Decision support for older adults with acute myeloid leukemia and their caregivers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized controlled trial enrolls older adults (≥60) with a new diagnosis of acute myeloid leukemia and randomizes them 1:1 to the UR-GOAL decisional intervention or an attention control. UR-GOAL is built on a geriatric oncology assessment and is delivered alongside usual oncology care to support shared decision-making. The trial measures patient distress, observed and patient-perceived shared decision-making, and patient decisional conflict as key outcomes. Sites include major academic centers and the intervention is available in English and Spanish.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham, Division of Hematology and Oncology
  Birmingham, Alabama, United States Recruiting
• University of Rochester Medical Center
  Rochester, New York, United States Recruiting
• University of North Carolina Lineberger Comprehensive Cancer Center
  Chapel Hill, North Carolina, United States Recruiting
• Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Kah Poh Loh
• Email: Kahpoh_Loh@URMC.Rochester.edu
• Phone: 585-276-4353

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.