Trial Outcomes & Findings for A Patient-Centered Communication Tool (UR-GOAL) Versus Usual Care for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists (NCT NCT05335369)

Last Updated: 2026-05-11

Results Overview

A 9-item Shared Decision Making questionnaire (SDM-Q-9) assessing patient satisfaction with the medical decision-making process. Scores are transformed to a 0-100 scale in accordance with measure guidelines, with higher scores indicating greater shared decision making between the patient and the provider.

Recruitment status

COMPLETED

Study phase

Target enrollment

161 participants

Primary outcome timeframe

Within 1-4 weeks after treatment initiation

Results posted on

2026-05-11

Participant Flow

Patients aged 60 and above with AML were recruited from June 2022 to July 2025. Patients were recruited from 1) the Wilmot Cancer Institute inpatient malignant hematology service and 2) hematology clinics at Wilmot Cancer Institute. Enrolled patients could enroll with a caregiver, but were not required to. Oncologists at the Wilmot Cancer Institute were eligible if they treated at least one enrolled patient.

Participant milestones

Participant milestones
Measure	Patient: UR-GOAL Intervention 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.	Patient: Usual Care Control Usual care	Caregiver: UR-GOAL Intervention Patients had the option to enroll with a caregiver. Caregivers were assigned to the same study arm as the patient with whom they enrolled. Before the AML treatment decision was made, caregivers in the UR-GOAL Intervention arm were provided with the same summary report and AML educational video as the patients.	Caregiver: Usual Care Control Patients had the option to enroll with a caregiver. Caregivers were assigned to the same study arm as the patient with whom they enrolled. Caregivers in the Usual Care Control were not provided with additional information beyond usual care.	Oncologist Oncologists treated patients who were allocated to either study arm. For patients in the UR-GOAL Intervention arm, the oncologist received a summary report containing the patient's treatment preferences, fitness level, and prognostic awareness. Oncologists did not receive this report for patients allocated to the Usual Care Control arm. Oncologists provided both data about themselves (for example, demographics) and data about the enrolled patients they treated (for example, disease understanding).
Overall Study STARTED	50	50	25	28	8
Overall Study COMPLETED	43	38	20	25	8
Overall Study NOT COMPLETED	7	12	5	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Patient: UR-GOAL Intervention 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.	Patient: Usual Care Control Usual care	Caregiver: UR-GOAL Intervention Patients had the option to enroll with a caregiver. Caregivers were assigned to the same study arm as the patient with whom they enrolled. Before the AML treatment decision was made, caregivers in the UR-GOAL Intervention arm were provided with the same summary report and AML educational video as the patients.	Caregiver: Usual Care Control Patients had the option to enroll with a caregiver. Caregivers were assigned to the same study arm as the patient with whom they enrolled. Caregivers in the Usual Care Control were not provided with additional information beyond usual care.
Overall Study Death	4	3	0	0
Overall Study Withdrawal by Subject	2	6	3	3
Overall Study Went to hospice	1	3	0	0
Overall Study Lost to Follow-up	0	0	2	0

