Clinical trial NCT06676852: Feasibility and Acceptability of Primary Palliative Care Intervention in Patients Undergoing Hematopoietic Stem Cell Transplantation
Official title: Feasibility and Acceptability of Primary Palliative Care Intervention in Patients Undergoing Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hematopoietic Cell Transplant
Hematologic Malignancy
Keywords: palliative care
supportive care
primary palliative care
hematopoietic cell transplantation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Society of Transplantation and Cellular Therapy
First posted: 2024-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm feasibility clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility
timeFrame: Up to Day 90
Secondary outcomes:
measure: Acceptability
timeFrame: At Day 30
Other outcomes:
measure: Quality of Life
timeFrame: Up to Day 90
measure: Physical Symptoms
timeFrame: Up to Day 90
measure: Anxiety Symptoms
timeFrame: Up to Day 90
measure: Depression Symptoms
timeFrame: Up to Day 90
measure: Post-traumatic stress symptoms
timeFrame: Up to Day 90
measure: Coping
timeFrame: Up to Day 90
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: