NCT06697600 · University of Rochester
A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
(UR-GOAL RCT)
What this study is about
This is a conducted at multiple hospitals randomly assigned controlled trial that assesses the effectiveness of a decisional intervention \[University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)\] compared to an attention control.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
- Rochester, New York
- Chapel Hill, North Carolina
- Winston-Salem, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations