Acute Myeloid Leukemia Clinical Trial

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

Summary

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

100

Study ID:

NCT05335369

Recruitment Status:

Recruiting

Sponsor:

University of Rochester

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There is 1 Location for this study

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University of Rochester
Rochester New York, 14642, United States More Info
Kah Poh Loh
Contact
585-275-4401
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

100

Study ID:

NCT05335369

Recruitment Status:

Recruiting

Sponsor:


University of Rochester

How clear is this clinincal trial information?

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