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Behavioural Intervention

Cognitive Training for Breast Cancer Survivors

N/A
Recruiting
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The participant must be able to understand, speak, read, and write in English or Spanish.
Participant must be able to understand, speak, read, and write in English or Spanish
Must not have
Previous central nervous system (CNS) radiation, intrathecal therapy or CNS-involved surgery
Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g. methotrexate exposure for treatment of rheumatoid arthritis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks from randomization
Awards & highlights

Summary

This trial will study if using a computerized cognitive training program (Brain HQ) is better than an attention control in improving how people perceive their cognitive abilities after the intervention.

Who is the study for?
This trial is for breast cancer survivors who've finished their initial treatment between 6 months and 5 years ago, but may still be on endocrine or HER2-directed therapy. They should have a first-time diagnosis of non-metastatic breast cancer (Stage I-III) and feel like they're experiencing cognitive issues post-treatment.Check my eligibility
What is being tested?
The study compares two types of computerized cognitive training games to see if they help with the perceived mental fog that some breast cancer survivors experience after treatment. Participants will use Brain HQ's neuroplasticity or global stimulation games.See study design
What are the potential side effects?
Since this trial involves computer-based cognitive exercises, there are no direct physical side effects expected from participating in these activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can understand, speak, read, and write in English or Spanish.
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I can understand, speak, read, and write in English or Spanish.
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My breast cancer is newly diagnosed and not spread, at Stage I-III.
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My breast cancer is newly diagnosed and not spread, at Stage I-III.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had brain surgery or treatment for my brain.
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I have had chemotherapy for a condition other than my current cancer.
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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks from randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks from randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Self-reported perceived cognitive impairment measured-post intervention
Secondary outcome measures
Objectively measured cognitive performance measured over time
Self-reported perceived cognitive impairment measured over time

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Computerized Cognitive Training-Neuroplasticity GamesExperimental Treatment1 Intervention
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.
Group II: Arm 1: Computerized Cognitive Training-Global Stimulation GamesActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
232 Previous Clinical Trials
100,363 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,015 Total Patients Enrolled
~257 spots leftby Feb 2027