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Cognitive training for breast cancer survivors with cognitive impairment

Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial

Not applicable Interventional NRG Oncology · NCT05896189

This study is testing if computer-based brain training can help breast cancer survivors who have trouble thinking clearly after their treatment.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment386 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNRG Oncology Academic / other
Drugs / interventionstrastuzumab, chemotherapy, immunotherapy, radiation, methotrexate
Locations680 sites (Anchorage, Alaska and 679 other locations)
Trial IDNCT05896189 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the effectiveness of computerized cognitive training methods in addressing cognitive impairments experienced by breast cancer survivors. It focuses on individuals who have undergone treatment for non-metastatic breast cancer and are experiencing cognitive dysfunction. The study employs a double-blind, randomized controlled design, comparing two types of cognitive training interventions against an attention control group. The goal is to provide a scientifically robust assessment of cognitive training's impact on improving cognitive function in this population.

Who should consider this trial

Good fit: Ideal candidates are breast cancer survivors diagnosed with non-metastatic Stage I-III cancer who are experiencing cognitive dysfunction at least 6 months post-treatment.

Not a fit: Patients with severe cognitive impairment or significant depressive symptoms may not benefit from this cognitive training intervention.

Why it matters

Potential benefit: If successful, this study could significantly improve cognitive function and quality of life for breast cancer survivors suffering from cognitive impairments.

How similar studies have performed: Previous pilot studies have shown promise for cognitive training in similar populations, but this trial aims to address limitations of those studies with a more rigorous design.

Eligibility criteria

Show full inclusion / exclusion criteria 
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, traumatic brain injury, brain surgery, Alzheimer's disease or other dementia.
* Participants with active substance abuse and/or in treatment for substance abuse, or history of bipolar disorder, psychosis, schizophrenia, ADHD, or learning disability.
* Participants who are enrolled in an active behavioral intervention (e.g., occupational therapy, physical therapy, etc.) or pharmaceutical intervention or who are in the follow-up phase of a cancer control trial or therapeutic trial that has extensive PRO follow-up after treatment ends. Participants who are enrolled in a therapeutic trial in which they have completed active treatment and require only minimal follow-up monitoring of toxicity and/or survival analysis (cancer-related mortality or all-cause mortality) would be eligible.
* Hearing impairment unless adequately corrected with hearing aids to be able to hear over the phone for the neuropsychological testing.

Where this trial is running

Anchorage, Alaska and 679 other locations

+630 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerCognitive Impairments
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.