Trial Outcomes & Findings for Feasibility of the Memory and Attention Adaptation-Training Geriatrics Intervention in Older Cancer Survivors With Mild Cognitive Impairment (NCT NCT05258058)
NCT ID: NCT05258058
Last Updated: 2024-07-10
Results Overview
Evaluate the feasibility of MAAT-G in older cancer survivors with mild cognitive impairment by determining study completion rate of this population.
COMPLETED
NA
12 participants
10 Weeks
2024-07-10
Participant Flow
Participant milestones
| Measure |
MAAT-G Intervention
MAAT-G Workshops \& participant workbook use (10 workshops)
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.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
MAAT-G Intervention
MAAT-G Workshops \& participant workbook use (10 workshops)
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Feasibility of the Memory and Attention Adaptation-Training Geriatrics Intervention in Older Cancer Survivors With Mild Cognitive Impairment
Baseline characteristics by cohort
| Measure |
MAAT-G Intervention
n=12 Participants
MAAT-G Workshops \& participant workbook use (8 workshops)
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.
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|---|---|
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Age, Continuous
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75.8 years
STANDARD_DEVIATION 7.8 • n=93 Participants
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Sex: Female, Male
Female
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12 Participants
n=93 Participants
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Sex: Female, Male
Male
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0 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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11 Participants
n=93 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=93 Participants
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Race (NIH/OMB)
White
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11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: 10 WeeksEvaluate the feasibility of MAAT-G in older cancer survivors with mild cognitive impairment by determining study completion rate of this population.
Outcome measures
| Measure |
MAAT-G Intervention
n=12 Participants
MAAT-G Workshops \& participant workbook use (10 workshops)
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.
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|---|---|
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MAAT-G Feasibility Completion Rate
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10 Participants
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PRIMARY outcome
Timeframe: 10 WeeksEvaluate 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).
Outcome measures
| Measure |
MAAT-G Intervention
n=120 workshops
MAAT-G Workshops \& participant workbook use (10 workshops)
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.
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|---|---|
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MAAT-G Intervention Adherence Rate
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88.33 percentage of workshops adhered to
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SECONDARY outcome
Timeframe: 10 WeeksPopulation: Two patients withdrew from the study and therefore not included in the population.
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.
Outcome measures
| Measure |
MAAT-G Intervention
n=10 Participants
MAAT-G Workshops \& participant workbook use (10 workshops)
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.
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|---|---|
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Proportion of Patients Who Described at Least One MAAT-G Skill
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9 Participants
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SECONDARY outcome
Timeframe: 10 WeeksPopulation: Two patients withdrew from the study and therefore not included in the population.
Examine the pre-post change in perceived and objective cognitive function in older cancer survivors with MCI using the Functional Assessment of Cancer Therapy-Cognition (FACT-Cog version 2): a 37 item scale assessing perceived cognitive impairment (Total score range 0-185, higher score indicates better cognitive function). Mean change from baseline score is reported.
Outcome measures
| Measure |
MAAT-G Intervention
n=10 Participants
MAAT-G Workshops \& participant workbook use (10 workshops)
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.
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|---|---|
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Change in Cognitive Function (Pre-Post Changes Functional Assessment of Cancer Therapy-Cognition [FACT-Cog])
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6.39 score on a scale
Standard Deviation 12.20
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SECONDARY outcome
Timeframe: 10 WeeksPopulation: Two patients withdrew from the study and therefore not included in the population.
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 using the System Usability Scale (SUS) (a score on a 10-item scale, with a total score ranging from 0-100; a higher score corresponds to greater usability).
Outcome measures
| Measure |
MAAT-G Intervention
n=10 Participants
MAAT-G Workshops \& participant workbook use (10 workshops)
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.
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|---|---|
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Mean Usability
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78.75 score on a scale
Standard Deviation 15.332
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Adverse Events
MAAT-G Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place