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

Primary Purpose

Cancer-related Problem/Condition, Cognitive Impairment

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MAAT-G

About this trial

This is an interventional supportive care trial for Cancer-related Problem/Condition

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Rochester Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MAAT-G Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

System Usability Scale (SUS)

The System Usability Scale is a metric to evaluate the usability of the intervention (Patients) and is scored 0 (minimum) to 100 (maximum). Higher scores indicate greater usability. A mean score >68 is consisted with optimal usability.

Experience Interview

Semi-structured interview with patients and caregivers about experience with MAAT-G. (Patients and caregivers) Qualitative Analysis of transcripts from participant/caregiver interviews will be analyzed for themes on intervention benefit and barriers and facilitators.

Secondary Outcome Measures

Full Information

NCT ID

NCT04230941

First Posted

January 13, 2020

Last Updated

June 27, 2023

Sponsor

University of Rochester

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04230941

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

June 12, 2020 (Actual)

Primary Completion Date

April 1, 2021 (Actual)

Study Completion Date

February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer-related Problem/Condition, Cognitive Impairment

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Usability

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MAAT-G Intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

MAAT-G

Intervention Description

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.

Primary Outcome Measure Information:

Title

System Usability Scale (SUS)

Description

Time Frame

Post-Intervention (up to 2 weeks)

Title

Experience Interview

Description

Time Frame

Post-Intervention (up to 2 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Patient 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) Patient 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allison Magnuson

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester Medical Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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