A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

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 telehealth-delivered advance care planning intervention among 20 older patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), their caregivers, and oncologists.

Detailed Description
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Older adults with AMLamd MDS are more likely to receive aggressive care and less likely to utilize hospice at the end-of-life. Advance care planning (ACP) intervention delivered through telehealth may improve patient-reported outcomes and end-of-life care in this population. This pilot study seeks to evaluate the usability and feasibility of a telehealth-delivered advance care planning intervention. We will adapt the Serious Illness Care Program.

Official Title
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A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Conditions
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Acute Myeloid Leukemia, Myelodysplastic Syndromes

Intervention / Treatment
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* Behavioral: Telehealth


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/MDS) AML or MDS diagnosis Being managed in the outpatient settings Able to provide informed consent English-speaking Inclusion criteria for caregivers: Age ≥21 years Selected by patient when asked if there is a family member, partner, friend, or caregiver with whom you discuss or who can be helpful in health-related matters Able to provide informed consent English-speaking Exclusion Criteria: N/A

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. | Behavioral: Telehealth<br>* Telehealth ACP intervention advance care planning intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Retention rate | Percentage of patients consented to the study ultimately completing all study components | 12 Weeks | 
| Recruitment rate | Percentage of patients who are approached and agree to enroll | 12 Weeks | 
| Usability | Telehealth Usability Questionnaire (TUQ) - A questionnaire (22 questions scored from 1 to 7) assessing the usability of telehealth implementation, average of >5 will be considered usable. | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-post changes | Disease Understanding - A questionnaire assessing patient and caregiver's prognostic understanding of illness. | 12 Weeks | 
| Pre-post changes | General Anxiety Disorder-7 (GAD-7): A 7-item screening tool for anxiety (range 0-21, higher score indicates greater anxiety symptoms) | 12 Weeks | 
| Pre-post changes | Patient Health Questionnaire-9 (PHQ-9): A 9-item valid and reliable screening tool depression in the general population (range 0-27, higher score indicates greater depressive symptoms). This will be used for patients and caregivers | 12 Weeks | 
| Pre-post changes | Distress Thermometer: A self-reported tool to screen for symptoms of distress, using a 0-10 rating scale (higher score indicates greater distress level). This will be used for patients and caregivers | 12 Weeks | 
| Pre-post changes | Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu): Consists of 17 questions on the general module and 17 leukemia-specific questions, score ranges from 0-176, higher score indicates better quality of life). This will be used for patients. Caregiver Quality of Life Index-Cancer: Consists of 35 questions, score ranges from 0-140. This will be used for caregivers. | 12 Weeks | 
| Post-intervention only | Health Care Communication Questionnaire (HCCQ): A questionnaire assessing patients' and caregivers' satisfaction with patient-oncologist communication (12 items for patients and 17 items for caregivers, range from 12-60 and 17-85, respectively), higher score indicates greater satisfaction with communication. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia, Myelodysplastic Syndromes