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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,020
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.
University of Alabama at Birmingham, Division of Hematology and Oncology
Birmingham, Alabama, United States
RECRUITINGUniversity of Rochester Medical Center
Rochester, New York, United States
RECRUITINGUniversity of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
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.
Time frame: 1 month
9-item Shared Decision Making Questionnaire at 2 weeks
9-item Shared Decision Making Questionnaire at 2 weeks
Time frame: 2 weeks
Decisional Conflict Scale Questionnaire at 2 weeks
Decisional Conflict Scale Questionnaire at 2 weeks
Time frame: 2 weeks
Observed shared decision making
OPTION5 instrument from audio-recorded treatment decision-making clinical visits
Time frame: Day 0
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Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology
Winston-Salem, North Carolina, United States
RECRUITING