A Telehealth Advance Care Planning Intervention (SICP RCT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes; Myelofibrosis; Myeloid Malignancy; Myelodysplastic/Myeloproliferative Neoplasm
• Intervention / Treatment: Behavioral: Telehealth Serious Illness Care Program; Other: Education Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 207
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kah Poh Loh, MD; Phone Number: 585-276-4353; Email: kahpoh_loh@urmc.rochester.edu
• Study Contact Backup: Name: Becky Gravenstede; Phone Number: 585-727-4728; Email: becky_gravenstede@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester
      • Contact: Kah Poh Loh, MD; Phone Number: 585-276-4353; Email: kahpoh_loh@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

- None

Inclusion and Exclusion Criteria for Caregivers

Inclusion criteria:

• Age ≥18 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:

- None

Inclusion and Exclusion Criteria for Oncology Providers

Inclusion criteria:

- Oncologists and/or APPs who will be conducting the telehealth-delivered ACP visit

Exclusion criteria:

- None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth Serious Illness Care Program; The adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide).	Behavioral: Telehealth Serious Illness Care Program; The adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide).
Other: Control; Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"	Other: Education Control; Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Communication: Health Care Climate Questionnaire	5-item questionnaire assessing patients' and caregivers' satisfaction with patient-clinician communication, range 0-20; higher score is better	Month 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distress: Distress Thermometer	1-item question for distress, range 0-10; higher scores indicate greater distress	Month 2
Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)	7-item screening tool for anxiety symptoms, total range 0-21); higher scores indicate greater anxiety symptoms	Month 2
Completion of advance directives	Percentage of patients who complete advance directives which include the Medical or Physician Orders for Life-Sustaining Treatment (MOST/POLST) forms, living will, durable power of attorney for healthcare, and healthcare proxy forms, as well as date of completion	Throughout the study, up to 2 years

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Kah Poh Loh, University of Rochester

Publications and helpful links

General Publications

• LoCastro M, Sanapala C, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin HD, Watson E, Liesveld J, Huselton E, O'Dwyer K, Baran A, Flannery M, Kluger B, Loh KP. Adaptation of Serious Illness Care Program to be delivered via telehealth for older patients with hematologic malignancy. Blood Adv. 2023 May 9;7(9):1871-1884. doi: 10.1182/bloodadvances.2022008996.
• LoCastro M, Sanapala C, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin H, Watson E, Liesveld J, Huselton E, O'Dwyer K, Baran A, Flannery M, Kluger BM, Loh KP. Advance care planning in older patients with acute myeloid leukemia and myelodysplastic syndromes. J Geriatr Oncol. 2023 Jan;14(1):101374. doi: 10.1016/j.jgo.2022.09.003. Epub 2022 Sep 10.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Older adults; Myeloid malignancies; Geriatric hematology; Serious illness conversations
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Bone Marrow Diseases; Leukemia; Myeloproliferative Disorders; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Primary Myelofibrosis
• Other Study ID Numbers: UOCPC23038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared with other investigators if requested. Published papers will be made available in portable document format.
• IPD Sharing Time Frame: The data will be available for 7 years after study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No