Frequently Asked Questions

Do I have to join this study?

You are not required to join this study. Participation is entirely voluntary and has no effect on your relationship with your physician or with the medical or university site in your region.

Who can participate?

Participation is open to anyone:

• Who had a bone marrow transplant for sickle cell disease at least one year ago
• Who was a bone marrow donor for a person with sickle cell disease and their recipient is a participant
• Anyone who has sickle cell disease and is matched in age, gender, and type of sickle cell disease to a person who received a bone marrow transplant (the research staff will determine this)

Why is this study being conducted?

Children’s Hospital of Atlanta and Emory University are a joint academic medical center. The physicians who provide care to the patients are also researchers and educators. Research is important in providing evidence-based health care to patients. The goal of this study is to understand the late term effects of bone marrow transplant on patients who had sickle cell disease. It is important to understand their over-all health and quality of life and to compare these outcomes to their donors and to those with sickle cell disease.

Do I have to be a patient at Children’s Hospital of Atlanta to participate?

This is a multi-center study, meaning that we are recruiting participants from several regions across the United States and in France. Participation is open to anyone who qualifies and is able to affiliate with a study site in order to collect surveys and blood samples.

What does it mean to participate in this study?

Participation is possible by consenting on-line and completing surveys. If you do so, you will be contacted by a research staff member to arrange for collection of blood and urine samples, a hand grip test, and a test of your ability to stand up and walk.

You may also contact the study team to consent over the telephone or in-person.

Whether you consent on-line or with a research staff member, you will be asked to complete surveys about your health and your quality of life. These surveys take a while to complete so we have arranged for you to complete some of them every 3 months. You will be compensated for each set of surveys you complete at the 3-month time intervals. These surveys may be completed on-line, via paper and pencil, or over the phone with a research staff member.

Once a year you will be asked to provide blood work, height, weight, hand grip, and other testing measures. These may be done during a clinic visit or in the comfort of your home.

We will also access your medical records once a year on your enrollment anniversary to review your health status.

How long does it take me to participate?

You will be asked to complete surveys every 3 months. These surveys will take 20-30 minutes to complete. You will also be asked to participate in a blood draw and urine collection on a yearly basis along with a hand grip test, height and weight and a stand up and walk test. These will take about 30 minutes to complete. You will be compensated for your time and effort.

What if I do not want to answer or complete certain parts of the study?

You do not have to answer or complete any parts of the study you do not feel comfortable with. You will have the option to decline participation for any individual surveys, assessments, and specimen collection if you prefer not to participate in this part of the study.

How long will my participation last?

We would like you to participate for as long as possible. And as long as you feel comfortable participating. This study is intended to last for years and possible decades.

How do I know what you are going to do with my information?

Your information will be de-identified, meaning that your name will not be connected to any data we collect. We will use the information to analyze health status of the participants and compare overall health between participant groups (those who had bone marrow transplant for sickle cell disease, those who donated their bone marrow, and those who have sickle cell disease). This will allow us to evaluate long-term effects of bone marrow transplant on those who were born with sickle cell disease.

How do I know my privacy will be protected?

There are ethical implications for research. The Institutional Review Board (IRB) at each participating site has the responsibility to oversight for the study. The IRB has approved the study and its recruitment process and data collection methods. The IRB has the responsibility to ensure that participant safety and rights are protected. The IRB also has oversight of the study throughout its duration and will ensure everything we do is ethical, legal, and understood by each participant.

Is my information secure?

We will keep your electronic information secure by using only a secure computer system. Only approved research staff will have access to your information. Your information will also be de-identified, meaning that your name will not be connected to your data but a unique identification number will be assigned.

Will participation in this study tell me if I am going to develop complications from my bone marrow transplant?

This study is intended to track the health of those who have had a bone marrow transplant and to identify late effects of this transplant. It will not tell us if you will develop these complications.

Can I see what information you collect about me?

Yes, you can see a summary of the information we collect about you if you log in to your account on the STELLAR website. This is a secure portal that will provide you with access but does not allow anyone else to see your data. Of course, the research staff will be able to see your data but will only use de-identified data for analysis. You may share any of the results with your healthcare provider if you wish to do so.

Will you share the information you collect about me with anyone else?

We will not share your identifiable information with anyone. We will only share your de-identified information with our affiliated study staff and researchers.

What happens if I join but later decide I do not want to participate?

You may withdraw from participation at any time by emailing the research coordinator at STELLAR@choa.org or calling 404-785-0905.

Why should I join this study?

Bone marrow transplant for sickle cell disease is a fairly new treatment and we do not yet understand the late effects of this treatment on the recipient’s health.

1. If you are a bone marrow recipient, you will help us determine what late effects occur or how your bone marrow preparation and transplant effected your health over a long period of time.
2. If you are a donor, we will be able to compare your health to that of bone marrow recipient to evaluate how their health compares to yours and what may be late effects from the bone marrow transplant.
3. If you are a person with sickle cell disease, we will be able to compare your health to that of the bone marrow recipient to evaluate how their health compares to yours and what may be late effects from the bone marrow transplant.