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

Not Applicable
Completed
Conditions
Myelodysplastic Syndromes
Acute Myeloid Leukemia
Interventions
Behavioral: Telehealth
Registration Number
NCT04745676
Lead Sponsor
University of Rochester
Brief Summary

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).

Detailed Description

Older adults with AML and 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
36
Inclusion Criteria

Not provided

Exclusion Criteria

N/A

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ExperimentalTelehealthThe SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.
Primary Outcome Measures
NameTimeMethod
Feasibility - Retention Rate12 Weeks

Percentage of patients, caregivers, and clinicians who consented to the study, ultimately completing all study components

Recruitment Rate12 Weeks

Number of patients, caregivers, and clinicians who are approached and agree to enroll.

Mean Usability of the Telehealth Advance Care Planning Intervention Using the Telehealth Usability Questionnaire (TUQ)12 Weeks

Telehealth Usability Questionnaire (TUQ) - A questionnaire (22 questions scored from 1 to 7, a higher score indicates greater usability) assessing the usability of telehealth implementation across the population (for patients or caregivers), the mean of all questions is then calculated, range 1-7, with an average of greater than 5 considered usable.

Secondary Outcome Measures
NameTimeMethod
Pre- and Post-Intervention Change of the Mean Score for the General Anxiety Disorder-7 (GAD-7)12 Weeks

General Anxiety Disorder-7 (GAD-7): A 7-item screening tool for anxiety (range 0-21, higher score indicates greater anxiety symptoms)

Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer12 Weeks

Distress Thermometer: A self-reported tool to screen for symptoms of distress, using a 0-10 rating scale (higher score indicates greater distress level).

Pre- and Post-Intervention Change of the Mean Score for the Patient Health Questionnaire-9 (PHQ-9)12 Weeks

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).

Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ)12 weeks

Health Care Communication Questionnaire (HCCQ): A questionnaire assessing patients' satisfaction with patient-oncologist communication (12 items, range from 12-60), higher score indicates greater satisfaction with communication.

Pre- and Post-Intervention Change of the Mean Score for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)12 Weeks

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).

Trial Locations

Locations (1)

University of Rochester

🇺🇸

Rochester, New York, United States

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