We are doing The LEGACY GIRLS STUDY to learn how lifestyle, environment and biology affect the growth and development of young girls and teens. The blood and urine samples and questionnaires collected over time will allow us to measure changes during childhood and the teen years. We hope to learn how these factors affect health later in life.
Our long term goal is to learn more about childhood factors that may be linked with health later in life. To do this, we are inviting girls between the ages of 6 and 13 years and their mothers (or other guardian) from different types of families to join the study; some with breast cancer histories and some without.
We will meet with parents and daughters twice a year for up to five years. This will be a total of eight visits.
Your first visit will take the longest (1-2 hours) with each follow-up visit after that being shorter (30mins – 1 hour). Your visit will lean towards the longer side if you have more than one participating daughter and if she is age 10 years or older in which case she’ll be completing questionnaires on her own during her visit.
The Legacy Girls Study will enroll 900 girls from 5 centers in the USA and Canada, including New York City, Philadelphia, Salt Lake City, the San Francisco bay area, and Toronto, Ontario (Canada).
We would be happy to provide your daughter with a letter describing her participation in the Legacy Girls Study that she could provide to her school. It would be up to the school to determine if study participation qualifies for volunteer credit.
Will we be paid to be in the study/ Will my daughter and I be reimbursed for the time spent in the study?
Toronto/possibly others: The Research Ethics Boards governing The LEGACY Girls Study prohibits direct payment for research participation, but travel or parking costs associated with getting to your clinic visits will be reimbursed and your daughter will receive a small study gift ($20 value) for her time and interest in the study.
California: At both the first visit and each follow-up visit, your daughter will receive a $20 gift card in appreciation of her participation in the study. At both the first visit and each follow-up visit, you will receive a $15 gift card in appreciation of your time and effort.
There are no costs to you or your daughter for participating in the study. If you need to travel to your study visit, you will be reimbursed the costs of travel or parking.
Any sample the study asks for from either you or your daughter is important for the study but it is your choice whether or not to give a blood sample.
Blood contains compounds that will help us understand how they influence development. Blood also contains DNA which can give us information about genetic factors that may be related to growth and development. Blood samples taken at different times gives us information on how hormones and other compounds change during the development of young girls and teenagers.
No, we are not going to be doing any genetic testing.
All tests of biological factors in the blood, urine and/or saliva will be done in research laboratories. No individual results will be provided to participating families.
I know I'm positive for the breast cancer gene (BRCA1 / BRCA2). Will my daughter get tested through this study?
We will not test your daughter for the breast cancer genes. The American Academy of Pediatrics and several other professional groups have recommended against the genetic testing of children for adult diseases when there is no medical benefit.
Yes, in fact it is a good idea to drink water before providing the urine sample.
Urine contains hormones and other compounds that tell us how the body is growing. Urine samples taken at different times gives us information on how these hormones and other compounds change during the development of young girls and teenagers.
Saliva contains DNA which can give us information about genetic factors.
Why does The LEGACY Girls Study prefer a blood sample from my daughter when a saliva sample is easier to get?
We prefer to obtain blood samples from girls because saliva samples do not provide with the full range of measurements that blood samples do (such as hormones and other compounds).
We’ll provide you with a kit (small tube or vial) to collect about 1/2 teaspoon of saliva). This should take about 5 minutes or less.
We ask that you not eat, drink, smoke, chew gum or brush your teeth for 30 minutes before giving your saliva sample.
The purpose of the behavioral questions for daughters is to learn how girls think and act, in general, as well as regarding health matters, including breast cancer. We will ask about girls’ current health practices (for example, wearing sunscreen), feelings (coping with stressful situations), and what, if anything, girls at their age know about breast cancer (risk of developing cancer).
The mother’s behavioral questions will be similar to your daughter’s. We will ask about your current health practices (for example, having mammograms), your thoughts and feelings in general (coping with stressful situations), as well as your opinions regarding health matters, including breast cancer (what women can do to prevent breast cancer). We will also ask your opinions about your daughter’s behaviors (coping with stressful situations), and your family’s’ interactions (communicating with one another).
I haven’t talked with my daughter about having had breast cancer/undergone BRCA1/2 testing. Will this get brought up at the appointment?
No. Our Behavioral Questionnaire for girls 10 and older will ask about your daughter’s awareness of cancer in general, and if your daughter knows about cancer in any of her family members, but we will not tell your daughter about your breast cancer (or genetic test results).
I am concerned that some of the questions about __________ (breast cancer/pubertal development/diet/exercise) might make my daughter uncomfortable. What will you do if that happens?
We will remind your daughter that it is OK to skip any question she prefers not to answer and it is also OK to check the “I don’t know” box. If she is uncomfortable while she is doing a particular section, she can stop and move on to the next section or next survey. You may feel better knowing that one of our study sites has asked many of the same questions in another study with over 150 girls aged 11 an older. Afterwards the girls are asked for their opinions about the survey. While many reported that the survey made them think about cancer or want to learn something about it, none of the girls reported that it made them worry about getting cancer. Mothers were also asked about their daughters’ reactions. Some said their daughters felt good about doing the survey and some said their daughters were uncomfortable with the questions about their development. Overall, the mothers said that their daughters did fine.
The body fat measurement tells us about the composition of the body and gives us an idea of what percent of the body’s mass is made up of fat.
Body fat is measured with a small handheld device. The measurement of body fat is based on a person’s age, height and weight. Age, height and weight are put into the device, which does the calculation of the body fat measurement.
Body fat is one of the factors of interest as it relates to puberty and health.
Foot size is another measurement that may be related to growth and development.
My daughter is self-conscious about her size/weight. I’m worried that having her hips, waist, weight, and height measured may be uncomfortable for her.
We understand your concern and our interviewers are sensitive to these issues. They are experienced with working with girls, including the taking of measurements. They have ways to minimize her discomfort. For example, if your daughter prefers, she can wrap the tape measure around her waist (or hips) herself rather than having the interviewer do it. Also, the interviewer will not read the measurements out loud.