Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors (NCT05896189) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors
United States, Puerto Rico386 participantsStarted 2024-02-29
Plain-language summary
This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
Who can participate
Age range
18 Years – 100 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:
* The participant must provide study-specific informed consent prior to any study specific procedures and authorization permitting release of personal health information.
* The participant must have a first time diagnosis of non-metastatic breast cancer which is Stage I-III.
* The participant must have a score of less than 12 on the PROMIS Adult v2.0 - Cognitive Function 4a.
* Participants must be at least 6 months and no more than 5 years (after completion of initial surgery +/- adjuvant chemotherapy/radiation therapy) and targeted therapies (e.g., PARP inhibitors, CDK4/6, or immunotherapy). Participants may still be taking endocrine therapy and/or trastuzumab.
* The participant must be able to understand, speak, read, and write in English or Spanish.
Exclusion Criteria:
* Scoring less than or equal to 3 on the 6-item cognitive screen.
* Patient Health Questionnaire-2 item (PHQ-2) score of greater than or equal to 3.
* Definitive clinical or radiologic evidence of metastatic disease.
* Current or past history of another cancer. Patients with history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
* Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g. methotrexate exposure for treatment of rheumatoid arthritis).
* Previous central nervous system (CNS) radiation, intrathecal therapy or CNS-involved surgery.
* Participants with history of stroke…
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.