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| ID | Type | Description | Link |
|---|---|---|---|
| 1K76AG064394-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
Cancer-related cognitive dysfunction (CRCD) is a significant problem, affecting up to 75% of patients receiving chemotherapy. 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 tool that improves perceived cognition in younger cancer survivors with CRCD. For older adults with cancer, MAAT could be delivered alongside chemotherapy to mitigate the development of CRCD (when risk is highest) and CRCD-related effects on functional independence for older adults. However, MAAT will require adaptation to meet the unique needs of older adults to optimize usability and efficacy for this population. The overarching goal of this project is to adapt MAAT for older adults using input from patient and caregiver stakeholders (phase I), and subsequently gather data on the preliminary effects of the adapted MAAT (MAAT-Geriatrics [G]) on perceived cognition, objective cognitive measures and functional independence. The provided details pertain to Phase I of the study, which will focus on the adaptation process and usability testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAAT-G Intervention | Experimental | MAAT-G Workshops & participant workbook use (8 workshops) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAAT-G | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
Eligible Caregiver Inclusion Criteria:
1. 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.
Eligible Caregiver Exclusion Criteria:
1. Caregivers unable to understand the consent form due to cognitive, health or sensory impairment will be excluded
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| Name | Affiliation | Role |
|---|---|---|
| Allison Magnuson | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Caregiver | Optional for caregiver to enroll with patient. Caregivers were not required to enroll for patients to be able to participate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | score on a scale | Post-Intervention (up to 2 weeks) |
|
From initiation of the intervention to post-assessment time point (approximately 14 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Magnuson, (Principal Investigator), Associate Professor of Medicine | University of Rochester | 585-276-7155 | allison_magnuson@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2020 | Feb 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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Usability
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| BG001 | Caregiver | Caregivers were optional to enroll with patients. A caregiver was not required to enroll for a patient to participate. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | 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. | MAX QDA Software utilized for qualitative analysis coding | Posted | Count of Participants | Participants | Post-Intervention (up to 2 weeks) |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Caregiver | Caregiver was allowed to enroll with patient. Caregiver enrollment was not required for patient to participate | 0 | 1 | 0 | 1 | 0 | 1 |
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