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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 weeks from randomization

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Self-reported perceived cognitive impairment measured-post intervention

Secondary study objectives

Objectively measured cognitive performance measured over time

Self-reported perceived cognitive impairment measured over time

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met