Toll-free: 1-877-692-SELF (7353)

 

Study of the Environment, Lifestyle & Fibroids

Frequently Asked Questions

 

General Study Overview

What is the purpose of SELF?

What are uterine fibroids?

How many women are participating in SELF?

Who is conducting SELF?

Who is Social & Scientific Systems (SSS)?

Are any physicians working on the study?

How long will my participation last?

How will you use my information?

Will my information be kept confidential?

Why Detroit?

Why do you need my social security number?

Can I get study results?

What happens after the study ends?

Whom should I contact if I have questions?

 

Eligibility & Participating in SELF

Who can participate?

What if my friend, neighbor or family member that’s between the ages of 23-34 wants to participate in SELF?

If you are studying fibroids, why can’t women who have fibroids join?

I’m over 34 without fibroids. Why can’t I join?

Why is the age-range 23-34?

What if I develop fibroids during the study?

I had a partial hysterectomy. Am I eligible for SELF?

Should I go to the doctor if I have heavy bleeding and/or menstrual pain?

Can I still participate in the study if I have ovarian cysts?

Why do you need three contacts? Why aren’t two enough?

What if I develop an autoimmune disease or cancer while participating in the study? Will I be able to continue participating?

Is there a skin tone cutoff, so that only those darker than the cut-off are considered African American?

Will I receive any test results?

Why is this not a diagnosis when you find fibroids on the ultrasound?

Can I volunteer for the sub-studies?

What would I have to do in this study?

Will I need to make any changes to my current lifestyle or take medications to participate in SELF?

Will evening and weekend appointments be available?

Will childcare be available at the clinic appointment?

Can I schedule my orientation session with a friend’s or relative’s session?

Can I schedule my clinic visit appointment with a friend’s or relative’s visit?

What is the difference between an orientation meeting and a phone call?

What is the difference between the long enrollment clinic visit and the short enrollment clinic visit?

What is the difference between the long follow-up clinic visit and the short follow-up clinic visit?

Will my doctor be notified if you find fibroids?

What if I get pregnant before my visit?

If I don’t want to send my social security number in the mail, is there another way?

What if I do not want to participate in SELF?

Who else can stop my participation?

I am using chemotherapy to treat a non-cancer condition. Can I still participate?

 

Specimen Collection

Can I participate if I don’t want to give the urine, vaginal swab or blood specimens?

Can someone help me collect the vaginal swabs, I don't feel comfortable putting things inside of me?

What is Hemoglobin?

Can I participate if I don’t want to have the ultrasound done?

Can I get a female sonographer?

Do registered nurses conduct SELF clinic activities?

Who will I see for my clinic visit?

Will I see a doctor at my clinic visit?

What is a vaginal ultrasound? What does it involve and will it hurt?

Can I have an abdominal ultrasound examination instead of the transvaginal ultrasound examination?

Will you provide me with the ultrasound images?

Will the clinic staff help me collect the vaginal swab specimen?

What kinds of tests will you perform on the urine, vaginal swab, and blood specimens?

Will I receive results from my urine, blood, or vaginal swab specimens?

What will you do with my specimens after you run the tests on the urine, vaginal swabs and blood specimens?

What if I am unable to give the urine, vaginal swab or blood specimens at the time of the visit?

What if I decide I don’t want you to store my samples any longer?

What if I am on my menstrual period, do I still collect the urine and vaginal swab specimens?

Do I need to reschedule my clinic visit if I start my menstrual period?

What if I am on my menstrual period, will I still have an ultrasound examination?

Can my own doctor do the ultrasound and blood collection?

Are the people taking my blood certified phlebotomists?

How much blood will be taken?

Why do you need so much blood?

How do you measure skin tone?

When can I expect to schedule my first follow-up clinic visit (and/or surveys)?

When can I expect to begin my follow-up activities?

I have not received my menstrual diary paperwork. When can I expect it?

Nothing’s changed; can’t you just copy my answers from before?

 

Compensation, Risks, and Benefits

What are the costs of participation?

What is an incentive?

Will I be paid in cash?

How much compensation will I receive?

When do I get paid?

How do I register my Visa gift card?

Will I need to activate my Visa gift card?

What should I do with the VISA gift card once I have spent the full balance?

Will I have to claim the money that I get for participating in SELF on my income tax?

Will I have to file insurance for the sonogram?

