Clinical trial NCT05875805: A Telehealth Advance Care Planning Intervention
Official title: A Telehealth Advance Care Planning Intervention for Older Patients With Myeloid Malignancies: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myeloid Malignancy
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasm
Myelofibrosis
Keywords: Older adults
Myeloid malignancies
Geriatric hematology
Serious illness conversations
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 207
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Healthcare Communication: Health Care Climate Questionnaire
timeFrame: Month 2
Secondary outcomes:
measure: Distress: Distress Thermometer
timeFrame: Month 2
measure: Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Month 2
measure: Completion of advance directives
timeFrame: Throughout the study, up to 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Kah Poh Loh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.