A Study to Examine Computerized Training to Improve Concentration, Learning New Things, and Remembering in Stage I-III Breast Cancer Survivors
Breast Cancer
Unknown Primary
18 Years and older, Male and Female
NRG-CC011 (primary)
NRG-CC011
NRG-CC011
NCI-2023-06537
Summary
This clinical trial evaluates a computer-delivered cognitive training intervention (BrainHQ) for improving cognitive function in stage I-III breast cancer survivors. Cancer and its treatment can lead to cancer-related cognitive dysfunction, a condition in which a person has trouble concentrating, learning new things, remembering, or making decisions that affect their everyday life. BrainHQ is a computerized cognitive training program designed to improve cognitive functioning. It consists of eight exercises specifically designed to address cognitive concerns including attention, working memory, processing speed, and executive function. BrainHQ adapts these exercises to the patient's skill and ability over time to ensure engagement, motivation, and optimal learning rates.
Objectives
PRIMARY OBJECTIVE:
I. 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 Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) Perceived Cognitive Impairment (PCI) scale.
SECONDARY OBJECTIVES:
I. To examine the efficacy of computerized cognitive training (BrainHQ) compared to the attention control in maintaining improved FACT-Cog PCI scores over time.
II. 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.
III. 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.
EXPLORATORY OBJECTIVE:
I. 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.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients receive the computer-assisted BrainHQ intervention, including 8 cognitive training exercises, over 4 hours per week for up to 10 weeks.
GROUP 2: Patients receive the computer-assisted active attention control intervention, including 8 computerized games, over 4 hours per week for up to 10 weeks.
After completion of study intervention, patients are followed up at 12, 24, and 36 post-randomization.
Eligibility
- 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 be = 18 years of age
- 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 < 12 on the Patient Reported Outcomes Measurement Information System (PROMIS) Adult version (v)2.0 - Cognitive Function 4a
- 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
- The participant must be able to understand, speak, read, and write in English or Spanish
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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