Is GET SET research?
The GET SET study is a type of medical research called a clinical trial. All the medications taken by study participants are standard medications prescribed by a woman’s regular doctor, but the text message reminders and telephone counseling used in the GET SET study to help women stick to their medications are experimental – they are being tested to see if they can help women stick to their treatment plan better than regular medical care alone. If you join the GET SET Study, you will be informed of all risks and benefits of the program, will give written agreement (“informed consent”) to participate, and will share information to help evaluate the text messages and telephone counseling by answering surveys, sharing medical records, and reporting your symptoms and experiences to the study team. The GET SET study staff are highly committed to keeping your data private and secure.
How is the GET SET Study supported?
GETSET is supported by the National Cancer Institute through a research grant (RO1CA237357-01) and through the Alliance for Clinical Trials in Oncology.
Who is eligible to participate in the GET SET Study?
You may be eligible to participate if…
- You are receiving care at a participating Alliance site.
- You have an initial diagnosis of stage I, II, III, hormone receptor positive, HER2-neu negative breast cancer within 18 months of enrollment;
- You have completed surgery and/or all other adjuvant therapy for your breast cancer, except reconstruction
- You have been prescribed medication called endocrine therapy.
More information about eligibility can be found here.
Do I have to participate in the study?
You can choose to take part in the GET SET Study or you can choose not to take part in the GET SET Study. You can also change your mind at any time. Whatever choice you make, you will not lose access to your medical care or give up any legal rights or benefits.
How do I enroll in the GET SET Study?
Please talk to your cancer care team about whether there is a study location near you, and someone at that location can help connect you to the study.
How long will I be in the study?
In the GET SET Study, you will be actively participating in your assigned group for about 9 months. However, you will be participating in the study for a total of 24 months or 2 years. A study timeline is shown below.
What are the benefits to me if I join the study?
It is not possible to know whether receiving support like what is provided in GET SET will actually help you take your medication consistently or helps lower the risk that the breast cancer will come back.
Some previous research studies have shown that text message reminders and/or telephone-based counseling for other medications or health conditions have helped people increase their ability to take their medication as prescribed.
For breast cancer, other studies have shown that women taking endocrine therapy medicine liked receiving these support programs and thought they were helpful.
What are the risks to me if I join the study?
If you choose to take part in the GET SET Study, there is a risk that the text messages and/or telephone counseling may not be as good as usual basic education in helping you take your endocrine therapy medicine.
It is possible that receiving extra support such as text messages or telephone counseling might make you feel upset or uncomfortable.
All women who join the study will share information about their health and cancer treatment with the study team. While this information is safeguarded to protect your privacy, there is a very small risk that your health information might be viewed by someone that you and the study team did not intend.