Homebound Stem Cell Transplantation for Multiple Myeloma

Overseen By Sergio Giralt, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Active infection, Uncontrolled arrhythmias, Pulmonary disease, others

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

Compensation: Varies

Number of Visits: Unknown

91 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the possibility of patients receiving care at home after undergoing an autologous stem cell transplant (ASCT). The goal is to determine if home care is safe, enhances patient satisfaction, and reduces infection risk. The trial monitors and reports outcomes from both patients and caregivers using tools like Caregiver Reported Outcomes instruments and Patient Reported Outcomes (PRO). Individuals diagnosed with plasma cell dyscrasia who plan to undergo ASCT, live in an appropriate home setting, have reliable Wi-Fi, and can provide caregiver support might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve post-transplant care for future patients.

Will I have to stop taking my current medications?

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 home care after ASCT is safe?

Research has shown that receiving care at home after a stem cell transplant is generally safe. Studies indicate that home care can improve patient satisfaction and reduce infection risk. For instance, telemedicine, which provides medical care through video or phone calls, is well-received by stem cell transplant patients.

Monitoring patients at home and reporting their progress are crucial components of this care approach. These methods track patient progress and detect problems early, enhancing safety. Overall, several studies have demonstrated positive safety outcomes for home care in stem cell transplant patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to stem cell transplantation by allowing patients to receive care at home. Unlike traditional treatments that require lengthy hospital stays, this method uses home monitoring teleconsult visits and caregiver-reported outcomes to ensure patient safety and comfort. This approach could make the recovery process more convenient and less stressful for patients and caregivers, potentially improving overall quality of life during treatment. Additionally, the use of video diaries and assessments provides a comprehensive view of the patient's experience, which could lead to more personalized and effective care strategies in the future.

What evidence suggests that home care after ASCT is effective?

Research has shown that monitoring patients at home and conducting online doctor visits after a stem cell transplant can be safe and effective. In this trial, participants will receive homebound care, which includes home monitoring and teleconsult visits. Studies have found that home care is as safe as hospital care. It also increases patient satisfaction and can reduce infection risk. Telemedicine, which involves online visits and remote health monitoring, has improved patient well-being. This approach can also lower healthcare costs while maintaining similar survival rates. Overall, evidence suggests that home-based care is a promising option for patients recovering from stem cell transplants. ^{1 3 5 6 7}

Who Is on the Research Team?

Heather Landau, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Lodging at the MSK Residence.

Diagnosis of Plasma cell dyscrasia

Treatment plan including Autologous HSCT

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Homebound Care

Participants receive care in the home setting after ASCT until neutrophil engraftment is achieved

Variable until engraftment

Home visits by healthcare providers

Post-Engraftment Standard Care

Standard of care practice resumes after neutrophil engraftment

21 days post HSCT

Follow-up

Participants complete routine post-HSCT follow-up visits in the clinic setting

4 weeks

Clinic visits

What Are the Treatments Tested in This Trial?

Interventions

• Caregiver Reported Outcomes instruments
• Home monitoring teleconsult visits
• Patient Reported Outcomes (PRO)

How Is the Trial Designed?

Group I: Homebound After Stem Cell Transplantation Experimental Treatment 3 Interventions

The primary research outputs and measurements are the instruments/surveys, assessments, and video diaries to be completed by the patients, their caregivers and the healthcare providers during the time of the home transplantation care. Protocol-specific interventions during homebound care will continue until patient has achieved neutrophil engraftment. Post engraftment, standard of care practice will resume. Once discharged from homebound care, the patient will complete routine post-HSCT follow-up visits in the clinic setting.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

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. tandfonline.com tandfonline.com/doi/full/10.2147/IJGM.S526025

Full article: Telemedicine-Supported Exercise Interventions ... Telemedicine for patients pre-, post- and during HSCT demonstrated to be feasible, beneficial, acceptable and effective with improvements in quality of life and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10452361/

Telemedicine in Hematopoietic Cell Transplantation and ... We review data on how telemedicine is being incorporated for patients who receive stem cell transplantation or cellular therapy.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666636722013082

eHealth-Generated Patient Data in an Outpatient Setting ... Collection of patient-reported outcomes was the most frequently reported eHealth intervention (n = 14; 63.6%), followed by vital sign monitoring (n = 5; 22.7%) ...

5. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1397115/full

Optimization of a home hospitalization program for ... Home hospitalization represents an alternative to traditional hospitalization, providing comparable clinical safety for hematological patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02671448

Pilot Trial of Homebound Stem Cell Transplantation Studies in other institutions have shown that providing care in the home setting after ASCT is safe, increases patient satisfaction, and can decrease the risk ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2016-01703

Homebound Care Utilizing Telemedicine in Reducing ... Homebound care may help to increase patient satisfaction and decrease the risk of infections associated with stem cell transplants. Eligibility Criteria ...