Clinical Trial Tests Decision Aids for Prostate Cancer Patients

UH Urology Institute - Fall 2017 

 Simon Kim, MD, MPH

Three years ago, Simon Kim, MD, MPH, received a five-year R01 grant from the National Cancer Institute (NCI) to develop decision aids for African-American men with prostate cancer to help them understand the severity of their disease, treatment guidelines applicable to them and risks and benefits of potential treatments.

There is conflicting evidence about the best treatment for prostate cancer, with randomized trials indicating that surgery and radiation each provide similar survival rates. “Current guidelines say the ideal treatment choice is what patients think is best for them based on their preferences, values and concerns about treatment-related quality of life issues,” says Dr. Kim. It falls to urologic oncologists to assist patients with choices. But how well is that being done?

“There’s some concern about misaligned incentives of care for patients, who may not receive all the information available about treatment options, benefits and side effects,” says Dr. Kim. “This is particularly true for minority patient populations, where there is a significant disparity in outcomes and patient expectations following treatment.”

Dr. Kim and Jon C. Tilburt, MD, MPH, developed a tablet-based decision aid for patients. While most existing decision aid tools only provide generalized information about prostate cancer and treatment options, their tool is individualized for specific patient encounters.

Using the online tool, patients enter information such as their age, co-morbidities and prostate cancer severity. They also complete an objective section assessing their quality of life related to urinary control and erectile dysfunction. The tool then creates a one-page summary that patients can bring to medical appointments. In addition, the tool provides patients with different treatment options based on current guidelines from the National Comprehensive Cancer Network and the American Urological Association.

“The tablet-based tool acts as a platform for patients to have discussions about their type of prostate cancer, quality of life issues and preferences for treatment,” says Dr. Kim. “We hope that it will align incentives for what the patient wants and what’s best for them.”

During the past two years, Dr. Kim and his colleagues conducted focus groups with prostate cancer survivors at six locations nationwide to receive feedback on the decision aid tool and hone it. Now they are spearheading a large, multi-center clinical trial. “It’s a randomized trial, but instead of a drug or surgery we are trialing a tool to see if it actually improves patient knowledge, quality of care and patient satisfaction and to see if the decisions patients make about their treatment are in line with their values,” says Dr. Kim.

The researchers plans to enroll 100 adult males in the trial who are newly diagnosed with prostate cancer, stage T1 through T3, that hasn’t spread to the lymph nodes or elsewhere in the body. The trial will take place at 30 sites across the country, with participants either receiving the tablet-based decision aids before and during clinical consultations or undergoing usual patient care.

Dr. Kim believes that the custom decision-making aid he has developed can help engage patients in the decision-making process and make the right choices for them. “The tool is designed to address all the issues related to prostate cancer, irrespective of the patient’s race, so when they make a decision about treatment they are fully informed,” he says. “As a consequence, there’s a low probability of treatment regret, which is very difficult to treat.”