NRG-CC011: Reopened After Temporary Hold Due to Unprecedented Rapid Accrual

03/17/2026

The NRG-CC011 study, a Phase III randomized trial evaluating computerized cognitive training for cancer-related cognitive impairment (CRCI) in breast cancer survivors, re-opened to accrual after a temporary hold driven by rapid enrollment. Accrual was paused in May 2025 when participating sites exceeded projections, allowing the study team to process the queue of consented participants. The trial is now resuming enrollment to complete its planned sample size. Investigators anticipate that the remaining accrual will be completed quickly, and sites are advised to monitor forthcoming correspondence closely as enrollment progresses.

The strong recruitment response underscores the clinical relevance of CRCI, a persistent survivorship issue affecting memory, attention, executive function, and processing speed. Many survivors experience long-term cognitive symptoms that interfere with occupational performance, social engagement, and quality of life, yet evidence-based treatment strategies remain limited. NRG-CC011 is designed to test rigorously whether structured, remotely delivered cognitive training can provide measurable benefit in this population.

Eligible participants are adults with Stage I–III breast cancer who completed primary therapy 6 months to 5 years prior and report clinically meaningful cognitive complaints on validated patient-reported outcome measures. Participants are randomized to one of two active computerized cognitive training programs. The primary outcome is self-reported perceived cognitive impairment measured post intervention. Secondary outcomes include objective cognitive performance measured over time and self-reported perceived cognitive impairment measured over time.

NRG-CC011 represents one of the most rigorous evaluations to date of a non-pharmacologic intervention for CRCI. If positive, results could support integration of structured cognitive training into survivorship care models as a low-risk, scalable strategy. The rapid accrual that prompted the temporary hold highlights both clinician engagement and patient demand for solutions addressing cognitive sequelae of cancer therapy, reinforcing the importance of continued awareness and timely participation as the study approaches completion.