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

Acute Myeloid Leukemia Clinical Trial

— UR-GOAL 2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05335369
• Other study ID #: UOCPC22010
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: Kah Poh Loh
• Phone: 585-275-4401
• Email: kahpoh_loh[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to conduct a pilot randomized trial to evaluate the preliminary efficacy of the UR-GOAL tool vs. usual care in improving shared decision making and communication between 100 older patients with AML and their oncologists.

Description:

The investigators have developed a patient-centered communication tool (University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia or UR-GOAL) that 1) conducts assessments of fitness, 2) elicits patient values via Best-Worst Scaling, and 3) elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video. The investigators have refined the tool based on feedback from stakeholders consisting of older patients with cancer, caregivers, and oncologists. This was further adapted in a qualitative study of 15 older patients with AML. In a single arm pilot study, the investigators have demonstrated feasibility of recruiting older patients with newly diagnosed AML to a single arm study, as well as their caregivers and oncologists.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

Patients

1. Age =60 years

2. Newly diagnosed AML or being worked up for possible AML

3. Able to provide informed consent

4. Agreement of their oncologist to participate in the study

5. 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

1. 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

2. Able to provide informed consent

3. English-speaking

Oncologists

1. A practicing oncologist

2. At least one of their patients are recruited to the study

3. English-speaking

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Behavioral:
• UR-GOAL
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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Loh 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient-Centered Communication in Cancer Care (PCC-Ca-36)	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. Scores in each domain range from 1-5, higher scores indicate better communication. Scores are reported in each domain and overall.	Within 1-4 weeks after treatment initiation