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

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ClinicalTrials.gov Identifier: NCT04230941
Recruitment Status : Active, not recruiting
First Posted : January 18, 2020
Last Update Posted : January 15, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Allison Magnuson, University of Rochester

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 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 (phase I), 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 provided details pertain to Phase I of the study, which will focus on the adaptation process. The investigators will adapt and refine MAAT-G using feedback from key stakeholders through iterative testing of MAAT-G with 10 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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) Phase I
Actual Study Start Date : June 12, 2020
Actual Primary Completion Date : November 19, 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: MAAT-G Intervention
MAAT-G Workshops & participant workbook use (8 workshops)
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. MAAT-G will be evaluated in up to 10 patient-caregiver dyads to further adapt MAAT-G to optimize usability.




Primary Outcome Measures :
  1. System Usability Scale [ Time Frame: Post-Intervention (up to 2 weeks) ]
    The System Usability Scale is a metric to evaluate the usability of the intervention (Patients) and is scored 0-100, with a target score >68,

  2. Experience Interview [ Time Frame: Post-Intervention (up to 2 weeks) ]
    Semi-structured interview with patients and caregivers about experience with MAAT-G. (Patients and caregivers)


Secondary Outcome Measures :
  1. Functional Assessment of Cancer Therapy-Cognition (FACT-COG) [ Time Frame: Baseline; Post-intervention (up to 2 weeks) ]
    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. (Patients only)

  2. Cambridge Neuropsychological Test Automated Battery (CANTAB) [ Time Frame: Baseline; Post-intervention (up to 2 weeks) ]
    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; Post-intervention (up to 2 weeks) ]
    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. Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Baseline; Post-intervention (up to 2 weeks) ]
    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)

  5. Geriatric Depression Screen (GDS) [ Time Frame: Baseline; Post-intervention (up to 2 weeks) ]
    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)

  6. Generalized Anxiety and Depression 7-item scale (GAD-7) [ Time Frame: Baseline; Post-intervention (up to 2 weeks) ]
    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)

  7. Instrumental Activities of Daily Living (IADL) [ Time Frame: Baseline; Post-intervention (up to 2 weeks) ]
    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)



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

Eligible Patient 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

Eligible Patient 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

Eligible Caregiver Inclusion Criteria:

  • Age 21 or older
  • Able to speak English
  • Able to provide informed consent

Eligible Caregiver Exclusion Criteria:

  • none

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): NCT04230941


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Allison Magnuson University of Rochester
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Responsible Party: Allison Magnuson, Director, Specialized Oncology Care and Research in the Elderly (SOCARE) Clinic, University of Rochester
ClinicalTrials.gov Identifier: NCT04230941    
Other Study ID Numbers: UCCS19102
1K76AG064394-01 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021

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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