Long Term Minor Sibling Donor Well-Being

NCT00667784 | Terminated

• 1 other identifier: 2007-0571
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

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

Keywords

pediatric stem cell donor; emotional sequelae; physical sequelae; psychological consequences of minor donation; Bone Marrow Transplantation; Questionnaire; Survey; Sibling Donor; Stem Cell Transplant; Well-Being

Outcome Measures

Primary Outcomes (1)

• Effect of Donor Status on Child's Anxiety (Sibling Donor vs. Sibling Non-Donor)

  Comparison of the two groups (i.e., donor vs. non-donor) using Revised Children's Manifest Anxiety Scale (RCMAS) administered prior to transplant, and two times during course of study to ascertain anxiety. The longitudinal nature of the data necessitates use of a multivariable repeated measures model to examine effects of donor vs. non-donor status on anxiety.

  7 months (one month pre-donation; one month post-donation; 6 months post-donation)

Study Arms (1)

Anxiety Assessment

Minor Donors + Sibling Non-Donors + Parents or Legal Guardians

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Questionnaires completed before the bone marrow or stem cells are collected, after the transplant, and 6 months after the transplant.

Also known as: Survey

Anxiety Assessment

Eligibility Criteria

• Age: 5 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

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.
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rhonda Robert, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 2, 2012

Record last verified: 2012-03

Locations

US (1)