Decision support for older adults with acute myeloid leukemia and their caregivers
A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
NA · University of Rochester · NCT06697600
This will test a decision-support program (UR-GOAL) to help people 60 and older with newly diagnosed AML and their caregivers make treatment decisions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1020 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Rochester (other) |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT06697600 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 or older with a new diagnosis of AML who have not started cancer-directed treatment, speak English or Spanish, and whose oncologist is enrolled in the study.
Not a fit: Patients with acute promyelocytic leukemia, prior AML-directed treatment, or psychiatric/cognitive conditions that prevent informed consent are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could reduce patient distress and decisional conflict while improving shared decision-making between patients, caregivers, and clinicians.
How similar studies have performed: Geriatric oncology assessments and decision-support interventions have shown benefits in other older-cancer populations, but applying a structured decisional program specifically for AML is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Birmingham, Alabama and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oncology, Myeloid Leukemia, Acute, Cancer, older adults, geriatric oncology, caregivers