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

Sponsor

University of Rochester (Other)

Overall Status

Recruiting

CT.gov ID

NCT05335369

Collaborator

(none)

100

Enrollment

Location

Arms

36.4

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Behavioral: UR-GOAL	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Supportive Care

Official 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

Actual Study Start Date :

Jun 17, 2022

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual care 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.

Arm

Intervention/Treatment

No Intervention: Usual care

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

Outcome Measures

Primary Outcome Measures

Shared Decision Making [Within 1-4 weeks after treatment initiation]
A 9-item reliable questionnaire assessing patient satisfaction with the medical decision-making process, range 0-45, higher score indicates greater shared decision making

Secondary Outcome Measures

Patient-Centered Communication in Cancer Care (PCC-Ca-36) [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. Scores in each domain range from 1-5, higher scores indicate better communication. Scores are reported in each domain and overall.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients

Age ≥60 years
Newly diagnosed AML
Able to provide informed consent
Agreement of their oncologist to participate in the study
English-speaking

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