A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
UR-GOAL RCT
2 other identifiers
interventional
1,020
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2024
CompletedFirst Posted
Study publicly available on registry
November 20, 2024
CompletedStudy Start
First participant enrolled
July 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
March 31, 2026
March 1, 2026
4.2 years
November 14, 2024
March 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Distress Thermometer Questionnaire at 1 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.
1 month
Secondary Outcomes (3)
9-item Shared Decision Making Questionnaire at 2 weeks
2 weeks
Decisional Conflict Scale Questionnaire at 2 weeks
2 weeks
Observed shared decision making
Day 0
Study Arms (2)
UR-GOAL Intervention
EXPERIMENTALPatients will view an AML video, complete the best-worst scaling, and be provided with a summary report consisting of their priorities; they will will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the same AML video and be provided with the same summary report. Oncologists will be provided with a summary report consisting of the patient's geriatric assessment, priorities, and perception of prognosis; they will be asked to review and discuss at upcoming clinical visits.
Attention Control Arm
NO INTERVENTIONPatients will view a nutritional video, complete a nutrition questionnaire, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the nutritional video, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Oncologists will be provided with the patient's completed nutrition questionnaire and asked to review and discuss at upcoming clinical visits.
Interventions
Patients will view an AML video, complete the best/worst scaling, will be provided with a summary report, and will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view an AML video, will be provided with a summary report, and will be asked to review. Oncologists will be provided with a summary report and will be asked to review and discuss at upcoming clinical visits.
Eligibility Criteria
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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- National Cancer Institute (NCI)collaborator
Study Sites (4)
University of Alabama at Birmingham, Division of Hematology and Oncology
Birmingham, Alabama, 35233, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology
Winston-Salem, North Carolina, 27157, United States
Related Publications (1)
LoCastro M, Sanapala C, Wang Y, Jensen-Battaglia M, Wittink M, Norton S, Klepin HD, Richardson DR, Mendler JH, Liesveld J, Huselton E, O'Dwyer K, Cortes AM, Rodriguez C, Dale W, Loh KP. Patient-centered communication tool for older patients with acute myeloid leukemia, their caregivers, and oncologists: A single-arm pilot study. Cancer Med. 2023 Apr;12(7):8581-8593. doi: 10.1002/cam4.5547. Epub 2022 Dec 19.
PMID: 36533397BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Division of Hematology/Oncology, Department of Medicine
Study Record Dates
First Submitted
November 14, 2024
First Posted
November 20, 2024
Study Start
July 11, 2025
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
June 1, 2030
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share