MAAT for Chemotherapy-Related Cognitive Impairment

(TAMS Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a therapy called Memory and Attention Adaptation Training (MAAT) for breast cancer survivors experiencing memory and concentration difficulties after chemotherapy. The goal is to determine if this cognitive-behavioral therapy, a type of talk therapy, can improve these issues. Participants will receive either MAAT via videoconference or a supportive therapy focusing on empathy and support. The trial seeks breast cancer survivors who completed treatment 1-5 years ago, are currently disease-free, and have noticed memory and focus problems since their chemotherapy. As an unphased trial, this study offers a unique opportunity to explore innovative therapy options that could enhance cognitive recovery and quality of life.

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 prior data suggests that Memory and Attention Adaptation Training (MAAT) is safe for treating chemotherapy-related cognitive impairment?

Research has shown that Memory and Attention Adaptation Training (MAAT) is generally safe and well-tolerated. Studies have found that this therapy helps breast cancer survivors with memory and attention problems after chemotherapy, often referred to as "chemobrain." MAAT avoids medication, thus sidestepping drug-related side effects. Instead, it teaches strategies to manage memory challenges. No major reports of negative effects from MAAT have emerged, suggesting it is a safe choice for those seeking to improve thinking skills after chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Memory and Attention Adaptation Training (MAAT) for chemotherapy-related cognitive impairment because it offers a fresh approach to tackling memory issues that arise after chemotherapy. Unlike standard cognitive therapies that mainly provide general support, MAAT is delivered via videoconference and combines cognitive-behavioral therapy with practical exercises aimed at boosting self-awareness and emotion regulation. It also teaches compensatory strategies to help improve daily task performance, which could be more effective in addressing specific cognitive challenges faced by cancer survivors. This tailored and interactive method of delivery is seen as a promising way to enhance survivors' quality of life by directly targeting the cognitive deficits experienced after chemotherapy.

What evidence suggests that this trial's treatments could be effective for chemotherapy-related cognitive impairment?

Research has shown that Memory and Attention Adaptation Training (MAAT), one of the treatments in this trial, may assist cancer survivors experiencing thinking and memory problems after chemotherapy, often referred to as "chemobrain." Studies have found that MAAT, a therapy conducted through video calls, can enhance memory and attention. It helps patients recognize situations where memory issues arise, teaches strategies to manage these problems, and aids in handling the emotions associated with these challenges. Early results suggest that MAAT effectively supports the cognitive health of cancer survivors, making it a promising option for those facing cognitive issues post-chemotherapy. Another treatment arm in this trial involves Supportive Therapy (ST), which provides empathy, support, and warmth to address concerns related to cancer survivorship and cognitive dysfunction. ^{1 3 6 7 8}

Who Is on the Research Team?

Robert J Ferguson, PhD

Principal Investigator

St. Jude Children's Research Hospital

Donna Posluszny, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6913782/

Chemotherapy-Related Cognitive Impairment #342 - PMC Changes in memory, attention, processing speeds, and problem solving during or after exposure to chemotherapy have been referred to as “chemobrain” or CRCI.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04586530

NCT04586530 | Telehealth and Memory Study The overall purpose of this trial is to confirm the efficacy of Memory and Attention Adaptation Training (MAAT), a cognitive-behavioral therapy (CBT) for ...

3. academic.oup.com academic.oup.com/book/30618/chapter/258928184

Introduction - Oxford Academic - Oxford University Press The results of research to date on MAAT presented suggest it is efficacious and can be delivered via telehealth services to enhance survivor healthcare access.

4. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10652586&term=CA244673

Division of Cancer Control & Population Sciences - Grant Details ABSTRACT The proposed research will examine the efficacy of a videoconference-delivered cognitive-behavioral therapy (CBT), Memory and Attention Adaptation ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pon.70251?af=R

Effect of Cognitive Training on Cancer‐Related ... Numerous studies have examined the impact of breast cancer-related cognitive impairment, with a primary focus on memory and executive function ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06150976

NCT06150976 | MAAT For Young Adult Cancer Survivors The goal of this clinical trial is to pilot-test a modified version of telehealth-delivered Memory and Attention Adaption Training (MAAT) that is tailored ...

7. withpower.com withpower.com/trial/phase-chemotherapy-related-cognitive-impairment-2-2021-a9ee7

MAAT for Chemotherapy-Related Cognitive Impairment ... This trial tests if a therapy called MAAT can help breast cancer survivors who have had chemotherapy improve their memory and attention.

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04230941/memory-and-attention-adaptation-training-geriatrics-maat-g

Memory and Attention Adaptation Training-Geriatrics ... For older adults with cancer, MAAT could be delivered alongside chemotherapy to mitigate the development of CRCD (when risk is highest) and CRCD ...