Baseline Characteristics

One oncologist declined to provide their year of birth

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Caregiver: Usual Care Control n=28 Participants Patients had the option to enroll with a caregiver. Caregivers were assigned to the same study arm as the patient with whom they enrolled. Caregivers in the Usual Care Control were not provided with additional information beyond usual care.	Caregiver: UR-GOAL Intervention n=25 Participants Patients had the option to enroll with a caregiver. Caregivers were assigned to the same study arm as the patient with whom they enrolled. Before the AML treatment decision was made, caregivers in the UR-GOAL Intervention arm were provided with the same summary report and AML educational video as the patients.	Patient: UR-GOAL Intervention n=50 Participants 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.	Patient: Usual Care Control n=50 Participants Usual care	Oncologist n=8 Participants Oncologists treated patients who were allocated to either study arm. For patients in the UR-GOAL Intervention arm, the oncologist received a summary report containing the patient's treatment preferences, fitness level, and prognostic awareness. Oncologists did not receive this report for patients allocated to the Usual Care Control arm. Oncologists provided both data about themselves (for example, demographics) and data about the enrolled patients they treated (for example, disease understanding).	Total n=161 Participants Total of all reporting groups
Age, Continuous	62.3 Years STANDARD_DEVIATION 17.7 • n=28 Participants • One oncologist declined to provide their year of birth	62.2 Years STANDARD_DEVIATION 13.8 • n=25 Participants • One oncologist declined to provide their year of birth	74.0 Years STANDARD_DEVIATION 8.3 • n=50 Participants • One oncologist declined to provide their year of birth	73.9 Years STANDARD_DEVIATION 6.1 • n=50 Participants • One oncologist declined to provide their year of birth	41.3 Years STANDARD_DEVIATION 12.2 • n=7 Participants • One oncologist declined to provide their year of birth	68.73 Years STANDARD_DEVIATION 13.60 • n=160 Participants • One oncologist declined to provide their year of birth
Sex: Female, Male Female	21 Participants n=28 Participants	16 Participants n=25 Participants	22 Participants n=50 Participants	17 Participants n=50 Participants	4 Participants n=8 Participants	80 Participants n=161 Participants
Sex: Female, Male Male	7 Participants n=28 Participants	9 Participants n=25 Participants	28 Participants n=50 Participants	33 Participants n=50 Participants	4 Participants n=8 Participants	81 Participants n=161 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=28 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=8 Participants	0 Participants n=161 Participants
Race (NIH/OMB) Asian	0 Participants n=28 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	1 Participants n=8 Participants	1 Participants n=161 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=28 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=8 Participants	0 Participants n=161 Participants
Race (NIH/OMB) Black or African American	2 Participants n=28 Participants	0 Participants n=25 Participants	4 Participants n=50 Participants	2 Participants n=50 Participants	0 Participants n=8 Participants	8 Participants n=161 Participants
Race (NIH/OMB) White	26 Participants n=28 Participants	25 Participants n=25 Participants	45 Participants n=50 Participants	48 Participants n=50 Participants	7 Participants n=8 Participants	151 Participants n=161 Participants
Race (NIH/OMB) More than one race	0 Participants n=28 Participants	0 Participants n=25 Participants	1 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=8 Participants	1 Participants n=161 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=28 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=8 Participants	0 Participants n=161 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=28 Participants	1 Participants n=25 Participants	2 Participants n=50 Participants	1 Participants n=50 Participants	0 Participants n=8 Participants	4 Participants n=161 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=28 Participants	22 Participants n=25 Participants	45 Participants n=50 Participants	48 Participants n=50 Participants	8 Participants n=8 Participants	149 Participants n=161 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=28 Participants	2 Participants n=25 Participants	3 Participants n=50 Participants	1 Participants n=50 Participants	0 Participants n=8 Participants	8 Participants n=161 Participants
Marital Status Divorced, Single, or Widowed	5 Participants n=28 Participants • Oncologists did not report their marital status.	7 Participants n=25 Participants • Oncologists did not report their marital status.	21 Participants n=50 Participants • Oncologists did not report their marital status.	15 Participants n=50 Participants • Oncologists did not report their marital status.	0 Participants Oncologists did not report their marital status.	48 Participants n=153 Participants • Oncologists did not report their marital status.
Marital Status Married or Long-term partner	23 Participants n=28 Participants • Oncologists did not report their marital status.	18 Participants n=25 Participants • Oncologists did not report their marital status.	29 Participants n=50 Participants • Oncologists did not report their marital status.	35 Participants n=50 Participants • Oncologists did not report their marital status.	0 Participants Oncologists did not report their marital status.	105 Participants n=153 Participants • Oncologists did not report their marital status.
