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

Study Overview
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Brief Summary
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The objective of this study is to conduct a pilot randomized trial to evaluate the preliminary efficacy of the UR-GOAL tool vs. usual care in improving shared decision making and communication between 100 older patients with AML and their oncologists.

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Behavioral: UR-GOAL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The UR-GOAL 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Usual care | |
| Experimental: UR-GOAL<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shared Decision Making | A 9-item reliable questionnaire assessing patient satisfaction with the medical decision-making process, range 0-45, higher score indicates greater shared decision making | 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) | 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. Scores in each domain range from 1-5, higher scores indicate better communication. Scores are reported in each domain and overall. | Within 1-4 weeks after treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute myeloid leukemia, communication, shared decision making, older adults, geriatric hematology