Breast Cancer Clinical Trial

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

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.

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Full 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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Eligibility Criteria

Eligible Patient Inclusion Criteria:

Be age 65 or older
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.
Able to read and understand English
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.
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.
Be independent in Activities of Daily Living (ADL)

Eligible Patient Exclusion Criteria:

Have surgery planned within 3 months of consent
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
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

Study is for people with:

Breast Cancer

Estimated Enrollment:

39

Study ID:

NCT04230941

Recruitment Status:

Recruiting

Sponsor:

University of Rochester

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There is 1 Location for this study

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University of Rochester Medical Center
Rochester New York, 14642, United States More Info
Allison Magnuson, DO
Contact
585-275-5863
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

39

Study ID:

NCT04230941

Recruitment Status:

Recruiting

Sponsor:


University of Rochester

How clear is this clinincal trial information?

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