A Telehealth Advance Care Planning Intervention

NCT ID: NCT05875805

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Telehealth Serious Illness Care Program

Intervention Type 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).

Control

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

Group Type OTHER

Education Control

Intervention Type OTHER

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

Interventions

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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).

Intervention Type BEHAVIORAL

Education Control

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

Intervention Type OTHER

Eligibility Criteria

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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


* 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


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

Exclusion Criteria

\- None



\- None



\- None
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Kah Poh Loh

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kah Poh Loh

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kah Poh Loh, MD

Role: CONTACT

585-276-4353

Becky Gravenstede

Role: CONTACT

585-727-4728

Facility Contacts

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Kah Poh Loh, MD

Role: primary

585-276-4353

References

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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.

Reference Type BACKGROUND
PMID: 36521100 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36100548 (View on PubMed)

Other Identifiers

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UOCPC23038

Identifier Type: -

Identifier Source: org_study_id

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