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NCT Number: NCT06676852

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

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.

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Key information

Conditions

Hematopoietic Cell Transplant Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02152, United States

Location status: Recruiting

Location contact

Richard A Newcomb, MD

CONTACT

[email protected]

617-996-7584

Richard A Newcomb, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility

    Time frame: Up to Day 90

    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

  1. Acceptability

    Time frame: At Day 30

    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

  1. Quality of Life

    Time frame: Up to Day 90

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

  2. Physical Symptoms

    Time frame: Up to Day 90

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

  3. Anxiety Symptoms

    Time frame: Up to Day 90

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

  4. Depression Symptoms

    Time frame: Up to Day 90

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

  5. Post-traumatic stress symptoms

    Time frame: Up to Day 90

    We will assess longitudinal symptoms of post-traumatic stress using the Post-traumatic Stress Checklist-Civilian Version (PCL-C)

  6. Coping

    Time frame: Up to Day 90

    We will use select subscales of the Brief-COPE, a 28-item questionnaire that assess patients' use of 14 methods of coping per a 4-point Likert scale. Coping will be classified as 'Approach-oriented' and 'Avoidant'

Study contacts

Contact information is provided by the study sponsor or research team.

Richard A Newcomb, MD

CONTACT

[email protected]

617-996-7584

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Society of Transplantation and Cellular Therapy

Registry information

Acronym: Primary PC HCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Nov 6, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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