Intellectual Impairment in Women With Breast Cancer (NCT00896324) | Clinical Trial Compass
CompletedNot Applicable
Intellectual Impairment in Women With Breast Cancer
United States50 participantsStarted 2009-01-12
Plain-language summary
RATIONALE: Breast cancer and its treatment may cause changes in a patient's ability to think, learn, and remember. Gathering information about a woman's genes, brain function, and personal history may help doctors learn more about the disease and plan the best treatment.
PURPOSE:
1. To determine changes in brain function that occur following breast cancer chemotherapy.
2. To gain further understanding of the individual differences in brain function changes and recovery based on demographic, medical and treatment variables.
Who can participate
Age range
40 Years – 65 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
.1.1 Primary, non-metastatic breast cancer
.1.2 Newly diagnosed patients who have not yet begun treatment.
.1.4 Female participants age 40-65 years of all ethnicities who speak fluent English will be recruited.
.1.5 There are no life expectancy restrictions.
.1.6 Karnofsky Performance Status 70% minimum. ECOG will not be employed.
.1.7 There are no requirements for marrow function. The brain must be free from gross neuropathology and metastases in order to participate.
.1.8 Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
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
1
Examine the effectiveness of a cognitive rehabilitation program for improving executive function (EF) deficits for preventing or lessening EF impairments in women with Breast Cancer
.2.1 History of cognitive, psychiatric or medical conditions prior or unrelated to cancer diagnosis and/or known to significantly impact assessments (e.g. premature birth, developmental delays, learning disabilities, severe psychiatric conditions, brain injury, stroke). Non-English speaking. Major sensory impairment (e.g. hearing loss, blindness) that would render assessments invalid. MRI contraindications (e.g. metallic implants or devices). Distant metastases. See also section 4.2.1.
.2.2 Participants currently involved in studies specifically aimed at improving cognitive symptoms will be excluded.
.2.3 Participants with significant co-morbid diseases known to significant impact neuropsychological function such as Alzheimer's or Parkinson's will be excluded.
.2.4 There are no known risks for allergic reactions to any of the study procedures.
.2.5 Participants taking certain medications that affect neuropsychological and/or brain function including Haldol, Aricept, Ritalin, etc. will be excluded. Most anti-depressants are acceptable. Some anti-anxiety medications may not be. Each case will be individually reviewed.
.2.6 There are no other agent-specific exclusion criteria.
.2.7 Pregnant individuals will be excluded as this is a contraindication for the 3 Tesla research MRI scanner employed by this study but not because of the treatment programs per se. Nursing individuals can enroll.
.2.8 Patients who are HIV positive will be excluded given the known effects of this condition on cognitive function which would confound the effects of anti-cancer treatments on cognitive outcome.