DREAMS Program for Pediatric Stem Cell Transplant Patients
(DREAMS Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dana-Farber Cancer Institute
Disqualifiers: Primary team declines permission
No Placebo Group
Trial Summary
What is the purpose of this trial?Pediatric patients undergoing stem cell transplant (SCT) are hospitalized for extended periods and are at high risk for sleep disturbances. In order to begin to address the environmental issues that SCT recipients face during inpatient hospitalizations, investigators will conduct a single arm pilot study of a program entitled 'Developing Restful Environments and Management Strategies' (DREAMS). The program will provide children receiving SCT and families with information and a kit that includes tools which may support sleep and circadian health during an inpatient hospitalization.
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 data supports the effectiveness of the DREAMS Program treatment for pediatric stem cell transplant patients?
Research shows that stem cell transplantation is effective for serious pediatric diseases, with improvements in survival rates over time. Additionally, bone marrow transplantation, a similar treatment, has been shown to offer potential cures for otherwise fatal diseases, with low mortality due to better supportive care.
12345Is the DREAMS Program for Pediatric Stem Cell Transplant Patients generally safe?
Stem cell transplants in children have shown improvements in survival rates over the years, but they can still lead to serious long-term health issues like chronic conditions and frail health. While transplant-related mortality has decreased, survivors often face higher risks of severe health problems compared to those who receive conventional treatments.
15678How is the DREAMS Program treatment different from other treatments for pediatric stem cell transplant patients?
The DREAMS Program is unique because it focuses on providing home care for pediatric stem cell transplant patients, which is an alternative to traditional inpatient or outpatient recovery programs. This approach may reduce the stress and demands on patients and their families by allowing recovery in a familiar home environment, although it requires significant support for caregivers.
134910Eligibility Criteria
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.
My child and I both speak English.
I am scheduled for a stem cell transplant at Boston Children's Hospital.
Exclusion Criteria
Primary team declines permission to approach
Trial Timeline
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)
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: DREAMS ProgramExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Children's HospitalBoston, MA
Boston Children's HospitalBoston, MA
Dana-Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
American Cancer Society, Inc.Collaborator
References
Hemopoietic stem cell transplantation in childhood: reduction in mortality and improvement of survival over the years. [2005]Stem cell transplantation (SCT) is an effective treatment for life-threatening hematologic and nonhematologic pediatric diseases. Reducing transplant-related mortality (TRM), a major complication of SCT, to improve long-term survival, therefore, is one of the main objectives of transplantation teams. We analyzed TRM and overall survival (OS) over the years in children undergoing SCT in our center. From June 1998 to October 2002, 156 consecutive children, 105 boys and 51 girls, median age 10 years (range, 2-18), with different diagnoses underwent SCT (100 autologous and 56 allogeneic). OS and TRM were analyzed in 2 different periods (June 1989-December 1998 and January 1999-October 2002) and grouped according to the different SCT modalities. The median follow-up was 18 months (range, 1-160). Autologous TRM showed a statistically significant improvement within 1999-2002 (0%) compared with 1989-1998 (12.2%) (P
Modification and Assessment of the Bedside Pediatric Early Warning Score in the Pediatric Allogeneic Hematopoietic Cell Transplant Population. [2019]To determine the validity of the Bedside Pediatric Early Warning Score system in the hematopoietic cell transplant population, and to determine if the addition of weight gain further strengthens the association with need for PICU admission.
Bone marrow transplantation: a children's hospital of New Orleans experience. [2004]Bone marrow transplantation has become an important therapeutic strategy in the treatment of pediatric malignancies and certain congenital disorders. We initiated a bone marrow transplant program at Children's Hospital in New Orleans at the start of January 1989. Both allogeneic and autologous bone marrow transplantations have been performed. To date, a total of 20 children have received transplants for a variety of diseases. Their ages ranged from 17 months to 20 years. The overall 2-year survival is 40%. For the good-risk patients, the projected 2-year disease-free survival is 85%, compared to 30% for the poor-risk patients. Regimen-related mortality has been extremely low in our settings primarily due to improvement of available supportive care. We conclude that bone marrow transplantation offers a potential cure for these otherwise fatal diseases.
Exploring the caregiver's experience in an innovative homebound hematopoietic stem cell transplantation program. [2022]Home care for hematopoietic stem cell transplants (HSCTs), an alternative to traditional inpatient or outpatient recovery programs, is safe and feasible but may place greater demand on full-time caregivers. The goal of this study was to characterize the experiences of caregivers in a newly piloted homebound HSCT program as a means of identifying unmet needs and ensuring adequate support.
[Clinical and epidemiological analysis of bone marrow transplantation in a pediatric oncology unit]. [2020]To describe the demographics and the most important acute clinical complications in patients undergoing bone marrow transplantation in the Pediatric Oncology Unit at Hospital de Clínicas de Porto Alegre, Brazil.
