Protocol of a decisional intervention for older adults with newly diagnosed acute myeloid leukemia and their caregivers: UR-GOAL 3.

Introduction: Therapeutic advances have allowed more adults aged ≥60 years with acute myeloid leukemia (AML) to receive life-prolonging treatments, with improvement in overall survival. In contrast to other cancers, the onset of AML is often sudden, high-risk treatment decisions must be made quickly, and survival is often compromised due to aging-related conditions (e.g., functional impairments). Studies have demonstrated that up to 78 % of older adults with AML and their caregivers experience significant psychological distress. Distress is associated with poor quality of life, increased healthcare utilization, and increased mortality. Shared decision making (SDM) can reduce patient and caregiver distress and is essential to achieve goal-concordant care. Therefore, interventions to alleviate distress and optimize SDM in older adults with AML and their caregivers are needed. We will conduct a multicenter randomized controlled trial to evaluate the efficacy of University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL) compared to an attention control for reducing patient distress and improving observed SDM, patient-perceived SDM, and decisional conflict.

Material and methods: We will recruit 300 patients aged ≥60 years with newly diagnosed AML, their caregivers (one caregiver per patient when available), and up to 40 oncologists from four institutions: (1) Patients will view an educational video about AML diagnosis, treatment, and prognosis; complete the Best Worst Scaling values clarification process; and review a summary report of their values with tailored question prompts and resources; (2) Caregivers will view the same educational video and receive the same summary report as patients; and (3) Oncologists will review a summary report of the patient's aging-related conditions, perception of prognosis, and values. Patients, caregivers, and oncologists will then meet during clinical visits to discuss aging-related conditions, prognosis, and patient values, and reach a treatment decision. The primary outcome measure is distress (Distress Thermometer). Secondary outcome measures include observed SDM, patient perceived SDM, and decisional conflict.

Discussion: This study will address significant knowledge gaps related to reducing distress and decisional conflict and improving SDM in older adults with AML. If successful, this research will inform future decisional interventions for a broader group of patients.