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Clinical Trials/NCT05875805
NCT05875805
Recruiting
N/A

A Telehealth Advance Care Planning Intervention for Older Patients With Myeloid Malignancies: A Pilot Randomized Controlled Trial

University of Rochester1 site in 1 country207 target enrollmentMay 20, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Myeloid Malignancy
Sponsor
University of Rochester
Enrollment
207
Locations
1
Primary Endpoint
Healthcare Communication: Health Care Climate Questionnaire
Status
Recruiting
Last Updated
3 months ago

Overview

Brief Summary

The objective of this project is to conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program on healthcare communication, patient anxiety and distress, as well as completion of advance directives (specifically MOLST and healthcare proxy forms) for older patients with acute myeloid leukemia, myelodysplastic syndrome, and similar myeloid malignancies.

Detailed Description

The Serious Illness Care Program (SICP) is an evidence-based intervention to enhance serious illness conversations between physicians and patients with advanced cancer. It consists of the Serious Illness Conversation Guide as well as training and system-level support for clinicians to conduct serious illness conversations. The investigators have previously adapted the SICP to be delivered via telehealth for older adults with myeloid malignancies. In this study, they will conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program compared to an education control.

Registry
clinicaltrials.gov
Start Date
May 20, 2024
End Date
December 31, 2027
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
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

  • Inclusion and

Exclusion Criteria

  • for Patients
  • Inclusion criteria:
  • Age ≥60 years
  • A diagnosis of AML, MDS, and similar myeloid malignancies (including but not limited to MDS/MPN overlap syndrome, myelofibrosis)
  • Being managed in the outpatient settings
  • Able to provide informed consent
  • English-speaking
  • Exclusion criteria:
  • Inclusion and Exclusion Criteria for Caregivers
  • Inclusion criteria:

Outcomes

Primary Outcomes

Healthcare Communication: Health Care Climate Questionnaire

Time Frame: Month 2

5-item questionnaire assessing patients' and caregivers' satisfaction with patient-clinician communication, range 0-20; higher score is better

Secondary Outcomes

  • Distress: Distress Thermometer(Month 2)
  • Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)(Month 2)
  • Completion of advance directives(Throughout the study, up to 2 years)

Study Sites (1)

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