MAAT for Chemotherapy-Related Cognitive Impairment

(TAMS Trial)

Recruiting at 1 trial location

Overseen By Robert J Ferguson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Neurological disorder, TBI, uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Memory and Attention Adaptation Training (MAAT) for chemotherapy-related cognitive impairment?

Research shows that MAAT, a type of cognitive-behavioral therapy, helps improve memory and attention in breast cancer survivors who have undergone chemotherapy. Participants in studies reported better cognitive function and quality of life after receiving MAAT, and they found it helpful in managing memory problems. ^{1 2 3 4 5}

Is Memory and Attention Adaptation Training (MAAT) safe for humans?

MAAT has been used in studies with breast cancer survivors to help manage cognitive issues after chemotherapy, and participants reported high satisfaction and found it helpful. There were no safety concerns mentioned in the studies, suggesting it is generally safe for humans. ^{1 2 3 5 6}

How is the treatment MAAT different from other treatments for chemotherapy-related cognitive impairment?

MAAT is unique because it is a cognitive-behavioral therapy specifically designed to help cancer survivors manage memory and attention problems after chemotherapy, improving their quality of life and cognitive function, whereas no other standard treatments currently exist for this condition. ^{1 2 3 6 7}

Research Team

Robert J Ferguson, PhD

Principal Investigator

St. Jude Children's Research Hospital

Donna Posluszny, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

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

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

Able to speak and read English

Exclusion Criteria

You have a mental disorder, such as ADHD, substance abuse, depression, anxiety, or psychosis, as defined by the DSM-5.

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Memory and Attention Adaptation Training (MAAT) or Supportive Therapy (ST) for 8 weeks via videoconferencing

8 weeks

8 weekly visits (virtual)

Post-Treatment Assessment

Participants undergo post-treatment assessments including cognitive function tests and optional fMRI

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6-month follow-up

6 months

Treatment Details

Interventions

• Memory and Attention Adaptation Training (MAAT)
• Supportive Therapy (ST)

Trial Overview 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.

Participant Groups

Group I: Memory and Attention Adaptation Training (MAAT) Experimental Treatment 1 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 Control 1 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.

Memory and Attention Adaptation Training (MAAT) is already approved in United States for the following indications:

Approved in United States as MAAT for:

• Chemotherapy-related cognitive dysfunction in breast cancer survivors

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A pilot study involving 29 breast cancer survivors, averaging 8 years post-chemotherapy, showed that a cognitive-behavioral treatment called Memory and Attention Adaptation Training (MAAT) led to significant improvements in self-reported cognitive function and quality of life.

Participants reported high satisfaction with MAAT, indicating it is a feasible and practical approach to help manage cognitive dysfunction related to chemotherapy, suggesting further evaluation is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral management of chemotherapy-related cognitive change. Ferguson, RJ., Ahles, TA., Saykin, AJ., et al.[2022]

A brief cognitive-behavioral therapy called Memory and Attention Adaptation Training (MAAT) showed significant improvements in verbal memory and spiritual well-being among 40 breast cancer survivors after 8 weeks of treatment compared to a waitlist control group.

Participants reported high satisfaction with MAAT, indicating its potential as a beneficial intervention for managing cognitive dysfunction following chemotherapy, despite not achieving statistical significance in self-reported daily cognitive complaints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of CBT for chemotherapy-related cognitive change: results of a waitlist control trial. Ferguson, RJ., McDonald, BC., Rocque, MA., et al.[2022]

Systemic cancer chemotherapy can lead to long-term cognitive deficits in survivors, affecting areas such as verbal learning, memory, attention, and information processing speed.

There is ongoing research into the mechanisms behind these cognitive deficits, including the potential role of genetic polymorphisms that may increase vulnerability to cognitive decline after chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive effects of cytotoxic cancer chemotherapy: predisposing risk factors and potential treatments. McAllister, TW., Ahles, TA., Saykin, AJ., et al.[2019]

A small randomized controlled trial involving 47 breast cancer survivors showed that Memory and Attention Adaptation Training (MAAT) significantly improved self-reported cognitive impairments and neuropsychological processing speed compared to supportive therapy.

MAAT demonstrated a large effect size in reducing anxiety related to cognitive problems, indicating it may be an effective psychological treatment for chemotherapy-related cognitive dysfunction, and it can be conveniently delivered via videoconference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of videoconference-delivered cognitive behavioral therapy for survivors of breast cancer with self-reported cognitive dysfunction. Ferguson, RJ., Sigmon, ST., Pritchard, AJ., et al.[2018]

Memory and attention adaptation training (MAAT) is a cognitive-behavioral therapy that has been shown to improve symptoms of cancer-related cognitive impairment (CRCI) and enhance the quality of life for cancer survivors.

The article proposes a single-case experimental design (SCED) approach to evaluate the effectiveness of MAAT in clinical settings, which can help in continuously assessing and improving treatments for CRCI as the number of cancer survivors increases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Single-Case Experimental Design and Patient-Reported Outcome Measures to Evaluate the Treatment of Cancer-Related Cognitive Impairment in Clinical Practice. Ferguson, RJ., Terhorst, L., Gibbons, B., et al.[2023]

Recent prospective trials indicate that patients undergoing chemotherapy can experience specific cognitive impairments, challenging previous beliefs that such dysfunction was not linked to cancer therapy.

Two case studies from a Geriatric Oncology clinic illustrate this issue: a 75-year-old male with lung cancer reported forgetfulness after chemotherapy, and a 65-year-old female with breast cancer experienced cognitive issues following multiple treatments, highlighting the need for awareness and assessment of cognitive health in older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of cancer therapy on cognition in the elderly. Mandilaras, V., Wan-Chow-Wah, D., Monette, J., et al.[2021]

A study evaluated a neuropsychological test battery for assessing cognitive dysfunctions in cancer patients, specifically focusing on breast cancer patients five years post-treatment and patients with hematological malignancies before and after stem cell transplantation.

The results indicated that attention measures, particularly the 'Alertness' subtest from the Test Battery for Attentional Performance (TAP), showed high reliability and are recommended as a basic screening tool for cognitive dysfunctions in these patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychometric evaluation of a neuropsychological test battery measuring cognitive dysfunction in cancer patients--recommendations for a screening tool]. Scherwath, A., Poppelreuter, M., Weis, J., et al.[2008]

References

1. England pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral management of chemotherapy-related cognitive change. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Development of CBT for chemotherapy-related cognitive change: results of a waitlist control trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Cognitive effects of cytotoxic cancer chemotherapy: predisposing risk factors and potential treatments. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of videoconference-delivered cognitive behavioral therapy for survivors of breast cancer with self-reported cognitive dysfunction. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Using Single-Case Experimental Design and Patient-Reported Outcome Measures to Evaluate the Treatment of Cancer-Related Cognitive Impairment in Clinical Practice. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The impact of cancer therapy on cognition in the elderly. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

[Psychometric evaluation of a neuropsychological test battery measuring cognitive dysfunction in cancer patients--recommendations for a screening tool]. [2008]