Will you pay me to travel to study clinic appointments?

What are the risks involved?

Why would I need emergency care?

How will I benefit from participating in SELF?

Can I get access to medical treatment for fibroids or other health conditions?

 


What is the purpose of SELF?

The purpose of this research is to learn how uterine fibroids develop, what factors might trigger their development, and how to help prevent health problems caused by fibroids.

 

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What are uterine fibroids?

The uterus is a muscular organ. The muscle tissue of the uterus can develop non-cancerous tumors, called fibroids. These tumors don’t spread to the rest of the body, and often they don’t cause any health problems at all. But for some women, the fibroids cause pelvic pain, very heavy menstrual bleeding, or reproductive problems. Fibroids are very common, especially for African American women. One in five African American women eventually have a hysterectomy because of their fibroids. For whites it is only one in 15 women.

 

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How many women are participating in SELF?

There will be approximately 1600 women in this research study.

 

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Who is conducting SELF?

The National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health (NIH), is conducting this research in collaboration with Henry Ford Health System (HFHS) and Social & Scientific Systems (SSS). 

This study is sponsored by the NIH. This means that the sponsor is compensating HFHS and SSS for the costs of carrying out this research. Social & Scientific Systems, an employee-owned company with years of experience in health research, will be managing the study and working directly with the scientists.

 

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Who is Social & Scientific Systems (SSS)?

Social & Scientific Systems (SSS) is an employee-owned company with years of experience in health research that supports the research work of the Epidemiology Branch at the National Institute of Environmental Health Sciences, one of the National Institutes of Health.
Social & Scientific Systems, Inc. helps NIEHS by:

  • Designing study materials and questionnaires.
  • Conducting interviews.
  • Mailing study supplies to participants.
  • Receiving and processing the information and specimens that participants complete.

Most of the NIEHS and SSS employees working on SELF are based in North Carolina.

 

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Are any physicians working on the study?

Yes, three medical doctors, trained in Obstetrics and Gynecology, are helping with this study. Dr. Shannon Laughlin-Tommaso from the Mayo Clinic, Dr. Carmen J. Williams, at NIEHS and Dr. Malana Moshesh-Richards, also at NIEHS. If you would like more information about them, you can go to the SELF website to learn more. Please note that they are research collaborators and do not provide clinical care to SELF participants.

 

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How long will my participation last?

SELF is only inviting women who are willing to commit to the study for 5 years. 

 

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How will you use my information?

The information we collect from you will be used to better understand why women develop uterine fibroids and how exposures and lifestyle factors may affect fibroid development and growth. This information will be for research purposes only, and is not part of any diagnosis or treatment. The results from all participants will be used to prepare statistical reports and summaries for scientific papers and presentations at meetings.

 

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Will my information be kept confidential?

Yes. You will be given a research ID number that we will use to identify you. Neither this ID number nor the information you provide for the study will be associated with your medical or health insurance records. Names will not be on any of the blood or other samples or any data collections forms. Every effort will be made to protect your privacy to the fullest extent possible under the law.

 

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Why Detroit?

Detroit has a large, active African American population, and there are health providers who have experience with long-term studies like this one. It is possible that other sites will be added in the future.

 

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Why do you need my social security number?

This would be used only if we lose contact with you. Having your social security number can help us get a working address or phone number for you.

 

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Can I get study results?

Yes, we will periodically send out SELF newsletters to women who participate in SELF. Study updates will also be listed on the study website. However, many things won’t be known until the end of the study, so we will continue to send you newsletters even after your participation ends.

 

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What happens after the study ends?

We will be sharing our findings throughout the study, but many things won’t be known until the study is completed. We will continue to send newsletters to participants after the study to share those findings.

 

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Whom should I contact if I have questions?

Dr. Donna Baird, Dr. Ganesa Wegienka or their staff member has explained this research study and has offered to answer any questions. If you have questions or concerns about the study procedures you may contact Dr. Donna Baird at NIEHS at 1-877-692-7353 (SELF) or Dr. Ganesa Wegienka at 313-874-3566.

If you have questions about your rights as a research subject you may contact the Henry Ford Health System IRB Coordinator at (313) 916-2024. The IRB (Institutional Review Board) is a group of people who review the research to protect your rights.

 

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Who can participate?