Education High School or Below	7 Participants n=28 Participants • Oncologists did not report their education.	5 Participants n=25 Participants • Oncologists did not report their education.	15 Participants n=50 Participants • Oncologists did not report their education.	17 Participants n=50 Participants • Oncologists did not report their education.	0 Participants Oncologists did not report their education.	44 Participants n=153 Participants • Oncologists did not report their education.
Education Some College/University	5 Participants n=28 Participants • Oncologists did not report their education.	6 Participants n=25 Participants • Oncologists did not report their education.	19 Participants n=50 Participants • Oncologists did not report their education.	14 Participants n=50 Participants • Oncologists did not report their education.	0 Participants Oncologists did not report their education.	44 Participants n=153 Participants • Oncologists did not report their education.
Education College or Post-Graduate	16 Participants n=28 Participants • Oncologists did not report their education.	14 Participants n=25 Participants • Oncologists did not report their education.	16 Participants n=50 Participants • Oncologists did not report their education.	19 Participants n=50 Participants • Oncologists did not report their education.	0 Participants Oncologists did not report their education.	65 Participants n=153 Participants • Oncologists did not report their education.
Employment Employed	10 Participants n=28 Participants • Oncologists did not report their employment.	10 Participants n=25 Participants • Oncologists did not report their employment.	8 Participants n=50 Participants • Oncologists did not report their employment.	6 Participants n=50 Participants • Oncologists did not report their employment.	0 Participants Oncologists did not report their employment.	34 Participants n=153 Participants • Oncologists did not report their employment.
Employment Retired, Unemployed, Homemaker	17 Participants n=28 Participants • Oncologists did not report their employment.	14 Participants n=25 Participants • Oncologists did not report their employment.	42 Participants n=50 Participants • Oncologists did not report their employment.	44 Participants n=50 Participants • Oncologists did not report their employment.	0 Participants Oncologists did not report their employment.	117 Participants n=153 Participants • Oncologists did not report their employment.
Employment Other	1 Participants n=28 Participants • Oncologists did not report their employment.	1 Participants n=25 Participants • Oncologists did not report their employment.	0 Participants n=50 Participants • Oncologists did not report their employment.	0 Participants n=50 Participants • Oncologists did not report their employment.	0 Participants Oncologists did not report their employment.	2 Participants n=153 Participants • Oncologists did not report their employment.
ECOG (KPS) 0 (90-100)	0 Participants Oncologists and Caregivers did not report their ECOG (KPS).	0 Participants Oncologists and Caregivers did not report their ECOG (KPS).	10 Participants n=50 Participants • Oncologists and Caregivers did not report their ECOG (KPS).	16 Participants n=50 Participants • Oncologists and Caregivers did not report their ECOG (KPS).	0 Participants Oncologists and Caregivers did not report their ECOG (KPS).	26 Participants n=100 Participants • Oncologists and Caregivers did not report their ECOG (KPS).
ECOG (KPS) 1 (70-80)	0 Participants Oncologists and Caregivers did not report their ECOG (KPS).	0 Participants Oncologists and Caregivers did not report their ECOG (KPS).	28 Participants n=50 Participants • Oncologists and Caregivers did not report their ECOG (KPS).	19 Participants n=50 Participants • Oncologists and Caregivers did not report their ECOG (KPS).	0 Participants Oncologists and Caregivers did not report their ECOG (KPS).	47 Participants n=100 Participants • Oncologists and Caregivers did not report their ECOG (KPS).
ECOG (KPS) 2 (50-60)	0 Participants Oncologists and Caregivers did not report their ECOG (KPS).	0 Participants Oncologists and Caregivers did not report their ECOG (KPS).	12 Participants n=50 Participants • Oncologists and Caregivers did not report their ECOG (KPS).	9 Participants n=50 Participants • Oncologists and Caregivers did not report their ECOG (KPS).	0 Participants Oncologists and Caregivers did not report their ECOG (KPS).	21 Participants n=100 Participants • Oncologists and Caregivers did not report their ECOG (KPS).
ECOG (KPS) 3 (30-40)	0 Participants Oncologists and Caregivers did not report their ECOG (KPS).	0 Participants Oncologists and Caregivers did not report their ECOG (KPS).	0 Participants n=50 Participants • Oncologists and Caregivers did not report their ECOG (KPS).	6 Participants n=50 Participants • Oncologists and Caregivers did not report their ECOG (KPS).	0 Participants Oncologists and Caregivers did not report their ECOG (KPS).	6 Participants n=100 Participants • Oncologists and Caregivers did not report their ECOG (KPS).
GDS-15 Not Impaired	0 Participants Oncologists and Caregivers did not report their GDS-15.	0 Participants Oncologists and Caregivers did not report their GDS-15.	40 Participants n=50 Participants • Oncologists and Caregivers did not report their GDS-15.	38 Participants n=50 Participants • Oncologists and Caregivers did not report their GDS-15.	0 Participants Oncologists and Caregivers did not report their GDS-15.	78 Participants n=100 Participants • Oncologists and Caregivers did not report their GDS-15.
Physical Function Not Impaired	0 Participants Oncologists and Caregivers did not report their Physical Function.	0 Participants Oncologists and Caregivers did not report their Physical Function.	12 Participants n=50 Participants • Oncologists and Caregivers did not report their Physical Function.	15 Participants n=50 Participants • Oncologists and Caregivers did not report their Physical Function.	0 Participants Oncologists and Caregivers did not report their Physical Function.	27 Participants n=100 Participants • Oncologists and Caregivers did not report their Physical Function.
Physical Function Impaired	0 Participants Oncologists and Caregivers did not report their Physical Function.	0 Participants Oncologists and Caregivers did not report their Physical Function.	37 Participants n=50 Participants • Oncologists and Caregivers did not report their Physical Function.	32 Participants n=50 Participants • Oncologists and Caregivers did not report their Physical Function.	0 Participants Oncologists and Caregivers did not report their Physical Function.	69 Participants n=100 Participants • Oncologists and Caregivers did not report their Physical Function.
Mini-Cog Missing	0 Participants Oncologists and Caregivers did not report their Mini-Cog.	0 Participants Oncologists and Caregivers did not report their Mini-Cog.	1 Participants n=50 Participants • Oncologists and Caregivers did not report their Mini-Cog.	2 Participants n=50 Participants • Oncologists and Caregivers did not report their Mini-Cog.	0 Participants Oncologists and Caregivers did not report their Mini-Cog.	3 Participants n=100 Participants • Oncologists and Caregivers did not report their Mini-Cog.
Physical Function Missing	0 Participants Oncologists and Caregivers did not report their Physical Function.	0 Participants Oncologists and Caregivers did not report their Physical Function.	1 Participants n=50 Participants • Oncologists and Caregivers did not report their Physical Function.	3 Participants n=50 Participants • Oncologists and Caregivers did not report their Physical Function.	0 Participants Oncologists and Caregivers did not report their Physical Function.	4 Participants n=100 Participants • Oncologists and Caregivers did not report their Physical Function.
Mini-Cog Not Impaired	0 Participants Oncologists and Caregivers did not report their Mini-Cog.	0 Participants Oncologists and Caregivers did not report their Mini-Cog.	45 Participants n=50 Participants • Oncologists and Caregivers did not report their Mini-Cog.	39 Participants n=50 Participants • Oncologists and Caregivers did not report their Mini-Cog.	0 Participants Oncologists and Caregivers did not report their Mini-Cog.	84 Participants n=100 Participants • Oncologists and Caregivers did not report their Mini-Cog.
Mini-Cog Impaired	0 Participants Oncologists and Caregivers did not report their Mini-Cog.	0 Participants Oncologists and Caregivers did not report their Mini-Cog.	4 Participants n=50 Participants • Oncologists and Caregivers did not report their Mini-Cog.	9 Participants n=50 Participants • Oncologists and Caregivers did not report their Mini-Cog.	0 Participants Oncologists and Caregivers did not report their Mini-Cog.	13 Participants n=100 Participants • Oncologists and Caregivers did not report their Mini-Cog.
GDS-15 Impaired	0 Participants Oncologists and Caregivers did not report their GDS-15.	0 Participants Oncologists and Caregivers did not report their GDS-15.	9 Participants n=50 Participants • Oncologists and Caregivers did not report their GDS-15.	11 Participants n=50 Participants • Oncologists and Caregivers did not report their GDS-15.	0 Participants Oncologists and Caregivers did not report their GDS-15.	20 Participants n=100 Participants • Oncologists and Caregivers did not report their GDS-15.
GDS-15 Missing	0 Participants Oncologists and Caregivers did not report their GDS-15.	0 Participants Oncologists and Caregivers did not report their GDS-15.	1 Participants n=50 Participants • Oncologists and Caregivers did not report their GDS-15.	1 Participants n=50 Participants • Oncologists and Caregivers did not report their GDS-15.	0 Participants Oncologists and Caregivers did not report their GDS-15.	2 Participants n=100 Participants • Oncologists and Caregivers did not report their GDS-15.
Nutrition Not Impaired	0 Participants Oncologists and Caregivers did not report their Nutrition.	0 Participants Oncologists and Caregivers did not report their Nutrition.	40 Participants n=50 Participants • Oncologists and Caregivers did not report their Nutrition.	42 Participants n=50 Participants • Oncologists and Caregivers did not report their Nutrition.	0 Participants Oncologists and Caregivers did not report their Nutrition.	82 Participants n=100 Participants • Oncologists and Caregivers did not report their Nutrition.
Nutrition Impaired	0 Participants Oncologists and Caregivers did not report their Nutrition.	0 Participants Oncologists and Caregivers did not report their Nutrition.	10 Participants n=50 Participants • Oncologists and Caregivers did not report their Nutrition.	8 Participants n=50 Participants • Oncologists and Caregivers did not report their Nutrition.	0 Participants Oncologists and Caregivers did not report their Nutrition.	18 Participants n=100 Participants • Oncologists and Caregivers did not report their Nutrition.

PRIMARY outcome

Timeframe: Within 1-4 weeks after treatment initiation

Population: 5 patients who completed some of the post-intervention surveys did not complete the SDM-Q-9 form.

Outcome measures

Outcome measures
Measure	Patient: UR-GOAL Intervention n=39 Participants 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.	Patient: Usual Care Control n=37 Participants Usual care
Shared Decision Making	85.98 Score on a Scale Standard Deviation 12.25	86.55 Score on a Scale Standard Deviation 14.04

SECONDARY outcome

Timeframe: Within 1-4 weeks after treatment initiation

Population: Analysis populations vary across domains due to missing responses and "does not apply" selections for specific items. Participants were included in each domain analysis if sufficient data were available for that domain.

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. The overall score and scores in each domain range from 1-5, higher scores indicate better communication.