Mass General - Division of Clinical Research

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

Purpose

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts 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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm feasibility clinical trial
Primary Purpose: Supportive Care
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02152

Contact:
Richard A Newcomb, MD
617-996-7584
richard.newcomb@mgh.harvard.edu

More Details

Status: Recruiting
Sponsor: Massachusetts General Hospital

Study Contact

Richard A Newcomb, MD
617-996-7584
richard.newcomb@mgh.harvard.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.