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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Behavioral: Behavioral: UR-GOAL communication tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Evaluate the usability and feasibility of a patient-centered communication tool (UR-GOAL)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Experimental Arm: single<br>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<br>* The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awarene<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Recruitment rates (percentage of patients who are approached and agree to enroll) | One week | 
| System Usability Scale | Score on 10-item scale, ranging 0-100; higher score corresponds to greater usability | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Two weeks | 
| Pre-post changes in the following outcomes: Disease Knowledge | A 14-item questionnaire assessing patients and caregivers' understanding of AML; ranging 0-14; higher score corresponds to greater understanding | Two weeks | 
| Pre-post changes in the following outcomes: Disease Understanding | A questionnaire assessing patient and caregiver's prognostic understanding of illness and preferences regarding life expectancy discussions. | Two weeks | 
| 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 | Two weeks | 
| 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 | Two Weeks | 
| Pre-post changes in the following outcomes: Patient Health Questionnaire-2 (PHQ-2 | 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 | Two weeks | 
| Pre-post changes in the following outcomes: Caregiver Ryff's Environmental Mastery | 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 | Two weeks | 
| Post-intervention only: Health Care Communication Questionnaire | 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. | Two weeks | 
| Post-intervention only: Shared Decision-Making Questionnaire (SDM-Q-9) | A 9-item reliable questionnaire assessing patient satisfaction with the medical decision-making process. Ranging 6-54, greater score corresponds to greater satisfaction | Two weeks | 
| Preparation for Decision Making Scale | A 10-item questionnaire assessing effect of the educational material on decision making. Ranging 10-100, greater score corresponds to greater preparation. | Two weeks |