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ACTIVE NOT RECRUITING

NCT05896189

Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors

Sponsor: NRG Oncology

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

386

Start Date

2024-02-29

Completion Date

2027-11-30

Last Updated

2026-07-30

Healthy Volunteers

Conditions

Breast Cancer Cognitive Impairments

Interventions

BEHAVIORAL

Arm 1: Computerized Cognitive Training-Global Stimulation Games

The program will includes 8 non-speeded exercises that include spin-offs of such games as breaking hex, lineup four, battleship, gems swap, double klondike, solitaire, reversi, word search, and sudoku. These games are well matched for time on task, novelty, and progression across levels. These are strategy-based games without adaptive, speeded, or accuracy-based algorithms underlying their personalization.

BEHAVIORAL

Arm 2: Computerized Cognitive Training-Neuroplasticity Games

Cognitive training exercises include Double Decision (targets visual speed of processing and useful field of view), Target Tracker (targets visuospatial working memory capacity), Visual Sweeps (targets speed of processing), Syllable Stacks (targets auditory memory), Eye for Detail (targets eye movement speed and visuo-spatial working memory), Mind Bender (targets mental flexibility), Divided Attention (a shape-color-pattern inhibitory control exercise that focuses on rapidly determining whether flashing colors, shapes, or patterns meet a pre-specified rule), Right Turn (targets spatial reasoning).

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 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. 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. * 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.