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The Microbiome in Breast Cancer Survivors

What is the purpose of the study?

Everyone has bacteria in their gut (intestines), and these bacteria help the body to digest food and synthesize vitamins. Studies have linked differences in the gut microbiome (the bacteria in your gut) to moods and to a person’s typical daily diet, as well as gut health and metabolic disorders.

This study is designed to help understand how your mood, your diet, and your cancer treatment may affect your gut microbiome and your immune system; the study will also assess how your microbiome might be related to fatigue following cancer treatment.

You were invited to participate in this study because you are part of the IMPACT or HEART studies for our Breast Cancer Survivors Research Program where you were asked about both cancer-related fatigue and immune responses that may be relevant for fatigue.  The same researchers who are conducting the IMPACT or HEART research projects are conducting this study. This new project will provide additional detailed information on your gut microbiome and how it may be related to fatigue.

What does the study involve?
The study involves a short telephone interview about your current health and medications to determine if you are eligible to take part in the study. If you are eligible for the study and you agree to participate, you will be scheduled for a 2.5 hour in-person appointment at The Ohio State University Wexner Medical Center. All visits will occur on a weekday starting between 7:30 AM and 9:30 PM.

What does the 2.5 hour in-person study visit involve?
You will complete survey questions of a personal nature regarding your medications, health conditions, mood, feelings, health behaviors, personality, as well as aspects of your current living environment (for example, partner, children, and pets) that may be related to your gut microbiome. You will be asked about depression and anxiety symptoms that you have experienced.
During the visit, you will have 65 ml (2.2 ounces, or just over 1/4 cup) of blood drawn from a vein in your arm by a trained study staff member.

A research assistant will place sensors on your chest and wrist to assess your heart rate and perspiration throughout the visit. Sensors will also be placed on your stomach to measure the activity of your stomach muscles. Your blood pressure may also be measured several times throughout the visit. The researchers are interested in how these measures may be related to your mood and the stress in your life.

In order to assess the typical foods you eat that are related to your microbiome, you will be interviewed and asked to list all the foods you ate in the last 24 hours three times: once during the visit, and twice on the phone. These interviews will last 15-25 minutes each.

You will provide a stool sample for your gut microbiome analysis, and you will be asked about bowel-related problems like constipation and diarrhea. You will be given the materials you need to collect your sample, including a paper collection band, disposable gloves and collection tube with attached spoon. You will collect the sample either at the visit or at your home, place the tube in an insulated container provided along with a reusable ice pack, store the container in your refrigerator and call study staff to schedule a pick-up. A link to the stool collection instructions is included HERE.

We will get information from your doctor’s treatment records about the tests you have had for your breast cancer, as well as information on the type of breast cancer, the stage, and the treatment you received, any current medications, and other health conditions so we can see if these are related to your immune responses.

Who is eligible to be in the study?
You may be eligible for this study if you:

  • Participated in the IMPACT or HEART study
  • Are a stage I-IIIA breast cancer survivor between the ages of 40 and 80
  • Are post-menopausal
  • Are not diabetic
  • Are a non-smoker

Participants who are pregnant or nursing are not eligible.

How would I benefit from being in the study?
~Free parking for the study visit
~Detailed report regarding your eating patterns, your average daily intake of different nutrients, and recommendations for improving your diet.

Will I be paid for participating?
You will either receive Amazon gift cards or a check (depending on the researchers’ funding at the time) to compensate you for your time. You will have an opportunity to receive a total of $100 for participating in the whole study.

Who are the investigators and where does the funding come from?
Our investigators are scientists and physicians in the Ohio State University Colleges of Medicine and Public Health.  Our project is a joint venture of the Institute for Behavioral Medicine Research, the Department of Medicine, Department of Human Nutrition, and the School of Public Health.

Please consider participating! If you would like to participate in this study, please contact us. We would be very happy to discuss our research with you and give you more specific information. If you have any questions, feel free to call us at 614-293-4736 or email us at stressandhealth@osumc.edu.

Need more info?
Click here to read the consent form (pdf)
Click here to read the HIPAA privacy policy (pdf)

Ready to apply!
Click HERE to complete the online screening form.