You may be able to join SELF if you:

  • are an African American/Black female
  • are between the ages of 23-34
  • have NEVER been diagnosed with fibroids
  • live in the U.S. and can travel to Detroit, MI for study visits
  • are NOT currently pregnant
  • have NEVER had any type of cancer that was treated with radiation or chemotherapy
  • have NEVER taken medication to treat lupus*, Grave’s disease, Sjogren’s, scleroderma, or multiple sclerosis (MS)
  • are willing to commit to being in the study over a 5 year timeframe to complete 5 ultrasound appointments
  • have NOT had your uterus removed
  • will provide contact information so you can be reached during the 5-year study

*For our purposes, you can still participate if you have only used a topical skin cream to treat lupus.

 

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What if my friend, neighbor or family member that’s between the ages of 23-34 wants to participate in SELF?

We encourage you to pass along information to women who you know may be able to participate in SELF. Please ask them to call 1-877-692-SELF (7353) or send an email to info@DetroitSELF.org along with their name, phone number and the best time to be reached. We will be more than happy to discuss SELF with them!

You may also contact SELF to request a few brochures to share with women you think may be able to participate in the study.

 

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If you are studying fibroids, why can’t women who have fibroids join?

In this study we are hoping to learn what triggers fibroids to develop in the first place, so including women who already have fibroids does not allow us to answer that question. If we follow women who don't have fibroids, and periodically look for fibroids with ultrasound, we can find out when fibroids first develop.This will help learn about what triggers fibroid development.

 

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I’m over 34 without fibroids. Why can’t I join?

Previous studies show that many women in their mid to late 30s have fibroids without knowing it. Because this study aims to understand how fibroids first develop, we focus on women in their 20s and early 30s.

 

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Why is the age-range 23-34?

Previous studies suggest that this is likely to be the time when African American women are most likely to develop fibroids.

 

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What if I develop fibroids during the study?

Each time you have an ultrasound we will measure any fibroids that develop in order to learn more about what might make fibroids grow.

 

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I had a partial hysterectomy. Am I eligible for SELF?

For this study, we are enrolling African American women who have not had their uterus removed. Therefore, you will not be able to participate in SELF since you have had a partial hysterectomy.

 

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Should I go to the doctor if I have heavy bleeding and/or menstrual pain?

By law, we are not able to provide you with medical advice. If you need to find a doctor or have questions about your health, you should contact your local health department or other organizations better qualified to address your health concerns. Visit SELF Resources to learn more about women’s health services available.

 

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Can I still participate in the study if I have ovarian cysts?

Having ovarian cysts will not make you ineligible to participate in SELF. Experienced sonographers who conduct transvaginal ultrasounds for SELF are trained to know the difference between ovarian cysts and uterine fibroids.

 

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Why do you need three contacts? Why aren’t two enough?

First, let me assure you that we would never try to reach your contacts unless we lose contact with you. However, young people tend to move often. Since your contacts may also move, having three people to contact is better than having just two.

 

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What if I develop an autoimmune disease or cancer while participating in the study? Will I be able to continue participating?

Yes, if autoimmune disease (cancer/uterine surgery) occurs after you finish enrollment, we hope you will still continue in SELF.

 

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Is there a skin tone cutoff, so that only those darker than the cut-off are considered African American?

No, anyone who self-identifies as African American/black is considered so by the study, regardless of skin color. The purpose of this measurement is to assess the relationship between skin color, Vitamin D levels and fibroids.

 

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Will I receive any test results?

Results of your height, weight and blood pressure measurements, as well as your hemoglobin level, a nutrition report (a report that summarizes your diet and includes body mass index (BMI)) and your ultrasound findings will be made available to you after each visit. Note your height is only measured at your first visit and your dietary intake is only collected once, either before or at your first visit. For this reason, results of your height measurement as well as your dietary analysis will be made available after your first visit only. You may choose which, if any, of these you would like to receive.

 

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Why is this not a diagnosis when you find fibroids on the ultrasound?

For a clinical diagnosis, a medical doctor would also be examining the sonograms and confirming that fibroids were seen. These ultrasounds are for research only, not a part of your medical care.

 

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Can I volunteer for the sub-studies?

The sun diary will only involve about 100 women who enroll during the summer. The vitamin D sub-study will involve the first 200 women who want to come back to the clinic for an extra blood draw at 6 months from the enrollment clinic appointment. Study staff at the clinic visit will know when these sub-studies are available.

