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

Primary Purpose

Cognitive Dysfunction

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Memory and Adaptation Training-Geriatrics

About this trial

This is an interventional supportive care trial for Cognitive Dysfunction focused on measuring cancer-related cognitive difficulties, mild cognitive impairment

Eligibility Criteria

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

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)

Sites / Locations

University of Rochester

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

MAAT-G Feasibility

Evaluate the feasibility of MAAT-G in older cancer survivors with mild cognitive impairment by determining consent rate, intervention adherence rate, and study completion rate in this population.

Secondary Outcome Measures

Qualitative assessment of feasibility

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.

Change in cognitive function

Examine the pre-post change in perceived and objective cognitive function in older cancer survivors with MCI.

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 through integration of quantitative data (from tertiary objective) with qualitative data from semi-structured interviews of patients and caregivers.

Full Information

NCT ID

NCT05258058

First Posted

February 17, 2022

Last Updated

September 12, 2023

Sponsor

Allison Magnuson

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT05258058

Brief Title

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

Acronym

urochester

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 10, 2021 (Actual)

Primary Completion Date

May 2, 2023 (Actual)

Study Completion Date

May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Allison Magnuson

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

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-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.

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.

6. Conditions and Keywords

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

Cognitive Dysfunction

Keywords

cancer-related cognitive difficulties, mild cognitive impairment

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

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)

Memory and Adaptation Training-Geriatrics

Other Intervention Name(s)

MAAT-G

Intervention Description

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.

Primary Outcome Measure Information:

Title

MAAT-G Feasibility

Description

Evaluate the feasibility of MAAT-G in older cancer survivors with mild cognitive impairment by determining consent rate, intervention adherence rate, and study completion rate in this population.

Time Frame

10 Weeks

Secondary Outcome Measure Information:

Title

Qualitative assessment of feasibility

Description

Time Frame

10 Weeks

Title

Change in cognitive function

Description

Examine the pre-post change in perceived and objective cognitive function in older cancer survivors with MCI.

Time Frame

10 Weeks

Title

Usability

Description

Time Frame

10 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allison Magnuson

Organizational Affiliation

Univ. of Rochester Wilmot Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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