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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA288318-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is a multicenter randomized controlled trial that assesses the efficacy of a decisional intervention [University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)] compared to an attention control.
This is a multicenter randomized controlled trial with four sites that assesses the efficacy of a decisional intervention [University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)] compared to an attention control. Subjects will be randomized 1:1 to either the intervention arm or the attention control arm. Compared to an attention control, UR-GOAL will improve patient distress, observed and patient-perceived shared decision making (SDM), and patient decisional conflict.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UR-GOAL Intervention | Experimental | Patients will view an AML video, complete the best-worst scaling, and be provided with a summary report consisting of their priorities; they will will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the same AML video and be provided with the same summary report. Oncologists will be provided with a summary report consisting of the patient's geriatric assessment, priorities, and perception of prognosis; they will be asked to review and discuss at upcoming clinical visits. |
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| Attention Control Arm | No Intervention | Patients will view a nutritional video, complete a nutrition questionnaire, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the nutritional video, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Oncologists will be provided with the patient's completed nutrition questionnaire and asked to review and discuss at upcoming clinical visits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UR-GOAL | Behavioral | Patients will view an AML video, complete the best/worst scaling, will be provided with a summary report, and will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view an AML video, will be provided with a summary report, and will be asked to review. Oncologists will be provided with a summary report and will be asked to review and discuss at upcoming clinical visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Distress Thermometer Questionnaire at 1 month | A self-report measure to capture distress and identify a list of sources of that distress. This is a 10-item scale, rated from 0-10 (0=no distress, 10=severe distress), with a possible total of 10; a higher score indicates greater distress. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 9-item Shared Decision Making Questionnaire at 2 weeks | 9-item Shared Decision Making Questionnaire at 2 weeks | 2 weeks |
| Decisional Conflict Scale Questionnaire at 2 weeks | Decisional Conflict Scale Questionnaire at 2 weeks |
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Patients
Inclusion criteria:
Age ≥60 years (from date of consent, confirmed on electronic medical records)
A new diagnosis of AML
Cancer-directed treatment has not started
The patient's oncologist has been or will be enrolled on the study
English or Spanish-speaking
Patients without a caregiver will still be eligible to participate in the study Exclusion criteria
A diagnosis of acute promyelocytic leukemia
Patients with psychiatric or cognitive conditions which the treating oncologist believes prohibits informed consent or compliance with study procedures
Prior cancer-directed treatment for AML
Caregivers
Inclusion criteria:
Oncologists
Inclusion criteria:
• Oncologists caring for patients with AML Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kah Poh Loh | Contact | 585-276-4353 | Kahpoh_Loh@URMC.Rochester.edu | |
| Becky Gravenstede | Contact | 585-727-4728 | becky_gravenstede@urmc.rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham, Division of Hematology and Oncology | Recruiting | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36533397 | Background | LoCastro M, Sanapala C, Wang Y, Jensen-Battaglia M, Wittink M, Norton S, Klepin HD, Richardson DR, Mendler JH, Liesveld J, Huselton E, O'Dwyer K, Cortes AM, Rodriguez C, Dale W, Loh KP. Patient-centered communication tool for older patients with acute myeloid leukemia, their caregivers, and oncologists: A single-arm pilot study. Cancer Med. 2023 Apr;12(7):8581-8593. doi: 10.1002/cam4.5547. Epub 2022 Dec 19. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
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Patients will be randomized 1:1 to either the UR-GOAL arm or the attention control arm. If the patient has a caregiver that agrees and consents to participate in the study, the caregiver will be enrolled onto the same arm as the patient.
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|
| 2 weeks |
| Observed shared decision making | OPTION5 instrument from audio-recorded treatment decision-making clinical visits | Day 0 |
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
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| University of North Carolina Lineberger Comprehensive Cancer Center | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| D006425 |
| Hemic and Lymphatic Diseases |