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Memory and Attention Adaptation Training-Geriatrics (MAAT-G) Phase II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04669301
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : January 18, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Allison Magnuson, University of Rochester

Study Description
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Brief Summary:
Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training (MAAT) is a promising treatment for CRCD that improves perceived cognition in younger cancer survivors, but needs to be adapted for older adults to address their unique needs. The proposed study will adapt MAAT for older adults using feedback from key stakeholders (older adults with cancer and their caregivers), and subsequently test the ability of MAAT to improve or maintain cognition for older adults with breast cancer receiving adjuvant chemotherapy.

Condition or disease Intervention/treatment Phase
Cancer-related Problem/Condition Cognitive Impairment Behavioral: MAAT-G Behavioral: Supportive therapy (time and attention control) Not Applicable

Detailed Description:
Cancer-related cognitive dysfunction (CRCD) is a significant problem, affecting up to 75% of patients receiving chemotherapy. Older adults are at greater risk of developing CRCD which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training (MAAT) is a promising tool that improves perceived cognition in younger cancer survivors with CRCD. For older adults with cancer, MAAT could be delivered alongside chemotherapy to mitigate the development of CRCD (when risk is highest) and CRCD-related effects on functional independence for older adults. However, MAAT will require adaptation to meet the unique needs of older adults to optimize usability and efficacy for this population. The overarching goal of this project is to adapt MAAT for older adults using input from patient and caregiver stakeholders, and subsequently gather data on the preliminary effects of the adapted MAAT (MAAT-Geriatrics [G]) on perceived cognition, objective cognitive measures and functional independence. The investigators will adapt and refine MAAT-G using feedback from key stakeholders through iterative testing of MAAT-G with 85 patient-caregiver dyads. The research plan combines the use of standardized quantitative measures of cognition and functional independence with semi-structured interviews (mixed methods), so that data from both can be integrated to optimize the adaptation and to gain a better understanding of MAAT-G's effects that are not fully captured by traditional quantitative measures alone.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Mitigating Cancer-Related Cognitive Impairment in Older Adults With Breast Cancer Receiving Chemotherapy: Memory and Attention Adaptation Training-Geriatrics (MAAT-G): A Randomized Pilot Study
Actual Study Start Date : April 2, 2021
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Supportive therapy (time and attention control)
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
 Behavioral: Supportive therapy (time and attention control)
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
Experimental: MAAT-G intervention
The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study
 Behavioral: MAAT-G
Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.


Outcome Measures
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Primary Outcome Measures :
  1. Functional Assessment of Cancer Therapy-Cognition (FACT-COG) [ Time Frame: Baseline ]
    The Functional Assessment of Cancer Therapy-Cognition tool is a 50-question tool that evaluates memory and mental function in the past 7 days. The range of scores for the tool are 0 to 4 with higher scores generally indicating worse health outcomes.

  2. Functional Assessment of Cancer Therapy-Cognition (FACT-COG) [ Time Frame: Within to weeks of intervention completion ]
    The Functional Assessment of Cancer Therapy-Cognition tool is a 50-question tool that evaluates memory and mental function in the past 7 days. The range of scores for the tool are 0 to 4 with higher scores generally indicating worse health outcomes.

  3. Experience Interview [ Time Frame: Within to weeks of intervention completion ]
    Semi-structured interview with patients and caregivers about experience with workshop sessions (Patients and caregivers)


Secondary Outcome Measures :
  1. Cambridge Neuropsychological Test Automated Battery (CANTAB) [ Time Frame: Baseline ]
    The CANTAB Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory, for non-verbalisable patterns. The subject is shown a complex visual pattern, followed by four similar patterns after a brief delay. The subject must select the pattern which exactly matches the sample. Better speed of response and higher number of correct patterns indicate better health outcomes. (Patients only)

  2. Cambridge Neuropsychological Test Automated Battery (CANTAB) [ Time Frame: Within to weeks of intervention completion ]
    The CANTAB Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory, for non-verbalisable patterns. The subject is shown a complex visual pattern, followed by four similar patterns after a brief delay. The subject must select the pattern which exactly matches the sample. Better speed of response and higher number of correct patterns indicate better health outcomes. (Patients only)

  3. Controlled Oral Word Association (COWA) [ Time Frame: Baseline ]
    The Controlled Oral Word Association (COWA) tool is a measure of verbal fluency evaluating expressive language and executive function. Subjects are asked to freely generate as many words as they can that start with one of the prompted letters ("C", "F", and "L") in the span of one minute. Greater numbers of words indicate better health outcomes. (Patients only)

