Feasibility and Acceptability of Primary Palliative Care Intervention in Patients Undergoing Hematopoietic Stem Cell Transplantation (Primary PC HCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Malignancy; Hematopoietic Cell Transplant
• Intervention / Treatment: Behavioral: Primary palliative care

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard A Newcomb, MD; Phone Number: 617-996-7584; Email: richard.newcomb@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02152
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Richard A Newcomb, MD; Phone Number: 617-996-7584; Email: richard.newcomb@mgh.harvard.edu
      • Principal Investigator: Richard A Newcomb, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sentinel, primary palliative care intervention; All participants will receive Sentinel, a primary palliative care intervention, in this single-arm feasibility trial. Participants will complete patient-reported assessments at the following time points: Baseline (prior to HCT admission); Week-2 of HCT hospitalization (+/- 3 business days); 1 month post-HCT (+/- 7 business days); 3 months post-HCT (+/- 7 business days)

Behavioral: Primary palliative care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	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	Up to Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	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)	At Day 30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	We will assess longitudinal quality of life using the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)	Up to Day 90
Physical Symptoms	We will assess longitudinal physical symptom burden using the Edmonton Symptom Assessment System - Revised (ESAS-r)	Up to Day 90
Anxiety Symptoms	We will assess longitudinal symptoms of depression with the Hospital Anxiety and Depression Scale (HADS)	Up to Day 90
Depression Symptoms	We will assess symptoms of depression with the Hospital Anxiety and Depression Scale (HADS)	Up to Day 90
Post-traumatic stress symptoms	We will assess longitudinal symptoms of post-traumatic stress using the Post-traumatic Stress Checklist-Civilian Version (PCL-C)	Up to Day 90
Coping	We will use select subscales of the Brief-COPE, a 28-item questionnaire that assess patients' use of 14 methods of coping per a 4-point Likert scale. Coping will be classified as 'Approach-oriented' and 'Avoidant'	Up to Day 90

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: American Society of Transplantation and Cellular Therapy

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: palliative care; supportive care; hematopoietic cell transplantation; primary palliative care
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 24-322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber/Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor, Investigator, or designee. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the study investigator at richard.newcomb@mgh.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

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