Trial Outcomes & Findings for A Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists (NCT NCT04625413)

Results Overview

Percentage of patients who consented to the study ultimately completed the study intervention and post-intervention assessment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Four weeks

Results posted on

2026-01-22

Participant Flow

We recruited older patients with AML, their caregivers, and oncologists from the University of Rochester Medical Center Wilmot Cancer Institute (WCI) and its affiliated oncology practices in upstate New York. Participants were recruited between October 2021 and March 2022.

Participant milestones

Participant milestones
Measure	Experimental: Experimental Arm: Single The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness. Behavioral: UR-GOAL communication tool: The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness
Overall Study STARTED	15
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Experimental Arm: Single The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness. Behavioral: UR-GOAL communication tool: The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness
Overall Study Hospice	2
Overall Study Distress	1
Overall Study Not feeling well	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Experimental Arm: Single n=15 Participants The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness. Behavioral: UR-GOAL communication tool: The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awarene
Age, Continuous	76 years STANDARD_DEVIATION 80 • n=270 Participants
Sex: Female, Male Female	7 Participants n=270 Participants
Sex: Female, Male Male	8 Participants n=270 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants
Race (NIH/OMB) Asian	0 Participants n=270 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants
Race (NIH/OMB) Black or African American	1 Participants n=270 Participants
Race (NIH/OMB) White	14 Participants n=270 Participants
Race (NIH/OMB) More than one race	0 Participants n=270 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants
Region of Enrollment United States	15 participants n=270 Participants

PRIMARY outcome

Timeframe: Four weeks

Percentage of patients who consented to the study ultimately completed the study intervention and post-intervention assessment

Outcome measures

Outcome measures
Measure	Experimental: Experimental Arm: Single n=15 Participants The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness. Behavioral: UR-GOAL communication tool: The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness
Feasibility (Recruitment Rates)	11 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Experimental: Experimental Arm: Single n=11 Participants The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness. Behavioral: UR-GOAL communication tool: The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness
Usefulness	3.8 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental: Experimental Arm: Single n=11 Participants The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness. Behavioral: UR-GOAL communication tool: The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness
Pre-post Changes in the Following Outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI)	1.5 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental: Experimental Arm: Single n=11 Participants The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness. Behavioral: UR-GOAL communication tool: The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness
Pre-post Changes in the Following Outcomes: General Anxiety Disorder-7	-1.6 score on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental: Experimental Arm: Single n=11 Participants The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness. Behavioral: UR-GOAL communication tool: The UR-GOAL tool will incorporate Best-Worst Scaling to elicit patient preferences as well as assessments of fitness and prognostic awareness
Pre-post Changes in the Following Outcomes: Geriatric Depression Scale-15	0.2 score on a scale Standard Deviation 2.1

Adverse Events

Experimental: Experimental Arm: Single

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kah Poh Loh

University of Rochester Medical Center

Phone: 585-276-4353

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place