 

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What would I have to do in this study?

To join SELF, you must complete study activities including:

  • A study orientation (by phone or in person)
  • Telephone and written surveys that include questions about health history and lifestyle
  • Clinic visits (1 enrollment visit and 4 follow-up visits) in the Detroit, MI area that include an ultrasound examination and other routine clinic activities over about 5 years

 

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Will I need to make any changes to my current lifestyle or take medications to participate in SELF?

No. There are no medications or pills to take to participate in SELF and SELF does not require any changes to your daily lifestyle or existing health care routine.

 

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Will evening and weekend appointments be available?

Yes, evening and weekend appointments will be available for all visits. However, because of the clinical setting for study visits, no children will be allowed to accompany women to any appointments.

 

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Will childcare be available at the clinic appointment?

There will be no childcare available at the appointment.

 

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Can I schedule my orientation session with a friend’s or relative’s session?

Yes, if she is in our study registry and has completed all the preliminary activities. She would need to have talked with study staff to make sure she is able to join so an orientation packet could be sent out to her.

 

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Can I schedule my clinic visit appointment with a friend’s or relative’s visit?

No, every woman gets an individual appointment time slot. There are no overlaps for clinic visits.

 

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What is the difference between an orientation meeting and a phone call?

In both the phone and in-person orientation, study staff will describe the study in detail and go over the consent form with you. You will have a chance to ask all your questions. The in-person meeting is with a group of other interested women at Henry Ford, so you would have a chance to hear other women’s questions. At the group meeting you could also go ahead and sign the consent and officially join the study. For the phone, you would send in materials (the study pays for sending them in) to continue with joining SELF.

 

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What is the difference between the long enrollment clinic visit and the short enrollment clinic visit?

A short enrollment clinic visit will take about 2 hours. At this visit you will only complete your clinic activities. If you select a short visit you will need to complete the telephone interview, the Online Survey (CAWI) and the Food Frequency Survey before the clinic visit. These (CATI, CAWI, FFQ) will take about 3 hours to complete. For the short enrollment clinic visit, it is very important that you are able to go to a comfortable, quiet place during these activities in order to avoid interruptions and distractions.

A long enrollment clinic visit will take about 5 to 6 hours. At this visit you will complete all the clinic activities in addition to the 1 hour telephone interview and 2 hours of online survey at the clinic. We will allow for breaks as needed and we will provide a light snack during this time.

 

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What is the difference between the long follow-up clinic visit and the short follow-up clinic visit?

A short follow-up clinic visit will take about 2 hours. At this visit you will only complete your clinic activities. If you select a short visit you will need to complete the telephone interview and the Online Survey (CAWI) before the clinic visit. These (CATI, CAWI) will take about 2 hours to complete. For the short follow-up clinic visit, it is very important that you are able to go to a comfortable, quiet place during these activities in order to avoid interruptions and distractions.

A long follow-up clinic visit will take about 4 hours. At this visit, you will complete all the clinic activities in addition to the 1 hour telephone interview and 1 hour online survey at the clinic. We will allow for breaks as needed and we will provide a light snack during this time.

 

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Will my doctor be notified if you find fibroids?

No, you can decide if you want the study to tell you. Many women will want to know, but some may just feel it is a burden. You can decide. Then, if you want, you can share the information with your doctor. No information from the study will go into your medical record.

 

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What if I get pregnant before my visit?

If you become pregnant before a scheduled visit occurs, it is extremely important that you call the study office so we can postpone your study activities until after the end of your pregnancy. The reason for this is that the ultrasound may not view fibroids clearly during the pregnancy and the ultrasound images are an important part of the study.

 

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If I don’t want to send my social security number in the mail, is there another way?

Women who attend the orientation meeting in person can just give the contact information directly to the study staff. Women who do it by phone need to mail in their contact information, but if you aren’t comfortable with that, you can call and give your social security number to one of our study staff.

 

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What if I do not want to participate in SELF?

Your participation in this research study is voluntary. If you decide to participate, you can stop at any time. There will be no penalties or loss of benefits to which you would otherwise be entitled if you choose not to participate or if you choose to stop your participation once you have started.

You may be asked to be involved in other research studies at some time in the future. However, your participation in this study does not require you to participate in other studies.

 

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Who else can stop my participation?

