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Clinical Trials/NCT04745676
NCT04745676
Completed
N/A

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

University of Rochester1 site in 1 country36 target enrollmentMarch 25, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Myeloid Leukemia
Sponsor
University of Rochester
Enrollment
36
Locations
1
Primary Endpoint
Feasibility - Retention Rate
Status
Completed
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 25, 2021
End Date
July 12, 2023
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kah Poh Loh

Associate Professor - Department of Medicine, Hematology/Oncology (SMD)

University of Rochester

Eligibility Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Feasibility - Retention Rate

Time Frame: 12 Weeks

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

Recruitment Rate

Time Frame: 12 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)

Time Frame: 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 Outcomes

  • Pre- and Post-Intervention Change of the Mean Score for the General Anxiety Disorder-7 (GAD-7)(12 Weeks)
  • Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer(12 Weeks)
  • Pre- and Post-Intervention Change of the Mean Score for the Patient Health Questionnaire-9 (PHQ-9)(12 Weeks)
  • Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ)(12 weeks)
  • Pre- and Post-Intervention Change of the Mean Score for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)(12 Weeks)

Study Sites (1)

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