DREAMS Program for Pediatric Stem Cell Transplant Patients

(DREAMS Trial)

Recruiting at 2 trial locations

Overseen By Lucille Lokko, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Primary team declines permission

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

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist children hospitalized for extended periods due to stem cell transplants. These children often struggle with sleep during their stay, so the trial will test the DREAMS Program, designed to enhance their sleep environment with helpful information and tools. The program includes a kit with items to support better sleep and daily rhythm while hospitalized. Children aged 9-17 scheduled for a stem cell transplant at Boston Children's Hospital, along with their English-speaking parents, may be suitable candidates for this trial. As an unphased trial, this study presents a unique opportunity to improve hospital stays for children by enhancing their sleep quality.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the DREAMS Program is safe for pediatric stem cell transplant patients?

Research has shown that the DREAMS Program is designed to help children sleep better during hospital stays for stem cell transplants. These transplants can be challenging, involving long hospital stays and sleep issues. The program aims to improve sleep by providing information and tools to make the hospital environment more sleep-friendly.

Specific safety data for the DREAMS Program is not available. However, as it is not a drug or medical procedure but rather a means of providing helpful information and tools, it is likely safe. The study is labeled "Not Applicable" for phase, indicating it is not expected to pose safety risks like a new drug might.

In summary, while specific safety data for the DREAMS Program is lacking, its role as an educational and supportive tool suggests it should be safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The DREAMS Program for pediatric stem cell transplant patients is unique because it focuses on improving sleep and circadian rhythms, which are often disrupted in children undergoing such intense treatments. Unlike standard care, which primarily addresses the medical aspects of stem cell transplants, this program incorporates a holistic approach with tools like a Sleep and Circadian Care Kit, Actigraph, and Fitbit to monitor and enhance sleep patterns. Researchers are excited about this trial because enhancing sleep can potentially improve recovery times and overall quality of life for young patients, offering a complementary benefit beyond traditional medical interventions.

What evidence suggests that the DREAMS Program is effective for improving sleep in pediatric stem cell transplant patients?

Research has shown that making hospital rooms more comfortable can help children undergoing stem cell transplants sleep better. Sleep problems are common during these hospital stays and can affect recovery. Early results suggest that programs like the DREAMS Program, studied in this trial, aim to create peaceful environments and might improve sleep and body clock health. This improvement could lead to better recovery, helping young patients heal and cope more effectively during long hospital stays. ^{1 2 3 6 7}

Who Is on the Research Team?

Eric Zhou, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for children aged 9-17 who are scheduled to receive a stem cell transplant at Boston Children's Hospital and speak English, along with their primary caregiver. It's not open to those whose medical team doesn't allow them to participate.

Inclusion Criteria

I am between 9 and 17 years old.

I am scheduled for a stem cell transplant at Boston Children's Hospital.

Exclusion Criteria

Primary team declines permission to approach

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Baseline

Baseline visit with survey and standard of care stem cell infusion

1 day

1 visit (in-person)

Treatment

Introduction to DREAMS program, Sleep and Circadian Care Kit, Actigraph, and Fitbit

2 weeks

1 visit (in-person)

Follow-up

Participants complete follow-up surveys and assessments

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• DREAMS Program

Trial Overview The DREAMS program, which includes an educational video and care kit designed to help pediatric SCT patients sleep better during hospital stays, is being tested in this single-arm pilot study.

How Is the Trial Designed?

Group I: DREAMS Program Experimental Treatment 1 Intervention

Enrolled participants and parent(s) will complete: * Baseline visit with survey * Standard of care stem cell infusion * In-clinic visit with introduction to DREAMS program, Sleep and Circadian Care Kit, Actigraph, and Fitbit. * Follow up survey

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

In a study of 156 children undergoing stem cell transplantation (SCT) from 1998 to 2002, the transplant-related mortality (TRM) for autologous SCT significantly improved from 12.2% to 0%, indicating enhanced safety in recent years.

Overall survival (OS) rates also improved dramatically from 34% in the earlier period (1989-1998) to 80.4% in the later period (1999-2002), showing that SCT has become a more effective treatment for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemopoietic stem cell transplantation in childhood: reduction in mortality and improvement of survival over the years. Espigado, I., Marín-Niebla, A., Pérez-Hurtado, JM., et al.[2005]

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]

In a bone marrow transplant program at Children's Hospital in New Orleans, 20 children aged 17 months to 20 years were treated, achieving an overall 2-year survival rate of 40%.

For patients classified as good-risk, the projected 2-year disease-free survival rate was significantly higher at 85%, highlighting the effectiveness of bone marrow transplantation as a potential cure for pediatric malignancies and congenital disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone marrow transplantation: a children's hospital of New Orleans experience. Yu, LC., Ode, D., Warrier, RP.[2004]

In a study of 41 pediatric patients undergoing bone marrow transplantation, the overall survival rate was 70% for allogeneic transplants and 59.4% for autologous transplants, indicating comparable outcomes to existing literature.

Acute graft-versus-host disease (GVHD) was a significant complication, with 4 patients experiencing severe forms, and infections were common, affecting 58.5% of patients, highlighting the need for careful monitoring and management during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical and epidemiological analysis of bone marrow transplantation in a pediatric oncology unit]. de Castro, CG., Gregianin, LJ., Brunetto, AL.[2020]

In a study of 31 children undergoing hematopoietic stem cell transplantation (HSCT), 94% experienced early infectious complications, with the first infections typically occurring around 6 days post-transplant and lasting about 9 days.

