Unspecified Complication of Bone Marrow TransplantNCT02052570
School Reintegration After Pediatric Hematopoietic Stem Cell Transplant
An observational study of Unspecified Complication of Bone Marrow Transplant, run by Duke University at 1 site in United States.
Trial summary
This is a qualitative study that will explore the experiences of school reentry following Hematopoietic Stem Cell Transplant (HSCT) in children ages 10-16 years of age, their parents, teachers and primary PBMT(Pediatric Bone Marrow Transplant) providers. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Unspecified Complication of Bone Marrow Transplant
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children transplanted in the PBMT (Pediatric Bone Marrow Transplant) program at DUMC (Duke University Medical Center) in the past 5 years for allogeneic HSCT to include diagnoses for malignancy, immunodeficiency, bone marrow failure and inherited metabolic disease. They must have previously attended school prior to transplant.
Who may be able to join
- Children transplanted in the PBMT program at DUMC in the past 5 years for allogeneic HSCT to include diagnoses for malignancy, immunodeficiency, bone marrow failure and inherited metabolic disease. They must have previously attended school prior to transplant
Who cannot join
- Autologous transplants
- Significant developmental delays that would impair ability to communicate
- Inability to get full team (child, parent, teacher, provider) to participate
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health Systems
Durham, North Carolina, 27705
About this study
Official title: School Reintegration After Pediatric Hematopoietic Stem Cell Transplant: Experiences of Children, Parents, Teachers and Providers
This is a qualitative study that will explore the experiences of school reentry following Hematopoietic Stem Cell Transplant (HSCT) in children ages 10-16 years of age, their parents, teachers and primary PBMT(Pediatric Bone Marrow Transplant) providers. This study will involve four focus groups: children post -transplant, parents, teachers and PBMT providers in an effort to understand the successes and challenges of returning to school following HSCT.
Read the detailed description
This is a qualitative descriptive study using purposive sampling to form the four focus groups to encourage diversity in diagnosis (immunodeficiency, malignancy, bone marrow failure and inherited metabolic diseases), age and location. Each group will participate via conference call due to difference in location. There will be semi-structured questions for each group but also allow flexibility by participants themselves.
- Keywords
- School Reentry after pediatric HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children post-HSCT | Children post-HSCT age 10-16 yrs of age who had allogeneic transplant who are within 5 years of transplant and returned to school in past 12-24 months after previously attending school pre-transplant | |
| Parents of children post-HSCT | Parents of children post-HSCT (children in focus group) will participate in focus group with other parents to discuss the challenges and successes of their child returning to school following HSCT. | |
| Teachers of children post-HSCT | Teachers of children post- HSCT (children in focus group) will participate in focus group with other teachers to discuss the challenges and successes of children returning to school post HSCT | |
| PBMT provider of child post-HSCT | PBMT provider of child-post HSCT (child in focus group) will participate in in focus group with other PBMT providers to discuss the successes and challenges of coordinating school reentry in child post-HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial issues
Psychosocial issues related to school reentry following pediatric hematopoietic stem cell transplant (HSCT) as gathered from children's, parent's, teacher's and health care provider's perspectives as obtained during focus group discussions.
Measured: 90 minutes
Cultural and environmental issues
Cultural and environmental issues (ie location, resources) issues related to school reentry following pediatric hematopoietic stem cell transplant (HSCT) gathered from the children's, parent's, teacher's and health care provider's perspectives as obtained during focus group discussions.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Unable to meet all criteria as outlined for participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Complication of Bone Marrow TransplantStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan J Wood, MN, Principal investigator, DUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052570
- Sponsor's protocol ID
- Pro00047417
- Status last verified
- Feb 2015
- First submitted
- 27 Jan 2014
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Reintegration After Pediatric Hematopoietic Stem Cell Transplant: Experiences of Children, Parents, Teachers and Providers
- ClinicalTrials.gov ID
- NCT02052570
- Acronym / sponsor ID
- Pro00047417
- Keywords
- School Reentry after pediatric HSCT
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to meet all criteria as outlined for participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a qualitative study that will explore the experiences of school reentry following Hematopoietic Stem Cell Transplant (HSCT) in children ages 10-16 years of age, their parents, teachers and primary PBMT(Pediatric Bone Marrow Transplant) providers. This study will involve four focus groups: children post -transplant, parents, teachers and PBMT providers in an effort to understand the successes and challenges of returning to school following HSCT.
Detailed description
This is a qualitative descriptive study using purposive sampling to form the four focus groups to encourage diversity in diagnosis (immunodeficiency, malignancy, bone marrow failure and inherited metabolic diseases), age and location. Each group will participate via conference call due to difference in location. There will be semi-structured questions for each group but also allow flexibility by participants themselves.
Study design
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children post-HSCT | – | –Children post-HSCT age 10-16 yrs of age who had allogeneic transplant who are within 5 years of transplant and returned to school in past 12-24 months after previously attending school pre-transplant |
| Parents of children post-HSCT | – | –Parents of children post-HSCT (children in focus group) will participate in focus group with other parents to discuss the challenges and successes of their child returning to school following HSCT. |
| Teachers of children post-HSCT | – | –Teachers of children post- HSCT (children in focus group) will participate in focus group with other teachers to discuss the challenges and successes of children returning to school post HSCT |
| PBMT provider of child post-HSCT | – | –PBMT provider of child-post HSCT (child in focus group) will participate in in focus group with other PBMT providers to discuss the successes and challenges of coordinating school reentry in child post-HSCT |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children transplanted in the PBMT (Pediatric Bone Marrow Transplant) program at DUMC (Duke University Medical Center) in the past 5 years for allogeneic HSCT to include diagnoses for malignancy, immunodeficiency, bone marrow failure and inherited metabolic disease. They must have previously attended school prior to transplant.
Key inclusion criteria (1 listed)
- Children transplanted in the PBMT program at DUMC in the past 5 years for allogeneic HSCT to include diagnoses for malignancy, immunodeficiency, bone marrow failure and inherited metabolic disease. They must have previously attended school prior to transplant
Key exclusion criteria (4 listed)
- Autologous transplants
- Significant developmental delays that would impair ability to communicate
- Inability to get full team (child, parent, teacher, provider) to participate
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychosocial issues
Time frame: 90 minutes
Psychosocial issues related to school reentry following pediatric hematopoietic stem cell transplant (HSCT) as gathered from children's, parent's, teacher's and health care provider's perspectives as obtained during focus group discussions.
Cultural and environmental issues
Time frame: 90 minutes
Cultural and environmental issues (ie location, resources) issues related to school reentry following pediatric hematopoietic stem cell transplant (HSCT) gathered from the children's, parent's, teacher's and health care provider's perspectives as obtained during focus group discussions.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J Wood, MN principal investigator
DUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unspecified Complication of Bone Marrow Transplant, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial issues (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.