Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

386

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline

17mo left

Started Feb 2024

Typical duration for not_applicable breast-cancer

Geographic Reach

2 countries

680 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.8 years study duration

Study Progress65%

Feb 2024Nov 2027

First Submitted

Initial submission to the registry

May 31, 2023

Completed

9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed

9 months until next milestone

Study Start

First participant enrolled

February 29, 2024

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

May 31, 2023

Last Update Submit

July 28, 2026

Conditions

Breast Cancer Cognitive Impairments

Outcome Measures

Primary Outcomes (1)

Self-reported perceived cognitive impairment measured-post intervention
FACT-Cog PCI scale score (Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive impairment)
12 weeks from randomization

Secondary Outcomes (2)

Self-reported perceived cognitive impairment measured over time
36 weeks from randomization
Objectively measured cognitive performance measured over time
36 weeks from randomization

Study Arms (2)

Arm 1: Computerized Cognitive Training-Global Stimulation Games

ACTIVE COMPARATOR

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.

Behavioral: Arm 1: Computerized Cognitive Training-Global Stimulation Games

Arm 2: Computerized Cognitive Training-Neuroplasticity Games

EXPERIMENTAL

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.

Behavioral: Arm 2: Computerized Cognitive Training-Neuroplasticity Games

Interventions

Arm 1: Computerized Cognitive Training-Global Stimulation GamesBEHAVIORAL

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 1: Computerized Cognitive Training-Global Stimulation Games

Arm 2: Computerized Cognitive Training-Neuroplasticity GamesBEHAVIORAL

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).

Arm 2: Computerized Cognitive Training-Neuroplasticity Games

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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 may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

NRG Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (680)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC