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Clinical Trials/NCT04625413
NCT04625413
Completed
N/A

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

University of Rochester1 site in 1 country15 target enrollmentOctober 23, 2021

Overview

Phase
N/A
Intervention
Behavioral: UR-GOAL communication tool
Conditions
Acute Myeloid Leukemia
Sponsor
University of Rochester
Enrollment
15
Locations
1
Primary Endpoint
Usefulness
Status
Completed
Last Updated
12 days ago

Overview

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.

Detailed Description

Older adults with AML and their caregivers may benefit from help and support in understanding their treatment options. This pilot study seeks to evaluate the usability and feasibility of the UR-GOAL communication tool. The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness.

Registry
clinicaltrials.gov
Start Date
October 23, 2021
End Date
October 11, 2022
Last Updated
12 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kah Poh Loh

Associate Professor - Department of Medicine, Hematology/Oncology (SMD)

University of Rochester

Eligibility Criteria

Inclusion Criteria

  • for Patients:
  • Age ≥60 years (conventional definition of older age in AML)
  • Newly diagnosed AML
  • Considering treatment
  • Able to provide informed consent
  • English-speaking
  • Inclusion Criteria for Caregivers:
  • 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

Exclusion Criteria

  • Not provided

Arms & Interventions

Experimental: Experimental Arm: single

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

Intervention: Behavioral: UR-GOAL communication tool

Outcomes

Primary Outcomes

Usefulness

Time Frame: Four weeks

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

Feasibility (Recruitment Rates)

Time Frame: Four weeks

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

Secondary Outcomes

  • Pre-post Changes in the Following Outcomes: Geriatric Depression Scale-15(Four Weeks)
  • Pre-post Changes in the Following Outcomes: General Anxiety Disorder-7(Four weeks)
  • Pre-post Changes in the Following Outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI)(Four weeks)

Study Sites (1)

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