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Trial Title:
A Telehealth Advance Care Planning Intervention
NCT ID:
NCT05875805
Condition:
Myeloid Malignancy
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasm
Myelofibrosis
Conditions: Official terms:
Neoplasms
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Conditions: Keywords:
Older adults
Myeloid malignancies
Geriatric hematology
Serious illness conversations
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Telehealth Serious Illness Care Program
Description:
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).
Arm group label:
Telehealth Serious Illness Care Program
Intervention type:
Other
Intervention name:
Education Control
Description:
Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) -
Patient Version"
Arm group label:
Control
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Rochester
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kah Poh Loh, MD
Phone:
585-276-4353
Email:
kahpoh_loh@urmc.rochester.edu
Contact backup:
Last name:
Cait F Sharma, MA
Phone:
585-276-5432
Email:
Cait_Fallone@URMC.rochester.edu
Start date:
May 20, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University of Rochester
Agency class:
Other
Source:
University of Rochester
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05875805