The Principal Investigator or sponsor may decide to withdraw you from the study if it is determined that the study cannot continue, or that you are not eligible or able to complete the requirements of the study.

 

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I am using chemotherapy to treat a non-cancer condition. Can I still participate?

Yes, you are still eligible.

 

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Can I participate if I don’t want to give the urine, vaginal swab or blood specimens?

No, only women who are willing to fully take part in SELF study activities are encouraged to join. It is very important that participants complete all study activities, including clinic visits that collect urine, vaginal fluid and blood. Researchers will need every piece of the puzzle to solve the mysteries of fibroids! We will use these specimens to perform tests, including but not limited to, hormones, Vitamin D, infections and African ancestry. We may look for genetic factors that could make some women more likely to develop fibroids. The analysis of these specimens is a critical part of study participation.

 

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Can someone help me collect the vaginal swabs, I don't feel comfortable putting things inside of me?

We will not be able to assist you in collecting the vaginal swabs. However, the vaginal swabs are very small – about the size of the cotton ball on the end of a “Q-tip”. Also, it only needs to be inserted one inch into the vagina – that is, just inside the opening. The clinic staff will provide instruction on how to self-collect the vaginal swab at the clinic.

 

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What is Hemoglobin?

Hemoglobin is the protein in red blood cells that carries oxygen. If it is very low, it indicates that you don’t have enough healthy red blood cells. This is also called “anemia”.

 

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Can I participate if I don’t want to have the ultrasound done?

No, it is very important that participants fully complete all study activities in order to remain actively enrolled. Researchers will need every piece of the puzzle to solve the mysteries of fibroids! The transvaginal ultrasound examination, conducted by experienced sonographers, is the best method to determine if uterine fibroids are present. This procedure is a critical part of study participation. There is minimal risk involved.

 

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Can I get a female sonographer?

All study sonographers are female.

 

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Do registered nurses conduct SELF clinic activities?

SELF staff members are not required to be registered nurses. However, they have been fully trained in the study protocol to complete all clinic activities.

 

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Who will I see for my clinic visit?

You will see study staff trained in blood collection (Phlebotomy), and how to measure and collect other information from you. You will also see a sonographer for the vaginal ultrasound - these sonographers are trained technicians with years of experience. All the study staff and sonographers are female. You will not see a medical doctor.

 

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Will I see a doctor at my clinic visit?

No, you will not see a medical doctor at your clinic visit. You will see study staff trained in blood collection (phlebotomy), and how to measure and collect other information from you. You will also see a sonographer for the vaginal ultrasound - these sonographers are trained technicians with years of experience. All the study staff and sonographers are female.

 

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What is a vaginal ultrasound? What does it involve and will it hurt?

The transvaginal ultrasound uses a narrow transducer about the size of a tampon. This is inserted into the vagina and emits sound waves. These sound waves bounce off the structures in its path, and a computer uses that information to create an image (sonogram). The uterus can be seen on the image. Most women do not experience pain during a vaginal ultrasound, but may feel some pressure when the probe is moved.

 

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Can I have an abdominal ultrasound examination instead of the transvaginal ultrasound examination

The transvaginal ultrasound examination, conducted by experienced sonographers, is the best method to determine if uterine fibroids are present. This procedure is a critical part of study participation. There is minimal risk involved. It is very important that you fully complete all study activities in order to remain actively enrolled. Researchers will need every piece of the puzzle to solve the mysteries of fibroids!

 

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Will you provide me with the ultrasound images?

The study is not able to provide ultrasound images to you. However, if you request results, you will receive a written summary of fibroid findings.

The ultrasound images are for research purposes to help us understand when women first develop fibroids and are not being used for clinical care. For formal diagnosis or treatment, physicians would likely get their own ultrasound images to address your condition rather than use the study images.

 

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Will the clinic staff help me collect the vaginal swab specimen?

The vaginal swab specimen is self-collected. You will collect the specimen yourself. The vaginal swab is very small – about the size of the cotton on the end of a “Q-tip”. It only needs to be inserted one inch into the vagina – that is, just inside the opening. The clinic staff will provide instruction on how to self-collect the vaginal swab at the clinic.

 

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What kinds of tests will you perform on the urine, vaginal swab, and blood specimens?

We will use these specimens to perform tests, including but not limited to, hormones, Vitamin D, infections and African ancestry. We may look for genetic factors that may make some women more likely to develop fibroids. None of your specimens will be tested for HIV or illegal substances. The specimens and data will only have a number attached to them so no one can identify you by name.

