The Sister Study Anniversary Biospecimen Collection involves collecting blood, urine, and stool samples from Sister Study participants. All Sister Study participants provided a blood and urine sample when they joined the study. Some provided a second set of samples about 7 years after they enrolled. Collecting another blood and urine sample will allow researchers to consider changes in exposures or biomarkers of health over time when studying the role of these factors in subsequent heath changes. For women who have developed breast cancer or other conditions since joining the study, these new samples will allow us to better study changes that occur after a diagnosis. Such changes may affect the risk for additional cancers or diseases.

We are also collecting stool samples, which is something new. Your stool sample will be used to study the gut microbiome, which includes the microorganisms that normally live in your digestive tract. Coupled with all the information we already have on your health, experiences, and lifestyle, your stool samples will be a valuable resource for research into whether the gut microbiome influences health and cancer development. This knowledge may help us develop new approaches for cancer prevention and to improve health after breast cancer.

What will this follow-up tell us?

Researchers expect that additional biological samples from Sister Study participants will help us better understand why some women get breast cancer and other chronic conditions, especially reasons related to the environment and lifestyle. These samples may also help us understand how genetic and environmental factors act together to influence health after treatment.

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

Breast cancer will affect 1 in 8 women in the US over their lifetimes. This additional sample collection will provide valuable information about the different reasons women get breast cancer and other chronic conditions. Women from different walks of life may differ in their exposures and experiences. It is important that women from all backgrounds participate so that the results of the study will apply to everyone.

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

The scientific results that come from the analyses of samples collected in the Anniversary Biospecimen Collection will be reported in scientific publications, including journals read by physicians, epidemiologists, and laboratory scientists. Results may also be reported in the national and regional press and to Sister Study participants via newsletters, the study website, and other online participant communications. Published summary reports will also be available to government agencies and other organizations that evaluate evidence about whether specific agents cause cancer or other diseases and to those who make policy recommendations. Also, these reports will be available to other scientific investigators who may wish to test new ways to prevent disease.

Is the research only about breast cancer?

No, this sample collection will also allow Sister Study researchers to study risk factors for many other diseases that affect women, such as coronary heart disease, diabetes, osteoporosis, and other types of cancers. We can increase the value of the Sister Study data and samples that you share with us by studying breast cancer and other diseases that might be influenced by the environment. We can also learn more about how having breast cancer or being treated for breast cancer influences the chances of developing other health conditions.

Who can be part of the Anniversary Biospecimen Collection?

All Sister Study participants are being invited to participate in the Sister Study Anniversary Biospecimen Collection, including those who have been diagnosed with breast cancer.

Why would I want to participate in this research?

Most people who choose to participate in research hope that it will produce information that will benefit themselves or others. Since there is no intervention or treatment offered in this study, the risks to you are very minimal. There is also 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 future generations.

What will I be asked to do?

If you participate in this sample collection, we will ask you to give us samples of your blood, urine, and stool. We will also ask you to complete a short questionnaire for each sample you provide.

What forms and questionnaires will I need to complete?

You will complete three short questionnaires that correspond with each of the sample types you provide that ask specific questions regarding each of your samples and a few aspects of your health and exposures at the time you donate the samples.

Why am I being asked to give a blood sample?

We are asking for a new blood sample to measure your 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 the development of breast cancer and other diseases. Since an individual’s exposures and biological characteristics may change over time, we want to be able to account for these when studying the factors that influence health over time. The data you have provided in questionnaires over the years gives us a good picture of your lifestyle and potential exposures to different chemicals and other risk factors over your lifetime, but the most accurate picture of some exposures is what we can measure in your blood.

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 resource for research as are any additional samples you have given over the years. Getting multiple blood samples over several years will allow researchers to account for changes in biological factors and environmental exposures over time that may be related to cancer development or health after a breast cancer diagnosis.

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

Collecting your samples and completing the questionnaires will take about 60 minutes total and the visit from ExamOne will take about 30-45 minutes.

Will it cost me anything to participate?

There is absolutely no cost to you, except for your time.

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

As a small token of gratitude, participants who provide the samples will be sent a $50 gift card. We are very grateful for your participation in women's health research.

