Telehealth and Memory Study

NCT04586530 | Active Not Recruiting DMC

• 2 other identifiers: HCC 20-064R01CA244673-01A1
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief Summary

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

Keywords

Memory and Attention Adaptation Training (MAAT); cognitive-impairment; cancer survivorship

Outcome Measures

Primary Outcomes (1)

• FACT-Cog PCI

  The FACT-Cog is a 37-item self-report measure that uses 5- point (0-4) Likert-type ratings that produce four scales: 1) Impact on quality of life; 2) Perceived cognitive impairments; 3) Comments from others; and 3) Perceived cognitive abilities. Higher scores indicate better function and quality of life on each scale. While each scale is scored and interpreted separately, they comprise the total Fact-cog assessment. The FACT-Cog has good evidence of reliability and construct validity. We are assessing change in PCI -- from baseline to post-treatment, to 6-month follow-up-- as our primary measure of outcome.

  At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up

Secondary Outcomes (5)

• California Verbal Learning Test-3 (CVLT-3)

  At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up

• Controlled Oral Word Association Test (COWAT)

  At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up

• Digit Span test

  At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up

• Symbol Digit Modalities Test (SDMT)

  At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up

• functional Magnetic Resonance Imaging (fMRI)

  At Baseline and Post-Treatment (8 weeks)

Study Arms (2)

Memory and Attention Adaptation Training (MAAT)

EXPERIMENTAL

A videoconference-delivered cognitive-behavioral therapy (CBT) for treatment of chemotherapy-related cognitive dysfunction (CRCD) among cancer survivors consisting of 8 weekly 45-minute visits with a survivor workbook, that targets: 1) enhancement of survivor self-awareness of "at risk" situations where memory failures occur; 2) emotion regulation through modification of survivor causal attributions and negative cognitive appraisals of memory failures; and 3) training in compensatory strategies to improve performance on daily tasks for which memory.

Behavioral: Memory and Attention Adaptation Training (MAAT)

Supportive Therapy (ST)

ACTIVE COMPARATOR

Standard attention control condition therapy for treatment of chemotherapy-related cognitive dysfunction (CRCD) among cancer survivors consisting of 8, 45-minutes visits. ST, emphasizes "non-specific" psychotherapeutic factors of clinician-participant alliance: empathy, support and warmth. ST will be directed at concerns with cancer survivorship and CRCD. Clinicians will set expectations with ST participants that they will be provided validation of experience, support, and encouragement of building their own coping resources if asked directly about what to do about cognitive problems. ST emphasizes reflective listening to help deepen knowledge of the emotional experience of the participant.

Behavioral: Supportive Therapy (ST)

Interventions

Supportive Therapy (ST) BEHAVIORAL

Standard attention control condition therapy for treatment of chemotherapy-related cognitive dysfunction (CRCD) among cancer survivors.

Supportive Therapy (ST)

Memory and Attention Adaptation Training (MAAT) BEHAVIORAL

A cognitive-behavioral therapy (CBT) for treatment of chemotherapy-related cognitive dysfunction (CRCD) among cancer survivors.

Memory and Attention Adaptation Training (MAAT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stage I-III breast cancer
• years post-treatment and currently disease free
• Treatment involved adjuvant or neoadjuvant chemotherapy
• 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)
• Able to speak and read English
• Age \>18
• Able to provide IRB-approved written informed consent
• Willing to use videoconferencing.

You may not qualify if:

• Previous CNS radiation, intrathecal therapy, or CNS-involved surgery
• Previous cancer history with the exception of non-melanoma skin cancer
• Previous exposure to chemotherapy with another cancer or due to other medical condition (e.g., methotrexate exposure for treatment of rheumatoid arthritis)
• 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)
• Currently meeting DSM-5 mental disorder criteria, including but not limited to neurodevelopmental, substance abuse, mood (e.g., Maj.Dep), anxiety, or psychotic disorders
• Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory disorders;43
• Severe uncorrected sensory impairment (severe hearing or visual impairment)

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Pittsburgh: lead

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Chemotherapy-Related Cognitive Impairment; Cognition Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Robert J Ferguson, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

• Donna Posluszny, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 14, 2020
• Study Start: March 18, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: We anticipate a completed data set in approximately December of 2025 and will make de-identified data available to qualified investigators for a period of 3 years after publication of primary results in a peer reviewed journal.
• Access Criteria: De-identified data sharing criteria include (for quality assurance): 1) Qualified researchers who have obtained IRB approval from their institution; 2) Sign a Data Use Agreement (DUA); 3) Agree to NIH, IRB policies and HIPAA requirements regarding privacy, data security and ethical practices; 4) The DUAs will ensure that data will be used only for the specific research purposes outlined in the DUA; 5) No personally identifiable or protected health information will be shared outside of University of Pittsburgh/Indiana University research staff who have a need to know this information for the purposes of the study; 6) Individual participant's data will not be disseminated; 7) Data access will be protected under security measures including encryption and password protection, and that the data will be destroyed or returned to the University of Pittsburgh/Indiana University study team after completion of relevant analyses. Collaborative analyses with project investigators are encouraged.

Locations

US (2)