Hematologic MalignanciesInpatient SICPNCT05433090

An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies

A study testing Inpatient serious illness care program in people with Hematologic Malignancies, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Hematologic Malignancies
What is being tested?: Inpatient serious illness care program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteUnited States
Study dates: 23 Nov 2022to 14 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester
Rochester, New York, 14642

Other trials in United States

About this study

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

Read the 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.

Conditions: Hematologic Malignancies
Being tested: Inpatient serious illness care program
Keywords: Advance Care Planning Intervention, Serious Illness Conversation, Hematologic Malignancies
Medical subject headings: Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inpatient serious illness care programBehavioural
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.

Study groups in NCT05433090
Study group	Role	What they receive
Experimental	Experimental	Patients will participate in an inpatient advance care planning intervention. Receives: Behavioral: Inpatient serious illness care program

What is being measured

The primary outcome is the main question the study is designed to answer.

Retention Rate
Retention rate is the percentage of consented patients who completed the ACP intervention visit. A retention rate of >70% was considered feasible.
Measured: From consent until completion of the ACP intervention visit, usually within 1 week.

Secondary outcomes (2)

Advance Directive Completion - HCP
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.
Measured: From baseline (pre-intervention) to 1 year post-intervention. The time interval is approximately 1 year.
Advance Directive Completion - MOLST
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.
Measured: From baseline (pre-intervention) to 1 year post-intervention. The time interval is approximately 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Nov 202214 Nov 2024

First posted27 Jun 2022
Study start23 Nov 2022
Primary completion23 Aug 2024
Study completion14 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
More trials run by University of RochesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Model description: The intervention used in this study is an inpatient advance care planning intervention. We will adapt the Serious Illness Care Program, an evidence-based intervention that promotes serious illness conversation between patients and clinicians, to be used by advance practice providers and hematology/oncology fellow physicians in the inpatient setting.
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05433090
Sponsor's protocol ID: UOCPC22039
Acronym: Inpatient SICP
Status last verified: Mar 2026
First submitted: 21 Jun 2022
Last updated: 31 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

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.
PubMed 34525170
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
LoCastro M, Wang Y, Baran A, Mortaz Hedjri S, Frumusa D, Natale T, Cohen J, Yates N, Podlucky J, Yu T, Carroll T, Liesveld J, Baumgart M, Sabatka S, Hettler D, Kaplan N, Mendler JH, Loh KP. An inpatient Serious Illness Care Program for older patients with hematologic malignancies: a single-arm pilot study. Blood Adv. 2026 Jun 23;10(12):4412-4422. doi: 10.1182/bloodadvances.2025018200.
PubMed 41949389

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hematologic Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies
ClinicalTrials.gov ID: NCT05433090
Acronym / sponsor ID: Inpatient SICP / UOCPC22039
Conditions: Hematologic Malignancies
Keywords: Advance Care Planning Intervention, Serious Illness Conversation, Hematologic Malignancies
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Study start: 23 Nov 2022 (actual)
Primary completion: 23 Aug 2024 (actual)
Study completion: 14 Nov 2024 (actual)
First posted: 27 Jun 2022 (actual)
Results: Posted 10 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The intervention used in this study is an inpatient advance care planning intervention. We will adapt the Serious Illness Care Program, an evidence-based intervention that promotes serious illness conversation between patients and clinicians, to be used by advance practice providers and hematology/oncology fellow physicians in the inpatient setting.

Arm	Type	Receives
Experimental	Experimental	Behavioral: Inpatient serious illness care programPatients will participate in an inpatient advance care planning intervention.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inpatient serious illness care programInpatient 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.	Behavioural	Experimental

Primary outcome

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.

2 secondary outcomes

Advance Directive Completion - HCP
Time frame: 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.

Results and safety

Results posted to the registry on 10 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Advanced Care Planning	41	35

Primary outcome: Retention Rate

Time frame: From consent until completion of the ACP intervention visit, usually within 1 week.. Count of participants. Unit: Participants

Measure	Advanced Care Planning n = 41
Retained - completed ACP intervention	38
Not retained - didn't complete ACP intervention	3

Population analysed: All consented participants who underwent baseline assessment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Patient adverse events and mortality were collected and reported from enrollment until the end of follow-up, up to approximately 2 months after enrollment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Advanced Care Planning	0 of 41 (0%)	0 of 41 (0%)	2 of 41

Limitations and caveats (from the sponsor): This was a single-center study with a relatively small sample size (enrolled n=41).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34525170LoCastro 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.
Results publicationMarissa 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
Derived from this study: PubMed 41949389LoCastro M, Wang Y, Baran A, Mortaz Hedjri S, Frumusa D, Natale T, Cohen J, Yates N, Podlucky J, Yu T, Carroll T, Liesveld J, Baumgart M, Sabatka S, Hettler D, Kaplan N, Mendler JH, Loh KP. An inpatient Serious Illness Care Program for older patients with hematologic malignancies: a single-arm pilot study. Blood Adv. 2026 Jun 23;10(12):4412-4422. doi: 10.1182/bloodadvances.2025018200.
Individual participant dataSharing planned: Yes. 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.

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RecruitingPhase 2
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Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kah Poh Loh principal investigator

University of Rochester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Inpatient serious illness care program in people with Hematologic Malignancies, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention Rate (time frame: From consent until completion of the ACP intervention visit, usually within 1 week.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05433090, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.