Skip to main content
OpenTrials
Completed

NCT Number: NCT04745676

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telehealth

Behavioral

Telehealth ACP intervention advance care planning intervention

Control

Behavioral

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

Primary outcomes

  1. Feasibility - Retention Rate

    Time frame: 12 Weeks

    Percentage of patients, caregivers, and clinicians who consented to the study, ultimately completing all study components

  2. Recruitment Rate

    Time frame: 12 Weeks

    Number of patients, caregivers, and clinicians who are approached and agree to enroll.

  3. 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.

Secondary outcomes

  1. 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)

  2. 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).

  3. 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).

  4. 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).

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Acronym: SICG

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2021
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.