Trial results for a study evaluating a patient-centered communication tool (UR-GOAL) in older patients with Acute Myeloid Leukemia were posted on ClinicalTrials.gov on 2026-05-11, involving 161 participants.
Background
Acute Myeloid Leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow. For older patients with AML, effective communication and shared decision-making between patients, caregivers, and oncologists are crucial for navigating complex treatment options and improving quality of care. The UR-GOAL tool was developed to enhance these interactions, aiming to empower patients and their families in making informed choices about their treatment journey.
Trial design
This completed study, designated as Phase NA, enrolled 161 participants with Acute Myeloid Leukemia. The trial's objective was to evaluate the preliminary efficacy of the UR-GOAL tool in improving shared decision-making and communication between older patients with AML and their oncologists. Participants were randomized to either receive the UR-GOAL intervention or usual care.
Key results
The trial reported key measurements and analyses comparing the UR-GOAL intervention to usual care:
- Shared Decision Making (Score on a Scale):
- Patient: UR-GOAL Intervention mean score was 85.98 (Standard Deviation 12.25).
- Patient: Usual Care Control mean score was 86.55 (Standard Deviation 14.04).
- Patient-Centered Communication in Cancer Care (PCC-Ca-36) (Score on a Scale):
- For the UR-GOAL Intervention group, mean scores were 4.20 (Standard Deviation 0.60), 4.43 (Standard Deviation 0.57), 4.45 (Standard Deviation 0.52), 4.37 (Standard Deviation 0.64), and 3.99 (Standard Deviation 0.91).
- For the Usual Care Control group, mean scores were 4.31 (Standard Deviation 0.58), 4.49 (Standard Deviation 0.62), 4.58 (Standard Deviation 0.45), 4.61 (Standard Deviation 0.54), and 4.26 (Standard Deviation 0.80).
Statistical analyses further clarified these comparisons:
- For Shared Decision Making, a Welch Two Sample t-test showed a Mean Difference (Final Values) of -0.56 (95% Confidence Interval: -6.6 to 5.5), with a p-value of 0.85.
- For the Overall PCC-Ca-36 Score, a Welch Two Sample t-test showed a Mean Difference (Final Values) of -0.1 (95% Confidence Interval: -0.36 to 0.16), with a p-value of 0.44. This analysis was applied only to the Overall PCC-Ca-36 Score.
What this means
The results indicate that the UR-GOAL patient-centered communication tool did not demonstrate a statistically significant improvement in shared decision-making or patient-centered communication among older patients with Acute Myeloid Leukemia when compared to usual care. The observed mean differences between the intervention and control groups were small, and the p-values for both primary analyses (0.85 for Shared Decision Making and 0.44 for Overall PCC-Ca-36 Score) suggest that any differences were likely due to chance. This pilot study's findings suggest that further refinement of the tool or different implementation strategies may be necessary to achieve a measurable impact on patient-provider communication in this population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05335369, titled "A Patient-Centered Communication Tool (UR-GOAL) Versus Usual Care for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists", were posted on 2026-05-11 on clinicaltrials.gov.