Chronic disease burden and frailty in survivors of childhood HSCT: a report from the St. Jude Lifetime Cohort Study. [2019]Outcomes of hematopoietic stem cell transplantation (HSCT) have markedly improved over the past 2 decades, underscoring a need to better understand the long-term health effects of this intensive treatment modality. We describe the burden of chronic medical conditions and frail health among St. Jude Lifetime Cohort Study participants treated for childhood hematologic malignancies with HSCT (n = 112) or with conventional therapy (n = 1106). Chronic conditions and frail health were ascertained clinically and classified according to a modified version of the Common Terminology Criteria for Adverse Events (version 4.03) and the Fried Frailty Criteria. Seventy-nine transplants were allogeneic (41 from a sibling donor, 34 unrelated, and 4 others from related donor). Twenty-five allogeneic donor recipients had a history of chronic graft-versus-host disease. Compared to those treated with conventional therapy, a higher percentage of HSCT survivors had severe, disabling, or life threatening (grade 3-4) chronic conditions (81.3% vs 69.2%, P = .007). By age 25 years, HSCT survivors experienced 148 grade 3-4 events/100 compared to 60 among conventional therapy survivors (P < .001). Percentages of survivors with second neoplasms (17.0% vs 7.9%, P = .003), grade 3-4 cardiovascular (19.6% vs 10.2%, P = .004) and pulmonary (16.1% vs 4.6%, P < .001) conditions, and frail health (7.1% vs 1.6%, P < .001) were higher after HSCT than conventional therapy. These results underscore the need for clinical follow-up and provide data to guide the development of prevention and/or intervention strategies for this vulnerable population.
[Clinical analysis of 29 children with early infectious complications following hematopoietic stem cells transplantation]. [2019]To study the clinical features and the incidence of early infectious complications following children hematopoietic stem cells transplantation (HSCT).
In-hospital mortality of hematopoietic stem cell transplantation among children with nonmalignancies: A nationwide study in the United States from 2000 to 2012. [2019]Hematopoietic stem cell transplant (HSCT) can cure or alleviate a wide range of nonmalignant childhood conditions. However, few studies have examined longitudinal national trends of frequency or short-term complications of HSCT before 2006 when an HSCT became a reportable procedure by US law. By using a US nationally representative database, we conducted nationwide longitudinal analyses on demographics, in-hospital mortality, and short-term complications in nonmalignant HSCT from 2000 to 2012.
Ethical problems in bone marrow transplantation in children. [2006]The medical staff caring for children with hematological or oncological diseases is often faced with delicate ethical and, at times, legal problems. Although many of these are common to other branches of pediatrics where patients are children lacking decision-making capacity, others, such as bone marrow transplantation (BMT), are peculiar to this specialty. This is a vanguard treatment for a wide range of diseases that are either incurable or resistant to conventional therapies. If the patient does not have a related donor, ethical and legal problems can occur: profound emotional dilemmas arise both because of the fretful search for a donor and because of the limited period the patient can be transplanted with good expectations of success. National and International Registries are linked to all BMT Units for the identification of compatible donors with the recipient. Hospitals hosting a BMT Unit must fulfill several requirements which are crucial to guaranteeing the best results when faced with the complexity and aggressiveness of transplantation and possible complications, such as a blood bank, an infectious diseases department, a rehabilitation unit, the availability of consultants, as well as playworkers, teachers, psychologists and social workers. Any trial carried out in a Center without sufficient experience, simply pleading the concept of "last hope" is not ethical, even considering possible late effects and sequelae. For allogeneic bone marrow transplantation it is necessary to obtain both the Consent of the donor and the Consent of parents of the recipient. Often the donor is a child sibling of the patient, lacking decision-making capacity as well. Information to parents of both children must be detailed. In reality, there are practically no risks for the child donor and, if any, they are linked to the general anaesthesia. The text of the Informed Consent is usually deliberated and accepted in advance by the Ethics Committee of the Institution where the patient is followed. Voluntary donor's Consent is required at different steps: at the entry in the Registry, when typing of major histocompatibility complex, at bone marrow harvesting under general anaesthesia. In Italy, Article No. 3, Law No. 107 of May 4, 1990 allows parents or legal guardians to consent to the bone marrow donation of a minor.
Ethical issues facing hematopoietic stem cell transplantation in India. [2021]A successful Hematopoietic stem cell transplantation (HSCT) is often the only hope of survival for children suffering from a range of potentially life-threatening hematological malignancies. The financial, ethical, and emotional problems faced by the matched sibling donor and their recipient siblings during the HSCT are extremely complex and challenging. Herein, the authors have attempted to pen down these in the configuration of a poem.