A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers (UR-GOAL RCT)

March 29, 2026 updated by: Kah Poh Loh, University of Rochester
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter randomized controlled trial with four sites 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. Subjects will be randomized 1:1 to either the intervention arm or the attention control arm. Compared to an attention control, UR-GOAL will improve patient distress, observed and patient-perceived shared decision making (SDM), and patient decisional conflict.

Study Type

Interventional

Enrollment (Estimated)

1020

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham, Division of Hematology and Oncology
        • Contact:
    • New York
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina Lineberger Comprehensive Cancer Center
        • Contact:
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Patients

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UR-GOAL Intervention
Patients 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.
Behavioral: UR-GOAL
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.
No Intervention: Attention Control Arm
Patients 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distress Thermometer Questionnaire at 1 month
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
9-item Shared Decision Making Questionnaire at 2 weeks
Time Frame: 2 weeks
9-item Shared Decision Making Questionnaire at 2 weeks
2 weeks
Decisional Conflict Scale Questionnaire at 2 weeks
Time Frame: 2 weeks
Decisional Conflict Scale Questionnaire at 2 weeks
2 weeks
Observed shared decision making
Time Frame: Day 0
OPTION5 instrument from audio-recorded treatment decision-making clinical visits
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2025

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOCPC24064
  • 1R01CA288318-01A1 (U.S. NIH Grant/Contract: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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