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

Trial Summary

What is the purpose of this trial?

This is a research study to compare the well-being (caregiver strain index) of caregivers of patients receiving home vs standard care after autologous hematopoietic stem cell transplant.

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 data supports the effectiveness of the treatment Home Care after stem cell transplantation?

Research shows that home care after stem cell transplantation can be safe and feasible, with patients being discharged earlier and having fewer days on total parenteral nutrition (intravenous feeding) compared to those in hospital care. This suggests that home care may offer advantages in recovery time and reduced need for intensive medical support. ^{1 2 3 4 5}

Is home care after stem cell transplantation safe?

Research shows that home care after stem cell transplantation is generally safe and can even have medical advantages, such as reducing certain complications compared to hospital care. ^{1 2 6 7 8}

How is home care after stem cell transplantation different from other treatments?

Home care after stem cell transplantation is unique because it allows patients to recover at home instead of staying in the hospital, which can reduce the risk of infections and shorten hospital stays. This approach involves daily visits from experienced nurses and regular phone calls from doctors, providing a more personalized and comfortable recovery environment. ^{1 2 4 5 8}

Research Team

Anthony Sung, MD

Principal Investigator

Duke Health

Nelson Chao, MD

Principal Investigator

Duke Health

Eligibility Criteria

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.

I am between 18 and 80 years old.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Hospital nurses' experiences of assessing health status changes in stem-cell transplanted patients in home care: A qualitative study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Exploring the caregiver's experience in an innovative homebound hematopoietic stem cell transplantation program. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Engaging Patients in Setting a Patient-Centered Outcomes Research Agenda in Hematopoietic Cell Transplantation. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Home care during the pancytopenic phase after allogeneic hematopoietic stem cell transplantation is advantageous compared with hospital care. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States 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. [2008]

7. Scotland pubmed.ncbi.nlm.nih.gov

Hospital care or home care after allogeneic hematopoietic stem cell transplantation--patients' experiences of care and support. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

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