COGNITIVE TRAINING FOR CANCER RELATED COGNITIVE IMPAIRMENT IN BREAST CANCER SURVIVORS: A MULTI-CENTER RANDOMIZED DOUBLE- BLINDED CONTROLLED TRIAL
T
Tarah Ballinger, MD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
3
5 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
Behavioral: Arm 1: Computerized Cognitive Training-Global Stimulation Games
Behavioral: Arm 2: Computerized Cognitive Training-Neuroplasticity Games
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Breast Cancer
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
- 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 have a first time diagnosis of non-metastatic breast cancer which is Stage I-III.
- The participant must have a score of less than 12 on the PROMIS Adult v2.0 - Cognitive Function 4a.
- Participants with greater than or equal to 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.
Exclusion Criteria:
- Scoring less than or equal to 3 on the 6-item cognitive screen.
- Patient Health Questionnaire-2 item (PHQ-2) score of greater than or equal to 3.
- Definitive clinical or radiologic evidence of metastatic disease.
- 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 central nervous system (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.
Updated on
11 Feb 2025.
Study ID: CTO-NRG-CC011, 24868
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