NCT02052570

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

January 27, 2014

Last Update Submit

February 2, 2015

Conditions

Keywords

School Reentry after pediatric HSCT

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    90 minutes

Study Arms (4)

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

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health Systems

Durham, North Carolina, 27705, United States

Location

Study Officials

  • Susan J Wood, MN

    DUMC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2014

First Posted

February 3, 2014

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations