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

Not Applicable

Not yet recruiting

• Conditions: Hematopoietic Cell Transplant; Hematologic Malignancy

• Registration Number: NCT06676852
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-05
• Last Update Submitted: 2024-11-05
• Study First Posted: 2024-11-06
• Last Update Posted: 2024-11-06
• Study Start: 2024-11-20
• Primary Completion: 2026-06-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility	Up to Day 90	We 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 Outcome Measures

Name	Time	Method
Acceptability	At Day 30	The 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)

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States