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Long Term Minor Sibling Donor Well-Being


N/A
5 Years
19 Years
Not Enrolling
Both
Disorder Related to Bone Marrow Transplantation, Blood Stem Cell Transplant Failure, Disturbance of Emotions Specific to Childhood and Adolescence, Transmission, Blood, Recipient/Donor, Sibling

Thank you

Trial Information

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.


Inclusion Criteria:



1. 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.

2. 5 to 19 years of age

3. speaks English or Spanish

4. one parent or legal guardian willing to participate

5. mentally able to render a valid assessment

6. donor is harvested at this institution

7. donors will participate in the standard psychosocial intervention

8. children in the non-donor group will be matched by age and gender to donor group
participants

Exclusion Criteria:

1. participation is limited to one donor per family

2. if a child had matched and declined to donate, that child would not be eligible to
participate in the non-donor group

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Rhonda Robert, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0571

NCT ID:

NCT00667784

Start Date:

April 2008

Completion Date:

April 2011

Related Keywords:

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

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030