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MAAT for Chemotherapy-Related Cognitive Impairment (TAMS Trial)

N/A

Recruiting

Led By Jessica J. Harrison, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

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

Must have

Diagnosis of stage I-III breast cancer

1-5 years post-treatment and currently disease free

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, post-treatment (8 weeks) and 6-month follow-up

Awards & highlights

TAMS Trial Summary

This trial is testing whether a cognitive-behavioral therapy called MAAT is effective at treating chemotherapy-related cognitive dysfunction in breast cancer survivors. The trial will also use fMRI to study brain activation patterns to understand how MAAT works.

Who is the study for?

This trial is for breast cancer survivors who've had chemotherapy, are currently disease-free, and experiencing memory or concentration issues. They must be 1-5 years post-treatment, over 18, speak English, and willing to use videoconferencing. Exclusions include severe memory disorders, previous CNS treatments unrelated to their cancer, other mental health conditions that could affect cognition.Check my eligibility

What is being tested?

The study tests Memory and Attention Adaptation Training (MAAT) against Supportive Therapy (ST) to see if MAAT improves cognitive dysfunction in breast cancer survivors after chemotherapy. It includes brain scans before and after treatment to understand changes in brain activity related to therapy.See study design

What are the potential side effects?

Since the interventions involve cognitive-behavioral therapy and supportive conversations rather than drugs or medical procedures, traditional side effects are not expected. Participants may experience fatigue or emotional discomfort during sessions.

TAMS Trial Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is at an early to mid-stage (I-III).

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I finished my cancer treatment between 1 to 5 years ago and am now cancer-free.

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I have received chemotherapy before or after surgery.

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I am older than 18 years.

TAMS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, post-treatment (8 weeks) and 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, post-treatment (8 weeks) and 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, post-treatment (8 weeks) and 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

FACT-Cog PCI

Secondary outcome measures

California Verbal Learning Test-3 (CVLT-3)

Controlled Oral Word Association Test (COWAT)

Digit Span test

+2 more

TAMS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Memory and Attention Adaptation Training (MAAT)Experimental Treatment1 Intervention

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.

Group II: Supportive Therapy (ST)Active Control1 Intervention

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,700 Previous Clinical Trials

7,506,676 Total Patients Enrolled

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

16,342,736 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,806 Total Patients Enrolled

Media Library

Cognitive Impairment Research Study Groups: Memory and Attention Adaptation Training (MAAT), Supportive Therapy (ST)

Frequently Asked Questions

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

What is the estimated population size for this clinical research?

"Affirmative. The clinical trial's page on ClinicalTrials.gov reveals that it is currently recruiting participants, with the initial post date of March 18th 2021 and last edit on April 21st 2022. 200 patients need to be enrolled between two sites for this experiment to proceed."

Answered by AI

Are enrolments being accepted for this trial currently?

"Affirmative. Clinicaltrials.gov provides evidence that this experiment, first launched on March 18th 2021, is currently in search of participants. Around 200 subjects must be enrolled from 2 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Telehealth and Memory Study

Robert J Ferguson, PhD 2021. "Telehealth and Memory Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04586530.

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