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Cognitive Training

Sponsor:

NRG Oncology

Code:

NCT05896189

Conditions

Breast Cancer

Cognitive Impairments

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Arm 1: Computerized Cognitive Training-Global Stimulation Games

Arm 2: Computerized Cognitive Training-Neuroplasticity Games

Study Details

Brief summary:

This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.

Conditions

Breast Cancer

Cognitive Impairments

Study ID

NCT05896189

Start date

Feb 29, 2024

Status verified date

Jul, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

386 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Arm 1: Computerized Cognitive Training-Global Stimulation Games

The global stimulation games active attention control intervention is composed of computerized games. These games are fully developed and are rated E (for everyone) by the Entertainment Software Rating Board. The program will present 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.

experimental: Arm 2: Computerized Cognitive Training-Neuroplasticity Games

The neuroplasticity games provide core elements necessary for inducing neuroplasticity. The five core elements include the principles of speed of processing, accuracy of processing, adaptivity, generalizability, and engagement. Importantly, all of the exercises adapt to user skill and ability. Behavioral tracking built within the program is used to monitor individual performance and ensure that the person is training at their uppermost threshold level. Specifically, we will use eight of these exercises which are designed to address cognitive concerns most noted in BCS including exercises to improve attention and working memory, processing speed, and executive function.

Interventions

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.

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).

Primary outcome measure

  • Self-reported perceived cognitive impairment measured-post intervention [ Time Frame: 12 weeks from randomization ]

Central Contacts and Locations

More Information

Sponsor

NRG Oncology

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by NRG Oncology on 2026-07-30.