health, H. Lee Moffitt Cancer Center and Research Institute, City of Hope Medical Center
Leads: Georgetown University

This content was sourced from clinicaltrials.gov