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

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.

Patients

Inclusion criteria

• Age ≥60 years (from date of consent, confirmed on electronic medical records)
• A new diagnosis of AML

• Diagnosis can be based on the International Consensus Classification or World Health Organization
• Myeloid sarcoma is allowed
• AML with central nervous system involvement is allowed
• Cancer-directed treatment has not started

• Treatment to temporarily decrease white blood cells is acceptable; these may include hydroxyurea, leukapheresis, or cytarabine
• Intrathecal chemotherapy is acceptable
• 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

• Selected by the patient when asked if there is a "family member, partner, friend or caregiver [age 18 or older] with whom you discuss or who can be helpful in healthrelated matters."
• Caregiver may be paid/professional or informal caregiver
• Able to provide informed consent
• English or Spanish-speaking

Oncologists

Inclusion criteria

• Oncologists caring for patients with AML Exclusion criteria