Video helps patients with decision-making process

Goal was to dispel misconceptions

A video created to dispel patient misconceptions about clinical trials benefited from a diverse array of viewpoints — everyone from physicians and nurses to subjects and even those who decide not to take part in clinical trials, says the woman who spearheaded the effort.

The goal was to get across to patients that the decision about whether to take part in a clinical trial is a personal one — there’s no one answer that’s right for everyone, says Christina Parker, MD, assistant director for faculty activities at Dana-Farber Cancer Institute in Boston.

The video, "Entering a Clinical Trial: Is it Right for You?" was developed to address concerns that patients were getting the wrong idea about cancer trials, Parker says.

The video was one of two winners of the Health Improvement Institute’s Awards for Excellence in Human Research Protection for Innovation.

"People think that when they enroll in clinical trials they’re getting the best treatment possible," she says. "Clinical trials aren’t really about getting the best treatment possible. They’re about figuring out what’s better. So we set out to try to make an educational tool that would make that more clear to people. There are videotapes that exist, but they often give the impression that to be in a clinical trial is better for you than to not be in one."

She says that while IRBs often pay attention to the informed consent aspects of individual trials, it’s also important to look the larger issue of explaining what a clinical trial is meant to do.

"I think that’s really critical to a patient’s understanding of whether or not they want to go into a clinical trial," Parker says. "As much effort needs to go into making sure that patients understand those basic elements as needs to go into patients understanding specifics of an individual clinical trial."

Video tailored to patient needs

In determining what would be in the video, Parker first consulted with a committee of health care providers, IRB members, and medical ethicists to arrive at what they wanted to say. Based on those decisions, Parker began setting up videotaped interviews, and even took steps toward editing the final product.

But as they got further into the project, and consulted other groups, they saw that they only had a piece of the total picture.

Research nurses pointed out that they were the ones patients interacted with most and needed to be more visible in the video. The institute’s patient and family advisory council suggested a number of changes, including inclusion of more minority faces and explanation of insurance issues.

Most importantly, Parker says, the patient and family advisory council provided a completely different perspective on the message the video needed to convey, Parker says.

"They said, Yes, you get across the point that clinical trials aren’t there to cure you, but the reality is that they provide hope, and that part of the equation cannot be ignored or left out,’" she recalls. "They were very, very clear about that. In our desire to tell the other side, to make it clear that we don’t know that [the trial is] going to work, we left out the reality that it might be better.

"But the patients stood up there and they said, You have to put this in.’ And so we went back to our videotaping, and fortunately we had that piece." Parker continues.

The format of the 22-minute video is a series of interviews with health care providers and patients, intercut with scenes of patient treatment and lab work. Because Dana-Farber is a cancer treatment facility, the patients interviewed are all cancer patients, and much of the discussion is cancer-specific. But Parker says the video’s content would be appropriate for anyone contemplating a clinical trial for treatment of a life-threatening disease.

"It wouldn’t be suitable for somebody who’s in a trial that doesn’t carry much risk associated with it," she says. "It might be a little bit too scary for somebody who’s just gonna sit there and have their blood drawn. But we’re a cancer institute, so that’s what we chose to focus on."

In the video, the head of the IRB talks about what an IRB considers when it reviews a clinical trial. Physicians and a research nurses describe the different phases of clinical trials and what they mean. And there are a number of interviews with patients who had different experiences with trials.

In one case, a patient who was in a trial describes how she had to withdraw because of a side effect. Another interview subject, a nursing professor, considered a clinical trial but ultimately decided not to enroll.

"The fact that she was a professor of nursing was very valuable because it really validates the fact that it’s OK to say no — that people who are smart say no, who are very knowledgeable medically," Parker says. "That doesn’t mean it’s the right choice to make, but it does mean that it really is OK to make it."

Right videographer is critical

Parker’s group didn’t stumble across these interview subjects entirely by chance; they sought them out, asking IRB members, staff, and patients for suggestions. In some cases, however, serendipity did play a role, she says.

"Between our scheduled [interviews], while we were waiting, we were in patient spaces, and patients agreed to be interviewed, just out of the blue," Parker says. "And they gave some of the nicest discussions of the issues."

Parker says they conducted many interviews for the each of the different points that they wanted to make in the video, so that they could choose the best person for each scene.

"We interviewed three or four different doctors and asked them essentially the same questions," she says. "And we ended up with one who’s almost a narrator. Even though it’s a spontaneous conversation, she says things with sound bites that are just right for leading into the next section, even though she wasn’t interviewed for that purpose."

Parker has advice for institutions that are considering creating their own patient information video:

  • Start with a group of people who can hone down what you think your message will be: "And I emphasize think,’" she says. In her case, that group included health care providers, medical ethicists, and the IRB.
  • Then, bring in a group of patients who are prepared to watch the evolving product three or four times. Use their input to help identify who the important players are — nurses, doctors, patients, family members — to set up interviews.
  • Finding the right videographer is critical to the success of the project. Parker found hers through a suggestion from an IRB member who also was a divinity student.

"She said, You should go with this guy; he really wants to get things right. He’s very ethical,’" she recalls.

Parker says that after speaking with the videographer, she decided to use him even though he lived six hours away, rather than contract with someone in Boston.

For those who lack the resources to create their own video, Dana-Farber’s project is available, and can even be personalized a bit for other healthcare institutions, Parker says.

"We made two copies," she says. "One is for use in our center, and it has pictures of our institutions at the beginning. And then we made what I call a generic version — it’s exactly the same movie except that we took out the pictures of the institutions at the beginning and replaced them with clinical scenes. So now there’s no pictures of our institutions other than the insides where we filmed, and we don’t explicitly identify those as part of our institution."

She says that several health care web sites already have plans to use a version of the video.

The video can be viewed on the Dana-Farber web site at www.dana-farber.org/res/clinical/trials-info/. A high-speed Internet connection is necessary. For more information about using the video, contact Parker at christina_parker@dfci.harvard.edu.