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The Sister Study

Making a difference for future generations of women.

Sisters Changing Lives

Frequently Asked Questions

WHAT IS THE SISTERS CHANGING LIVES SAMPLE COLLECTION?
WHY INCLUDE ME?
WHAT DOES SISTERS CHANGING LIVES SAMPLE COLLECTION INVOLVE?
HOW IS MY PRIVACY PROTECTED?
WHY DO I PROVIDE...?
I HAVE QUESTIONS ABOUT MY SISTER STUDY SECOND SAMPLE KIT.
TELL ME MORE ABOUT THE BLOOD DRAW AND VISIT.
HOW DO I FIND OUT MORE?

 

Was your question answered? Go to our Contact Us page.

What is the Sisters Changing Lives Sample Collection all about?

The Sister Study Sisters Changing Lives Sample Collection involves collecting blood, urine, toenails, dust, and simple body measurements from eligible Sister Study participants with and without breast cancer. The purpose of this second sample collection is to identify biological factors that change over time as well as monitor changes in environmental exposures across Sister Study participants. We can measure these changes by re-collecting many of the same samples that you provided when you first joined the study. This effort will allow researchers to compare changes between the samples you gave when you joined to those you give this second time. This comparison is to help learn how exposures and biological factors can change with time, age, and health. The differences we find may inform cancer prevention and how to improve health after breast cancer. If we are unable to collect your blood for any reason, you may be asked to provide a saliva sample.


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What will this follow-up tell us?

Researchers believe this part of the Sister Study will help us better understand reasons some women get breast cancer, especially reasons that concern environment and genes. Results from the Sister Study may also help us understand how genetic and environmental factors act together to influence health after treatment. Knowledge gained from the Sister Study may possibly be used to develop recommendations for preventing breast cancer in the future and how to improve health after breast cancer.


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Who is running the study?

Researchers at the National Institute of Environmental Health Sciences (NIEHS) are running the Sister Study, including the Sisters Changing Lives Sample Collection. NIEHS is one of the National Institutes of Health, part of the U.S. Department of Health and Human Services. The website for NIEHS is www.niehs.nih.gov. exit disclaimer

The Investigators are —

Dale P. Sandler, PhD
Chief of Epidemiology Branch

Clarice Weinberg, PhD
Chief of Biostatistics Branch

Learn more about the Investigators leading the study by visiting Who is Leading the Study.


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Why is it important for me to help with this follow-up?

Breast cancer is a serious disease that will affect 1 in 8 women in the US over their lifetimes. We believe this follow-up will give us valuable information about the different reasons women get breast cancer. This information may help us learn about ways to prevent breast cancer or influence health after breast cancer. Everyone’s life experiences are different although women from all walks of life may have common experiences that increase their chances of developing breast cancer. It is important that women from all backgrounds participate so that the results of the study will apply to everyone.

 

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Who will get results from this follow-up and how will it benefit public health?

The information collected in the Sisters Changing Lives Sample Collection will be used to identify risk factors for breast cancer. The results will be reported in papers that will be published in scientific magazines, including journals read by physicians, epidemiologists, and laboratory scientists. Results will also be reported in the national and regional press, and to the participants in newsletters and on our Publications page. Published summary reports will also be available to government and other organizations that make decisions about evidence that specific agents cause cancer or other diseases and to those who make policy recommendations. Also, these reports will be available to other investigators who may wish to test ways to prevent disease.

 

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Who can be part of the Sisters Changing Lives Sample Collection?

The Sisters Changing Lives Sample Collection is being offered to women participating in the Sister Study who have been diagnosed with breast cancer as well as some women who have not been diagnosed.

 

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Why would I want to participate in this research?

Most people who choose to participate in research hope it will produce knowledge -- for example, the role of genetics in the disease -- that will benefit themselves or others. Since there is no intervention or treatment offered in the study, the risks to the participant are very minimal and there is no immediate medical benefit. Most people who participate in studies like this do it because they want to help other people. In this case, women who participate may want to help people learn how to prevent breast cancer. They are doing it for themselves, but also for their sisters, daughters, and future generations of women.

