- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05433090
An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies (Inpatient SICP)
March 29, 2026 updated by: Kah Poh Loh, University of Rochester
This is a pilot study to assess the preliminary efficacy of an inpatient advance care planning intervention on outcomes in older patients with hematologic malignancies
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Older adults with hematologic malignancies receive more aggressive inpatient care at the end of life compared to patients with solid tumors.
Advance care planning may promote early serious illness conversations for patients with hematologic malignancies, leading to less aggressive healthcare utilization at the end of life.
This pilot aims to assess the preliminary efficacy of an inpatient advance care planning intervention on outcomes in older patients with hematologic malignancies.
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥60 years
- A diagnosis of hematologic malignancy [including but not limited to acute leukemia, myeloid malignancies (e.g., atypical CML, MDS/MPN overlap syndromes, CMML), multiple myeloma, lymphoma, or any other hematologic malignancies based on the primary oncologist's judgment]
- Able to provide informed consent
- Being managed in the inpatient setting
- English-speaking
Exclusion Criteria:
• None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Patients will participate in an inpatient advance care planning intervention.
|
Inpatient advance care planning intervention that will be delivered by advanced care practitioners or hematology/oncology fellow physicians.
The intervention will be an adapted version of the serious illness care program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention Rate
Time Frame: From consent until completion of the ACP intervention visit, usually within 1 week.
|
Retention rate is the percentage of consented patients who completed the ACP intervention visit.
A retention rate of >70% was considered feasible.
|
From consent until completion of the ACP intervention visit, usually within 1 week.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Advance Directive Completion - HCP
Time Frame: From baseline (pre-intervention) to 1 year post-intervention. The time interval is approximately 1 year.
|
Data on the patient's completion of scanned healthcare proxy form that was completed with their physician was collected via the electronic medical record.
This is expressed as a percentage.
|
From baseline (pre-intervention) to 1 year post-intervention. The time interval is approximately 1 year.
|
|
Advance Directive Completion - MOLST
Time Frame: From baseline (pre-intervention) to 1 year post-intervention. The time interval is approximately 1 year.
|
Data on the patient's completion of scanned medical order for life sustaining treatment (MOLST) form that was completed with their clinician was collected via the electronic medical record.
This is expressed as a percentage.
|
From baseline (pre-intervention) to 1 year post-intervention. The time interval is approximately 1 year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kah Poh Loh, University of Rochester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- LoCastro M, Baran AM, Liesveld JL, Huselton E, Becker MW, O'Dwyer KM, Aljitawi OS, Baumgart M, Snyder E, Kluger B, Loh KP, Mendler JH. Portable medical orders and end-of-life measures in acute myeloid leukemia and myelodysplastic syndromes. Blood Adv. 2021 Dec 28;5(24):5554-5564. doi: 10.1182/bloodadvances.2021004775.
- Marissa Locastro, Ying Wang, Soroush Mortaz-Hedjri, Danielle Frumusa, Tracy Natale, Jessica Cohen, Nicole Yates, Jenna Podlucky, Tristan Yu, Thomas Carroll, Jane L. Liesveld, Megan Baumgart, Sandra Sabtka, Dwight Hettler, Nicole Kaplan, Jason H. Mendler, Kah Poh Loh; An Inpatient Advance Care Planning Intervention for Older Patients with Hematologic Malignancies: A Single-Arm Pilot Study. Blood 2024; 144 (Supplement 1): 5054. doi: https://doi.org/10.1182/blood-2024-206137
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 23, 2022
Primary Completion (Actual)
August 23, 2024
Study Completion (Actual)
November 14, 2024
Study Registration Dates
First Submitted
June 21, 2022
First Submitted That Met QC Criteria
June 21, 2022
First Posted (Actual)
June 27, 2022
Study Record Updates
Last Update Posted (Actual)
March 31, 2026
Last Update Submitted That Met QC Criteria
March 29, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOCPC22039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
A final study protocol including a description of the study participants, measurements, data, and analyses will be available on clinicaltrials.gov
before the results are published.
