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Behavioral Intervention

Cognitive Training for Chemobrain

N/A

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be between 35 and 80 years of age

Participants must have no active unstable medical condition

Must not have

Participants will be excluded for history of significant head trauma followed by persistent neurologic deficits

Participants will be excluded for use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a cognitive training program can help people with chemotherapy-related cognitive impairment.

Who is the study for?

This trial is for adults aged 35-80 who have had breast cancer and received chemotherapy within the last 1-8 years. They must speak English, report ongoing cognitive issues post-treatment, and be medically stable. Exclusions include significant cognitive impairment or dementia, recent investigational drug use, certain unstable conditions, color blindness, unstable psychiatric disorders, and substance abuse history.

What is being tested?

The study tests a computer program designed to improve thinking skills affected by chemotherapy (nCCR) against an educational control condition. Participants will randomly receive either the nCCR treatment or education sessions to compare effectiveness in treating 'chemobrain'.

What are the potential side effects?

Since this trial involves non-drug interventions like computer exercises and educational activities rather than medications, traditional side effects are not expected. However, participants may experience fatigue or frustration during tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 35 and 80 years old.

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I do not have any unstable health conditions.

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I have been diagnosed with breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had a severe head injury with lasting brain problems.

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I haven't taken any experimental drugs in the last 30 days or longer.

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I do not have an active neurological condition or untreated major psychiatric disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Assess whether nCCR training produces change in subjective cognitive complaints breast cancer survivors with CRCI.

Secondary study objectives

Assess whether 6-weeks of nCCR training produces change in cognitive performance on neuropsychological measures in breast cancer survivors with CRCI.

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: Neuroplasticity-based Computerized Cognitive RemediationExperimental Treatment1 Intervention

Behavioral: Neuroplasticity-based Computerized Cognitive Remediation The nCCR has two major components: Bottom up and Top down training. * Bottom up" training: The training includes selected tasks from "Brain HQ", a program designed for older adults, that enhances basic processing of sensory stimuli with the goal to improve fidelity of auditory and visual encoding. * Top down training": We designed programs to target cognitive control functions associated with poor treatment response, i.e., initiation and use of verbal strategy and susceptibility to interference. These "Top Down" Programs include a visual attention program, either Catch the Ball or Neurogrow, and a semantic strategy program, Semantic Organization.

Group II: Education Comparison ControlActive Control1 Intervention

The education control condition is a learning-based approach that utilizes DVDs on history, art, science, etc. This active condition is comparable to nCCR in length of exposure, audio-visual presentation, computer use and contact with research staff.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neuroplasticity-based Computerized Cognitive Remediation

2020

N/A

~30

0 / 6Eligibility criteria met