To meet these goals, we are conducting a pragmatic randomized-controlled trial, meaning participants are assigned by chance to one of three groups: one-on-one peer support, facilitated support groups, and usual care - enhanced with a mailed ECANA support package. We call the study “pragmatic” because it is happening in real-world conditions so we can test if the programs will work in practice. The SISTER Study is based out of nine large cancer centers in the United States. From these centers, we will enroll 252 Black women with high-risk endometrial cancer who will be undergoing radiation, chemotherapy, immunotherapy, or a combination of these treatments.
Potentially eligible participants will talk with clinic staff at a participating site and receive more information about the study. For example, they may be shown our study flyer, brochure, or video. After making sure all eligibility criteria are met, the clinic staff member will go over the informed consent form. After consenting, the clinic staff will confirm that treatment (chemotherapy, radiation, or immunotherapy) are scheduled to begin. Once a treatment appointment is confirmed, the first study survey will be available to complete. Then, the computer will randomly assign the participant to one of the three study groups.
The SISTER Study will collect information in three different ways:
All identifying information will be kept confidential and shared only the study team. When we share information outside of the study team, it will be anonymous, meaning that names or other information that could be used to identify an individual will NEVER be attached to the information that is shared.
The study has been designed and is being conducted with close collaboration of ECANA ambassadors and other stakeholders—individuals and groups to whom outcomes of Black women with endometrial cancer matter. Making sure that the voices and experiences of Black women with endometrial cancer are at the center of all we do is a top priority. We also value transparency. With guidance from all stakeholders, we will share what we learn from study results many different ways, including recommendations for changes to clinical guideline and cancer center programming, reports and webinars for women who participated in the study, and webinars and summaries for clinicians and researchers.