Categories:
Psychology and Biobehavioral Medicine
Diseases Treated:
Non-therapeutic
Eligibility Overview:
This is a non-therapeutic clinical trial open only to St. Jude patients.
- 12 years old or younger
- Has had a hematopoietic stem cell transplant (HCST)
- Recruitment occurs within two weeks before or after discharge from transplant admission
- Prescribed oral medication at discharge
- Speaks and reads English
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Brief Summary
Children who undergo hematopoietic stem cell transplants receive comprehensive care from medical professionals while hospitalized. After discharge, however, that responsibility is transferred to the parents or other caregivers.
The post-transplant regimen is complex, particularly during the initial seven months following HCST. Caregivers must manage frequent and changing medications and dosages, strict nutritional requirements and follow-up clinical appointments to prevent life-threatening infections and graft versus host disease. Such highly-complex regimens are often associated with poorer adherence and medical outcomes.
This study will assess adherence to the pediatric post-HSCT regimen to identify modifiable variables and inform the development of targeted interventions to prevent non-adherence.
Primary Objective
The main goal of this study is to test a model to predict outpatient regimen adherence in children who have received a stem cell transplant.
Eligibility Criteria
Inclusion criteria include:
- 12 years old or younger
- Has had a hematopoietic stem cell transplant (HCST)
- Recruitment occurs within two weeks before or after discharge from transplant admission
- Prescribed oral medication at discharge
- Speaks and reads English
- St. Jude patient
Exclusion Criteria include:
- No consistent caregiver
- Caregiver unable to complete questionnaires
- Caregiver does not speak English
Study Sites
St. Jude Children’s Research Hospital
Memphis, TennesseeCollaborating sites in the U.S.
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About this study
Stem cells are produced in the spongy area of bones known as the bone marrow. A stem cell transplant replaces damaged or destroyed bone marrow stem cells with healthy ones. Stem cell transplants, also known as bone marrow transplants, are used to treat cancer and other diseases.
A patient who has a stem cell transplant must take medicine and come to the doctor for follow-up appointments after discharge from the hospital. When the patient is a child, it is the responsibility of the parent or other home caregiver to be sure this follow-up care is provided.
Purpose of this clinical trial
The main purpose of this study is to understand how children and their parents manage follow-up care after a stem cell transplant. Researchers also want to understand how this care affects future hospitalizations and infections after transplant.
Eligibility overview
- 12 years old or younger
- Has had a hematopoietic stem cell transplant (HCST)
- Recruitment occurs within two weeks before or after discharge from transplant admission
- Prescribed oral medication at discharge
- Speaks and reads English
- St. Jude patient
-
SJHOME Quick View Sponsors National Institutes of Health Trial Start Date February 2017 Estimated Enrollment 281 nationwide Study Type Non-therapeutic Conditions Stem cell transplant Ages 12 years old and younger Principal investigator Sean Phipps, PhD (St. Jude) Study Sites St. Jude Children’s Research Hospital and collaborating sites in the U.S. For a consultation or to discuss SJHOME St. Jude Physician/Patient Referral Office
1-888-226-4343
referralinfo@stjude.org
Contact
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org
The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.