A Telehealth Advance Care Planning Intervention

Acute Myeloid Leukemia Clinical Trial

— TeleSICP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05875805
• Other study ID #: UOCPC23038
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: University of Rochester
• Contact: Kah Poh Loh, MD
• Phone: 585-276-4353
• Email: Kahpoh_Loh[@]URMC.Rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 207
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion and Exclusion Criteria for Patients

Inclusion Criteria:

• Age =60 years

• A diagnosis of acute myeloid leukemia, myelodysplastic syndrome (MDS), or similar myeloid malignancies (including but not limited to MDS/myeloproliferative neoplasms 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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasm
• Myelofibrosis
• Myeloid Malignancy
• Myeloproliferative Disorders
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Month 2
Secondary	Distress: Distress Thermometer	1-item question for distress, range 0-10; higher scores indicate greater distress	Month 2
Secondary	Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)	7-item screening tool for anxiety symptoms, total range 0-21); higher scores indicate greater anxiety symptoms	Month 2
Secondary	Completion of advance directives	Percentage of patients who complete advance directives which include the Medical or Physician Orders for Life-Sustaining Treatment (MOST/POLST) forms, living will, durable power of attorney for healthcare, and healthcare proxy forms, as well as date of completion	Throughout the study, up to 2 years