 

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Will I receive results from my urine, blood, or vaginal swab specimens?

We will not provide you with the results of tests performed on these specimens because it may be a long time before your individual specimens are analyzed.

 

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What will you do with my specimens after you run the tests on the urine, vaginal swabs and blood specimens?

We will store your urine, blood, and vaginal swab specimens, without your name or anything that would tell your identity, indefinitely in a secure building. As scientists discover new information about fibroids, these specimens could be used to evaluate these new ideas. Some specimens and data may be shared with researchers at other institutions for collaborative or future studies. The specimens and data will only have a number attached to them so no one can identify you. Specimens and data will only be shared for scientifically valid studies that meet approved standards for good science and for protecting your rights as a participant.

 

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What if I am unable to give the urine, vaginal swab or blood specimens at the time of the visit?

It is important that you collect a first-morning urine specimen at home before the visit. The clinic staff will provide instruction on how to self-collect the vaginal swab at the clinic. The clinic staff is also experienced in blood collections so they will be able to draw blood from nearly everyone. If after their attempts, they were unable to collect sufficient blood, you will proceed with the rest of the study activities just like other study participants. You will not have an extra study visit to try again.

 

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What if I decide I don’t want you to store my samples any longer?

If in the future, you decide that you no longer wish for your specimens to be stored, you must send a written and dated notice to Dr. Donna Baird, C/O Social & Scientific Systems, 1009 Slater Road, Suite 120, Durham, NC 27703, to request that the specimens are disposed of according to standard medical research procedures.

 

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What if I am on my menstrual period, do I still collect the urine and vaginal swab specimens?

The analysis of the urine and vaginal swabs specimens is a critical part of study participation. You may collect both the urine and the vaginal swab specimens even if you are on your menstrual period. We will provide specific collection instructions for each of these specimens.

 

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Do I need to reschedule my clinic visit if I start my menstrual period?

No, you may still attend your clinic visit if you start your menstrual period.

 

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What if I am on my menstrual period, will I still have an ultrasound examination?

The ultrasound examination can be performed during your menstrual period. If you are on your menstrual period and wearing a tampon, you will need to remove the tampon before the ultrasound examination. The ultrasound examination will be used to screen for fibroids and is a critical part of study participation.

 

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Can my own doctor do the ultrasound and blood collection?

Only study staff that has been fully trained in the study protocol can do the ultrasound and collect blood for the study. This requirement helps to ensure that all data and specimens are collected in a standardized way for all study participants.

 

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Are the people taking my blood certified phlebotomists?

Yes.

 

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How much blood will be taken?

About 3.5 tablespoons of blood will be collected.

 

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Why do you need so much blood?

Actually, only about 3.5 tablespoons of blood is collected. Each tube of blood is designated for unique analysis.

 

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How do you measure skin tone?

We use a camera-like machine that shines light on the inside of your upper arm and records what light is reflected back. It does not hurt or use anything but light.

 

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When can I expect to schedule my first follow-up clinic visit (and/or surveys)?

For women who completed their first clinic visit before July 2011, the first follow-up visit has been slightly delayed. We estimate that we will begin contacting women around October 2012 to schedule the first follow-up activities around November 2012.

 

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When can I expect to begin my follow-up activities?

Participation in SELF involves completion of follow-up clinic visits and surveys. The first follow-up activities will begin around November 2012.

 

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I have not received my menstrual diary paperwork. When can I expect it?

Not every participant will receive the menstrual diary paperwork. If you were selected for the menstrual diary study activity then you would have received the menstrual diary and menstrual diary questionnaire at the time of your clinic visit. If you did not receive these study forms at your clinic visit then you were not selected for the menstrual diary activity during this phase of the study. There is still a possibility that you will be selected at your next clinic visit. If you have not yet attended your clinic visit, you may be selected to receive one at that time.

 

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Nothing’s changed; can’t you just copy my answers from before?

I do need to record your answer again. We find that many people don’t realize how many small changes may have occurred, until they start answering the question again, for this new time period. Thank you for your patience.

 

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What are the costs of participation?

There are no costs to you, other than your time, for participating in SELF.

 

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What is an incentive?

An incentive is a monetary payment you may receive to compensate you for your time and effort spent to complete activities at different intervals of the study.

