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Behavioral Intervention

Cognitive Training for Breast Cancer

N/A
Recruiting
Led By Allison Magnuson, DO
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned to receive systemic therapy for breast cancer or actively receiving systemic therapy for breast cancer with two additional cycles remaining
Be age 65 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within to weeks of intervention completion
Awards & highlights

Study Summary

This trial will study whether a cognitive training program can help older adults with breast cancer who are receiving chemotherapy.

Who is the study for?
This trial is for older adults (65+) with invasive breast cancer who are undergoing or planning to undergo chemotherapy. They must be able to give informed consent and read/understand English, or have a health proxy who can. Those only on endocrine therapy, planning surgery within 3 months, or without decision-making capacity and no prior health proxy are excluded.Check my eligibility
What is being tested?
The study tests Memory and Attention Adaptation Training adapted for geriatrics (MAAT-G) against supportive therapy as a control. It aims to see if MAAT-G can improve or maintain cognitive functions in older adults receiving chemotherapy for breast cancer.See study design
What are the potential side effects?
Since the interventions involve cognitive training and supportive therapy rather than drugs, typical medical side effects aren't expected. Participants may experience fatigue or frustration related to the exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently undergoing or about to start systemic therapy for breast cancer, with at least two cycles left.
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I am 65 years old or older.
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I have been diagnosed with invasive breast cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within to weeks of intervention completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and within to weeks of intervention completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Experience Interview
Functional Assessment of Cancer Therapy-Cognition (FACT-COG)
Secondary outcome measures
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Controlled Oral Word Association (COWA)
Anxiety
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MAAT-G interventionExperimental Treatment1 Intervention
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
Group II: Supportive therapy (time and attention control)Active Control1 Intervention
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MAAT-G
2020
N/A
~10

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
834 Previous Clinical Trials
518,207 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,658 Previous Clinical Trials
28,004,414 Total Patients Enrolled
Allison Magnuson, DOPrincipal Investigator - University of Rochester
University of Rochester
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

MAAT-G (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04669301 — N/A
Cancer Research Study Groups: Supportive therapy (time and attention control), MAAT-G intervention
Cancer Clinical Trial 2023: MAAT-G Highlights & Side Effects. Trial Name: NCT04669301 — N/A
MAAT-G (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04669301 — N/A

Frequently Asked Questions

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

Are there any remaining slots open for those seeking to participate in this research endeavor?

"ClinicalTrials.gov indicates that this trial is actively searching for participants, with the initial posting occurring on April 2nd 2021 and the most recent update taking place January 14th 2022."

Answered by AI

What are the fundamental points of inquiry for this research project?

"The primary endpoint of this trial, to be monitored over a two-week period post-intervention, is the Experience Interview. Secondary outcomes include Geriatric Depression Screen (GDS), Generalized Anxiety and Depression 7-item scale (GAD-7) and Instrumental Activities of Daily Living (IADL). The GDS assesses emotional states through 15 'yes' or 'no' questions that present both positively and negatively; the GAD-7 evaluates anxiety levels with seven 0 - 3 ranked queries; while IADL examines functional independence on an unnumbered scale from most to least independent."

Answered by AI

How many participants have been deemed eligible for this clinical experiment?

"Affirmative. According to information sourced from clinicaltrials.gov, this research venture is open for recruitment; it was first shared on April 2nd 2021 and updated January 14th 2022. Eighty-five participants need to be recruited across a single trial site."

Answered by AI
~22 spots leftby Mar 2025