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

NCT ID: NCT04230941

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-12
• Study Completion Date: 2022-02-01

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 test usability of the intervention.

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 and usability testing.

Conditions

Cancer-related Problem/Condition; Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MAAT-G Intervention

MAAT-G Workshops \& participant workbook use (8 workshops)

Group Type: EXPERIMENTAL

MAAT-G

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Have a diagnosis of invasive breast cancer

2. Planned to receive systemic therapy for breast cancer or actively receiving systemic therapy for breast cancer with two additional cycles remaining.

3. Be age 65 or older

4. Able to provide informed consent

5. 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)

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.

Exclusion Criteria

1. Have surgery planned within 3 months of consent

2. 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

3. Patients with breast cancer receiving endocrine therapy as their only systemic therapy will not be eligible.

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Allison Magnuson

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison Magnuson

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K76AG064394-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UCCS19102

Identifier Type: -

Identifier Source: org_study_id