Cognitive Dysfunction
Conditions
Keywords
cancer-related cognitive difficulties, mild cognitive impairment
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-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.
Detailed 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.
Interventions
BEHAVIORALMemory 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.
Sponsors
National Institute on Aging (NIA)
Allison Magnuson
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAAT-G Feasibility Completion Rate | 10 Weeks | Evaluate the feasibility of MAAT-G in older cancer survivors with mild cognitive impairment by determining study completion rate of this population. |
| MAAT-G Intervention Adherence Rate | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Described at Least One MAAT-G Skill | 10 Weeks | 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. |
| Change in Cognitive Function (Pre-Post Changes Functional Assessment of Cancer Therapy-Cognition [FACT-Cog]) | 10 Weeks | 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. |
| Mean Usability | 10 Weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MAAT-G Intervention 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | MAAT-G Intervention |
|---|---|
| Age, Continuous | 75.8 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
MAAT-G Feasibility Completion Rate
Evaluate the feasibility of MAAT-G in older cancer survivors with mild cognitive impairment by determining study completion rate of this population.
Time frame: 10 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAAT-G Intervention | MAAT-G Feasibility Completion Rate | 10 Participants |
Primary
MAAT-G Intervention Adherence Rate
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).
Time frame: 10 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MAAT-G Intervention | MAAT-G Intervention Adherence Rate | 88.33 percentage of workshops adhered to |
Secondary
Change in Cognitive Function (Pre-Post Changes Functional Assessment of Cancer Therapy-Cognition [FACT-Cog])
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.
Time frame: 10 Weeks
Population: Two patients withdrew from the study and therefore not included in the population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MAAT-G Intervention | Change in Cognitive Function (Pre-Post Changes Functional Assessment of Cancer Therapy-Cognition [FACT-Cog]) | 6.39 score on a scale | Standard Deviation 12.2 |
Secondary
Mean 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 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).
Time frame: 10 Weeks
Population: Two patients withdrew from the study and therefore not included in the population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MAAT-G Intervention | Mean Usability | 78.75 score on a scale | Standard Deviation 15.332 |
Secondary
Proportion of Patients Who Described at Least One MAAT-G Skill
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.
Time frame: 10 Weeks
Population: Two patients withdrew from the study and therefore not included in the population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAAT-G Intervention | Proportion of Patients Who Described at Least One MAAT-G Skill | 9 Participants |