A Patient-Centered Communication Tool (UR-GOAL) Versus Usual Care for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists
UR-GOAL 2
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
1 other identifier
interventional
170
1 country
1
Brief Summary
The objective of this study is to conduct a pilot randomized trial to evaluate the preliminary efficacy of the UR-GOAL tool in improving SDM and communication between 100 older patients with AML and their oncologists.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2022
CompletedFirst Posted
Study publicly available on registry
April 19, 2022
CompletedStudy Start
First participant enrolled
June 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2025
CompletedFebruary 9, 2026
February 1, 2026
2.8 years
April 12, 2022
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Shared Decision Making
A 9-item reliable questionnaire assessing patient satisfaction with the medical decision-making process, range 0-45, higher score indicates greater shared decision making
Within 1-4 weeks after treatment initiation
Secondary Outcomes (1)
Patient-Centered Communication in Cancer Care (PCC-Ca-36)
Within 1-4 weeks after treatment initiation
Study Arms (2)
Usual care
NO INTERVENTIONUsual care
UR-GOAL
EXPERIMENTALUR-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients
- Age ≥60 years
- Newly diagnosed AML or being worked up for possible AML
- Able to provide informed consent
- Agreement of their oncologist to participate in the study
- English-speaking
- If patients screen positive for cognitive impairment on the Mini-Cog test performed as part of the baseline assessment, they can still enroll if they are able to provide informed consent and have decision making capacity as determined by their treating oncologist
- 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
- A practicing oncologist
- At least one of their patients are recruited to the study
- English-speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester
Rochester, New York, 14642, United States
Related Publications (3)
DuMontier C, Loh KP, Soto-Perez-de-Celis E, Dale W. Decision Making in Older Adults With Cancer. J Clin Oncol. 2021 Jul 1;39(19):2164-2174. doi: 10.1200/JCO.21.00165. Epub 2021 May 27. No abstract available.
PMID: 34043434BACKGROUNDLoh KP, Abdallah M, Kadambi S, Wells M, Kumar AJ, Mendler JH, Liesveld JL, Wittink M, O'Dwyer K, Becker MW, McHugh C, Stock W, Majhail NS, Wildes TM, Duberstein P, Mohile SG, Klepin HD. Treatment decision-making in acute myeloid leukemia: a qualitative study of older adults and community oncologists. Leuk Lymphoma. 2021 Feb;62(2):387-398. doi: 10.1080/10428194.2020.1832662. Epub 2020 Oct 11.
PMID: 33040623BACKGROUNDJensen-Battaglia M, LoCastro M, Oh H, Sanapala C, Flannery M, Mendler JH, Liesveld J, Huselton E, Loh KP. Patient-oncologist discussion of treatment decisions: Exploring the role of a patient-centered communication tool for older adults with acute myeloid leukemia and their caregivers. J Geriatr Oncol. 2024 Jun;15(5):101716. doi: 10.1016/j.jgo.2024.101716. Epub 2024 Feb 9. No abstract available.
PMID: 38336521DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kah Poh Loh
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor - Department of Medicine, Hematology/Oncology (SMD)
Study Record Dates
First Submitted
April 12, 2022
First Posted
April 19, 2022
Study Start
June 17, 2022
Primary Completion
April 7, 2025
Study Completion
October 6, 2025
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be available for 7 years after study completion
De-identified data will be shared with other investigators if requested. The investigators will publish our study protocol. Published papers will be made available in portable document format.