Study of a Decision Support Program for Older Adults 60 with Acute Myeloid Leukemia and Their Caregivers

What this Trial Is About

Researchers are evaluating a decisional support intervention called the University of Rochester-Geriatric Oncology assessment for Acute Myeloid Leukemia UR-GOAL compared to an attention control among older adults newly diagnosed with acute myeloid leukemia AML. This multicenter randomized controlled trial aims to assess whether UR-GOAL can reduce patient distress, improve shared decision making between patients, caregivers, and oncologists, and decrease decisional conflict. The study is sponsored by the University of Rochester and is conducted at four sites. Participants will be randomly assigned to one of two groups the UR-GOAL intervention or an attention control group. Patients in the UR-GOAL group will watch an AML-focused video, complete a best-worst scaling exercise to identify their care priorities, and receive a summary report to review and discuss during clinical visits. Caregivers, if available, will also watch the AML video and receive the summary report. Oncologists will receive a report summarizing the patients geriatric assessment, priorities, and prognosis perception. The control group patients and caregivers will watch a nutritional video, complete a nutrition questionnaire, and receive nutrition handouts for review and discussion. Oncologists in this arm will be provided with the patients nutrition questionnaire. Both arms involve reviewing these materials during upcoming clinical visits. Participants will be assessed at several time points including 1 month for distress, 2 weeks for shared decision making and decisional conflict, and observation of shared decision making at the start. All participants must be 60 years or older with a new AML diagnosis and have not started cancer-directed treatment except some temporary measures. The study involves questionnaires, videos, and discussions to measure decision-related outcomes. The total study duration extends to June 2030, with ongoing monitoring of patient distress and decision-making quality. Caregivers and oncologists also participate in aspects of the assessments and interventions.

A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers