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

Mass General Brigham

Status: Not yet enrolling

Conditions: Hematologic Malignancy; Hematopoietic Cell Transplant

Treatments: Behavioral: Primary palliative care

Study type: Interventional

Funder types: Other

Identifiers

NCT06676852

24-322

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Sentinel, primary palliative care intervention

Experimental group

Description:

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)

Treatment:

Behavioral: Primary palliative care