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

March 29, 2026 updated by: Kah Poh Loh, University of Rochester
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Newly diagnosed AML (in the prior one month)

Description

Inclusion Criteria for Patients:

  • 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

Exclusion Criteria: N/A

Inclusion Criteria for Caregivers

  • 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

Exclusion Criteria: N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Telehealth
Telehealth ACP intervention advance care planning intervention
Behavioral: Control
For the control arm, no telehealth visit will be scheduled.
Experimental: 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.
Behavioral: Telehealth
Telehealth ACP intervention advance care planning intervention
Behavioral: Control
For the control arm, no telehealth visit will be scheduled.
Experimental: 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.
Behavioral: Telehealth
Telehealth ACP intervention advance care planning intervention
Behavioral: Control
For the control arm, no telehealth visit will be scheduled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility - Retention Rate
Time Frame: 12 Weeks
Percentage of patients, caregivers, and clinicians who consented to the study, ultimately completing all study components
12 Weeks
Recruitment Rate
Time Frame: 12 Weeks
Number of patients, caregivers, and clinicians who are approached and agree to enroll.
12 Weeks
Mean Usability of the Telehealth Advance Care Planning Intervention Using the Telehealth Usability Questionnaire (TUQ)
Time Frame: 12 Weeks
Telehealth Usability Questionnaire (TUQ) - A questionnaire (22 questions scored from 1 to 7, a higher score indicates greater usability) assessing the usability of telehealth implementation across the population (for patients or caregivers), the mean of all questions is then calculated, range 1-7, with an average of greater than 5 considered usable.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre- and Post-Intervention Change of the Mean Score for the General Anxiety Disorder-7 (GAD-7)
Time Frame: 12 Weeks
General Anxiety Disorder-7 (GAD-7): A 7-item screening tool for anxiety (range 0-21, higher score indicates greater anxiety symptoms)
12 Weeks
Pre- and Post-Intervention Change of the Mean Score for the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 12 Weeks
Patient Health Questionnaire-9 (PHQ-9): A 9-item valid and reliable screening tool depression in the general population (range 0-27, higher score indicates greater depressive symptoms).
12 Weeks
Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer
Time Frame: 12 Weeks
Distress Thermometer: A self-reported tool to screen for symptoms of distress, using a 0-10 rating scale (higher score indicates greater distress level).
12 Weeks
Pre- and Post-Intervention Change of the Mean Score for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
Time Frame: 12 Weeks
Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu): Consists of 17 questions on the general module and 17 leukemia-specific questions, score ranges from 0-176, higher score indicates better quality of life).
12 Weeks
Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ)
Time Frame: 12 weeks
Health Care Communication Questionnaire (HCCQ): A questionnaire assessing patients' satisfaction with patient-oncologist communication (12 items, range from 12-60), higher score indicates greater satisfaction with communication.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Kah Poh Loh, Univ. of Rochester Wilmot Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2021

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

July 12, 2023

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCCO20134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing. Published papers will be made available in portable document format.

IPD Sharing Time Frame

The data will be available for 7 years from accrual of the first subject.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myeloid Leukemia

Clinical Trials on Telehealth

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe