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

NCT06676852 | Recruiting

• 1 other identifier: 24-322
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Cell Transplant; Hematologic Malignancy

Keywords

palliative care; supportive care; primary palliative care; hematopoietic cell transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability

  At Day 30

Other Outcomes (6)

• Quality of Life

  Up to Day 90

• Physical Symptoms

  Up to Day 90

• Anxiety Symptoms

  Up to Day 90

Study Arms (1)

Sentinel, primary palliative care intervention

EXPERIMENTAL

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

Interventions

Primary palliative care BEHAVIORAL

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.

Sentinel, primary palliative care intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Society of Transplantation and Cellular Therapy: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02152, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Richard A Newcomb, MD

CONTACT

617-996-7584; richard.newcomb@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single arm feasibility clinical trial

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 6, 2024
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the study investigator at richard.newcomb@mgh.harvard.edu

Locations

US (1)