Who makes sure this research is safe and scientifically sound?

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

NIH 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.

Who is collecting the samples for NIEHS?

The Sister Study team at DLH Corp, a professional services research firm specializing in health studies and epidemiologic research, is working closely with NIEHS investigators to manage the day-to-day activities of the Anniversary Biospecimen Collection.

Licensed phlebotomists from ExamOne will assist with drawing blood for this collection.

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

Yes, you can complete these follow-up activities from any residence within the United States including Puerto Rico, but it is best if we can collect the samples from the residence where you spend the most time during the year.

How will your study be identified on my caller ID when you call?

Your caller ID will display: 877-440-2138.

What if I change my mind after I have signed up to participate?

You may decline to participate in this Anniversary Biospecimen Collection effort of the Sister Study at any time. If you change your mind, please call our toll-free number, 877-440-2138 and we will help you end your participation. We will keep the information you already provided during the Anniversary Biospecimen Collection unless we get a signed written request from you asking us not to do so.

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

Yes. All information is kept confidential. Sister Study staff sign confidentiality forms and undergo training in research ethics. We have put several protections in place 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 is covered by a NIH 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.

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.

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 Confidentiality Certificate can be used by the researcher to avoid compelled "involuntary disclosure" (e.g., subpoenas) of identifying information about a research subject.

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, for example, 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.

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, researchers can collect new data under the Certificate only during the length of the study. But your privacy is protected even after the study has ended.

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.

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.

Can I get the results of my blood test?

No. All the tests we will do are for research purposes only. They are not intended to be diagnostic tests or to be used to make decisions about your individual medical care. If you have concerns about your health, we encourage you to contact your healthcare provider.

If you find something wrong with my blood test, will you notify me?

No, the Sister Study is not designed to detect or diagnose disease. The tests we will do are for research purposes only and are not intended to help with decisions about individual medical care. We will not perform all tests for all persons in the study. It may be many years before we test your samples.. Even when samples are tested, we cannot provide results because we will not know how to interpret a single woman’s results in terms of risks or benefits.

Can I get my 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 our findings will not directly explain why specific women develop breast cancer or help to improve your own health in any direct way.

The scientific results that come from the samples collected in the Anniversary Biospecimen Collection will be reported in scientific publications, including journals read by physicians, epidemiologists, and laboratory scientists. Results will also be reported in the national and regional press, and to Sister Study participants via newsletters, our study website sisterstudy.niehs.nih.gov and other online participant communications.

Why collect a blood sample from women who have already developed breast cancer?

Blood samples from women who have already developed breast cancer will be used for studies about how exposures and biological factors affect health after a breast cancer diagnosis. Because we already have samples from women before they developed breast cancer, we will also be able to study changes in biomarkers of health and aging following a diagnosis.

Why are you collecting stool samples?

Your stool sample will be used to study the gut microbiome, which includes the microorganisms that normally live in your digestive tract. These microorganisms influence your health and susceptibility to diseases in ways we are just beginning to understand. Coupled with all the information we already have on your health and lifestyle; your stool samples will be a valuable resource for research into whether the gut microbiome influences cancer development and health after treatment.

The stool sample is easy to collect. This is something you can do at home, at any time of day. Directions for the stool collection will be included in your Anniversary Biospecimen Collection Kit.

Why are you collecting urine samples?

Your urine samples will be used to study chemicals that may not stay in your body for very long. The concentrations of these chemicals may vary throughout the day or across the week, depending on your routine and daily activities. We are asking you to collect your urine samples 2 times per day for 3 consecutive days, once in the morning and once in the evening. Our goal is to get the best possible measure of your usual chemical levels across an average week.

The urine sample is easy to collect. Directions for the urine collection will be included in your Anniversary Biospecimen Collection Kit.

What is included in the Sister Study Anniversary Biospecimen Collection Kit?

The Kit contains all the instructions, forms, and supplies needed to complete the Anniversary Biospecimen Collection including:

“Answers to Your Questions” and instructions for completing study activities

Supplies and instructions for specimen collections

Questionnaire(s)

When will my Kit get here?

