NRG-CC011: Cognitive Training for Cancer-Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial
About
The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.
Eligibility Criteria
Inclusion Criteria
- Patients ≥ 18 years of age
- The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage I-III
- Participants with ≥ 6 months to 5 years post-treatment (completion of initial surgery +/- adjuvant chemotherapy/radiation therapy) except may still be taking endocrine therapy or HER2-directed adjuvant therapy
Exclusion Criteria
- Prior history of past or current other cancer, except for non-melanoma skin cancer or in situ cervical cancer within the past 5 years
- Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g. methotrexate exposure for treatment of rheumatoid arthritis)
- Previous 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
Primary Investigator
Modupe (Seyi) White, DNP, FNP-C, is a nurse practitioner with Carilion Clinic Breast Surgical Oncology and Survivorship Clinic. White received her Master of Science in nursing and Doctor of Nursing Practice from Old Dominion University in Norfolk, VA. Before she earned her DNP, White was a registered nurse providing cancer care in both inpatient and outpatient settings. She completed a nurse educator certificate program and enjoys her time with graduate nursing students as an adjunct faculty member for Radford University Carilion when able. White is the Survivorship Program coordinator for the Carilion Clinic Cancer Committee. She is enthusiastic about having the opportunity to help advance the follow-up treatment of breast cancer through research.
Contact Information
Bailey Steele, MPH
Clinical Research Coordinator
