A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
Recruiting now · Not applicable
Conditions studied: Oncology, Myeloid Leukemia, Acute, Cancer
In brief
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.
Key facts
- Study ID
- NCT06697600
- Run by
- University of Rochester
- People needed
- 1020
- Starts
- 2025-07-11
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-07-06
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 is running
- University of Alabama at Birmingham, Division of Hematology and Oncology — Birmingham, Alabama, United States (enrolling)
- University of Rochester Medical Center — Rochester, New York, United States (enrolling)
- University of North Carolina Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (enrolling)
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology — Winston-Salem, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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