Long Term Minor Sibling Donor Well-Being
FOR PARENT or Legal Guardian:
Half of the young persons being asked to participate in this study will be donating bone
marrow or stem cells and will be referred to as "minor donors." The other half will not be
donating marrow or cells but have a sick family member who will be having a bone marrow or
stem cell transplant and will be referred to as "non-donors". For each participating young
person, one parent or legal guardian will need to complete the parent questionnaires as
well.
You are being asked to participate in this study because you have a sick family member who
will have a bone marrow or stem cell transplant at this hospital and you are a caregiver to
a healthy child. You will be asked to complete 5 questionnaires shortly before the bone
marrow or stem cells are collected, shortly after the transplant, and 6 months after the
transplant. You will be asked about your children, family atmosphere, and parental
well-being. Most of the questions have a list of possible answers, and you will choose the
answer that best describes you. Some questions are left blank for you to write in your
answer. It will take about 45 minutes to complete the questionnaires.
FOR CHILD:
If you agree to take part in this study, you will be asked to complete 9 questionnaires
shortly before the bone marrow or stem cells are collected, shortly after the transplant,
and 6 months after the transplant. You would be asked about your feelings, behavior, and how
you are doing in school. These types of questions do not have wrong answers. Most of the
questions have a list of possible answers, and you will choose the answer that best
describes you. Some questions are left blank for you to write in your answer. It will take
about 1 hour to fill out the questionnaires.
Length of Study:
You will participate in the study across a 7 month period. You will begin the study one
month before donation and complete the study 6 months after the donation.
This is an investigational study. Up to 30 participants (15 minor donor's parents and 15
non-donor's parents) will be enrolled on this study. All will be enrolled at M. D.
Anderson.
Observational
Observational Model: Case Control, Time Perspective: Prospective
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)
No
Rhonda Robert, PhD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
2007-0571
NCT00667784
April 2008
April 2011
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |