Overview
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.
Description
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.
Eligibility
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