A Patient-Centered Communication Tool (UR-GOAL) Versus Usual Care for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists (UR-GOAL 2)

May 8, 2026 updated by: Kah Poh Loh, University of Rochester

A Pilot Randomized Controlled Trial of a Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists

The objective of this study is to evaluate the preliminary efficacy of the UR-GOAL tool in improving shared decision making and communication between older patients with AML and their oncologists in a pilot randomized trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators have developed a patient-centered communication tool (University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia or UR-GOAL) that 1) conducts assessments of fitness, 2) elicits patient values via Best-Worst Scaling, and 3) elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video. The investigators have refined the tool based on feedback from stakeholders consisting of older patients with cancer, caregivers, and oncologists. This was further adapted in a qualitative study of 15 older patients with AML. In a single arm pilot study, the investigators have demonstrated feasibility of recruiting older patients with newly diagnosed AML to a single arm study, as well as their caregivers and oncologists.

Study Type

Interventional

Enrollment (Actual)

161

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 Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients

  1. Age ≥60 years
  2. Newly diagnosed AML or being worked up for possible AML
  3. Able to provide informed consent
  4. Agreement of their oncologist to participate in the study
  5. English-speaking

If patients screen positive for cognitive impairment on the Mini-Cog test performed as part of the baseline assessment, they can still enroll if they are able to provide informed consent and have decision making capacity as determined by their treating oncologist

Caregivers

  1. Selected by the patient when asked if there is a "family member, partner, friend or caregiver [age 21 or older] with whom the patient discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") can be eligible for the study. A caregiver need not be someone who lives with the patient or provides direct hands-on care. A caregiver can be any person who provides support (in any way) to the patient
  2. Able to provide informed consent
  3. English-speaking

Oncologists

  1. A practicing oncologist
  2. At least one of their patients are recruited to the study
  3. English-speaking

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
No Intervention: Usual care
Experimental: UR-GOAL
UR-GOAL helps conducts assessments of fitness, elicits patient values via Best-Worst Scaling, and elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video.
Behavioral: UR-GOAL
UR-GOAL helps conducts assessments of fitness, elicits patient values via Best-Worst Scaling, and elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shared Decision Making
Time Frame: Within 1-4 weeks after treatment initiation
A 9-item Shared Decision Making questionnaire (SDM-Q-9) assessing patient satisfaction with the medical decision-making process. Scores are transformed to a 0-100 scale in accordance with measure guidelines, with higher scores indicating greater shared decision making between the patient and the provider.
Within 1-4 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Centered Communication in Cancer Care (PCC-Ca-36)
Time Frame: Within 1-4 weeks after treatment initiation
A 36-item questionnaire assessing patient-centered communication in six domains: exchanging information, making decisions, fostering healing relationships, enabling patient self-management, managing uncertainty, and responding to emotions. The overall score and scores in each domain range from 1-5, higher scores indicate better communication.
Within 1-4 weeks after treatment initiation

Collaborators and Investigators

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

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Kah Poh Loh, University of Rochester

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)

June 17, 2022

Primary Completion (Actual)

April 7, 2025

Study Completion (Actual)

October 6, 2025

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOCPC22010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared with other investigators if requested. The investigators will publish our study protocol. Published papers will be made available in portable document format.

IPD Sharing Time Frame

The data will be available for 7 years after study completion

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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.

Clinical Trials on Acute Myeloid Leukemia

Clinical Trials on UR-GOAL

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe