Long Term Minor Sibling Donor Well-Being
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|ClinicalTrials.gov Identifier: NCT00667784|
Recruitment Status : Terminated (Slow accrual.)
First Posted : April 28, 2008
Last Update Posted : April 2, 2012
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.
- Compare minor donor adjustment to minor non-donor adjustment, including anxiety, self-esteem, traumatic stress, achievement, and behavior.
- Evaluate minor donor adjustment across time, including self -esteem, traumatic stress, anxiety, achievement, and behavior.
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).
Evaluate satisfaction with the donor program.
|Condition or disease||Intervention/treatment|
|Disorder Related to Bone Marrow Transplantation Blood Stem Cell Transplant Failure Disturbance of Emotions Specific to Childhood and Adolescence Transmission, Blood, Recipient/Donor Sibling||Behavioral: Questionnaire|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||2 participants|
|Observational Model:||Case Control|
|Official Title:||Long Term Minor Sibling Donor Well-Being|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Minor Donors + Sibling Non-Donors + Parents or Legal Guardians
Questionnaires completed before the bone marrow or stem cells are collected, after the transplant, and 6 months after the transplant.
Other Name: Survey
- Effect of Donor Status on Child's Anxiety (Sibling Donor vs. Sibling Non-Donor) [ Time Frame: 7 months (one month pre-donation; one month post-donation; 6 months post-donation) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667784
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Rhonda Robert, PhD||M.D. Anderson Cancer Center|