NCT04230941

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

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

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

First Submitted

Initial submission to the registry

January 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

June 12, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 19, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

January 13, 2020

Results QC Date

December 20, 2022

Last Update Submit

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

EXPERIMENTAL

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

Behavioral: MAAT-G

Interventions

MAAT-GBEHAVIORAL

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.

MAAT-G Intervention

Eligibility Criteria

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

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

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Allison Magnuson, (Principal Investigator), Associate Professor of Medicine
Organization
University of Rochester

Study Officials

  • Allison Magnuson

    University of Rochester

    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
Model Details: Usability
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

Locations