Patient-centered communication tool for older patients with acute myeloid leukemia, their caregivers, and oncologists: A single-arm pilot study.
Marissa LoCastro, Chandrika Sanapala, Ying Wang...
https://pubmed.ncbi.nlm.nih.gov/36533397Actively Recruiting
Phase Not Applicable
Age: 60Years +
All Genders
ID06697600
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 patient's 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
Age: 60Years +
All Genders
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
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Behavioral Intervention
Duration - Up to 2 weeks
Participants view educational videos and complete questionnaires to support decision making; caregivers and oncologists receive related materials to review and discuss at clinical visits.
1 baseline visit and 1 follow-up visit
Follow-up
Duration - 1 month
Participants complete questionnaires assessing distress, shared decision making, and decisional conflict after the intervention.
1 visit (in-person)
Trial Site Locations
Total: 4 locations
1
University of Alabama at Birmingham, Division of Hematology and Oncology
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
3
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
4
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
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Research Team
K
Kah Poh Loh
B
Becky Gravenstede
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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