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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Primary palliative care
BehavioralEnrolled 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
Trial outcomes
Primary outcomes
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
Secondary outcomes
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)
Other outcomes
Quality of Life
We will assess longitudinal quality of life using the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)
Physical Symptoms
We will assess longitudinal physical symptom burden using the Edmonton Symptom Assessment System - Revised (ESAS-r)
Anxiety Symptoms
We will assess longitudinal symptoms of depression with the Hospital Anxiety and Depression Scale (HADS)
Depression Symptoms
We will assess symptoms of depression with the Hospital Anxiety and Depression Scale (HADS)
Sponsors and contacts
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Massachusetts General Hospital
Lead sponsor
American Society of Transplantation and Cellular Therapy
Collaborator