A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
SICG
1 other identifier
interventional
36
1 country
1
Brief Summary
This is a pilot study to evaluate the usability and feasibility of a telehealth-delivered advance care planning intervention among 20 older patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2021
CompletedFirst Posted
Study publicly available on registry
February 9, 2021
CompletedStudy Start
First participant enrolled
March 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2023
CompletedResults Posted
Study results publicly available
February 10, 2025
CompletedMarch 31, 2026
March 1, 2026
1.9 years
February 4, 2021
March 20, 2024
March 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility - Retention Rate
Percentage of patients, caregivers, and clinicians who consented to the study, ultimately completing all study components
12 Weeks
Recruitment Rate
Number of patients, caregivers, and clinicians who are approached and agree to enroll.
12 Weeks
Mean Usability of the Telehealth Advance Care Planning Intervention Using the Telehealth Usability Questionnaire (TUQ)
Telehealth Usability Questionnaire (TUQ) - A questionnaire (22 questions scored from 1 to 7, a higher score indicates greater usability) assessing the usability of telehealth implementation across the population (for patients or caregivers), the mean of all questions is then calculated, range 1-7, with an average of greater than 5 considered usable.
12 Weeks
Secondary Outcomes (5)
Pre- and Post-Intervention Change of the Mean Score for the General Anxiety Disorder-7 (GAD-7)
12 Weeks
Pre- and Post-Intervention Change of the Mean Score for the Patient Health Questionnaire-9 (PHQ-9)
12 Weeks
Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer
12 Weeks
Pre- and Post-Intervention Change of the Mean Score for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
12 Weeks
Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ)
12 weeks
Study Arms (3)
Patient
EXPERIMENTALThe SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.
Caregiver
EXPERIMENTALThe SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.
Oncology and Palliative Provider
EXPERIMENTALThe SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.
Interventions
Telehealth ACP intervention advance care planning intervention
For the control arm, no telehealth visit will be scheduled.
Eligibility Criteria
You may qualify if:
- Age ≥60 years (conventional definition of older age in AML/MDS)
- AML or MDS diagnosis
- Being managed in the outpatient settings
- Able to provide informed consent
- English-speaking
You may not qualify if:
- Age ≥21 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester
Rochester, New York, 14642, United States
Related Publications (3)
LoCastro M, Wang Y, Yu T, Mortaz-Hedjri S, Mendler J, Norton S, Bernacki R, Carroll T, Klepin H, Wedow L, Goonan S, Erdos H, Bagnato B, Liesveld J, Huselton E, Kluger B, Loh KP. Clinicians' Perspectives on the Telehealth Serious Illness Care Program for Older Adults With Myeloid Malignancies: Single-Arm Pilot Study. JMIR Form Res. 2024 Jun 27;8:e58503. doi: 10.2196/58503.
PMID: 38935428DERIVEDLoCastro M, Mortaz-Hedjri S, Wang Y, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin H, Liesveld J, Huselton E, Kluger B, Loh KP. Telehealth serious illness care program for older adults with hematologic malignancies: a single-arm pilot study. Blood Adv. 2023 Dec 26;7(24):7597-7607. doi: 10.1182/bloodadvances.2023011046.
PMID: 38088668DERIVEDLoCastro 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.
PMID: 36521100DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Research Project Manager
- Organization
- University of Rochester Medical Center, Wilmot Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Kah Poh Loh
Univ. of Rochester Wilmot Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor - Department of Medicine, Hematology/Oncology (SMD)
Study Record Dates
First Submitted
February 4, 2021
First Posted
February 9, 2021
Study Start
March 25, 2021
Primary Completion
March 1, 2023
Study Completion
July 12, 2023
Last Updated
March 31, 2026
Results First Posted
February 10, 2025
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be available for 7 years from accrual of the first subject.
A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing. Published papers will be made available in portable document format.