Feasibility of the Memory and Attention Adaptation-Training Geriatrics Intervention in Older Cancer Survivors With Mild Cognitive Impairment (urochester)

Mitigating Cancer-Related Cognitive Impairment in Older Adults With Cancer: Memory and Attention Adaptation Training-Geriatrics (MAAT-G) Phase I

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-Geriatrics (MAAT-G) is a cognitive behavioral therapy-based intervention tailored specifically for older adults and the feasibility of MAAT-G in older cancer survivors with Mild Cognitive Impairment (MCI) is being evaluated.

Study Overview

• Status: Completed
• Conditions: Cognitive Dysfunction
• Intervention / Treatment: Behavioral: Memory and Adaptation Training-Geriatrics

Detailed Description

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-Geriatrics (MAAT-G) is a cognitive behavioral therapy-based intervention tailored specifically for older adults. MAAT-G is a series of 10 workshops delivered by a trained health profession via videoconferencing technology. The feasibility of MAAT-G in older cancer survivors with Mild Cognitive Impairment (MCI) is being evaluated.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be age 65 or older
2. 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.
3. Able to read and understand English
4. 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.
5. 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.
6. Be independent in Activities of Daily Living (ADL)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MAAT-G Intervention; MAAT-G Workshops & participant workbook use (8 workshops)	Behavioral: Memory and Adaptation Training-Geriatrics; MAAT-G is a cognitive behavioral therapy-based intervention comprised of 10 workshop sessions as well as a participant workbook. The workshop sessions are delivered one on one by a health professional via videoconferencing technology.; Other Names: MAAT-G

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAAT-G Feasibility Completion Rate	Evaluate the feasibility of MAAT-G in older cancer survivors with mild cognitive impairment by determining study completion rate of this population.	10 Weeks
MAAT-G Intervention Adherence Rate	Evaluate the feasibility of MAAT-G in older cancer survivors with mild cognitive impairment by determining the study intervention adherence rate of this population (proportion of MAAT-G workshops completed).	10 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Who Described at Least One MAAT-G Skill	To obtain descriptive feedback on the usability of the intervention and guide further adaptation, qualitative interviews with patients and their caregivers (if available) will be conducted at completion of the intervention.	10 Weeks
Change in Cognitive Function (Pre-Post Changes Functional Assessment of Cancer Therapy-Cognition [FACT-Cog])	Examine the pre-post change in perceived and objective cognitive function in older cancer survivors with MCI using the Functional Assessment of Cancer Therapy-Cognition (FACT-Cog version 2): a 37 item scale assessing perceived cognitive impairment (Total score range 0-185, higher score indicates better cognitive function). Mean change from baseline score is reported.	10 Weeks
Mean Usability	Enhance our understanding of the usability of a telehealth CRCD intervention (including barriers and facilitators) for older cancer survivors with MCI and the perceived MAAT-G intervention effect using the System Usability Scale (SUS) (a score on a 10-item scale, with a total score ranging from 0-100; a higher score corresponds to greater usability).	10 Weeks

Collaborators and Investigators

• Sponsor: Allison Magnuson
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Allison Magnuson, Univ. of Rochester Wilmot Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 26, 2023

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: mild cognitive impairment; cancer-related cognitive difficulties
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: UCCS19102- Part 2; K76AG064394-03S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No