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Completed

NCT Number: NCT05335369

A Patient-Centered Communication Tool (UR-GOAL) Versus Usual Care 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.

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Key information

Conditions

Acute Myeloid Leukemia Behavior Communication Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients

  • Age ≥60 years
  • Newly diagnosed AML or being worked up for possible AML
  • Able to provide informed consent
  • Agreement of their oncologist to participate in the study
  • 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

  • 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
  • Able to provide informed consent
  • English-speaking

Oncologists

  • A practicing oncologist
  • At least one of their patients are recruited to the study
  • English-speaking

Treatment and study plan

UR-GOAL

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Acronym: UR-GOAL 2

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 19, 2022
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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