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A Telehealth Advance Care Planning Intervention (TeleSICP)

Primary Purpose

Myeloid Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth Serious Illness Care Program
Education Control
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myeloid Malignancy focused on measuring Older adults, Myeloid malignancies, Geriatric hematology, Serious illness conversations

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Telehealth Serious Illness Care Program

Control

Arm 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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Distress: Distress Thermometer
1-item question for distress, range 0-10; higher scores indicate greater distress
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
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

Full Information

First Posted
May 16, 2023
Last Updated
May 24, 2023
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT05875805
Brief Title
A Telehealth Advance Care Planning Intervention
Acronym
TeleSICP
Official Title
A Telehealth Advance Care Planning Intervention for Older Patients With Myeloid Malignancies: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloid Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm, Myelofibrosis
Keywords
Older adults, Myeloid malignancies, Geriatric hematology, Serious illness conversations

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telehealth Serious Illness Care Program
Arm Type
Experimental
Arm 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 Title
Control
Arm Type
Other
Arm Description
Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Serious Illness Care Program
Intervention 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).
Intervention Type
Other
Intervention Name(s)
Education Control
Intervention Description
Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"
Primary Outcome Measure Information:
Title
Healthcare Communication: Health Care Climate Questionnaire
Description
5-item questionnaire assessing patients' and caregivers' satisfaction with patient-clinician communication, range 0-20; higher score is better
Time Frame
Month 2
Secondary Outcome Measure Information:
Title
Distress: Distress Thermometer
Description
1-item question for distress, range 0-10; higher scores indicate greater distress
Time Frame
Month 2
Title
Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)
Description
7-item screening tool for anxiety symptoms, total range 0-21); higher scores indicate greater anxiety symptoms
Time Frame
Month 2
Title
Completion of advance directives
Description
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
Time Frame
Throughout the study, up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kah Poh Loh
Phone
585-276-4353
Email
kahpoh_loh@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Lauren Mitchell
Phone
585-275-1192
Email
Lauren_Mitchell@URMC.rochester.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared with other investigators if requested. Published papers will be made available in portable document format.
IPD Sharing Time Frame
The data will be available for 7 years after study completion
Citations:
PubMed Identifier
36521100
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.
Results Reference
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PubMed Identifier
36100548
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.
Results Reference
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A Telehealth Advance Care Planning Intervention

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