Trial Outcomes & Findings for Memory and Attention Adaptation Training-Geriatrics (MAAT-G) (NCT NCT04230941)
NCT ID: NCT04230941
Last Updated: 2023-11-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
Post-Intervention (up to 2 weeks)
Results posted on
2023-11-13
Participant Flow
Participant milestones
| Measure |
MAAT-G Intervention
MAAT-G Workshops \& participant workbook use (10 workshops)
MAAT-G: Memory and Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive-behavioral therapy (CBT)-based intervention for Cancer Related Cognitive Decline (CRCD). As a CBT-based intervention, MAAT-G focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT-G 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 evaluating the usability of MAAT-G.
|
Caregiver
Optional for caregiver to enroll with patient. Caregivers were not required to enroll for patients to be able to participate.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
|
Overall Study
COMPLETED
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Memory and Attention Adaptation Training-Geriatrics (MAAT-G)
Baseline characteristics by cohort
| Measure |
MAAT-G Intervention
n=4 Participants
MAAT-G Workshops \& participant workbook use (10 workshops)
MAAT-G: Memory and Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT-G focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT-G 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 evaluating the usability of MAAT-G.
|
Caregiver
n=1 Participants
Caregivers were optional to enroll with patients. A caregiver was not required to enroll for a patient to participate.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
73.25 years
n=5 Participants
|
78 years
n=7 Participants
|
73.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-Intervention (up to 2 weeks)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.
Outcome measures
| Measure |
MAAT-G Intervention
n=4 Participants
MAAT-G Workshops \& participant workbook use (10 workshops)
MAAT-G: Memory and Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT-G focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT-G 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 evaluating the usability of MAAT-G.
|
Caregiver
Optional for caregiver to enroll with patient. Caregivers were not required to enroll for patients to be able to participate.
|
|---|---|---|
|
System Usability Scale (SUS)
|
90.6 score on a scale
Interval 67.5 to 100.0
|
—
|
PRIMARY outcome
Timeframe: Post-Intervention (up to 2 weeks)Population: MAX QDA Software utilized for qualitative analysis coding
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.
Outcome measures
| Measure |
MAAT-G Intervention
n=4 Participants
MAAT-G Workshops \& participant workbook use (10 workshops)
MAAT-G: Memory and Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT-G focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT-G 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 evaluating the usability of MAAT-G.
|
Caregiver
n=1 Participants
Optional for caregiver to enroll with patient. Caregivers were not required to enroll for patients to be able to participate.
|
|---|---|---|
|
Experience Interview
Number of participants describing the MAAT-G intervention as beneficial
|
4 Participants
|
1 Participants
|
|
Experience Interview
Number of participants using study-based facilitators to overcome Telehealth barriers
|
3 Participants
|
1 Participants
|
Adverse Events
MAAT-G Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caregiver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Allison Magnuson, (Principal Investigator), Associate Professor of Medicine
University of Rochester
Phone: 585-276-7155
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place