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Slow accrual.
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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:
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:
Secondary Aim:
Evaluate satisfaction with the donor program.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anxiety Assessment | Minor Donors + Sibling Non-Donors + Parents or Legal Guardians |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Behavioral | Questionnaires completed before the bone marrow or stem cells are collected, after the transplant, and 6 months after the transplant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Parent, legal guardian, or sibling of a patient that will have a bone marrow or stem cell transplant.
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| Name | Affiliation | Role |
|---|---|---|
| Rhonda Robert, PhD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |