NRG-CC011: Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial

NRG-CC011 is a clinical study trying to determine if computerized cognitive training can improve cancer-related cognitive impairment including the ability to concentrate, learn new things, remember, and make decisions that affect daily life in breast cancer survivors. We are doing this study to determine the usefulness of computerized cognitive training for cancer-related cognitive impairment and to compare different approaches to cognitive training. The usual approach for participants who are not in a study is to get advice about cancer-related cognitive impairment from their doctors.

For more information, visit https://clinicaltrials.gov/study/NCT05896189

Inova Schar Cancer Institute 
8081 Innovation Park Drive
Fairfax VA 22031

Inova Alexandria Hospital 
4320 Seminary Road
Alexandria, VA 22304

Inova Fairfax Medical Campus 
3300 Gallows Road 
Falls Church, VA 22042

Inova Fair Oaks Hospital 
3600 Joseph Siewick Drive 
Fairfax, VA 22033)

Inova Loudoun Hospital 
44045 Riverside Pkwy
Leesburg, VA 20176

• 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.

• 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.