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

Not Applicable

Completed

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT04625413
• Lead Sponsor: University of Rochester

Brief Summary

This is a pilot study to evaluate the usability and feasibility of a patient-centered communication tool (University of Rochester-Geriatric Oncology Assessment for acute myeloid Leukemia or UR-GOAL) among 15 older patients with AML, their caregivers, and oncologists.

Detailed Description

Older adults with AML and their caregivers may benefit from help and support in understanding their treatment options. This pilot study seeks to evaluate the usability and feasibility of the UR-GOAL communication tool. The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness.

Study Timeline

• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Study Start: 2021-10-23
• Primary Completion: 2022-10-11
• Study Completion: 2022-10-11
• Results First Submitted: 2023-06-06
• Results First Submitted QC: 2024-03-04
• Results First Posted: 2024-03-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Usefulness	Four weeks	Usefulness was assessed using the Preparation for Decision Making Scale (mean score range from 1 to 5, and higher scores indicate greater usefulness)
Feasibility (Recruitment Rates)	Four weeks	Percentage of patients who consented to the study ultimately completed the study intervention and post-intervention assessment

Secondary Outcome Measures

Name	Time	Method
Pre-post Changes in the Following Outcomes: Geriatric Depression Scale-15	Four Weeks	A 15-item valid and reliable screening tool for depression in older adults. This will be used for patients; ranging 0-15; higher score corresponds to greater depressive symptoms. Pre-post changes from baseline to four weeks.
Pre-post Changes in the Following Outcomes: General Anxiety Disorder-7	Four weeks	A 7-item screening tool for anxiety; ranging 7-21; higher score corresponds to greater anxiety symptoms. Pre-post changes from baseline to four weeks.
Pre-post Changes in the Following Outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI)	Four weeks	A valid and reliable assessment of perceived self-efficacy of older patients interacting with physicians; score on 5-item scale, ranging 5-25; higher score corresponds to greater perceived efficacy. Pre-post changes from baseline to four weeks.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States