Long Term Minor Sibling Donor Well-Being

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00667784

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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:

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).

Secondary Aim:

Evaluate satisfaction with the donor program.

Condition or Disease	Intervention/Treatment	Phase
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

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

2 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Long Term Minor Sibling Donor Well-Being

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Anxiety Assessment Minor Donors + Sibling Non-Donors + Parents or Legal Guardians	Behavioral: Questionnaire Questionnaires completed before the bone marrow or stem cells are collected, after the transplant, and 6 months after the transplant. Other Names: Survey

Arm

Intervention/Treatment

Anxiety Assessment

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

Behavioral: Questionnaire

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

Other Names:

Survey

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.
5 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

Exclusion Criteria:

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