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

Cognitive Dysfunction Clinical Trial

— urochester  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05258058
• Other study ID #: UCCS19102- Part 2
• Secondary ID: K76AG064394-03S1
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: May 1, 2024
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Allison Magnuson	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 Weeks
Secondary	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.	10 Weeks
Secondary	Change in cognitive function	Examine the pre-post change in perceived and objective cognitive function in older cancer survivors with MCI.	10 Weeks
Secondary	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.	10 Weeks