RecruitingNot Applicable

Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer

United States200 participantsStarted 2015-03

Plain-language summary

This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.

Who can participate

Age range

60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Breast cancer patients treated with chemotherapy- Group 1 (experimental group) * Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study * New diagnosis histologically confirmed invasive breast cancer * Treatment plan to include chemotherapy * Female subjects age ≥ 60 years. * Life expectancy ≥ 1 year * Karnofsky Performance Score (KPS) ≥ 80 * Ability to understand and the willingness to sign a written informed consent document. * Non-treated breast cancer patient controls- Group 2 (control group) * Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study: * New diagnosis histologically confirmed invasive breast cancer * Treatment plan does not include chemotherapy * Age ≥ 60 years. * Life expectancy ≥ 1 year * Karnofsky Performance Score (KPS) ≥ 80 * Ability to understand and the willingness to sign a written informed consent document. * Healthy control subjects- Group 3 (control group) * Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study: * Age ≥ 60 years. * Life expectancy ≥ 1 year * Karnofsky Performance Score (KPS) ≥ 80 * Ability to understand and the willingness to sign a written informed consent document. * Participants …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in cognitive performance scores

Timeframe: Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy

Trial details

NCT IDNCT02290834

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Michael W Parsons, PhD

617-643-0282 mwparsons@mgh.harvard.edu

View on ClinicalTrials.gov More Impaired Cognition trials