40 Participants Needed

Palliative Care for Bone Marrow Transplant

(Primary PC HCT Trial)

RA
Overseen ByRichard A Newcomb, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Sentinel for palliative care in bone marrow transplant patients?

The research highlights that early integration of palliative care in bone marrow transplant patients can improve quality of life, patient satisfaction, and reduce caregiver burden. Although Sentinel is not directly mentioned, the benefits of palliative care in similar settings suggest potential effectiveness.12345

Is bone marrow donation safe for humans?

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 fatigue. Serious adverse events are rare, with a study showing only 1.24% of bone marrow donors experiencing them, and no donor fatalities reported.678910

How is the treatment Sentinel unique for bone marrow transplant patients?

Sentinel is unique because it integrates palliative care early in the bone marrow transplant process, focusing on improving quality of life and reducing symptom burden, which is often overlooked in traditional, cure-focused treatments.2341112

What is the purpose of 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 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

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Sentinel, primary palliative care interventionExperimental Treatment1 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)

Find a Clinic Near You

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+

Findings from Research

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.
Overall and cause-specific mortality in the Sentinel system: A power analysis.Swain, RS., Taylor, LG., Woodworth, TS., et al.[2019]
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.
Safety of bone marrow stem cell donation: a review.Bosi, A., Bartolozzi, B.[2010]
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.
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]

References

What do transplant physicians think about palliative care? A national survey study. [2019]
Early Intervention With Transplantation Recipients to Improve Access to and Knowledge of Palliative Care. [2023]
Perceptions and Misperceptions of Early Palliative Care Interventions for Patients With Hematologic Malignancies Undergoing Bone Marrow Transplantation. [2021]
Spanning the canyon between stem cell transplantation and palliative care. [2022]
Integration of Palliative Care in Hematopoietic Cell Transplant: Pediatric Patient and Parent Needs and Attitudes. [2023]
Overall and cause-specific mortality in the Sentinel system: A power analysis. [2019]
Safety of bone marrow stem cell donation: a review. [2010]
What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care. [2021]
Serious Adverse Events in Related Donors: A Report from the Related Donor Safe Study. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Adverse effects of drugs used to treat hematologic malignancies: surveillance efforts from the research on adverse drug events and reports project. [2013]
11.United Statespubmed.ncbi.nlm.nih.gov
Strange Bedfellows No More: How Integrated Stem-Cell Transplantation and Palliative Care Programs Can Together Improve End-of-Life Care. [2020]
Optimizing the delivery of early palliative care for hematology patients receiving a stem cell transplant: A role for a Nurse Practitioner. [2020]
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