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

• ClinicalTrials.gov Identifier: NCT04230941
• Recruitment Status: Recruiting
• First Posted: January 18, 2020
• Last Update Posted: January 18, 2022
• Sponsor: University of Rochester
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Allison Magnuson, University of Rochester

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 39 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
• Estimated Primary Completion Date: March 1, 2023
• Estimated Study Completion Date: March 1, 2023

Arms and Interventions

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 has been adapted to optimize usability. We are now testing the feasibility of MAAT-G in older cancer survivors with Mild Cognitive Impairment.

Outcome Measures

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. 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)
3. 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)
4. 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)
5. 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)
6. 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)

Eligibility Criteria

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

Criteria

Eligible Patient Inclusion Criteria:

1. Be age 65 or older
2. Able to provide informed consent. All patients will be assessed using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)56 - a score >14.5 will define ability to independently provide informed consent. For patients scoring <14.5, or if investigators have additional concerns, we will require that their health care proxy participate in the consenting process and sign an informed consent and patients will required to provide assent.
3. Able to read and understand English
4. Have a prior diagnosis of cancer and completed curative intent chemotherapy. Patients are permitted to be receiving maintenance therapy (e.g. endocrine therapy) in the adjuvant setting.
5. Have a clinical diagnosis of MCI, a score <26 on the Montreal Cognitive Assessment (MOCA), or a score <18 on the Montreal Cognitive Assessment-BLIND (MOCA-BLIND). If the patient had a MOCA evaluation completed as a part of routine clinical care in the preceding 3 months prior to consent date, this may be used for eligibility purposes.
6. Be independent in Activities of Daily Living (ADL)

Eligible Patient Exclusion Criteria:

1. Have surgery planned within 3 months of consent
2. Patients who do not have decision-making capacity (as determined by UBACC as described above) AND do NOT have a previously designated health care proxy (established prior to their cognitive impairment) available to sign consent
3. Have an ADL dependence

Eligible Caregiver Inclusion Criteria:

1. Selected by the patient when asked if there is a "family member, partner, friend or caregiver [age 21 or older] with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") will remain eligible for the study.

Eligible Caregiver Exclusion Criteria:

1. Caregivers unable to understand the consent form due to cognitive, health or sensory impairment will be excluded

Contacts and Locations

Contacts

Contact: Allison Magnuson, DO; 585-275-5863; Allison_Magnuson@URMC.Rochester.edu

Contact: Jessica Mortimer; Jessica_mortimer@urmc.rochester.edu

Locations

United States, New York

University of Rochester Medical Center; Recruiting

Rochester, New York, United States, 14642

Contact: Allison Magnuson, DO 585-275-5863 Allison_Magnuson@urmc.rochester.edu

Sponsors and Collaborators

University of Rochester

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Allison Magnuson; University of Rochester

More Information

• 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
• Last Update Posted: January 18, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders