Bladder cancer is the fourth-most-common cancer in men and 10th-most-common cancer in women. In 2017, over 77,000 Americans were diagnosed with bladder cancer, and about three-quarters had a type called non-muscle invasive bladder cancer (NMIBC), in which the cancer is limited to the inner layers of the bladder. NMIBC can usually be treated with a combination of an endoscopy procedure that removes the tumor while leaving the bladder in place and a medical treatment called Bacillus Calmette-Guerin (BCG) that is placed directly into the bladder.
However, this type of tumor frequently returns or worsens. When that happens, patients face a difficult choice. The first option is to undergo a surgery to remove their bladder. This surgery is likely to cure them but can have a negative impact on their daily activities and relationships. The other option is to try additional medical treatments, including repeat BCG, which would allow them to keep their bladder. Unfortunately, these treatments do not work as well, and in some patients their cancer will get worse and spread outside the bladder.
The proposed study compares bladder removal with medical therapy. We will include both patients and their caregivers in this study and ask them questions about their experiences and outcomes following treatment for up to three years. We will also ask them questions about how they made their decisions. The goal of this study is to provide information to future patients, their caregivers, and their providers so that patients can choose the treatment that best meets their needs based on the outcomes and preferences of patients like them.
We worked with the Bladder Cancer Advocacy Network (BCAN), which is the only national advocacy organization devoted to advancing bladder cancer research and supporting those impacted by bladder cancer, to bring together a Patient Survey Network of over 1,300 bladder cancer patients. These bladder cancer patients identified questions that were most important to them. The top two questions for NMIBC patients were the following: How can patients and providers make decisions about the need for bladder removal, and what is the best timing? What are the best treatments for patients whose cancer returns or worsens after BCG treatment? We have designed this study to help answer these questions for bladder cancer patients.
We have incorporated the patients’ voice throughout the development of this study. In addition, we have a team of patients and caregivers who have agreed to continue to provide input into the design of the study and the sharing of results. Patients, caregivers, and BCAN will participate in regular meetings, blog posts, tweet chats, webinars, and preparing reports and videos. Partners in this study also include the largest professional society of urologists in the world, the American Urological Association, which will incorporate the results in educational materials and practice guidelines to help ensure that providers receive and use the results from this study when talking with their patients.
Engagement Awards Teams Ride Momentum to Research Projects
Read a feature story that highlights how three Eugene Washington PCORI Engagement Awards teams clinched additional PCORI funding to channel the lessons and successes of their work into three new research projects -- which includes this study -- that answer patient-centered research questions.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.