RecruitingNot ApplicableNCT06697600

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

Sponsor

University of Rochester

Enrollment

1,020 participants

Start Date

Jul 11, 2025

Study Type

INTERVENTIONAL

Conditions

Cancer Oncology Myeloid Leukemia, Acute

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.

Eligibility

Min Age: 60 Years

Inclusion Criteria16

Patients
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
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

Exclusion Criteria4

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

Interventions

BEHAVIORALUR-GOAL

Patients will view an AML video, complete the best/worst scaling, will be provided with a summary report, and will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view an AML video, will be provided with a summary report, and will be asked to review. Oncologists will be provided with a summary report and will be asked to review and discuss at upcoming clinical visits.