What side effects are associated with this type of intervention?

Cognitive-Behavioral Therapy (CBT) and similar non-pharmacologic treatments for cognitive impairment, such as Memory and Attention Adaptation Training (MAAT), are generally safe with minimal side effects. Some individuals may experience temporary increases in anxiety or emotional discomfort as they work through challenging thoughts and behaviors during therapy. Overall, these treatments are well-tolerated and considered a safe option for improving cognitive function.

What prior FDA approvals exist?

FDA-approved treatments for cognitive impairment primarily include pharmacological options such as memantine and cholinesterase inhibitors like donepezil, which are used for conditions like Alzheimer's disease. These drugs aim to manage symptoms and slow progression rather than improve cognitive function directly. Cognitive-behavioral therapies, like the Memory and Attention Adaptation Training (MAAT) being studied, focus on non-pharmacological approaches to enhance cognitive function and manage cognitive dysfunction, particularly in conditions like chemotherapy-related cognitive impairment.

What other types of research exist?

Promising novel alternatives to MAAT for cognitive impairment patients include: 1) Computerized Cognitive Rehabilitation Therapy (CCRT), which uses culturally adapted video games to improve cognitive function, as demonstrated in studies with older adults and specific populations like those with HIV. 2) Transcranial Direct Current Stimulation (tDCS), which has shown potential in improving inattention in adults with ADHD and could be adapted for cognitive impairment. 3) Cognitive training combined with work therapy, which has been effective in improving verbal learning and memory deficits in veterans with alcohol use disorders. These alternatives offer innovative approaches that leverage technology and neurostimulation to enhance cognitive rehabilitation.

← Back to Search

MAAT for Chemotherapy-Related Cognitive Impairment (TAMS Trial)

N/A

Recruiting

Led By Robert J Ferguson, 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

Must not have

Previous exposure to chemotherapy with another cancer or due to other medical condition (e.g., methotrexate exposure for treatment of rheumatoid arthritis)

Severe uncorrected sensory impairment (severe hearing or visual impairment)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a therapy called MAAT can help breast cancer survivors who have had chemotherapy improve their memory and attention. The therapy involves learning new thinking and behavior strategies to manage cognitive problems better.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

Select...

I have received chemotherapy before or after surgery.

Select...

I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated with chemotherapy for a condition other than my current cancer.

Select...

I have severe hearing or vision problems that cannot be corrected.

Select...

I have had brain surgery or treatment for my brain.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

FACT-Cog PCI

Secondary study objectives

California Verbal Learning Test-3 (CVLT-3)

Controlled Oral Word Association Test (COWAT)

Digit Span test

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive-Behavioral Therapy (CBT) for cognitive impairment, such as Memory and Attention Adaptation Training (MAAT), works by addressing distorted cognitions and improving behavioral strategies to enhance cognitive function. CBT helps patients reframe negative thoughts, develop problem-solving skills, and adopt healthier behaviors, which can lead to improved memory, attention, and overall cognitive performance. This is particularly important for cognitive impairment patients as it not only targets cognitive deficits but also enhances their ability to manage daily activities and improve their quality of life.

Cognitive rehabilitation interventions after stroke: protocol for a systematic review and meta-analysis of randomized controlled trials.