The Sister Study lab will ship your Kit via FedEx after you have completed your Informed Consent form.

What do I do with the Sister Study Anniversary Biospecimen Collection Kit box and its contents when I am finished with it?

The ExamOne phlebotomist will ship the completed questionnaire(s), the stool, urine, and blood back to the Sister Study using the provided shipping containers and frozen gel packs.

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

Please complete the questionnaires as well as the urine and stool collections before your scheduled phlebotomist visit. If for some reason you are unable to get everything done, please let the phlebotomist know what parts of the Kit you have not completed. We have included a postage-paid envelope in your Kit that you can use for returning your stool sample to us as soon as possible after the visit, If you have not completed your urine collection by the time the phlebotomist comes, please contact us at 877-440-2138 so that we can send you materials to return the urine samples to us.

What if my Sister Study Anniversary Biospecimen Collection Kit does not have all the items mentioned?

Please call us as soon as possible at the toll-free number 877-440-2138. We will send you the items you need.

What kind of company is ExamOne?

ExamOne is a network of experienced medical professionals who conduct blood draws and other health testing, and personal health interviews for insurance physicals and research studies. ExamOne’s website is examone.com.

What can I expect at the visit?

A licensed phlebotomist from ExamOne will visit you in your home or you may schedule your blood draw at an ExamOne location. Your blood draw visit should take about 30‐45 minutes.

How much blood will be drawn during my visit?

The phlebotomist will draw blood equivalent to about three tablespoons.

Where do I have my blood drawn?

The ExamOne licensed phlebotomist will call you to schedule an appointment at your home. If there is an ExamOne office near your home, your blood collection can be done there if you prefer. When the ExamOne representative calls to schedule the appointment, you can talk about these choices.

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

If you are undergoing treatment for breast or another cancer, you should postpone your sample collection until your treatment is complete and you are feeling better. Please call us at 877-440-2138 to postpone your blood collection. Blood draw precautions are advised if you have had an axillary lymph node dissection (ALND) / surgery to remove lymph nodes from under the arm. It is advised not to have blood drawn from an arm affected by lymphedema. Performing a blood draw on the unaffected side is considered safe.

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

ExamOne licensed phlebotomists are well-trained and follow strict study procedures so that all blood is drawn safely for all participants. They will take all precautions needed to ensure a safe blood draw. They will also check for signs of lymphedema, extremity swelling, and/or 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.

Can someone besides the ExamOne examiner draw my blood?

No. All samples will be drawn by a phlebotomist from ExamOne. Their staff has been trained to follow the Anniversary Biospecimen Collection procedures exactly. This way, all measurements are made in the same way which is important for research.

What if I do not want to have the examiner come to my home or office, but I want to have the examination someplace else?

There are several options for you. You can go to an ExamOne office in your area. When ExamOne calls to set up a visit, just tell the representative what you have in mind or if you would like to meet someplace else. They will arrange to visit the place that is most comfortable for you. When you come to the ExamOne office or other location, please remember to bring your Anniversary Biospecimen Collection Kit and your collected urine and stool samples with you. When you bring them with you, please keep your samples cool by using the gel packs provided to you in your Kit.

What do I do if the ExamOne licensed phlebotomist does not show up for my appointment, or I forgot about it and I wasn't there at the scheduled time?

Please call ExamOne as soon as possible at the special toll-free number: 408-346-3394. Tell ExamOne the date, time, and location of your scheduled appointment so that it can be rescheduled.

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: 877-440-2138. Tell us the problem, time, place, and date of your appointment. We will take any action that is necessary.

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

Please call our toll-free number: 877-440-2138 or send an email to info@sisterstudy.org. A Sister Study Help Desk staff member will answer your questions.

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 able to provide medical advice. If you need to find a doctor or have questions about breast cancer, please contact your local health department, the American Cancer Society (www.cancer.org or 800-227-2345), or other organizations that provide breast cancer information. Links to some of these organizations can be found on our website at sisterstudy.niehs.nih.gov.

National Institute of Environmental Health Sciences — National Institutes of Health — U.S. Department of Health and Human Services

The Sister Study

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