The use of antibiotic prophylaxis, specifically Tienam, was effective in delaying the onset of these early infections, highlighting its potential role in managing infection risks during the critical post-transplant period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical analysis of 29 children with early infectious complications following hematopoietic stem cells transplantation]. Li, Y., Huang, SL., Fang, JP., et al.[2019]

From 2000 to 2012, the number of pediatric hematopoietic stem cell transplants (HSCT) for nonmalignant conditions doubled, indicating a significant increase in the use of this treatment.

In-hospital mortality rates for these procedures decreased from 13.4% to 7.1%, while infections like bacteremia and vascular catheter infections also declined, suggesting improved safety and outcomes over the years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-hospital mortality of hematopoietic stem cell transplantation among children with nonmalignancies: A nationwide study in the United States from 2000 to 2012. Takahashi, T., Pereda, MA., Bala, N., et al.[2019]

Hematopoietic stem cell transplantation (HSCT) is a critical treatment option for children with serious blood cancers, often being their only chance for survival.

The process of HSCT involves complex financial, ethical, and emotional challenges for both the donor siblings and the recipients, highlighting the need for support during this difficult time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethical issues facing hematopoietic stem cell transplantation in India. Raturi, M., Das, K.[2021]

A Pediatric Early Warning Score (PEWS) of 8 or higher is significantly associated with the need for PICU admission in pediatric hematopoietic cell transplant patients, showing a sensitivity of 76% and specificity of 90%.

Incorporating weight gain into the PEWS model enhances its predictive ability for critical care needs, increasing the area under the receiver operating characteristic curve from 0.83 to 0.88, suggesting that monitoring weight gain could improve patient assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification and Assessment of the Bedside Pediatric Early Warning Score in the Pediatric Allogeneic Hematopoietic Cell Transplant Population. Cater, DT., Tori, AJ., Moser, EAS., et al.[2019]

Survivors of hematopoietic stem cell transplantation (HSCT) have a significantly higher burden of severe chronic conditions compared to those treated with conventional therapy, with 81.3% of HSCT survivors experiencing grade 3-4 conditions versus 69.2% in the conventional therapy group.

By age 25, HSCT survivors had a much higher incidence of serious health issues, including second cancers (17.0% vs 7.9%), cardiovascular (19.6% vs 10.2%), and pulmonary conditions (16.1% vs 4.6%), highlighting the need for ongoing clinical follow-up and targeted prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic disease burden and frailty in survivors of childhood HSCT: a report from the St. Jude Lifetime Cohort Study. Eissa, HM., Lu, L., Baassiri, M., et al.[2019]

Bone marrow transplantation (BMT) is a critical treatment for children with severe hematological or oncological diseases, but it raises unique ethical and legal challenges, especially when a related donor is not available.

The process requires informed consent from both the donor and the recipient's parents, and it is essential that BMT units meet specific requirements to ensure patient safety and successful outcomes, including having experienced medical staff and support services in place.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethical problems in bone marrow transplantation in children. Massimo, L.[2006]

Citations

1. dana-farber.org dana-farber.org/cancer-care/treatment/pediatric-stem-cell-transplant

Pediatric Stem Cell Transplant Program Stem Cell Transplant Outcomes. Our 1-year survival rates exceed those of other stem cell transplant programs. Based on data from 182 patients who had their ...

2. withpower.com withpower.com/trial/phase-gvhd-9-2024-8e054

Educational Intervention for Bone Marrow Transplant ... Improving medication adherence monitoring and clinical outcomes through mHealth: A randomized controlled trial protocol in pediatric stem cell transplant.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40045826/

Evolution of the Florida Pediatric Bone Marrow Transplant ... Results: The 1-year posttransplant survival for the FPBCC centers significantly improved from 77.5% (2016-2018) to 89.5% (2019-2021; p = 0.0313). During the ...

4. app.trialscreen.org app.trialscreen.org/trials/developing-restful-environments-management-strategies-pediatric-stem-cell-trial-nct06468618

Restful Environments for Pediatric Stem Cell Transplant ... Benefits: Participation in this study may help improve the sleep and circadian health of pediatric SCT patients during their hospitalization, which could ...

5. childrenshospital.org childrenshospital.org/newsroom/news-events/dana-farberboston-childrens-cancer-and-blood-disorders-center-recognized

Dana-Farber/Boston Children's Cancer and Blood ... The CIBMTR report is a federally mandated analysis of outcomes data for allogeneic stem cell transplant centers. It reflects a rolling, three- ...

6. physicianresources.dana-farber.org physicianresources.dana-farber.org/news/strong-outcomes-for-our-stem-cell-transplantation-programs

Strong Outcomes for our Stem Cell Transplantation Programs The CIBMTR report is a federally mandated analysis of outcomes data for allogeneic stem cell transplant centers. It reflects a rolling, 3-year ...

7. childrenshospital.org childrenshospital.org/programs/hematopoietic-stem-cell-transplant-program/volumes-outcomes

Hematopoietic (Stem) Cell Transplant Program Stem cell transplant outcomes. Our one-year survival rates exceed those of other stem cell transplant centers. Based on data from 182 patients who ...