Palliative Care for Bone Marrow Transplant

(Primary PC HCT Trial)

Overseen By Richard A Newcomb, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Psychiatric disorders, Dementia, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of providing supportive care for individuals undergoing a bone marrow transplant. The focus is on Sentinel, a primary palliative care intervention designed to help patients and their healthcare teams manage symptoms and improve quality of life. The study will evaluate Sentinel's effectiveness and assess whether patients and doctors find it beneficial. It is suitable for those undergoing a bone marrow transplant at Massachusetts General Hospital who have not recently received intensive palliative care. As an unphased trial, this study allows patients to contribute to innovative supportive care research that could enhance their quality of life during treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Sentinel intervention is safe for patients?

Research shows that the Sentinel program aims to ease symptoms and improve the quality of life for patients undergoing bone marrow or stem cell transplants. Studies have found that similar supportive care approaches can greatly enhance patients' quality of life and lessen symptoms like depression. This suggests that the Sentinel program is likely safe and manageable, as it emphasizes supportive care rather than drugs or invasive methods. Available studies have reported no negative effects directly linked to these supportive care methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Sentinel is unique because it focuses on providing primary palliative care specifically tailored for patients undergoing bone marrow transplants, a crucial yet often challenging treatment. Unlike traditional methods that primarily address the medical aspects, Sentinel emphasizes the holistic well-being of patients by integrating supportive care directly into the transplant process. Researchers are excited about this approach because it aims to improve overall quality of life, reduce symptom burden, and potentially enhance recovery outcomes during and after the transplant journey. This patient-centered approach could set a new standard in managing the complex needs of bone marrow transplant patients.

What evidence suggests that the Sentinel intervention is effective for palliative care in bone marrow transplant patients?

Research shows that the Sentinel program, a type of care focused on comfort, can improve the quality of life for patients undergoing bone marrow transplants. Studies have found that programs like Sentinel can reduce the physical and emotional symptoms often associated with these procedures, meaning patients might experience less pain and stress. Additionally, Sentinel aims to support patients by caring for their overall well-being during and after the transplant. While specific data on Sentinel's effectiveness is still being collected, similar programs have proven helpful, suggesting positive outcomes for participants. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pediatric patients undergoing bone marrow or hematopoietic stem cell transplantation to treat blood cancers. It's designed to see if it's practical and acceptable for the clinicians who perform these transplants to also provide primary palliative care.

Inclusion Criteria

I am scheduled for a stem cell transplant at MGH.

Exclusion Criteria

I have been admitted for specialized comfort care twice in the last 6 months.

I do not have severe mental health issues or cognitive impairments that prevent me from understanding this study.

Inability to comprehend English as this is a preliminary/pilot study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete patient-reported assessments prior to HCT admission

1 week

1 visit (in-person)

Treatment

Participants receive the Sentinel primary palliative care intervention during HCT hospitalization

2 weeks

Continuous during hospitalization

Follow-up

Participants are monitored for feasibility, acceptability, and quality of life post-HCT

3 months

Assessments at 1 month and 3 months post-HCT

What Are the Treatments Tested in This Trial?

Interventions

• Sentinel

Trial Overview

The study is testing 'Sentinel,' a program where transplant doctors give supportive palliative care during routine treatment. The goal is to evaluate how well this approach works in practice and if patients and doctors find it helpful.

How Is the Trial Designed?

Group I: Sentinel, primary palliative care intervention Experimental Treatment 1 Intervention

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)

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

American Society of Transplantation and Cellular Therapy

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

Allogeneic hematopoietic stem cell transplantation (HSCT) is a critical treatment option for various diseases, but it carries risks of morbidity and mortality, highlighting the importance of donor safety during the stem cell donation process.

Bone marrow donation is a well-established and generally safe procedure, with a low incidence of serious adverse events (only 1 fatal event reported among 27,770 donations), and the most common side effects being pain and fatigue, indicating that careful donor selection is essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of bone marrow stem cell donation: a review. Bosi, A., Bartolozzi, B.[2010]

The Sentinel database contains a substantial amount of mortality data, with 479,694 deaths recorded over 68 million person-years, making it a potentially valuable resource for assessing medical product safety.

