Memory and Attention Adaptation Training-Geriatrics (MAAT-G)
Mitigating Cancer-Related Cognitive Impairment in Older Adults With Breast Cancer Receiving Chemotherapy: Memory and Attention Adaptation Training-Geriatrics (MAAT-G) Phase I
2 other identifiers
interventional
4
1 country
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 test usability of the intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
June 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedResults Posted
Study results publicly available
July 19, 2023
CompletedNovember 13, 2023
November 1, 2023
10 months
January 13, 2020
December 20, 2022
November 8, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Post-Intervention (up to 2 weeks)
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.
Post-Intervention (up to 2 weeks)
Study Arms (1)
MAAT-G Intervention
EXPERIMENTALMAAT-G Workshops \& participant workbook use (8 workshops)
Interventions
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.
Eligibility Criteria
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.
- \. 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.
- \. Caregivers unable to understand the consent form due to cognitive, health or sensory impairment will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of Rochester Medical Center
Rochester, New York, 14642, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Allison Magnuson, (Principal Investigator), Associate Professor of Medicine
- Organization
- University of Rochester
Study Officials
- PRINCIPAL INVESTIGATOR
Allison Magnuson
University of Rochester
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
January 13, 2020
First Posted
January 18, 2020
Study Start
June 12, 2020
Primary Completion
April 1, 2021
Study Completion
February 1, 2022
Last Updated
November 13, 2023
Results First Posted
July 19, 2023
Record last verified: 2023-11