Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors
a study on Breast Cancer Cognitive Impairments
Summary
- Eligibility
- for people ages 18-100 (full criteria)
- Location
- at Los Angeles, California and other locations
- Dates
- study startedcompletion around
- Principal Investigator
- by Patricia A. Ganz
Description
Summary
This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
Official Title
Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial
Details
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.
Keywords
Breast Cancer, Cognitive Impairments, Breast Neoplasms, Cognitive Dysfunction, Arm 1: Computerized Cognitive Training-Global Stimulation Games, Arm 2: Computerized Cognitive Training-Neuroplasticity Games, Computerized Cognitive Training-Global Stimulation Games, Computerized Cognitive Training-Neuroplasticity Games
Eligibility
You can join if…
Open to people ages 18-100
- 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 must be at least 6 months and no more than 5 years (after completion of initial surgery +/- adjuvant chemotherapy/radiation therapy) and targeted therapies (e.g., PARP inhibitors, CDK4/6, or immunotherapy). Participants may still be taking endocrine therapy and/or trastuzumab.
- The participant must be able to understand, speak, read, and write in English or Spanish.
You CAN'T join if...
- 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.
- Current or past history of another cancer. Patients with history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
- 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.
- Participants who are enrolled in an active behavioral intervention (e.g., occupational therapy, physical therapy, etc.) or pharmaceutical intervention or who are in the follow-up phase of a cancer control trial or therapeutic trial that has extensive PRO follow-up after treatment ends. Participants who are enrolled in a therapeutic trial in which they have completed active treatment and require only minimal follow-up monitoring of toxicity and/or survival analysis (cancer-related mortality or all-cause mortality) would be eligible.
- Hearing impairment unless adequately corrected with hearing aids to be able to hear over the phone for the neuropsychological testing.
Locations
- UCLA / Jonsson Comprehensive Cancer Center
accepting new patients
Los Angeles California 90095 United States - Saint John's Cancer Institute
accepting new patients
Santa Monica California 90404 United States - Cedars Sinai Medical Center
accepting new patients
Los Angeles California 90048 United States - Providence Saint Joseph Medical Center/Disney Family Cancer Center
accepting new patients
Burbank California 91505 United States - Torrance Memorial Physician Network - Cancer Care
accepting new patients
Torrance California 90505 United States - Torrance Memorial Medical Center
accepting new patients
Torrance California 90509 United States
Lead Scientist at UCLA
- Patricia A. Ganz
Professor, Health Policy And Management, Public Health. Authored (or co-authored) 507 research publications
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- NRG Oncology
- ID
- NCT05896189
- Study Type
- Interventional
- Participants
- Expecting 386 study participants
- Last Updated