IRB Study Number 24-643
Status Recruiting
Location Akron General
Institute Taussig Cancer Institute
Description
1.1 Primary Objective
1.1.1 To examine the efficacy of computerized cognitive training (BrainHQ) compared to the attention control on perceived cognitive impairment post intervention (12 weeks post-randomization) as measured by the FACT-Cog PCI scale.
1.2 Secondary Objectives
1.2.1 To examine the efficacy of computerized cognitive training (BrainHQ) compared to the attention control in maintaining improved FACT-Cog PCI scores over time.
1.2.2 To examine the efficacy of computerized cognitive training (BrainHQ) compared to the attention control in improving objectively measured cognitive performance (neuropsychological tests of memory, attention and working memory, speed of processing and executive function) over time.
1.2.3 To examine the efficacy of computerized cognitive training (BrainHQ) compared to attention control on self-reported cognitive function over time as measured by the FACT-Cog total.
1.3 Exploratory Objectives
To examine the impact of computerized cognitive training (BrainHQ) compared to the attention control on real-life, everyday outcomes (e.g., work-related outcomes and health-related outcomes) over time.
Inclusion Criteria
3.2.1 The participant must provide study-specific informed consent prior to any study specific procedures and authorization permitting release of personal health information.
3.2.2 The participant must be ≥ 18 years of age.
3.2.3 The participant must have a first time diagnosis of non-metastatic breast cancer which is Stage I-III.
3.2.4 The participant must have a score of < 12 on the PROMIS Adult v2.0 - Cognitive Function 4a.
3.2.5 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.
3.2.6 The participant must be able to understand, speak, read, and write in English or Spanish.
Exclusion Criteria
3.3.1 Scoring ≤ 3 on the 6-item cognitive screen.
3.3.2 Patient Health Questionnaire-2 item (PHQ-2) score of ≥ 3.
3.3.3 Definitive clinical or radiologic evidence of metastatic disease.
3.3.4 Prior history of past or current other cancer, except for non-melanoma skin cancer or in situ cervical cancer within the past 5 years.
3.3.5 Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g. methotrexate exposure for treatment of rheumatoid arthritis).
3.3.6 Previous CNS radiation, intrathecal therapy or CNS-involved surgery.
3.3.7 Participants with history of stroke, traumatic brain injury, brain surgery, Alzheimer’s disease or other dementia.
3.3.8 Participants with active substance abuse and/or in treatment for substance abuse, or history of bipolar disorder, psychosis, schizophrenia, ADHD, or learning disability.
3.3.9 Participants who are enrolled in other therapeutic trials and/or quality of life trials.
