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NCT05875805 | RECRUITING | Myeloid Malignancy

A Telehealth Advance Care Planning Intervention
Sponsor:

University of Rochester

Information provided by (Responsible Party):

Kah Poh

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

NA

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
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 : 2024-05-20
Estimated Primary Completion Date : 2025-09-30
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
    • A Telehealth Advance Care Planning Intervention

    Location Details

    NCT05875805

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    How to Participate

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

    Locations

    RECRUITING

    United States, New York

    University of Rochester

    Rochester, New York, United States, 14642