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
Overview
- Phase
- N/A
- Intervention
- Usual care
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- University of Rochester
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Shared Decision Making
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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.
Detailed 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.
Investigators
Kah Poh Loh
Associate Professor - Department of Medicine, Hematology/Oncology (SMD)
University of Rochester
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Usual care
Usual care
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.
Intervention: UR-GOAL
Outcomes
Primary Outcomes
Shared Decision Making
Time Frame: Within 1-4 weeks after treatment initiation
A 9-item reliable questionnaire assessing patient satisfaction with the medical decision-making process, range 0-45, higher score indicates greater shared decision making
Secondary Outcomes
- Patient-Centered Communication in Cancer Care (PCC-Ca-36)(Within 1-4 weeks after treatment initiation)