Long Term Minor Sibling Donor Well-Being - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00667784

Purpose

Primary Aims:

Compare minor sibling donor adjustment to minor non-donor sibling adjustment, including anxiety, self-esteem, traumatic stress, achievement, and behavior.
Evaluate minor sibling donor adjustment across time, including self -esteem, traumatic stress, anxiety, achievement, and behavior.
Investigate the effect of the following on donor well-being:
1. 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, and 6) donor's decision-making and ambivalence regarding donation.
2. Recipient variables: 1) the recipient's level of well-being or death, and 2) genetic versus acquired disease types.
3. 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 (PTSD, depression).
  
  Secondary Aim:
Evaluate satisfaction with the donor program.

Condition	Intervention
Bone Marrow Transplantation	Behavioral: Questionnaire

MedlinePlus related topics: Bone Marrow Transplantation

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Long Term Minor Sibling Donor Well-Being

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To understand what it is like for a young person to have a sick brother or sister and what it is like to donate bone marrow or stem cells for a sick brother or sister. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	April 2008
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Parent, legal guardian, or sibling of a patient that will have a bone marrow or stem cell transplant.	Behavioral: Questionnaire Questionnaires completed before the bone marrow or stem cells are collected, after the transplant, and 6 months after the transplant.

Eligibility

Study Population

Parent, legal guardian, or sibling of a study participant that will have a bone marrow or stem cell transplant.

Criteria

Inclusion Criteria:

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
If sibling is also a bone marrow or stem cell donor, harvest occurs at this institution
Siblings in the bone marrow or stem cell donor group will participate in the standard psychosocial intervention
Siblings in the non-donor group will be matched by age and gender to donor group participants
The allogeneic cell therapy transplant patient is having a first transplant

Exclusion Criteria:

Participation is limited to one sibling per family
If a sibling had matched and declined to donate, that sibling would not be eligible to participate in the non-donor sibling group

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667784

Contacts

Contact: Rhonda Robert, PhD

713-792-6620

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Rhonda Robert, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Rhonda Robert, PhD

U.T.M.D. Anderson Cancer Center

More Information

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Rhonda Robert, PhD/Associate Professor )
Study ID Numbers:	2007-0571
Study First Received:	April 24, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00667784
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Bone Marrow Transplantation
Questionnaire
Survey

Sibling Donor
Stem Cell Transplant
Well-Being

ClinicalTrials.gov processed this record on January 16, 2009