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

NCT ID: NCT04669301

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-02
• Study Completion Date: 2024-08-30

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.

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.

Conditions

Cancer-related Problem/Condition; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Supportive therapy (time and attention control)

Intervention Type: BEHAVIORAL

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.

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

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.

Caregivers

Patients on this study had the option to enroll a caregiver.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• 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 - Department of Medicine , Hematology/Oncology (SMD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison Magnuson, DO

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K76AG064394

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UCCS20127

Identifier Type: -

Identifier Source: org_study_id