NCT05258058

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-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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 10, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 10, 2024

Completed
Last Updated

July 10, 2024

Status Verified

June 1, 2024

Enrollment Period

1.6 years

First QC Date

February 17, 2022

Results QC Date

May 2, 2024

Last Update Submit

June 13, 2024

Conditions

Keywords

cancer-related cognitive difficultiesmild cognitive impairment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Proportion of Patients Who Described at Least One MAAT-G Skill

    10 Weeks

  • Change in Cognitive Function (Pre-Post Changes Functional Assessment of Cancer Therapy-Cognition [FACT-Cog])

    10 Weeks

  • Mean Usability

    10 Weeks

Study Arms (1)

MAAT-G Intervention

EXPERIMENTAL

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

Behavioral: Memory and Adaptation Training-Geriatrics

Interventions

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.

Also known as: MAAT-G
MAAT-G Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. Allison Magnuson
Organization
University of Rochester

Study Officials

  • Allison Magnuson

    Univ. of Rochester Wilmot Cancer Center

    PRINCIPAL INVESTIGATOR

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
SPONSOR INVESTIGATOR
PI Title
Associate Professor - Department of Medicine , Hematology/Oncology (SMD)

Study Record Dates

First Submitted

February 17, 2022

First Posted

February 28, 2022

Study Start

December 10, 2021

Primary Completion

July 20, 2023

Study Completion

July 26, 2023

Last Updated

July 10, 2024

Results First Posted

July 10, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Locations