IPD Sharing Time Frame
Data will be available for 7 years after the study closes, from approximately November 15, 2025 until November 15, 2030.
IPD Sharing Access Criteria
The protocol is publicly available on ClinicalTrials.gov.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hematologic Malignancies
-
Fondazione EMN Italy OnlusCompletedHEMATOLOGIC MALIGNANCIESItaly
-
Cooperative Study Group A for HematologyCompletedHEMATOLOGIC MALIGNANCIESKorea, Republic of
-
Chia Tai Tianqing Pharmaceutical Group Nanjing...RecruitingAdvanced Hematologic MalignanciesChina
-
Washington University School of MedicineRecruitingPediatric Hematologic MalignanciesUnited States
-
University of UtahTerminatedHigh Risk Hematologic MalignanciesUnited States
-
King Faisal Specialist Hospital & Research CenterCompletedTransplantation for Hematologic MalignanciesSaudi Arabia
-
University of California, DavisCompletedHematologic MalignanciesUnited States
-
Precision BioSciences, Inc.CompletedHematologic Malignancy | CD19 Expressing MalignanciesUnited States
-
Tel-Aviv Sourasky Medical CenterMeir Medical Center; Max Planck Institute for Infection BiologyUnknownPediatric Solid Malignancies | Pediatric Hematological MalignanciesIsrael
-
Millennium Pharmaceuticals, Inc.CompletedAdvanced Solid Malignancies | Hematologic MalignanciesUnited States
Clinical Trials on Inpatient serious illness care program
-
Oregon Health and Science UniversityUniversity of Colorado, Denver; University of Iowa; University of Wisconsin,... and other collaboratorsActive, not recruitingCardiovascular Diseases | Cancer | Chronic Obstructive Pulmonary Disease | Frail Elderly Syndrome | Cerebrovascular Accident | Congestive Heart FailureUnited States, Canada
-
University of RochesterRecruitingAcute Myeloid Leukemia | Myelodysplastic Syndromes | Myelofibrosis | Myeloid Malignancy | Myelodysplastic/Myeloproliferative NeoplasmUnited States
-
Ohio State University Comprehensive Cancer CenterNot yet recruitingMalignant Solid Neoplasm | Endocrine Gland Neoplasms | Breast Carcinoma | Malignant Female Reproductive System Neoplasm | Malignant Thoracic Neoplasm | Malignant Head and Neck Neoplasm | Malignant Digestive System Neoplasm | Central Nervous System Neoplasm | Soft Tissue Neoplasm | Skin Neoplasm | Malignant... and other conditionsUnited States
-
Dartmouth-Hitchcock Medical CenterAmerican Cancer Society, Inc.CompletedCommunicationUnited States
-
Daren K. HeylandTerminated
-
Southcentral FoundationUniversity of Colorado, Denver; University of Washington; Washington State University and other collaboratorsCompletedAdvance Care PlanningUnited States
-
Case Western Reserve UniversityMagnolia Clubhouse; The CentersNot yet recruitingSchizophrenia | Schizo Affective Disorder | Schizophreniform DisordersUnited States
-
Stanford UniversityTerminatedHepatocellular Carcinoma | Gastric Cancer | Colorectal Cancer | Esophageal Cancer | Pancreatic Adenocarcinoma | Neuroendocrine Tumors | Cholangiocarcinoma | Gastrointestinal Cancer | GIST, MalignantUnited States
-
Cumhuriyet UniversityNot yet recruitingSchizophrenia | Schizoaffective Disorder | Major Depressive Disorder With Psychotic Features | Bipolar Disorder With Psychotic Features
-
Universitätsklinikum Hamburg-EppendorfWuerzburg University Hospital; University of Kassel; University DüsseldorfRecruitingAdvanced Cancer, Various, NOSGermany