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NCT06697600NARecruiting

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

University of Rochester

Start Date

7/11/2025

Completion Date

6/1/2030

Summary

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.

Detailed 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 Criteria

Age Range: 60 years to No maximum

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

Interventions

BEHAVIORAL

UR-GOAL

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Conditions

OncologyMyeloid Leukemia, AcuteCancer

Locations

University of Alabama at Birmingham, Division of Hematology and Oncology

Birmingham, Alabama 35233

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina 27514

United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology

Winston-Salem, North Carolina 27157

United States