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

NCT04669301 | Completed Results DMC

• 2 other identifiers: UCCS20127K76AG064394
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer-related Problem/Condition; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Mean of the Functional Assessment of Cancer Therapy-Cognition (FACT-COG)

  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 200 with higher scores generally indicating worse health outcomes.

  Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).

Secondary Outcomes (7)

• Least Squares Mean for Delay Match to Sample Total Correct at the 12-second Delay (DMSTC-12) From the Cambridge Neuropsychological Test Automated Battery (CANTAB)

  Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).

• Mean of the Controlled Oral Word Association (COWA) Tool

  Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).

• Mean of the Hopkins Verbal Learning Test-Revised (HVLT-R)

  Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).

• Mean of the Geriatric Depression Screen (GDS)

  Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).

• Mean of the Generalized Anxiety and Depression 7-item Scale (GAD-7)

  Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).

Study Arms (3)

Supportive therapy (time and attention control)

ACTIVE COMPARATOR

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.

Behavioral: Supportive therapy (time and attention control)

MAAT-G intervention

EXPERIMENTAL

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

Behavioral: MAAT-G

Caregivers

NO INTERVENTION

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

Interventions

MAAT-G 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 intervention

Supportive therapy (time and attention control) 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.

Supportive therapy (time and attention control)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14623, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Palliative Care; Time

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Physical Phenomena

Results Point of Contact

• Title: Dr. Allison Magnuson
• Organization: University of Rochester

allison_magnuson@urmc.rochester.edu

585-602-5085

Study Officials

• Allison Magnuson, DO

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Medicine , Hematology/Oncology (SMD)

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 16, 2020
• Study Start: April 2, 2021
• Primary Completion: April 17, 2024
• Study Completion: August 30, 2024
• Last Updated: July 15, 2025
• Results First Posted: July 15, 2025

Record last verified: 2025-06

Locations

US (1)