The study found that all-cause mortality rates in Sentinel were comparable to national estimates, indicating that the database is well-powered for safety studies, particularly for overall mortality outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall and cause-specific mortality in the Sentinel system: A power analysis. Swain, RS., Taylor, LG., Woodworth, TS., et al.[2019]

Hematopoietic stem-cell transplantation (HSCT) can offer a chance for cure but also comes with high risks of morbidity and mortality, leading to significant symptom burden and decreased quality of life for patients.

Integrating palliative care early in the HSCT process can improve the well-being of patients and their families, as it focuses on comfort and quality of life, even when curative intent is present.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strange Bedfellows No More: How Integrated Stem-Cell Transplantation and Palliative Care Programs Can Together Improve End-of-Life Care. Levine, DR., Baker, JN., Wolfe, J., et al.[2020]

The paper emphasizes the importance of developing robust serious adverse event (SAE) reporting procedures in non-pharmaceutical palliative care trials, as patients often face high risks of hospitalization or death due to their underlying conditions rather than the trial interventions.

Recommendations for improving SAE management include allowing sufficient planning time, defining what constitutes a serious adverse event for the specific study population, and refining reporting procedures throughout the trial to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care. Dunleavy, L., Collingridge Moore, D., Korfage, I., et al.[2021]

In a study of 1680 related donors of hematopoietic cell transplants, only 12 severe adverse events (SAEs) were reported, indicating a low incidence rate of 0.71%, with no fatalities among donors.

Most SAEs occurred in donors who were either overweight or obese, and some had pre-existing medical conditions that could have made them ineligible for donation, highlighting the importance of careful donor screening and counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious Adverse Events in Related Donors: A Report from the Related Donor Safe Study. Seftel, MD., Chitphakdithai, P., Miller, JP., et al.[2023]

Citations

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sciencedirect.com

sciencedirect.com/science/article/pii/S2666636724004330

A Biobehavioral Perspective on Caring for Allogeneic ...

A recent national study examining HSCT recipients' perceptions about palliative care demonstrated that more than 40% of these recipients reported limited ...

2.

withpower.com

withpower.com/trial/palliative-care-for-bone-marrow-transplant-f0174

Palliative Care for Bone Marrow Transplant ...

Bone marrow donation is generally considered safe, with the main risk being related to anesthesia. Common side effects include pain in the aspiration area and ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5803752/

Palliative Care During and Following Allogeneic ...

The purpose of this review is to synthesize recent literature regarding the provision of palliative care to patients during and following allogeneic HSCT.

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app.trialscreen.org

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A Primary Palliative Care Intervention for Hematopoietic ...

Benefits: Participation in the Sentinel program may help reduce physical and psychological symptom burden, improve quality of life, and provide better ...

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astctjournal.org

astctjournal.org/article/S2666-6367(24)00433-0/fulltext

A Biobehavioral Perspective on Caring for Allogeneic ...

A biobehavioral perspective on caring for allogeneic hematopoietic stem cell transplant survivors with graft-versus-host disease.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40549982/

Multisite Randomized Trial of Inpatient Palliative Care ...

PC led to substantial improvements in patients' QOL, depression, and PTSD symptoms with sustained effects on PTSD symptoms up to 6 months post-HSCT.

7.

astctjournal.org

astctjournal.org/article/S2666-6367(22)01743-2/fulltext

Primary Preventive Care of Hematopoietic Stem Cell ...

This was a single-center cohort study of allogeneic HCT recipients who underwent transplantation at TOH with linkage to population-based health ...

8.

bmcpalliatcare.biomedcentral.com

bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-024-01499-z

Impact of early palliative care intervention in autologous bone ...

This prospective multicentre study evaluates the impact of Palliative Care Unit (PCU) intervention (Experimental Group, EG), during autologous ...