Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy (NCT01382082) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
United States1,432 participantsStarted 2011-07-14
Plain-language summary
Cognitive impairments in cancer patients represent an important clinical problem. Studies to date estimating prevalence of difficulties in memory, executive function, and attention deficits have been limited by small sample sizes and many have lacked healthy control groups. More information is needed on promising biomarkers and allelic variants that may help to determine the etiology of impairment, identify those most vulnerable to impairment, and develop interventions for these difficulties.
This is a longitudinal observational study of cognitive function in breast cancer and lymphoma patients receiving chemotherapy to better understand the prevalence of cognitive difficulties (i.e., problems with memory, executive function, and attention) in these populations.
Who can participate
Age range
21 Years
Sex
ALL
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:
Subjects Receiving Chemotherapy:
* Have a diagnosis of invasive breast cancer (stage I-IIIC) or intermediate or high-grade\* lymphoma (\*defined by the treating physician)
* Be scheduled to begin a course of chemotherapy
* Oral chemotherapy is acceptable
* Previous or concurrent treatment with hormones or biological response modifiers is acceptable. (Subjects receiving biological response modifiers only are not eligible).
* Be chemotherapy naïve
* Life expectancy greater than 10 months
* Be able to speak and read English
* Give written informed consent
Inclusion Criteria, Controls:
* Must be the same gender as the subject receiving chemotherapy
* Must be within 5 years of the age of the subject receiving chemotherapy
* Life expectancy greater than 10 months
* Be able to speak and read English
* Give written informed consent
* Must be willing to participate in the study for the entire period
Inclusion Criteria, Long-Term Followup Study:
* Must be a subject who had breast cancer, or control who was paired with that subject with breast cancer, who provided CANTAB data at any time-point during assessments 1 through 3.
Exclusion Criteria:
Subjects Receiving Chemotherapy:
* Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness
* Must not be diagnosed with a neurodegenerative disease
* Must not have primary central nervous system (CNS) disease
* Must not have received chemotherapy in the past
* Must n…
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
Short-term memory
Timeframe: Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls
Trial details
NCT IDNCT01382082
SponsorUniversity of Rochester NCORP Research Base