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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04625413
• Other study ID #: UCCS20090
• Status: Completed
• Phase: N/A
• Start date: October 23, 2021
• Est. completion date: October 11, 2022

Study information

• Verified date: March 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 11, 2022
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Inclusion Criteria for Oncologists:

• A practicing oncologist

• At least one of their patients are recruited to the study

• English-speaking

Exclusion Criteria: None

Related Conditions & MeSH terms

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

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (Recruitment Rates)	Percentage of patients who consented to the study ultimately completed the study intervention and post-intervention assessment	Four weeks
Primary	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	Pre-post Changes in the Following Outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI)	A valid and reliable assessment of perceived self-efficacy of older patients interacting with physicians; score on 5-item scale, ranging 5-25; higher score corresponds to greater perceived efficacy. Pre-post changes from baseline to four weeks.	Four weeks
Secondary	Pre-post Changes in the Following Outcomes: General Anxiety Disorder-7	A 7-item screening tool for anxiety; ranging 7-21; higher score corresponds to greater anxiety symptoms. Pre-post changes from baseline to four weeks.	Four weeks
Secondary	Pre-post Changes in the Following Outcomes: Geriatric Depression Scale-15	A 15-item valid and reliable screening tool for depression in older adults. This will be used for patients; ranging 0-15; higher score corresponds to greater depressive symptoms. Pre-post changes from baseline to four weeks.	Four Weeks