Decisional Intervention for Older Adults with Acute Myeloid Leukemia

This study is testing a program called UR-GOAL (University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia) for older adults with a new diagnosis of acute myeloid leukemia (AML) and their caregivers. UR-GOAL involves watching a video about AML, completing a survey about treatment preferences, and discussing a summary report with your care team. Caregivers will also watch a video and review a summary report. Researchers want to see if UR-GOAL can help reduce distress, improve shared decision-making (when you and your doctor make treatment choices together), and lower decisional conflict. We are looking for people aged 60 or older with a new AML diagnosis who have not yet started cancer treatment. The study aims to enroll 1020 participants. The current status of this study is unclear.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to either receive the UR-GOAL intervention or a comparison group. It is being conducted at multiple centers.
What's involved
Patients will view an AML video, complete a survey, and discuss a summary report at upcoming clinical visits. Caregivers will view an AML video and review a summary report.
Compensation
Not stated in the trial record.
Follow-up
Your distress levels will be measured at 1 month after starting the study.

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NCT06697600

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

Recruiting
NAAges 60+InterventionalSupportive care
University of Rochester
~1,020 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:UR-GOAL

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Distress Thermometer Questionnaire at 1 month
Measured over 1 month
Oncology
Myeloid Leukemia, Acute
Cancer
4 sites across 3 states
North Carolina2
Alabama1
New York1

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Distress Thermometer Questionnaire at 1 month1 month

    A self-report measure to capture distress and identify a list of sources of that distress. This is a 10-item scale, rated from 0-10 (0=no distress, 10=severe distress), with a possible total of 10; a higher score indicates greater distress.