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

NCT ID: NCT04745676

Last Updated: 2025-09-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-25

Study Completion Date

2023-07-12

Brief Summary

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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

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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.

Conditions

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Acute Myeloid Leukemia Myelodysplastic Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patient

The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.

Group Type EXPERIMENTAL

Telehealth

Intervention Type BEHAVIORAL

Telehealth ACP intervention advance care planning intervention

Control

Intervention Type BEHAVIORAL

For the control arm, no telehealth visit will be scheduled.

Caregiver

The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.

Group Type EXPERIMENTAL

Telehealth

Intervention Type BEHAVIORAL

Telehealth ACP intervention advance care planning intervention

Control

Intervention Type BEHAVIORAL

For the control arm, no telehealth visit will be scheduled.

Oncology and Palliative Provider

The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.

Group Type EXPERIMENTAL

Telehealth

Intervention Type BEHAVIORAL

Telehealth ACP intervention advance care planning intervention

Control

Intervention Type BEHAVIORAL

For the control arm, no telehealth visit will be scheduled.

Interventions

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Telehealth

Telehealth ACP intervention advance care planning intervention

Intervention Type BEHAVIORAL

Control

For the control arm, no telehealth visit will be scheduled.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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


* 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
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

Univ. of Rochester Wilmot Cancer Center

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

References

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LoCastro M, Wang Y, Yu T, Mortaz-Hedjri S, Mendler J, Norton S, Bernacki R, Carroll T, Klepin H, Wedow L, Goonan S, Erdos H, Bagnato B, Liesveld J, Huselton E, Kluger B, Loh KP. Clinicians' Perspectives on the Telehealth Serious Illness Care Program for Older Adults With Myeloid Malignancies: Single-Arm Pilot Study. JMIR Form Res. 2024 Jun 27;8:e58503. doi: 10.2196/58503.

Reference Type DERIVED
PMID: 38935428 (View on PubMed)

LoCastro M, Mortaz-Hedjri S, Wang Y, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin H, Liesveld J, Huselton E, Kluger B, Loh KP. Telehealth serious illness care program for older adults with hematologic malignancies: a single-arm pilot study. Blood Adv. 2023 Dec 26;7(24):7597-7607. doi: 10.1182/bloodadvances.2023011046.

Reference Type DERIVED
PMID: 38088668 (View on PubMed)

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 DERIVED
PMID: 36521100 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UCCO20134

Identifier Type: -

Identifier Source: org_study_id

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