 

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What will I be asked to do?

If you participate in this follow-up we will ask you to give us samples of your blood, urine, and toenails, as well as dust samples collected from your home. We will also measure your blood pressure, weight, height, waist and hips and ask you to complete a short questionnaire about the 24 hours before your blood is drawn.


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What forms and questionnaires will I need to complete?

This part of the study involves completing just two brief forms: an Informed Consent Form for you to read and sign and the short questionnaire about the 24 hours before your blood is drawn. There are no other detailed telephone interviews or questionnaires to complete as part of this effort.


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Why am I being asked to give a blood sample?

We are asking for a new blood sample to measure your level of exposure to environmental agents such as chemicals or metals, levels of hormones, vitamins and nutrients, and specific variations in genes that may be related to your risk of developing breast cancer and other diseases. You have been selected to participate in the Sisters Changing Lives Sample Collection because we are interested in measuring any changes in these environmental exposures over time. The data you have provided can give us a good picture of your lifestyle and potential exposure to different chemicals and other risk factors over your lifetime. But the most accurate picture of your actual exposures is what we can measure in your blood.


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I already gave a blood sample, why can’t you use that?

The blood sample you provided when you joined the Sister Study is an important source of DNA for Sister Study analyses. However, for this sample collection we want to monitor changes in biological factors and environmental exposures over time.


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How much time will it take me to complete the follow-up activities?

The enrollment process should take about 5-10 minutes. Collecting your samples and completing the questionnaire in your Kit will take about 20 minutes and the visit will take about 30-45 minutes. So, you will spend roughly 60-75 minutes total.


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Will it cost me anything to participate?

There is absolutely no cost, except for your time.


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Will I get paid to take part in this follow-up?

No. Volunteers are not paid. We greatly appreciate the contributions participants are making to breast cancer research.


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Who makes sure this research is safe and scientifically sound?

Research funded by the federal government is carefully reviewed and monitored. First, the Institutional Review Board (IRB) of the NIEHS reviews the study, identifying issues and concerns, and works with the investigators as needed to improve the study. The NIEHS IRB is diverse and includes ethicists, lawyers, physicians, scientists from NIEHS, as well as scientists and members from the local community.

All institutions, including the National Institutes of Health (NIH), that receive funds from the Department of Health and Human Services to conduct or support research with human subjects must follow specific rules and are guided by ethical principles of a document known as The Belmont Report . exit disclaimerNIH has developed a system of education and approval procedures to assist investigators in understanding and complying with well-established ethical and regulatory requirements.

The investigators and staff who are conducting the Sister Study receive ongoing education and monitoring to ensure that these requirements are fulfilled. If you would like more information on this important topic, please visit the U.S. Department of Health & Human Services website at www.hhs.gov/ohrp. exit disclaimer


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Who is collecting the samples for NIEHS?

Social and Scientific Systems, Inc., a professional services research firm specializing in health studies and epidemiologic research, works closely with NIEHS investigators to recruit participants, collect samples, and manage the day-to-day activities of the study. More information can be found at www.s-3.com. exit disclaimer

Female examiners from Examination Management Services, Inc. (EMSI) will assist with drawing blood, and measuring height and weight, hip and waist circumference, and blood pressure. EMSI’s website is www.emsinet.com. exit disclaimer


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Can I complete my follow-up activities from my winter/vacation address?

We would like you to complete these follow-up activities from your primary residence, that is, the residence at which you spend the most time. This makes sure that samples we collect reflect your usual activities.


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Will my information be kept confidential? How will this be done?

All of the Sister Study staff sign confidentiality forms and undergo training in research ethics. We have put in place several protections for the privacy of your samples. When your samples are collected, they are labeled with an ID number and stored separately from all personal identifiers, such as your name, address, and telephone number. Your personal contact information is kept in separate files accessible only to Sister Study staff on a need-to-know basis.

