Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion 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 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.

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.
  • 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.

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) 505 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