Older Breast Cancer Patients: Risk for Cognitive Decline
Older Breast Cancer Patients: Risk for Cognitive Decline. The Thinking and Living With Cancer (TLC) Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 60 Years to 105 Years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Investigators conduct follow-up interviews and repeat the neuropsychological testing, physical measures, blood/saliva collection, sleep monitoring and optional neuroimaging 12 months after baseline assessment; this time point corresponds to 3-6 months post-treatment among women who receive chemotherapy."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how breast cancer treatments that work throughout the body affect memory and thinking in older women. It includes women age 60 and older with newly diagnosed breast cancer and a comparison group. It also looks at links between thinking skills, quality of life, genes, signs of swelling in the body, sleep, and physical measures.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Must be female.
- Women with breast cancer must have been age 60 or older when their new breast cancer was diagnosed. Women in the comparison group must be age 60 or older.
- Women with breast cancer must have adenocarcinoma, a type of breast cancer confirmed by a tissue test.
- Women with breast cancer must have stage 0–3 cancer or plan to have treatment before surgery.
- Must be able to speak and write English well enough to complete study tasks and agree to join.
- If taking medicines for mood, anxiety, seizures, or other brain-related conditions, the dose must have stayed the same for at least 2 months.
- Women with breast cancer must report no past or current chemotherapy or cancer hormone treatment. Hormone replacement therapy and thyroid hormones do not count.
Who can't join
- A diagnosed brain or nerve disorder, such as Alzheimer's, Parkinson's, multiple sclerosis, dementia, seizures, or a brain tumor; or any past brain surgery.
- A past stroke, or a moderate to severe head injury with loss of consciousness for over 60 minutes or brain changes seen on a scan. A TIA, sometimes called a mini-stroke, is allowed if it happened at least 1 year ago.
- HIV or AIDS.
- A major mental health disorder, such as untreated or poorly treated major depression, bipolar disorder, schizophrenia, or a substance abuse disorder.
- Past breast cancer or another cancer, except non-melanoma skin cancer. Women in the breast cancer group may have had another cancer if treatment ended at least 5 years ago and did not include chemotherapy or hormone treatment. Past or current chemotherapy or cancer hormone treatment is not allowed.
- Use of methotrexate or rituximab for rheumatoid arthritis, psoriasis, or Crohn's disease; or cyclophosphamide for lupus.
- Vision or hearing problems that prevent completing interviews or thinking tests, or not speaking English.
- For optional brain scans only: fear of enclosed spaces, any implanted electrical device, or a pacemaker, aneurysm clip, or other implant that is not safe for MRI.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 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. Exclusion: We apply the same exclusion criteria for patients and controls. * 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 * Participant report of moderate to severe head trauma (loss of consciousness \> 60 min or with evidence of structural brain changes on imaging) * 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). * 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. * Participant report of previous or current chemotherapy or hormonal therapy use * Participant use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for Lupus. * 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 * Non-English speaking * To participate in the optional neuroimaging portion of the study: Participant cannot be claustrophobic Participant cannot have a pacemaker, aneurysm clip or other implants that are not MRI safe Participant cannot have any type of implanted electrical device
Study sites (1)
DC
- Georgetown University · Washington D.C., DC 20007More trials in Washington D.C.