The Sister Study has received a Certificate of Confidentiality that helps us protect the confidentiality of your data against compulsory legal demands (e.g., court orders and subpoenas) that seek the name or other identifying characteristics of a research subject.


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What is a Certificate of Confidentiality and what does this mean for me?

A Certificate of Confidentiality helps researchers protect the privacy of subjects in biomedical, behavioral, clinical, or other research projects against compulsory legal demands (e.g., court orders and subpoenas) that seek the name or other identifying characteristics of a research subject. With a Certificate of Confidentiality, researchers cannot be forced by anyone to give out information that could identify you.


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What protection does a Certificate of Confidentiality provide?

Confidentiality Certificates are issued by the U.S. Department of Health and Human Services to provide privacy protection to research subjects. These certificates are authorized by law in provision 301(d) of the Public Health Services Act (42 U.S.C. Section 241(d)). A Certificate can be used by the researcher to avoid compelled "involuntary disclosure" (e.g., subpoenas) of identifying information about a research subject.


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What protection does a Certificate NOT provide?

A Certificate of Confidentiality does NOT prevent researchers from voluntarily disclosing information about a participant if it is considered necessary to protect a participant or someone else from serious harm, as in cases of child abuse. A Certificate of Confidentiality also does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer or employer learns about your participation from you, and you consent in writing to having information about you released, then we cannot use the Certificate of Confidentiality to withhold this information. This means that you and your family must also actively protect your own privacy. We will keep your participation in this research study confidential to the extent permitted by law. However, it is possible that other people may become aware of your participation in this study without your permission, for example, if it is required by the Food and Drug Administration (FDA), members of Congress, law enforcement officials, or other authorized people.


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How long is my information protected under the terms of the Certificate?

The Certificate covers the collection of sensitive research information for a defined time period (the term of the project); however, personally identifiable information obtained under protection of a Certificate is protected forever. In other words, we researchers can collect new data under the Certificate only during the agreed upon length of the study. But your privacy is protected even after the study has ended.


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What will you do with the information from this sample?

We will combine the data you already gave us and the data from these new samples for statistical analyses.


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Can my insurance company or employer obtain the information you get from this sample?

No, we will not provide any study information to insurance companies or employers, as it is strictly protected by confidentiality rules. However, this does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research should you choose to do so on your own.


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Can I get the results of my blood test?

No. Most of the tests we will do are for research purposes only. They are not intended to be used as diagnostic tests or to make decisions about your medical care.


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Can I get any results from the study?

Personal results will not be provided to participants. We will let you know what we learn by combining the results of tests from many participants. We hope that our analyses will provide information that can be used in the future to help women prevent breast cancer. However, one study will not be able to answer all the questions about this disease and our findings will not directly explain specific cases of breast cancer or help to improve your own health in any direct way. Still, we will make sure to share the findings from this research with you.

On a regular basis, we will send you newsletters with highlights of general study results. Results of the study will also be published in scientific journals, and we will post them on our Publications page.


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Why collect a blood sample from some women who have developed breast cancer and others who have not?

It is important to monitor trends in environmental exposures across Sister Study participants. Many conditions such as breast cancer will cause the blood measurements to change. For example, the disease or the treatments might change hormone levels. If women lose or gain weight, the levels of some chemicals or hormones might change. Blood samples from women without breast cancer will be very valuable to the study because they can be compared to blood samples collected from participants who have developed breast cancer or other diseases. If you develop breast cancer in the future, it is also useful to analyze samples collected before your diagnosis.


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Will my samples be used for genetic (DNA) testing?

Most participants’ samples will be used for genetic (DNA) testing. Although we may be testing for genes that directly influence breast cancer risk (e.g. known breast cancer genes), most of the tests will focus on genes that influence risk only indirectly, for example, by enhancing risk related to diet or environmental exposures. It is important that you know that any analyses using your samples will NEVER include information that would identify you personally. Also, it is important that you know you will not get any results of the tests that may be performed on your samples. If you have specific concerns about your health, you should consult with your own doctor to find out about tests that are available and appropriate for you.


