Study
Why the SHINE study?
The SHINE study team has decades of research and clinical experience with women who have gone through breast cancer treatment. We know that:
- Most breast cancer survivors report sexual concerns following their cancer treatment
- Cancer-related sexual concerns can be very upsetting
- Most breast cancer survivors have never talked with their cancer care providers about sexual concerns
Aspects of survivors’ cancer treatment, personal history, and relationships can affect their sexual health following cancer. This means there are many different strategies and kinds of information that might help cancer-related sexual concerns.
What is the SHINE study?
The SHINE research team are testing four online program Cores (or lessons) designed to help women address breast cancer-related sexual concerns. Study participants are assigned to one of 16 groups at random – it is like flipping a coin. These groups receive different combinations of the Cores for their SHINE program.
Participants use their SHINE program for about three months. They complete online assessments (or surveys) at three time points:
- When they join the study
- 12 weeks after joining the study (receive a $50 gift card when complete)
- 24 weeks after joining the study (receive a $75 gift card when complete)
Your answers to the online assessments and use of your SHINE program are kept private. Learn about how we protect your privacy at the bottom of this page.
What are the SHINE program Cores?
Participants receive one, two, three, or four Cores as part of their SHINE program. Cores are a lesson based on information and strategies shown to work. Each Core takes about 20-45 minutes to complete.
You can complete your Cores at your own pace, as the SHINE program allows you to return where you left off. Once you complete a Core, you also can return and review it as often as you would like.
All participants will get access to a Sexual Health Essentials Core to learn about sexual health after cancer in one of two ways:
- Traditional webpage: Self-guided information to read and review at your own pace
- Web-based program: Interactive, self-guided online program containing information and activities (for example, questions, games, and video)
In addition to the Sexual Health Essentials Core, participants may receive any of the following Cores as part of their SHINE program. Each of these Cores are interactive and self-guided web programs with information and activities (for example, questions, games, and video):
- Health Care Discussions: talking to your health care providers about sexual concerns
- Partner Conversations: talking to your partner about sexual concerns
- Intimacy Insights: strategies to increase intimacy in your relationship
All participants will have the option to request access to all of the Cores after their 24-week assessment.
Will I get an incentive for being in the study?
You will get up to $125 in gift cards for completing online assessments.
- 12-week assessment complete: $50 gift card
- 24-week assessment complete: $75 gift card
How is my privacy protected?
Your privacy is very important to us. The study team will make every effort to protect it. Your name and identifying information is not stored with your responses on study assessments.
The research team is committed to protecting participant privacy about their SHINE program as well. Your privacy is protected by the following:
1. All the Cores are provided online through a private, secure web platform. You access your SHINE program with a password.
2. The information you submit is stored on a secured server. Servers meet Health Insurance Portability and Accountability Act (HIPAA) Privacy Rules.
3. The SHINE program Cores are on servers maintained by IT staff at the University of Virginia. The IT staff assess network structure to make sure the latest security technology software is used.
4. Only authorized research staff have access to these servers. Access to your data is limited to researchers approved to do so. All research staff has completed Institutional Review Board (IRB) training. Your health care team will not see your data.
5. SHINE study procedures have been reviewed and approved by the National Cancer Institute (NCI) Central IRB, which is the primary IRB for this study. Federal regulations regarding human research studies require this. The primary role of the IRB is to protect the safety and welfare of human participants.