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Completed

NCT Number: NCT04625413

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

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14623, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Feasibility (Recruitment Rates)

    Time frame: Four weeks

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

  2. 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)

Secondary outcomes

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

    Time frame: Four weeks

    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.

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

    Time frame: Four weeks

    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.

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

    Time frame: Four Weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Acronym: UR-GOAL 1

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 12, 2020
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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