Long Term Minor Sibling Donor Well-Being

Stopped early

Conditions studied: Disorder Related to Bone Marrow Transplantation, Blood Stem Cell Transplant Failure, Disturbance of Emotions Specific to Childhood and Adolescence, Transmission, Blood, Recipient/Donor, Sibling

In brief

The goal of this research study is to understand what it is like for a young person to have a sick family member and what it is like to donate bone marrow or stem cells for a sick family member. Primary Aims: 1. Compare minor donor adjustment to minor non-donor adjustment, including anxiety, self-esteem, traumatic stress, achievement, and behavior. 2. Evaluate minor donor adjustment across time, including self -esteem, traumatic stress, anxiety, achievement, and behavior. 3. Investigate the effect of the following on donor well-being: * Donor variables: 1) the impact of the harvest, including type of harvest (needle aspiration of bone marrow or peripheral blood stem cell collection by apheresis after injection of G-CSF), pre-procedural anxiety and perceived pain; 2) age of donor at time of transplant, 3) gender, 4) preparedness for transplant, 5) sibling order (for sibling participants), and 6) donor's decision-making and ambivalence regarding donation. * Recipient variables: 1) the recipient's level of well-being or death, 2) genetic versus acquired disease types, and 3) familial relationship of donor to recipient. * Family support variables: 1) the distress of the family, 2) the quality of the relationship between the potential donor and the recipient, and 3) parent's well-being (post-traumatic stress disorder or PTSD, depression). Secondary Aim: Evaluate satisfaction with the donor program.

Key facts

Study ID

NCT00667784

Run by

M.D. Anderson Cancer Center

People needed

2

Starts

2008-04-01

Expected to finish

2011-04-01

Last updated by the study team

2012-04-02

Who can join

Age: 5 and older, up to 19. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• sibling of an allogeneic cell therapy transplant patient -- the persons receiving allogeneic transplant may have either an acquired or congenital disease. Acquired diseases include acute lymphoblastic leukemia, acute myelogenous leukemia, severe aplastic anemia, hemoglobinopathies, and lymphomas.Congenital diseases are comprised of hemoglobinopathies and glycogen/lysosomal disorders. Transplant is being considered after failure to respond to traditional therapies or due to the nature of the disease.
• 5 to 19 years of age
• speaks English or Spanish
• one parent or legal guardian willing to participate
• mentally able to render a valid assessment
• donor is harvested at this institution
• donors will participate in the standard psychosocial intervention
• children in the non-donor group will be matched by age and gender to donor group participants

You may not qualify if…

• participation is limited to one donor per family
• if a child had matched and declined to donate, that child would not be eligible to participate in the non-donor group

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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