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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Undergoing autologous or allogeneic HCT at MGH

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Sentinel, primary palliative care interventionExperimental treatment 1 intervention

Trial outcomes

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

Time frame
Up to Day 90

Secondary outcomes

1

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)

Time frame
At Day 30

Other outcomes

1

Quality of Life

We will assess longitudinal quality of life using the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)

Time frame
Up to Day 90
2

Physical Symptoms

We will assess longitudinal physical symptom burden using the Edmonton Symptom Assessment System - Revised (ESAS-r)

Time frame
Up to Day 90
3

Anxiety Symptoms

We will assess longitudinal symptoms of depression with the Hospital Anxiety and Depression Scale (HADS)

Time frame
Up to Day 90
4

Depression Symptoms

We will assess symptoms of depression with the Hospital Anxiety and Depression Scale (HADS)

Time frame
Up to Day 90

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

American Society of Transplantation and Cellular Therapy

Collaborator