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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

10 Weeks

Results posted on

2024-07-10

Participant Flow

Participant milestones

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.
Overall Study
STARTED
12
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

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.
Overall Study
Withdrawal by Subject
2

Baseline Characteristics

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

Baseline characteristics by cohort

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.
Age, Continuous
75.8 years
STANDARD_DEVIATION 7.8 • n=93 Participants
Sex: Female, Male
Female
12 Participants
n=93 Participants
Sex: Female, Male
Male
0 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=93 Participants
Race (NIH/OMB)
White
11 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants

PRIMARY outcome

Timeframe: 10 Weeks

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

Outcome measures

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.
MAAT-G Feasibility Completion Rate
10 Participants

PRIMARY outcome

Timeframe: 10 Weeks

Evaluate 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

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.
MAAT-G Intervention Adherence Rate
88.33 percentage of workshops adhered to

SECONDARY outcome

Timeframe: 10 Weeks

Population: 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

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.
Proportion of Patients Who Described at Least One MAAT-G Skill
9 Participants

SECONDARY outcome

Timeframe: 10 Weeks

Population: 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

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.
Change in Cognitive Function (Pre-Post Changes Functional Assessment of Cancer Therapy-Cognition [FACT-Cog])
6.39 score on a scale
Standard Deviation 12.20

SECONDARY outcome

Timeframe: 10 Weeks

Population: 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

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.
Mean Usability
78.75 score on a scale
Standard Deviation 15.332

Adverse Events

MAAT-G Intervention

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

Dr. Allison Magnuson

University of Rochester

Phone: 585-602-5085

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place