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| ID | Type | Description | Link |
|---|---|---|---|
| K76AG064394-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| 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-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.
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.
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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 |
|---|---|---|---|---|
| Memory and Adaptation Training-Geriatrics | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 Weeks |
| 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). | 10 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 Weeks |
| Change in Cognitive Function (Pre-Post Changes Functional Assessment of Cancer Therapy-Cognition [FACT-Cog]) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison Magnuson | Univ. of Rochester Wilmot Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | 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) 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Mar 15, 2023 |
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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. |
| 10 Weeks |
| 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). | 10 Weeks |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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, Continuous | Mean | Standard Deviation | 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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| 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 | 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. | Posted | Count of Participants | Participants | 10 Weeks |
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| 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. | Two patients withdrew from the study and therefore not included in the population. | Posted | Count of Participants | Participants | 10 Weeks |
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| 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. | Two patients withdrew from the study and therefore not included in the population. | Posted | Mean | Standard Deviation | score on a scale | 10 Weeks |
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| 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). | Two patients withdrew from the study and therefore not included in the population. | Posted | Mean | Standard Deviation | score on a scale | 10 Weeks |
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| 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). | Posted | Number | percentage of workshops adhered to | 10 Weeks | workshops | workshops |
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10 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 (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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Allison Magnuson | University of Rochester | 585-602-5085 | allison_magnuson@urmc.rochester.edu |
| May 2, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 20, 2023 | May 2, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| workshops |
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