  4. Controlled Oral Word Association (COWA) [ Time Frame: Within to weeks of intervention completion ]
    The Controlled Oral Word Association (COWA) tool is a measure of verbal fluency evaluating expressive language and executive function. Subjects are asked to freely generate as many words as they can that start with one of the prompted letters ("C", "F", and "L") in the span of one minute. Greater numbers of words indicate better health outcomes. (Patients only)

  5. Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Baseline ]
    The Hopkins Verbal Learning Test-Revised (HVLT-R) tool is a test of verbal learning and memory. Researchers read a list of 12 words to subjects and ask them to report as many of the words as they can recall. The reporting period is timed. Higher numbers of correctly remembered words, along with lower reporting times, are indicative of better health outcomes. (Patients only)

  6. Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Within to weeks of intervention completion ]
    The Hopkins Verbal Learning Test-Revised (HVLT-R) tool is a test of verbal learning and memory. Researchers read a list of 12 words to subjects and ask them to report as many of the words as they can recall. The reporting period is timed. Higher numbers of correctly remembered words, along with lower reporting times, are indicative of better health outcomes. (Patients only)

  7. Geriatric Depression Screen (GDS) [ Time Frame: Baseline ]
    The Geriatric Depression Screen (GDS) tool is a 15 question psychological assessment with "yes" or "no" answers. The questions pertain to emotional state and vary between positive and negative presentation. (Patients only)

  8. Geriatric Depression Screen (GDS) [ Time Frame: Within to weeks of intervention completion ]
    The Geriatric Depression Screen (GDS) tool is a 15 question psychological assessment with "yes" or "no" answers. The questions pertain to emotional state and vary between positive and negative presentation. (Patients only)

  9. Generalized Anxiety and Depression 7-item scale (GAD-7 [ Time Frame: Baseline ]
    The Generalized Anxiety and Depression 7-item scale (GAD-7) is a 7-item question tool that evaluates feelings of anxiety over the previous 2 weeks. Each question is ranked from 0 to 3, with higher scores indicating worse health outcomes. (Patients only)

  10. Generalized Anxiety and Depression 7-item scale (GAD-7 [ Time Frame: Within to weeks of intervention completion ]
    The Generalized Anxiety and Depression 7-item scale (GAD-7) is a 7-item question tool that evaluates feelings of anxiety over the previous 2 weeks. Each question is ranked from 0 to 3, with higher scores indicating worse health outcomes. (Patients only)

  11. Instrumental Activities of Daily Living (IADL) [ Time Frame: Baseline ]
    The Instrumental Activities of Daily Living (IADL) tool asks questions about functional independence. There are 7 questions on an unnumbered scale of most to least independence. (Patients only)

  12. Instrumental Activities of Daily Living (IADL) [ Time Frame: Within to weeks of intervention completion ]
    The Instrumental Activities of Daily Living (IADL) tool asks questions about functional independence. There are 7 questions on an unnumbered scale of most to least independence. (Patients only)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of invasive breast cancer
  • Planned to receive systemic therapy for breast cancer or actively receiving systemic therapy for breast cancer with two additional cycles remaining.
  • Be age 65 or older
  • Able to provide informed consent
  • Able to read and understand English (or possess a designated health care proxy that can do the same that was designated prior to the patient losing decision-making capabilities)

Exclusion Criteria:

  • Have surgery planned within 3 months of consent
  • Patients who do not have decision-making capacity (decisionally or cognitively impaired) AND do NOT have a previously designated health care proxy (established prior to their cognitive impairment) available to sign consent
  • Patients with breast cancer receiving endocrine therapy as their only systemic therapy will not be eligible.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669301


Contacts
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Contact: Allison Magnuson, DO 585-275-5863 Allison_Magnuson@URMC.Rochester.edu
Contact: Jessica Mortimer Jessica_mortimer@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14623
Contact: Allison Magnuson, DO    585-275-5863    Allison_Magnuson@urmc.rochester.edu   
Sponsors and Collaborators
University of Rochester
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Allison Magnuson, DO University of Rochester
More Information
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Responsible Party: Allison Magnuson, Assistant Professor - Department of Medicine , Hematology/Oncology (SMD), University of Rochester
ClinicalTrials.gov Identifier: NCT04669301    
Other Study ID Numbers: UCCS20127
K76AG064394 ( U.S. NIH Grant/Contract )
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders