Recruiting

Telehealth Intervention

Sponsor:

University of Rochester

Code:

NCT05875805

Conditions

Myeloid Malignancy

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Myelodysplastic/Myeloproliferative Neoplasm

Myelofibrosis

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Telehealth Serious Illness Care Program

Education Control

Study Details

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.

Conditions

Myeloid Malignancy

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Myelodysplastic/Myeloproliferative Neoplasm

Myelofibrosis

Study ID

NCT05875805

Start date

May 20, 2024

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

207 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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).

other: Control

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

Interventions

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).

Education Control

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

Primary outcome measure

  • Healthcare Communication: Health Care Climate Questionnaire [ Time Frame: Month 2 ]

Central Contacts and Locations

Central contacts

Kah Poh Loh, MD

585-276-4353Kahpoh_Loh@URMC.Rochester.edu

Becky Gravenstede

585-727-4728becky_gravenstede@urmc.rochester.edu

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Kah Poh Loh, MD

585-276-4353kahpoh_loh@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Sep 11, 2026

Last verified

Jul, 2026

Keywords

  • Older adults
  • Myeloid malignancies
  • Geriatric hematology
  • Serious illness conversations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.