Actively Recruiting
A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
Led by University of Rochester · Updated on 2026-03-31
1020
Participants Needed
4
Research Sites
34 weeks
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a decisional support intervention called the University of Rochester-Geriatric Oncology assessment for Acute Myeloid Leukemia UR-GOAL in older adults newly diagnosed with acute myeloid leukemia AML. This randomized controlled trial compares the UR-GOAL intervention to an attention control to see if it improves patient distress, shared decision making, and decisional conflict. The study involves four sites and includes patients aged 60 years and older with a new AML diagnosis who have not yet started cancer-directed treatment. Participants are randomly assigned to one of two groups. In the UR-GOAL intervention arm, patients and their caregivers view an AML educational video, complete a best-worst scaling exercise to identify their priorities, and receive a summary report to review and discuss with healthcare providers during clinic visits. Oncologists receive a report including the patients geriatric assessment, priorities, and prognosis perception to guide discussions. In the attention control arm, patients and caregivers watch a nutritional video, complete a nutrition questionnaire, and receive related handouts to review. Oncologists receive the completed nutrition questionnaire for review. During the study, participants will complete several assessments including the Distress Thermometer Questionnaire at one month, the Shared Decision Making Questionnaire and Decisional Conflict Scale at two weeks, and observed shared decision making at the start. Researchers will monitor patient distress, decision-making quality, and patient-caregiver-oncologist communication. The study is expected to last through June 2030, with patients and caregivers engaging in educational and assessment activities alongside their usual clinical care.
CONDITIONS
Brief Title
A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older at time of consent
- New diagnosis of acute myeloid leukemia (AML) based on accepted classification
- Myeloid sarcoma or AML with central nervous system involvement allowed
- Has not started cancer-directed treatment for AML (temporary white blood cell lowering treatments allowed)
- Oncologist caring for patient is or will be enrolled in the study
- English or Spanish-speaking
- Patients without a caregiver are eligible
- Caregivers must be selected by patient, age 18 or older, able to consent, English or Spanish-speaking
- Oncologists caring for AML patients must be enrolled
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Psychiatric or cognitive conditions preventing informed consent or study compliance
- Prior cancer-directed treatment for AML
Research Team
K
Kah Poh Loh
B
Becky Gravenstede
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