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Feasibility and Acceptability of Primary Palliative Care Intervention in Patients Undergoing Hematopoietic Stem Cell Transplantation

Feasibility and Acceptability of Primary Palliative Care Intervention in Patients Undergoing Hematopoietic Stem Cell Transplantation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06676852
Acronym
Primary PC HCT
Enrollment
40
Registered
2024-11-06
Start date
2026-01-05
Completion date
2027-03-30
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancy, Hematopoietic Cell Transplant

Keywords

palliative care, supportive care, primary palliative care, hematopoietic cell transplantation

Brief summary

Primary PC - or training HCT clinicians to deliver PC domains as part of routine practice - is an alternative model of supportive care. We have developed Sentinel, a primary PC intervention for HCT clinicians and patients. This study will assess Sentinel's feasibility and acceptability.

Detailed description

Patients hospitalized for hematopoietic cell transplantation (HCT) experience physical and psychological symptoms that lead to a deterioration in quality of life (QOL). Integrating specialty palliative care (PC) reduces physical and psychological symptom burden and improves QOL during HCT hospitalization. However, specialty PC remains unavailable and underused at many HCT centers. Primary PC - or training HCT clinicians to deliver PC domains as part of routine practice - is an alternative model of supportive care. We have developed Sentinel, a primary PC intervention for HCT clinicians and patients. We will train HCT clinicians to deliver PC to patients before and during HCT hospitalization. This study will assess Sentinel's feasibility and acceptability.

Interventions

Enrolled patient participants will receive Sentinel prior to and during their hospitalization for HCT. Prior to HCT, a transplant clinician (nurse practitioner - NP) will conduct a focused PC visit to build rapport, manage expectations regarding HCT, review anticipated symptoms, and discuss illness coping strategies. During the HCT hospitalization, HCT physicians and advanced practice providers will incorporate PC domains into their routine care of patients undergoing HCT.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER
American Society of Transplantation and Cellular Therapy
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Single arm feasibility clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years or older * Undergoing autologous or allogeneic HCT at MGH

Exclusion criteria

* Prior receipt of inpatient specialty palliative care on two prior admissions in the past 6 months. * Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary oncologist believes prohibits informed consent or ability to participate in study procedures * Inability to comprehend English as this is a preliminary/pilot study

Design outcomes

Primary

MeasureTime frameDescription
FeasibilityUp to Day 90We will assess feasibility of Sentinel based on the proportion of eligible patients who enroll and the proportion of enrolled patients retained. Sentinel will be deemed feasible if at least 60% of eligible patients are enrolled in the study and patient retention through study procedures is at least 80%, commonly utilized metrics in PC trials

Secondary

MeasureTime frameDescription
AcceptabilityAt Day 30The intervention will be acceptable for patients if at least 80% of patients report intervention satisfaction (Client Satisfaction Questionnaire mean greater than or equal 3.0/4.0)

Countries

United States

Contacts

CONTACTRichard A Newcomb, MD
richard.newcomb@mgh.harvard.edu617-996-7584

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026