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Behavioural Intervention

Arm 2: Computerized Cognitive Training-Neuroplasticity Games for Cognitive Impairment

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 weeks from randomization

Awards & highlights

Study 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.

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

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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

NRG OncologyLead Sponsor

231 Previous Clinical Trials

100,466 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,055 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently being actively enrolled in this medical study?

"Indeed, information retrieved from clinicaltrials.gov affirms that patient recruitment is ongoing for this particular investigation. The trial was initially listed on February 2nd, 2024 and the latest update was also on February 2nd, 2024. A total of 386 participants are sought at a single designated facility."

Answered by AI

Is it possible for me to be enrolled in this medical study?

"The investigation aims to recruit 386 individuals aged between 18 and 100 who have been diagnosed with non-metastatic breast cancer in stages I-III for the first time. Essential criteria include providing informed consent, having a PROMIS Adult v2.0 - Cognitive Function score of less than 12, being within six months to five years post-treatment (inclusive of initial surgery +/- adjuvant chemotherapy/radiation therapy), and possessing proficiency in English or Spanish language skills."

Answered by AI

Is this clinical study enrolling individuals who are at least 18 years of age?

"Individuals between the ages of 18 and 100 are eligible to participate in this study. Notably, there are a total of 97 trials available for individuals under 18 years old and 3094 studies catering to those above the age of consent."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors

2024. "Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05896189.

All > Breast Cancer Glendale > Knoxville