NRG-CC011: Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors

March 12 2024

NRG-CC011 Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial” (NCT05896189)

Recently activated & now enrolling breast cancer survivors!

Written by Diane Von Ah, PhD, RN, FAAN; NRG-CC011 Principal Investigator

The NRG-CC011 trial is designed to address cancer related cognitive impairment, often referred to as ‘chemobrain’ or ‘brain fog’ by breast cancer survivors. Cancer related cognitive impairment is a significant problem for many breast cancer survivors and may persist months and years after treatment. It has been linked to other negative outcomes impacting cancer survivor’s everyday life, including their ability to work, maintain social relationships, and optimal quality of life. And although, cancer related cognitive impairment is a prevalent and potentially debilitating symptom, there is very little interventional research for clinicians to utilize to support patients with cognitive concerns after treatment.

This trial addresses this need. This will be the first full-scale efficacy trial to address cancer related cognitive impairment for breast cancer survivors. The trial, which is co-funded by a NIH/NCI R01 grant (R01CA276222,), has CIRB approval and will seek to enroll a total of 386 breast cancer survivors who had been previously diagnosed with Stage I-III breast cancer and are ≥6 months to 5 years post-treatment and have substantial cancer related cognitive impairment. This two-group, double-masked, randomized controlled trial will test whether computerized cognitive training, which uses a cognitive rehabilitative approach, will improve perceived cognitive impairment, cognitive performance, and will also explore its impact on real-world everyday functioning including work ability and health-related quality of life. Breast cancer survivors participating in the study will be asked to complete 40 hours of training over a 10-week period (4 hours/week) and complete survey questionnaires regarding their perceived cognitive impairment and quality of life as well as complete a brief set of cognitive assessments.

The trial developers, Drs. Diane Von Ah, Patti Ganz, and Brenna McDonald, believe a significant strength of the study design is that the intervention and assessments will be delivered remotely, online in the convenience of the participant’s own home, offered in English and Spanish, and will take the burden of the follow-up assessments out the responsibility of the busy clinic environment, reducing common barriers to study trial enrollment and participation. Protocol officer, Dr. Von Ah from The Ohio State University College of Nursing and Comprehensive Cancer Center believes that this large-scale trial is so important in answering the question as to whether computerized cognitive training is beneficial to breast cancer survivors with cognitive concerns and recognizes that this study has the potential to inform evidence-based practice for clinicians caring for cancer survivors with cancer related cognitive impairment, who to date have had limited evidence to address this detrimental symptom.

Watch our interview with Drs. Diane Von Ah and Patricia Ganz at #NRG2024 in Orlando as they discuss the NRG-CC011 trial for cognitive training for cancer-related cognitive impairment in breast cancer survivors.

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