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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-weeks
Awards & highlights
Study 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.Check my eligibility
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'.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess whether nCCR training produces change in subjective cognitive complaints breast cancer survivors with CRCI.
Secondary outcome measures
Assess whether 6-weeks of nCCR training produces change in cognitive performance on neuropsychological measures in breast cancer survivors with CRCI.
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
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,172 Total Patients Enrolled
University of UtahOTHER
1,099 Previous Clinical Trials
1,778,702 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any major illnesses that would prevent me from following the study's requirements.My dose for CNS active medications like antidepressants has been stable for 3 months.I am between 35 and 80 years old.I do not have any unstable health conditions.I have been diagnosed with breast cancer.I have never had a severe head injury with lasting brain problems.I haven't taken any experimental drugs in the last 30 days or longer.I do not have an active neurological condition or untreated major psychiatric disorder.I have had chemotherapy between 1 and 8 years ago.I feel ongoing cognitive issues due to cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Neuroplasticity-based Computerized Cognitive Remediation
- Group 2: Education Comparison Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the qualifications to join this research initiative?
"To meet the prerequisites of this clinical trial, patients must have a history of chemotherapy-induced cognitive deficits and be aged between 35 to 80 years old. This medical experiment is looking for 16 volunteers in total."
Answered by AI
Are there any current opportunities for individuals to be involved in this research?
"Affirmative. According to information available on clinicaltrials.gov, this investigation commenced recruitment on August 1st 2022 and was recently updated in September 12th 2022. 16 patients are required from a single medical centre for the trial to be successful."
Answered by AI
Does this research study accommodate individuals aged 35 and over?
"As outlined in the trial's inclusion criteria, potential participants must be between 35 and 80 years of age."
Answered by AI
How many individuals are taking part in this exploration?
"Absolutely. Clinicaltrials.gov indicates that this trial is actively seeking participants - 16 in total, from a single site - since its posting on August 1st 2022 and most recent update on September 12th 2022."
Answered by AI
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