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

NCT04625413 | Completed Results DMC

• 1 other identifier: UCCS20090
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to evaluate the usability and feasibility of a patient-centered communication tool (University of Rochester-Geriatric Oncology Assessment for acute myeloid Leukemia or UR-GOAL) among 15 older patients with AML, their caregivers, and oncologists.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• Feasibility (Recruitment Rates)

  Percentage of patients who consented to the study ultimately completed the study intervention and post-intervention assessment

  Four weeks

• Usefulness

  Usefulness was assessed using the Preparation for Decision Making Scale (mean score range from 1 to 5, and higher scores indicate greater usefulness)

  Four weeks

Secondary Outcomes (3)

• Pre-post Changes in the Following Outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI)

  Four weeks

• Pre-post Changes in the Following Outcomes: General Anxiety Disorder-7

  Four weeks

• Pre-post Changes in the Following Outcomes: Geriatric Depression Scale-15

  Four Weeks

Study Arms (1)

Experimental: Experimental Arm: single

EXPERIMENTAL

The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness.

Behavioral: Behavioral: UR-GOAL communication tool

Interventions

Behavioral: UR-GOAL communication tool BEHAVIORAL

The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awarene

Experimental: Experimental Arm: single

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60 years (conventional definition of older age in AML)
• Newly diagnosed AML
• Considering treatment
• Able to provide informed consent
• English-speaking
• Selected by the patient when asked if there is a "family member, partner, friend or caregiver \[age 21 or older\] with whom you 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
• A practicing oncologist
• At least one of their patients are recruited to the study
• English-speaking

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14623, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. Kah Poh Loh
• Organization: University of Rochester Medical Center

kahpoh_loh@urmc.rochester.edu

585-276-4353

Study Officials

• Kah Poh Loh, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Medicine, Hematology/Oncology (SMD)

Model Details: Evaluate the usability and feasibility of a patient-centered communication tool (UR-GOAL)

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 12, 2020
• Study Start: October 23, 2021
• Primary Completion: October 11, 2022
• Study Completion: October 11, 2022
• Last Updated: April 20, 2026
• Results First Posted: March 5, 2024

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available for 7 years from accrual of the first subject.

Locations

US (1)