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This is a pilot study to evaluate the usability and feasibility of a patient-centered communication tool (University of Rochester-Geriatric Oncology Assessment for acute myeloid Leukemia or UR-GOAL) among 15 older patients with AML, their caregivers, and oncologists.
Older adults with AML and their caregivers may benefit from help and support in understanding their treatment options. This pilot study seeks to evaluate the usability and feasibility of the UR-GOAL communication tool. The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Experimental Arm: single | Experimental | The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral: UR-GOAL communication tool | Behavioral | The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awarene |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (Recruitment Rates) | Percentage of patients who consented to the study ultimately completed the study intervention and post-intervention assessment | Four weeks |
| Usefulness | Usefulness was assessed using the Preparation for Decision Making Scale (mean score range from 1 to 5, and higher scores indicate greater usefulness) | Four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-post Changes in the Following Outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI) | A valid and reliable assessment of perceived self-efficacy of older patients interacting with physicians; score on 5-item scale, ranging 5-25; higher score corresponds to greater perceived efficacy. Pre-post changes from baseline to four weeks. | Four weeks |
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Inclusion Criteria for Patients:
Inclusion Criteria for Caregivers:
Inclusion Criteria for Oncologists:
Exclusion Criteria: None
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| Name | Affiliation | Role |
|---|---|---|
| Kah Poh Loh, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14623 | United States |
A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing. Published papers will be made available in portable document format.
The data will be available for 7 years from accrual of the first subject.
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We recruited older patients with AML, their caregivers, and oncologists from the University of Rochester Medical Center Wilmot Cancer Institute (WCI) and its affiliated oncology practices in upstate New York. Participants were recruited between October 2021 and March 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Experimental Arm: Single | The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness. Behavioral: UR-GOAL communication tool: The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness |
| 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 | Dec 17, 2021 |
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Evaluate the usability and feasibility of a patient-centered communication tool (UR-GOAL)
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| Pre-post Changes in the Following Outcomes: General Anxiety Disorder-7 | A 7-item screening tool for anxiety; ranging 7-21; higher score corresponds to greater anxiety symptoms. Pre-post changes from baseline to four weeks. | Four weeks |
| Pre-post Changes in the Following Outcomes: Geriatric Depression Scale-15 | A 15-item valid and reliable screening tool for depression in older adults. This will be used for patients; ranging 0-15; higher score corresponds to greater depressive symptoms. Pre-post changes from baseline to four weeks. | Four Weeks |
| COMPLETED |
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| NOT COMPLETED |
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Older adults aged 60 and over
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Experimental Arm: Single | The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness. Behavioral: UR-GOAL communication tool: The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awarene |
| 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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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Feasibility (Recruitment Rates) | Percentage of patients who consented to the study ultimately completed the study intervention and post-intervention assessment | Posted | Count of Participants | Participants | Four weeks |
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| Primary | Usefulness | Usefulness was assessed using the Preparation for Decision Making Scale (mean score range from 1 to 5, and higher scores indicate greater usefulness) | Posted | Mean | Standard Deviation | score on a scale | Four weeks |
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| Secondary | Pre-post Changes in the Following Outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI) | A valid and reliable assessment of perceived self-efficacy of older patients interacting with physicians; score on 5-item scale, ranging 5-25; higher score corresponds to greater perceived efficacy. Pre-post changes from baseline to four weeks. | Posted | Mean | Standard Deviation | score on a scale | Four weeks |
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| Secondary | Pre-post Changes in the Following Outcomes: General Anxiety Disorder-7 | A 7-item screening tool for anxiety; ranging 7-21; higher score corresponds to greater anxiety symptoms. Pre-post changes from baseline to four weeks. | Posted | Mean | Standard Deviation | score on a scale | Four weeks |
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| Secondary | Pre-post Changes in the Following Outcomes: Geriatric Depression Scale-15 | A 15-item valid and reliable screening tool for depression in older adults. This will be used for patients; ranging 0-15; higher score corresponds to greater depressive symptoms. Pre-post changes from baseline to four weeks. | Posted | Mean | Standard Deviation | score on a scale | Four Weeks |
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4 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 | Experimental: Experimental Arm: Single | The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness. Behavioral: UR-GOAL communication tool: The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness | 0 | 15 | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kah Poh Loh | University of Rochester Medical Center | 585-276-4353 | kahpoh_loh@urmc.rochester.edu |
| Jun 6, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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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