Home Care After Stem Cell Transplantation

Overseen By Andrea Pires, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Homeopathic, Prebiotics, Probiotics

Disqualifiers: Lack of caregiver, Pregnancy, Active infection

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how home care for patients after a stem cell transplant affects caregiver well-being compared to hospital or clinic care. It focuses on caregivers' stress levels when patients receive home care (non-medical support provided at home) versus standard care in a hospital or clinic. Individuals scheduled for a stem cell transplant with a caregiver to assist them might be suitable candidates. The trial is open to those living within 90 minutes of Duke and having a home suitable for medical care. As an unphased trial, this study offers a unique opportunity to contribute to understanding the impact of home care on caregiver stress.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients using homeopathic medications, prebiotics, or probiotics that may affect gut health.

What prior data suggests that home care is safe for stem cell transplant patients?

Research has shown that home care after a stem cell transplant is generally safe. One study followed 252 children and teenagers over 20 years and found that home care was safe and even beneficial. Another study found that home care, including transplants done at home, had survival rates similar to traditional hospital methods, but with lower costs and higher patient satisfaction. This evidence suggests that patients tolerate home care well and achieve good results without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about home care after stem cell transplantation because it offers a new way to support patient recovery without the need for extended hospital stays. Unlike the standard care options, which require either hospital-based aftercare or daily outpatient clinic visits, this approach allows patients to receive their post-transplant care in the comfort of their own homes. This method has the potential to improve patients' quality of life by reducing the stress and inconvenience associated with frequent hospital visits. Additionally, home care could also lower healthcare costs and free up hospital resources for other critical needs.

What evidence suggests that home care is effective for improving caregiver well-being after stem cell transplantation?

This trial will compare different aftercare settings for stem cell transplant patients. Research has shown that patients receiving care at home, one of the treatment arms in this trial, have survival rates similar to those treated in hospitals. Studies have found that home care can also reduce costs and enhance the patient experience. Patients in these programs receive supportive care in the comfort of their homes, which can be a significant advantage. Additionally, using digital health tools for remote monitoring can make medical assistance faster and more effective. Overall, home care for stem cell transplant patients appears promising for maintaining steady health outcomes while providing greater convenience. ^{1 4 6 7 8}

Who Is on the Research Team?

Anthony Sung, MD

Principal Investigator

Duke Health

Nelson Chao, MD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for patients aged 18-80 scheduled for autologous stem cell transplant due to cancer or other illnesses, with a performance score indicating they can care for themselves. They must read/write English and have a caregiver who meets criteria like driving ability. Homes must be suitable for medical care within 90 minutes of Duke.

Inclusion Criteria

I am scheduled for a stem cell transplant using my own cells.

A home that is deemed, upon inspection, in suitable condition to serve as a medical home, within a 90-minute driving distance of Duke

Able to read/write English

Exclusion Criteria

I use homeopathic treatments or supplements that affect gut health.

I do not have a severe infection right now.

Lack of a caregiver

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation and Initial Care

Participants undergo autologous hematopoietic stem cell transplantation and receive initial care either at home or in the hospital

2 weeks

Follow-up

Participants are monitored for caregiver well-being and quality of life after transplantation

14 days

What Are the Treatments Tested in This Trial?

Interventions

• Home Care

Trial Overview

The study compares the strain on caregivers when patients receive home care versus standard care after an autologous hematopoietic stem cell transplant. It aims to determine which setting is better for the well-being of those providing care.

How Is the Trial Designed?

Group I: Home care Experimental Treatment 1 Intervention

This is the arm for patients who receive their transplant care in their homes.

Group II: Hospital Care Active Control 1 Intervention

Standard of care for stem cell transplant recipients where the aftercare is done in hospital.

Group III: Clinic Care Active Control 1 Intervention

Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

Patients who received home care during the acute post-transplantation phase reported higher satisfaction with their care compared to those treated in the hospital, indicating that home care can be a viable option for patient support.

The study highlights that patients valued safety, empathy, and continuous information from healthcare staff, suggesting that these factors are crucial for enhancing patient experiences regardless of the care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital care or home care after allogeneic hematopoietic stem cell transplantation--patients' experiences of care and support. Bergkvist, K., Larsen, J., Johansson, UB., et al.[2015]

Close follow-up care is crucial for patients who have undergone bone marrow or peripheral blood stem cell transplantation, especially during the first year, due to potential severe side effects like compromised immune systems and graft versus host disease.

Nurses play a vital role in monitoring these patients by conducting thorough assessments to identify both treatable and non-treatable issues that could impact their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory care after bone marrow or peripheral blood stem cell transplantation. Hurley, C.[2013]

Hospital nurses play a crucial role in assessing the health status of stem-cell transplanted patients receiving home care, and effective communication along with clinical intuition significantly enhances their assessments.