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Why do I have to provide a urine sample?

The urine sample will be used to measure some hormones that are not easy or accurate to measure in blood. The urine samples will also be used to measure some chemicals to which you may have been exposed. We will not test for illegal drugs. The urine sample is easy to collect. This is something you can do at home, first thing in the morning on the day of the examiner visit.


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Why do I have to provide toenail clippings?

Toenails are valuable to researchers because the measurements from toenails reflect exposures over a longer time period than either blood or urine. Also, there are some things like metals that we can easily measure in toenails. Practically speaking, toenail clippings are usually easy to collect and store. We will not test for illegal drugs.


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Why do I have to provide a house dust sample?

House dust is valuable to researchers because the measurements from house dust will tell us about the chemicals you may breathe or ingest in your living environment. There are things like pesticides and allergy-provoking substances that we can measure in house dust.


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What is included in the Sister Study Second Sample Kit?

The Kit contains all the instructions, forms, and supplies that women need to complete the Sisters Changing Lives Sample Collection:

  • Informed Consent form with a copy to keep, a quick reference summary of the consent form, 'Answers to Your Questions' and instructions for completing study activities.
  • Supplies and instructions to collect household dust, toenail clippings and a first-waking urine.
  • Past 24 Hours Questionnaire.


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When will my Kit get here?

Your Kit will be shipped by FedEx after you complete your enrollment in this phase of the study or after the date you’ve indicated you will be available to begin your study activities.


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What do I do with the Sister Study Second Sample Kit box and its contents when I'm finished with it?

You will give the EMSI Examiner only the completed questionnaire, signed consent form, the urine, dust and toenail samples, and the folder labeled “Examiner Folder.” Do not give her the entire box. You should keep your copy of the Consent Form for your records.


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What if I did not complete some items before the visit?

It is best if you complete the forms and sample collection before your scheduled examiner visit. If for some reason you are unable to get everything done, please let the examiner know what parts of the Kit you have not completed. We will then send you an envelope that you can use for returning those items to us as soon as possible after the visit.

Please note, the Informed Consent Form must be signed before the EMSI examiner can begin the visit activities, and she must take our copy with her when she leaves. You may keep your copy for your own records.


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What if my Sister Study Second Sample Kit does not have all the items as mentioned?

Please call us as soon as possible at the toll-free number 877-4SISTER. We will send you the items you need.


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What kind of company is EMSI?

EMSI is a network of experienced medical professionals who conduct physical examinations, testing, and personal health interviews for insurance physicals and research studies. EMSI’s website is www.emsinet.com. exit disclaimer


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What can I expect at the visit?

A female examiner from EMSI will visit you in your home, doctor’s office or other location to take a blood sample and measure your blood pressure, weight, height, waist and hips. The examiner will also pick up your signed informed consent form, completed questionnaire and the urine, dust, and toenail clippings. The visit should take about 30–45 minutes.


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How much blood will be drawn during my visit?

The examiner will draw blood equivalent to about three tablespoons.


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Where do I have my blood drawn?

The EMSI examiner will call you to schedule an appointment at your home. If you prefer, you may also go to an EMSI office located in your city to have your blood drawn. Or, the visit can be scheduled at your office or some other place. When the EMSI representative calls to schedule the appointment, you can talk about these choices.


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I have been diagnosed with breast cancer or another cancer. Are there precautions that should be taken when having my blood drawn or having my blood pressure taken?

Blood draw precautions are advised if you have had an axillary dissection/surgery. It is advised not to have blood drawn on the surgically-affected side of your body or in cases of lymphedema. Performing a blood draw or blood pressure on the unaffected side is considered safe.


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Are EMSI examiners trained in blood draw precautions for women diagnosed with cancer?

EMSI examiners are well-trained and follow strict study procedures so that all the measurements are made in the same way and the blood is drawn in the same way for all participants. They will take the following steps to ensure a safe blood draw. They will not draw blood on the surgically affected side of your body, including the side where any axillary nodes were taken. They will also check for obvious lymphedema, extremity swelling, and signs of local infection, and will not do a blood draw if any of these signs are observed. You should inform the examiner about any concerns you have, including lymphedema. If you are still concerned about an EMSI examiner drawing your blood, we encourage you to have your blood drawn at your doctor’s office.


