Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
ID05875805

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

Led by University of Rochester · Updated on 2026-04-03

207

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the preliminary effects of a telehealth-delivered Serious Illness Care Program (SICP) on communication about healthcare, patient anxiety, distress, and completion of advance directives for older adults with acute myeloid leukemia, myelodysplastic syndrome, and related myeloid cancers. The trial is a pilot randomized study comparing this telehealth program to an education control. The SICP is designed to improve serious illness conversations between patients and their doctors through structured guidance and support. The study involves two groups: one receives the telehealth Serious Illness Care Program, which includes clinician tools like the Serious Illness Conversation Guide, patient education pamphlets on serious illness conversations, and guides for caregiver involvement. The other group receives educational materials about communication in cancer care provided by the National Cancer Institute. The intervention engages patients, caregivers, clinicians, and the healthcare system to promote better communication and planning. Participants will be assessed primarily on healthcare communication two months after starting the study. Secondary measures include distress levels, anxiety symptoms, and the completion of advance directives tracked throughout the study for up to two years. The study involves ongoing evaluations through questionnaires and monitoring to understand how the telehealth program impacts communication and patient well-being. The entire study participation timeline extends up to two years for some outcomes.

CONDITIONS

Brief Title

A Telehealth Advance Care Planning Intervention

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or older
  • Diagnosis of acute myeloid leukemia, myelodysplastic syndrome, or similar myeloid malignancies including MDS/MPN overlap syndrome and myelofibrosis
  • Managed in outpatient settings
  • Able to provide informed consent
  • English-speaking
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Outpatient Treatment

Duration - Up to 2 years

Participants engage in a telehealth intervention or receive education materials to support serious illness conversations and advance care planning.

Visits as scheduled via telehealth throughout the study period

Follow-up

Duration - Up to 2 years

Participants are monitored for healthcare communication, distress, anxiety, and completion of advance directives.

Assessments at Month 2 and ongoing monitoring up to 2 years

Trial Site Locations

Total: 1 location

1

University of Rochester

Rochester, New York, United States, 14642

Actively Recruiting

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Research Team

K

Kah Poh Loh, MD

B

Becky Gravenstede

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Adaptation of Serious Illness Care Program to be delivered via telehealth for older patients with hematologic malignancy.

Marissa LoCastro, Chandrika Sanapala, Jason H Mendler...

https://pubmed.ncbi.nlm.nih.gov/36521100