Challenges arise in remote assessments due to the lack of physical presence, highlighting the need for training in remote communication and the use of telehealth tools to improve accuracy and nurse confidence in patient evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital nurses' experiences of assessing health status changes in stem-cell transplanted patients in home care: A qualitative study. Wergeland, D., Harsten, K., Klarare, A., et al.[2023]

Bone marrow transplantation is a complex treatment option for both malignant and nonmalignant diseases, requiring home care professionals to stay updated on the latest therapies to ensure quality care.

The article highlights the importance of understanding the transplant process and potential complications, emphasizing the critical role of home care in supporting patients undergoing this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home care of the bone marrow transplant recipient: high tech, high touch. Randolph, SR.[2019]

The homebound hematopoietic stem cell transplant (HSCT) program is perceived as safe and effective by caregivers, providing high-quality medical care in a familiar environment that enhances the patient's sense of normalcy and privacy.

Caregivers reported unmet needs, particularly in feeling unprepared for nursing responsibilities and managing emotional distress, highlighting the need for additional psychotherapeutic support and training to better equip them for home care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the caregiver's experience in an innovative homebound hematopoietic stem cell transplantation program. Jenkelowitz, J., Garzon, MG., Lynch, K., et al.[2022]

Patients who received at-home care after allogeneic hematopoietic stem-cell transplantation (ASCT) had a significantly lower incidence of acute graft-versus-host disease (GVHD) and better survival rates (65% vs. 47% at five years) compared to those treated in the hospital.

The study found that home-care patients received more oral nutrition, which correlated with reduced acute GVHD and improved survival, suggesting that better nutrition may play a key role in the benefits of at-home care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case-control comparison of at-home and hospital care for allogeneic hematopoietic stem-cell transplantation: the role of oral nutrition. Svahn, BM., Remberger, M., Heijbel, M., et al.[2008]

A 2-year initiative by the National Marrow Donor Program engaged patients, caregivers, and researchers to establish a patient-centered outcomes research (PCOR) agenda for hematopoietic cell transplantation (HCT), identifying six key areas of interest for future research.

The initiative highlighted the need for consistent measures and homogenous patient populations in HCT research to improve the comparability of outcomes, and it provided recommendations for priority research questions to address existing knowledge gaps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Patients in Setting a Patient-Centered Outcomes Research Agenda in Hematopoietic Cell Transplantation. Burns, LJ., Abbetti, B., Arnold, SD., et al.[2021]

Patients receiving home care after allogeneic stem cell transplantation (SCT) experienced earlier discharge from the hospital and had significantly lower rates of complications such as acute graft-versus-host disease and transplantation-related mortality compared to those treated in the hospital.

The 2-year survival rate for home care patients was 70%, which was higher than the 51% and 57% rates in the hospital control groups, indicating that home care is a safe and effective alternative to traditional hospital care after SCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home care during the pancytopenic phase after allogeneic hematopoietic stem cell transplantation is advantageous compared with hospital care. Svahn, BM., Remberger, M., Myrbäck, KE., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11082320/

Brave new world: expanding home care in stem cell ...

Outpatient models, including at-home transplantation, have been developed, resulting in similar survival results, reduced costs, and increased patient ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01725022?term=AREA%5BBasicSearch%5D(cancer)%20AND%20AREA%5BStudyFirstPostDate%5D%20RANGE%5B2012-11-10,2012-11-12%5D&rank=2

A Controlled Study of Stem Cell Transplantation Medical ...

Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic. Intervention/Treatment. What is the ...

3.

astctjournal.org

astctjournal.org/article/S2666-6367(22)01786-9/fulltext

Feasibility of a Hospital-at-Home Program for Autologous ...

Hospital at Home (HaH) is a feasible strategy after autologous stem cell transplantation. Patients receive integral supportive care measures in the comfort of ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666636725012655

The Caregiver Paradigm in Hematopoietic Cell Transplant

It examines: (1) whether caregivers are in good health (to assess availability as well as encourage them to stay engaged in their own care ...

5.

frontiersin.org

frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1403249/pdf

centered care at home after CAR T-cell therapy or ...

Using digital health technologies (DHT) to monitor patients remotely can improve time-to-intervention and health outcomes. Providing follow-up ...

6.

frontiersin.org

frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1384137/full

Better clinical outcomes and lower triggering of ...

Home care was found to be safe and beneficial for children and adolescents. Over two decades, 252 patients received home care post-Allo-HCT ...

7.

astctjournal.org

astctjournal.org/article/S2666-6367(22)01841-3/fulltext

Fit for Duty: Lessons Learned from Outpatient and ...

Lessons learned from outpatient and homebound hematopoietic cell transplantation to prepare family caregivers for home-based care.

8.

journals.lww.com

journals.lww.com/cancernursingonline/fulltext/9900/patients__experiences_with_hospital_at_home.384.aspx

Patients' Experiences With Hospital at Home Following...

This study suggests that HaH positively influences recovery and well-being among HSCT patients and has the potential to improve patient outcomes.