This is not the best frame of mind for decision making. And for men whose cancer, like Conwill’s, is confined to the prostate, decisions can be complicated. Several kinds of surgery and radiation are highly effective; nearly all men are alive, most without signs of recurrence, five years later. But both surgery and radiation carry substantial risk of side effects like impotence and incontinence.

Making the decision even more difficult, many localized prostate cancers never cause a problem. So men with certain types of tumors can opt for active surveillance—regular monitoring for signs of trouble—and face no treatment (or side effects) for years, if ever.

It was to help others with such decisions that Conwill became involved in a project known as CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation), a study at Vanderbilt University originally funded by the Agency for Healthcare Quality and Outcomes to document clinical and personal consequences of different options.

The Personal Touch

Many studies of prostate cancer have compared treatment outcomes, but the results don’t necessarily direct patients to a single, best treatment path. Vanderbilt’s David Penson, MD, MPH, principal investigator of CEASAR, wanted more: to personalize information for men of different ages, personality types, and family situations and go beyond standard clinical results.

“We want to get at risks and benefits others don't quantify,” he says. “How does treatment affect things like anxiety, work life, the patient's vision of himself as a man? Do patients feel they were adequately informed when making their choice? Do they regret the treatment they chose? How much do they worry about cancer coming back?"

CEASAR initially gathered information from 3,691 men diagnosed with prostate cancer in 2011, and the researchers surveyed them 6 and 12 months later.

In that initial phase, a six-member stakeholder panel, which included a patient advocate and several healthcare payers and providers, consulted occasionally with researchers via teleconference.

In 2013, PCORI awarded Penson funding for a three-year follow-up. “We will specifically compare the effectiveness of contemporary surgical and radiation techniques for localized prostate cancer in terms of the 6-, 12-, and 36-month patient-reported outcomes and quality of life, side effects, cancer control, and treatment complications,” says Penson.

“We will also identify subgroups of patients who respond better to certain treatments than others, and we will explore how the effectiveness of therapy is influenced by the quality of care delivered, in hopes of aiding patients in their choice not only of the treatment to receive but also of the facility and provider.”

"This is more than an extension," Penson says. "It's allowing us to recraft CEASAR in a way that better incorporates the patient perspective. We're making patients part of the research team, partners from start to finish.

”Maybe they won't know about statistics and study design, but I sure don't know about the experience of having prostate cancer. I can guess—and it’s an educated guess—because I see these guys all the time in my clinical practice. But if you want information patients can use, you need to have patients working with you. "

The current project’s 10-patient team meets with researchers monthly to define and discuss matters that make a real difference to men. “I told the team: ‘I’m not looking for a rubber stamp,’” Penson says. “’I want you to tell me what we’re doing right or wrong. I’ll do what you guys tell me to, as long as I can justify it scientifically.’”

He reports, “We’ve made wholesale changes to the survey in ways I’d never have thought. In nitty-gritty areas of sexuality, patients gave us insights that you’d only have if you’d lived through it.”

There were also “Aha!” moments related to incontinence, a common problem after prostate cancer treatment. Although, surveys of side effects generally ask about this aspect, they miss some of the intricacies. One patient partner noted that some men adapt their behaviors and therefore might report that they were not experiencing incontinence. For example, this patient leaked urine when he was active, so he’s become more sedentary. “You wouldn’t know about that as a researcher unless you got it from the patient,” Penson says.

A Real Partnership

For Dan McCollum, who works at the Vanderbilt Biomedical Library and is one of two patient team leaders, his role in the prostate cancer project is familiar, yet new. “Many groups ask researchers to have a patient representative working with them, but what this usually means is sitting there and being a good boy. You rarely get to speak, and if you do, the others say, ‘Let’s talk about this later,’ and later never comes.

“That’s not the way it’s done here,” he says.

At the first patient meeting, Penson said that anyone who had the time and inclination was welcome to also join weekly research conferences where scientific details and data analysis are addressed. McCollum and Conwill, the other team leader, took him up on it.

“I interject the patient’s perspective, live and in color,” says Conwill. A retired engineer and no stranger to statistics, he readily engages technical issues. “These conferences have given me insights into how researchers look at data and enabled me to start putting pieces of the puzzle together,” he says. “Penson told me, ‘I want your questions out there, on the table.’“

The ultimate aim is to organize a rich lode of information representing the collective experience of thousands of men into a format that will help those newly diagnosed with prostate cancer choose the treatment best suited to themselves and their lives, and offer guidance on where to seek it.

Penson envisions a digital decision-aid tool, with perhaps a paper version for the computer-shy, disseminated widely via patient and professional groups, and possibly available to all on the internet. The patient team will be intimately involved in these decisions and plans as well.

He calls the project “one of the most rewarding things I’ve done in my career. They’re the stars, I’m in the background," he says of his patient team. "The study will be a star because of them.”

That gratitude is apparently mutual. "It's been such a learning experience, and there's such a sense of pride in feeling I have the opportunity to make a difference in men's lives for generations to come," says McCollum. "I shouldn’t tell Dr. Penson, but I'd pay him to let me do this."

Posted: January 6, 2015