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NCT05875805 | Not yet recruiting | Myeloid Malignancy


A Telehealth Advance Care Planning Intervention
Sponsor:

University of Rochester

Information provided by (Responsible Party):

Kah Poh Loh

Brief Summary:

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.

Condition or disease

Myeloid Malignancy

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Myelodysplastic/Myeloproliferative Neoplasm

Myelofibrosis

Intervention/treatment

Telehealth Serious Illness Care Program

Education Control

Phase

Not Applicable

Detailed Description:

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.

Study Type : Interventional
Estimated Enrollment : 207 participants
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Telehealth Advance Care Planning Intervention for Older Patients With Myeloid Malignancies: A Pilot Randomized Controlled Trial
Actual Study Start Date : April 1, 2024
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : December 31, 2025
Arm Intervention/treatment

Experimental: 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).

Behavioral: Telehealth Serious Illness Care Program

Other: Control

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

Other: Education Control

Ages Eligible for Study: 60 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion and Exclusion Criteria for Patients
  • Inclusion Criteria
    • Age ≥60 years
    • A diagnosis of acute myeloid leukemia, myelodysplastic syndrome (MDS), or similar myeloid malignancies (including but not limited to MDS/myeloproliferative neoplasms 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

  • A Telehealth Advance Care Planning Intervention

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    A Telehealth Advance Care Planning Intervention

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    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations


    Not yet recruiting

    United States, New York

    University of Rochester

    Rochester, New York, United States, 14642

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