If you would like more information about the GET SET Study, please contact the GET SET Project Manager via email at GETSETstudy@unc.edu, or via phone at (919) 445-6147.
What is the GET SET Study?
The GET SET Study is a research study for women, like you, who are taking certain medications to help prevent a recurrence of breast cancer. These medications are called endocrine therapies. Commonly used endocrine therapies include tamoxifen and the aromatase inhibitors (“AIs”) anastrozole, letrozole and exemestane.
Endocrine therapies are great at preventing the breast cancer from spreading to other parts of the body, and lowering the chance of death related to breast cancer. However, it is common for women to have trouble taking these medications on a regular basis for the length of time recommended by their doctors, even though most women want to use endocrine therapy.
To help women, like you, succeed with their endocrine therapy goals, we have developed the GET SET Program. GET SET stands for: Guiding Endocrine Therapy Success through Empowerment & Technology.
The GET SET Study was designed to understand which components of the program are most effective.
Why was the GET SET Program created?
Taking endocrine therapy after breast cancer is a journey that is different for every woman.
Most breast cancer patients will be prescribed endocrine therapy for somewhere between five to ten years total. These medications are an important part of the treatment plan. Endocrine therapy can reduce the risk of the breast cancer coming back by about 50%.
Usually women receive basic education about endocrine therapy from their healthcare team at the time it is prescribed. Unfortunately, this does not seem to be enough help for many women. About half of the women taking endocrine therapy skip doses on a frequent basis, or stop taking the medication altogether within five years.
Our research team focuses on designing tools to improve women’s experiences during ET. In our previous research, many women said that they need extra support to help them stay on track with their medication. Our previous research shows that women commonly do not start medications, quit early, or skip many doses. Reasons for these patterns are as varied as our patients – side effects, medication costs, doubts about the benefits of the medicine, and forgetfulness are just a few of the common reasons women identify why they have trouble sticking with ET. Because the reasons are varied, the best kind of support may look different for each woman. With help from other patients taking ET, we’ve designed a flexible, positive program that uses different tools to support women, like you, on their unique ET journey.
In the GET SET Study, we will test several different types of extra support to see which ones help you stick to your endocrine therapy medication. These different types of extra support include text message reminders and a telephone counseling program.
Who can participate in the GET SET Study?
If you meet all of the following criteria, you may be eligible to participate in the GET SET Study:
- You are receiving care at a participating Alliance site.
- You have an initial diagnosis of stage I, II, and/or III, hormone receptor positive, HER2-neu negative invasive breast cancer within 18 months prior to registration.
- You have received surgery for your breast cancer, and/or completed all other therapy after surgery, except reconstruction.
- You have started an endocrine therapy medicine (such as tamoxifen, anastrozole, letrozole, or exemestane) within the 6 months prior to joining, or you have received a prescription for endocrine therapy and plan to start taking the medication within 6 weeks after joining the study.
- You have no history of breast cancer or another cancer in your lifetime, except non-melanoma skin cancer (ex: basal cell carcinoma or squamous cell carcinoma of the skin).
- You are 18 years or older
- You are willing to use a smart phone for study activities.
- You are willing to use a study-provided bottle to store your endocrine therapy medication
- You can speak and read English.
What is involved in the GET SET Study?
The GET SET Study will look at 4 different types of support for women, like you, who are taking endocrine therapy:
- Daily text message reminders: if you are in this group, you will receive daily text messages on your smart phone to help you remember to take your medication.
- Telephone-based counseling program: if you are in this group, you will complete 5 telephone sessions with a counselor/coach to help you take your medications every day.
- Combination of text message reminders and telephone-based counseling program: if you are in this group, you will receive daily text message reminders, and complete 5 telephone sessions with a counselor/coach. This group tests whether combining these types of extra support will make it easier for you to take yourendocrine therapy every day.
- Educational materials on endocrine therapy medication and staying healthy after breast cancer: if you are in this group, you will receive a website address where you can go to learn more about endocrine therapy medicine on the Endocrine Therapy page. Additionally, there will be interactive educational materials that can help you learn about staying healthy after breast cancer. If you are in another study group, you can use these materials too, if you choose.
We have designed this support program with help from other survivors, like you. However, we do not yet know whether any or all parts of our program will help other groups of women. To find out, we will divide the women in the program into four groups.
If you join the study, you will be randomly assigned to one of these four groups. This will be done by chance, using a computer. You will not get to choose which group you are assigned to. This process helps us achieve the best study results, and ensures that each group is similar.
We will keep in touch with you over time to see how much endocrine therapy medication you take. We are also interested in learning about the side effects of the medicine and how the medicine impacts your quality of life. To make sharing information as convenient as possible, you will fill out surveys using an app on your smart phone, and keep track of your medication using a special pill bottle cap.
Every woman has a different experience taking her medication and it is important to us to learn from you and every other woman in the study.
How long will I be in the GET SET Study?
In the GET SET Study, you will be actively participating in your assigned group for about 9 months. However, the study staff will keep in touch with you for a total of 24 months, or 2 years. A study timeline is shown below.
Between months 10-24, you will be asked to complete three short surveys using an app called “ePRO” on your smartphone.
What happens if I want to leave the GET SET Study?
You are free to leave the GET SET Study at any time. There will be no penalty or loss of medical benefits to you, and you will not lose medical care or any legal rights.
Additionally, you may choose to participate in only certain aspects of the study. For example, if you are interested in continuing to share information through surveys, but don’t wish to do more telephone counseling or text messages, that is okay.
If you wish to stop any aspect of the study, please tell a staff member at the clinic where you enrolled in the study. He/she will be able to help guide you through these decisions.