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

Sponsor
University of Rochester (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04625413
Collaborator
(none)
15
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral: UR-GOAL communication tool
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Evaluate the usability and feasibility of a patient-centered communication tool (UR-GOAL)Evaluate the usability and feasibility of a patient-centered communication tool (UR-GOAL)
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Feasibility [One week]

    Recruitment rates (percentage of patients who are approached and agree to enroll)

  2. System Usability Scale [Two weeks]

    Score on 10-item scale, ranging 0-100; higher score corresponds to greater usability

Secondary Outcome Measures

  1. Pre-post changes in the following outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI) [Two 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

  2. Pre-post changes in the following outcomes: Disease Knowledge [Two weeks]

    A 14-item questionnaire assessing patients and caregivers' understanding of AML; ranging 0-14; higher score corresponds to greater understanding

  3. Pre-post changes in the following outcomes: Disease Understanding [Two weeks]

    A questionnaire assessing patient and caregiver's prognostic understanding of illness and preferences regarding life expectancy discussions.

  4. Pre-post changes in the following outcomes: General Anxiety Disorder-7 [Two weeks]

    A 7-item screening tool for anxiety; ranging 7-21; higher score corresponds to greater anxiety symptoms

  5. Pre-post changes in the following outcomes: Geriatric Depression Scale-15 [Two 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

  6. Pre-post changes in the following outcomes: Patient Health Questionnaire-2 (PHQ-2 [Two weeks]

    A 2-item valid and reliable screening tool depression in the general population. This will be used for caregivers. Ranging 0-6; higher score corresponds to greater depressive symptoms

  7. Pre-post changes in the following outcomes: Caregiver Ryff's Environmental Mastery [Two weeks]

    A 7-item questionnaire measuring whether the respondent makes effective use of opportunities and has a sense of mastery in managing environmental factors and activities, including managing everyday affairs and creating situations to benefit personal needs. Ranging 7-35; higher score corresponds to greater depressive

  8. Post-intervention only: Health Care Communication Questionnaire [Two weeks]

    A questionnaire assessing patients' and caregivers' satisfaction with patient-oncologist communication. 1) Satisfaction with communication about overall health, 6-items, ranging from 6-30, greater score corresponds to greater satisfaction; 2) Satisfaction with communication about aging-related concerns, ranging from 7-35, greater score corresponds to greater satisfaction.

  9. Post-intervention only: Shared Decision-Making Questionnaire (SDM-Q-9) [Two weeks]

    A 9-item reliable questionnaire assessing patient satisfaction with the medical decision-making process. Ranging 6-54, greater score corresponds to greater satisfaction

  10. Preparation for Decision Making Scale [Two weeks]

    A 10-item questionnaire assessing effect of the educational material on decision making. Ranging 10-100, greater score corresponds to greater preparation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Rochester Medical Center Rochester New York United States 14623

Sponsors and Collaborators

  • University of Rochester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kah Poh Loh, Senior Instructor, Department of Medicine-Hematology/Oncology, University of Rochester
ClinicalTrials.gov Identifier:
NCT04625413
Other Study ID Numbers:
  • UCCS20090
First Posted:
Nov 12, 2020
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022