A Telehealth Advance Care Planning Intervention

NCT05875805 | Recruiting DMC

• 1 other identifier: UOCPC23038
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloid Malignancy; Acute Myeloid Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasm; Myelofibrosis

Keywords

Older adults; Myeloid malignancies; Geriatric hematology; Serious illness conversations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Arms (2)

Telehealth Serious Illness Care Program

EXPERIMENTAL

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

Control

OTHER

Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"

Other: Education Control

Interventions

Telehealth Serious Illness Care Program BEHAVIORAL

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).

Telehealth Serious Illness Care Program

Education Control OTHER

Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• \- None
• 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
• \- None
• \- Oncologists and/or APPs who will be conducting the telehealth-delivered ACP visit
• \- None

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 36521100 BACKGROUND

• 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.

  PMID: 36100548 BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Myeloproliferative Disorders

Study Officials

• Kah Poh Loh

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kah Poh Loh, MD

CONTACT

585-276-4353; Kahpoh_Loh@URMC.Rochester.edu

Becky Gravenstede

CONTACT

585-727-4728; becky_gravenstede@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Medicine, Hematology/Oncology (SMD)

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: May 20, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available for 7 years after study completion

Locations

US (1)