Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventional

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

NCT ID: NCT05875805Sponsor: University of RochesterLast updated: 2026-04-03

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.

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.

Arms & interventions

  • BehavioralTelehealth 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).

  • OtherEducation Control

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

Outcome measures

Primary

  • Healthcare Communication: Health Care Climate Questionnaire

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

    Time frame: Month 2

Secondary

  • Distress: Distress Thermometer

    Time frame: Month 2

  • Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Month 2

  • Completion of advance directives

    Time frame: Throughout the study, up to 2 years

Eligibility criteria

Sex: AllAge: 60 Years and olderHealthy volunteers: No
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 locations (1)

University of Rochester

Rochester, New York, 14642

Recruiting
Kah Poh Loh, MD · Contact
585-276-4353kahpoh_loh@urmc.rochester.edu

References

  • LoCastro M, Sanapala C, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin HD, Watson E, Liesveld J, Huselton E, O'Dwyer K, Baran A, Flannery M, Kluger B, Loh KP. Adaptation of Serious Illness Care Program to be delivered via telehealth for older patients with hematologic malignancy. Blood Adv. 2023 May 9;7(9):1871-1884. doi: 10.1182/bloodadvances.2022008996.(PubMed)
  • LoCastro M, Sanapala C, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin H, Watson E, Liesveld J, Huselton E, O'Dwyer K, Baran A, Flannery M, Kluger BM, Loh KP. Advance care planning in older patients with acute myeloid leukemia and myelodysplastic syndromes. J Geriatr Oncol. 2023 Jan;14(1):101374. doi: 10.1016/j.jgo.2022.09.003. Epub 2022 Sep 10.(PubMed)