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Can someone besides the EMSI examiner draw my blood?

Many women prefer to have their blood drawn by an examiner from EMSI. Their staff has been trained to follow this study’s procedures exactly. This way, all the measurements are made in the same way and the blood is drawn in the same way for all participants. However, if you would like your doctor or someone else to draw your blood, you can call the Sister Study office toll-free at 877-4SISTER or you can talk about these choices when study staff calls to schedule the appointment.


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What if I don't want to have the examiner come to my home or office, but I want to have the examination some place else (someone else's home, mall, public health department, etc.)?

There are several options for you. You can go to an EMSI office in your area. When EMSI calls to set up a visit, just tell the representative what you have in mind or if you would like to meet some place else. She will arrange a visit place that is most comfortable for you.

Remember that during the visit, the EMSI examiner will collect a fasting blood sample, measure your height, weight, waist, hips, blood pressure and pulse, and collect your urine sample and forms. So, choose a place where you will feel comfortable having these measurements taken. When you come to the EMSI office or other location, remember to continue fasting and bring your Sister Study Second Sample Kit and all of your collected samples with you. Please keep urine cool when you bring it with you.


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Who will pay for the blood draw if my doctor does it?

The Sister Study will cover reasonable costs for having your blood drawn provided arrangements are worked out before you have this done. You should speak to a Sister Study staff member about making alternate arrangements to have your blood drawn. An EMSI examiner will still need to meet you at your doctor’s office to receive the blood, forms, and other samples you have collected. Our staff will contact your doctor to work out the details and arrange to pay the doctor directly. Call the Sister Study office toll-free at 877-4SISTER to make these arrangements.


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What does it mean to “fast” before my blood draw?

To fast means to not have anything to eat or drink in a specified time period. In this case, we ask that you not have anything to eat or drink, except water, for the 8 hours prior to your scheduled visit for the blood draw. If you take medications, please continue to take them as you usually would.


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Why do I have to fast before my blood draw and for how long?

Some of the laboratory tests we will do are easier to interpret if you have not eaten for at least 8 hours. However, not all tests require a fasting blood sample. So, if you forget to fast, we can still collect your blood sample. Be sure to let the examiner know how long it has been since you have eaten so we will know which tests we can do and how to interpret the results.


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What if I have not fasted before my appointment to have my blood drawn?

It is very important to fast because some of the blood tests will not work if you have not fasted. However, we will still want to draw your blood even if you have not fasted. It is important for us to know when you last had something to eat or drink so that we can determine which tests we can do and so that we can better interpret any test results. You should be sure to let the examiner know when you last ate or drank. She will record this information for us.


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What do I do if the EMSI examiner didn't show up for my appointment, or I forgot about it and wasn't there at the scheduled time?

You may end your fast and eat. Please call EMSI as soon as possible at the special toll-free number: 888-337-2345. Tell EMSI the date, time and location of your scheduled appointment so that it can be rescheduled. If your examiner should arrive late and you are still willing to go through with the visit, tell the examiner that you have eaten.


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What if I have a problem or complaint about the visit?

Please call us as soon as possible at the Sister Study toll-free number 877-4SISTER. Tell us the problem, the time, place, and date of your appointment. We will take any action that is necessary.


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How can I learn more and have my questions answered about the Sister Study?

Please call our toll-free number, 877-4SISTER or email update@sisterstudy.org. A Sister Study Helpdesk staff member will answer your questions.


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Is there a physician on staff who could talk to me about breast cancer?

The Sister Study does not have a physician on staff. We are not in a position to provide medical advice. If you need to find a doctor or have questions about breast cancer, you should contact your local health department, the American Cancer Society, or other organizations better qualified to provide you with breast cancer information. Links to some of these organizations are updated regularly on our Resources page.


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