Telehealth and Memory Study

Description

The overall purpose of this trial is to confirm the efficacy of Memory and Attention Adaptation Training (MAAT), a cognitive-behavioral therapy (CBT) for treatment of chemotherapy-related cognitive dysfunction among (female or male) breast cancer survivors. This is a multi-center, multi-clinician randomized control trial (MAAT vs. supportive therapy attention control condition). This trial will also evaluate a sub-sample of survivors pre-and post treatment with functional magnetic resonance imaging (fMRI) in a working memory task to evaluate pre-to-post treatment brain activation patterns to elucidate underlying mechanisms of clinical therapeutic change.

Conditions

Chemotherapy-related Cognitive Dysfunction

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Study Overview

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Study Details

Study overview

The overall purpose of this trial is to confirm the efficacy of Memory and Attention Adaptation Training (MAAT), a cognitive-behavioral therapy (CBT) for treatment of chemotherapy-related cognitive dysfunction among (female or male) breast cancer survivors. This is a multi-center, multi-clinician randomized control trial (MAAT vs. supportive therapy attention control condition). This trial will also evaluate a sub-sample of survivors pre-and post treatment with functional magnetic resonance imaging (fMRI) in a working memory task to evaluate pre-to-post treatment brain activation patterns to elucidate underlying mechanisms of clinical therapeutic change.

Mobile Device CBT for Chemotherapy-Related Cognitive Dysfunction: A Multi-Center Randomized Controlled Trial

Telehealth and Memory Study

Condition
Chemotherapy-related Cognitive Dysfunction
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Pittsburgh

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States, 15232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Diagnosis of stage I-III breast cancer
  • 2. 1-5 years post-treatment and currently disease free
  • 3. Treatment involved adjuvant or neoadjuvant chemotherapy
  • 4. Report cognitive problems of memory and concentration attributed to chemotherapy with a score of 10 or below on the FACT-Cog Impact on Quality of Life Scale (a score \~1SD below pre-chemotherapy treatment norms; this criterion was used in our prior R21 study, ensures a clinically meaningful level of cognitive concerns,41 and discriminates high and low PCI scores in prior research42)
  • 5. Able to speak and read English
  • 6. Age \>18
  • 7. Able to provide IRB-approved written informed consent
  • 8. Willing to use videoconferencing.
  • 1. Previous CNS radiation, intrathecal therapy, or CNS-involved surgery
  • 2. Previous cancer history with the exception of non-melanoma skin cancer
  • 3. Previous exposure to chemotherapy with another cancer or due to other medical condition (e.g., methotrexate exposure for treatment of rheumatoid arthritis)
  • 4. Significant neurodevelopmental, neurobehavioral, or medical risk factors likely to affect cognitive functioning (e.g., history of neurological disorder or TBI of greater than mild severity, such as loss of consciousness \>30 minutes, medical disorder that is unstable or likely to affect cognition such as metabolic disorder, heart attack or stroke, uncontrolled diabetes or endocrine dysfunction)
  • 5. Currently meeting DSM-5 mental disorder criteria, including but not limited to neurodevelopmental, substance abuse, mood (e.g., Maj.Dep), anxiety, or psychotic disorders
  • 6. Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory disorders;43
  • 7. Severe uncorrected sensory impairment (severe hearing or visual impairment)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pittsburgh,

Robert J Ferguson, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2025-05-31