 

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Will I be paid in cash?

No, you will receive compensation with VISA gift cards.

 

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How much compensation will I receive?

You will receive:

  • $150 for completing the enrollment clinic visit and 3 surveys
  • $100 for completing each follow-up visit and 2 surveys every 15 months for 4 follow-ups
  • $30 for completing the Early Life questionnaire
  • $20 for completing the menstrual diary
  • An additional $100 for completing of all study activities (at the end of 5 years).

Participants who complete and return the 7-day Sun Exposure Diary will receive an additional $35.

Participants who provide the additional blood sample at 6-months after the first visit will receive an additional $30.

The amount of payment to research volunteers is guided by the National Institutes of Health policies.

 

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When do I get paid?

For enrollment activities:
After enrollment activities are completed (diet survey, web questionnaire, telephone interview, and clinic ultrasound and measurements), you will get paid.  If all activities are finished by the end of the clinic visit, you will receive a VISA gift card at that time. Otherwise, payment will be given once the enrollment activities have been completed.

For follow-up activities:
After follow-up activities are completed (web questionnaire, telephone interview, and clinic ultrasound and measurements), you will get paid. If all activities are finished by the end of the clinic visit, you will receive a VISA gift card at that time. Otherwise, payment will be given once the follow-up activities have been completed.

 

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How do I register my Visa gift card?

You can register your Visa gift card with the bank at www.ncsecu.org. Once registered, you should be able to view your transaction history and obtain your card balance. Also, your available balance can be obtained 24 hours a day by calling the bank at 1-866-902-6082. This phone number is on the back your card. Just a reminder, the gift card sleeve does list guidelines on use of your card.

 

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Will I need to activate my Visa gift card?

Your Visa gift card is ready for use as soon as you get it. You do not need to activate it. However, we do encourage you to register your card with the bank at www.ncsecu.org. Once registered, you should be able to view your transaction history and obtain your card balance.

 

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What should I do with the VISA gift card once I have spent the full balance?

The card is not re-loadable. You may discard the card when you spend all of the funds. Incentives for other study activities will be issued in the form of a new card.

 

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Will I have to claim the money that I get for participating in SELF on my income tax?

The study does not take out money for taxes, nor does it send a record to the IRS. The money is compensation for the time and travel expenses you incur by volunteering, and is not a large enough amount on its own to require reporting to the IRS. If you receive other compensation for volunteering, you should consult a tax expert to learn if the total amount for all of your volunteer efforts requires reporting to the IRS.

 

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Will I have to file insurance for the sonogram?

No, the study pays for the ultrasound examination.

 

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Will you pay me to travel to study clinic appointments?

For participants who live in the Detroit area, travel expenses are covered by the incentive payment. Participants who travel from outside the Detroit area would need to finance the travel themselves.

The study does provide vouchers for valet parking and bus vouchers for those who take the bus to their appointments.

 

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What are the risks involved?

Procedures for SELF are considered minimal risk. There are no anticipated risks associated with ultrasonography, obtaining urine and vaginal swabs samples or the collection of blood pressure, height, weight and skin reflectance measurements.

The risks of drawing blood are minimal and involve minor discomfort, and a small risk of bruising or infection at the site. If you experience signs of infections such as swelling, redness or tenderness at the site of the blood draw, immediate first aid will be provided.

We recognize that some of the questions in the questionnaires are personal and potentially embarrassing. The most sensitive questions have been included in the self-administered formats rather than interview format. Your answers are never linked to your name by study staff working with the data. All study staff including telephone interviewers have been trained to follow strict guidelines to protect the privacy of study participants. You have the right to refuse to answer any question.

 

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Why would I need emergency care?

If, for example, we took your blood pressure and found that it was extremely high, you would immediately be directed to emergency care. Emergencies will be extremely rare (they may never happen), but we need to be prepared and let all participants know that it is possible.

 

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How will I benefit from participating in SELF?

There are no immediate benefits to the participants in the study. However, this study will provide important information about the incidence and growth of uterine fibroids so that in the future, other women might benefit from this study.

 

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Can I get access to medical treatment for fibroids or other health conditions?

You should talk with your health care provider about medical advice and treatment. Please visit the Resources page on the SELF website to get a list of organizations that you may want to contact about health care services. SELF staff may also be able to provide you with printed copy of this information.

 

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