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NCT Number: NCT05875805

A Telehealth Advance Care Planning Intervention

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.

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Key information

Conditions

Myeloid Malignancy Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Neoplasm Myelofibrosis Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Primary Myelofibrosis

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

Location status: Recruiting

Location contact

Kah Poh Loh, MD

CONTACT

[email protected]

585-276-4353

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion and Exclusion Criteria for Patients

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

Exclusion criteria

  • None

Inclusion and Exclusion Criteria for Caregivers

Inclusion criteria

  • 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

Exclusion criteria

  • None

Inclusion and Exclusion Criteria for Oncology Providers

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

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).

Education Control

Other

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

Primary outcomes

  1. Healthcare Communication: Health Care Climate Questionnaire

    Time frame: Month 2

    5-item questionnaire assessing patients' and caregivers' satisfaction with patient-clinician communication, range 0-20; higher score is better

Secondary outcomes

  1. Distress: Distress Thermometer

    Time frame: Month 2

    1-item question for distress, range 0-10; higher scores indicate greater distress

  2. Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Month 2

    7-item screening tool for anxiety symptoms, total range 0-21); higher scores indicate greater anxiety symptoms

  3. Completion of advance directives

    Time frame: Throughout the study, up to 2 years

    Percentage of patients who complete advance directives which include the Medical or Physician Orders for Life-Sustaining Treatment (MOST/POLST) forms, living will, durable power of attorney for healthcare, and healthcare proxy forms, as well as date of completion

Study contacts

Contact information is provided by the study sponsor or research team.

Becky Gravenstede

CONTACT

[email protected]

585-727-4728

Kah Poh Loh, MD

CONTACT

[email protected]

585-276-4353

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

A Telehealth Advance Care Planning Intervention for Older Patients With Myeloid Malignancies: A Pilot Randomized Controlled Trial

Acronym: SICP RCT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 25, 2023
Registry last updated
Apr 3, 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.

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