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A publication  of the UC Davis Cancer Center
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Current Issue: Fall/Winter 2003
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  FEATURES
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RAISING AWARENESS

A novel multimedia ad campaign aims to boost participation in cancer clinical trials

 "" PHOTO -- Primo "Lucky" Lara with patient Dolores Pfarr.
 
Primo "Lucky" Lara with patient Dolores Pfarr.
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From battery-charged bunnies to sneakers with a swoosh, successful advertising reaches out and touches us all. But can a multimedia ad campaign also convey important messages about complex cancer treatment decisions? Primo "Lucky" Lara, associate professor of medicine, is betting that it can.

Last summer, Lara received a two-year, $1 million grant to develop and test a multimedia advertising campaign to promote a message he feels passionate about: the importance of early phase cancer clinical trials.

Lara's grant was awarded by the National Cancer Institute in concert with five major pharmaceutical companies. The unusual public-private partnership was formed to address low rates of participation in early cancer clinical trials, the rigorous scientific studies that determine whether a potential new therapy is safe and effective in patients. All told, the public-private consortium awarded nearly $6 million in grants to six top cancer centers nationwide. All of the grants are to develop and evaluate practical approaches to boost clinical trial participation. UC Davis Cancer Center was the only West Coast institution to win a grant.

Nationally, 2 to 3 percent of adult cancer patients enroll in a clinical trial. Such low participation rates prolong the drug development process, and can delay public access to potentially effective new cancer treatments. Low participation rates also make it harder for researchers to answer important questions about existing cancer treatments.

Academic institutions like UC Davis Cancer Center typically boast above-average participation rates — generally about 15 percent. But Lara wants to do better. By systematically addressing the barriers that keep patients from choosing clinical trials, he believes this rate can be doubled or even tripled.

As evidence, he points to pediatric clinical trials. Nationally, about half of all children with cancer receive treatment through clinical trial, in large part because most pediatric cancer patients are cared for at major cancer centers, where advancing medicine through research is a basic part of the culture.

PHOTO -- Debora Paterniti, left, hopes to bridge communication gaps that may keep patients from enrolling in clinical trials.  ""

Debora Paterniti, left, hopes to bridge communication gaps that may keep patients from enrolling in clinical trials.
 
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"The gold standard in pediatrics is that all children with cancer should participate in trials in order to improve their outcomes," says Lara, a hematologist-oncologist who serves as principal investigator of six early phase cancer clinical trials at UC Davis Cancer Center right now. "Adults with cancer, on the other hand, confront barriers to participation at many levels."

Chief among those barriers, Lara's previous research has shown, are fear of investigational treatments, transportation problems and health insurance limitations.

Coverage: It's the law

One health insurance barrier has been knocked down, and Lara wants to make sure the public knows it. SB-37, a state law authored by California Sen. Jackie Speier (D-Hillsborough), requires most private health insurers in California to pay for routine medical costs associated with clinical trials. At least 18 other states have passed similar laws.

Before SB-37 took effect in 2002, private insurance companies typically refused to cover the routine medical costs associated with participating in a clinical trial, from X-rays to lab tests. (Drugs and other cancer treatments provided in clinical trials are usually provided at no charge).

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Clinical trial phases

A cancer clinical trial is a study conducted with cancer patients, usually to evaluate a new treatment. Clinical trials take place in three phases, each designed to answer specific questions.

Phase I: A phase I trial evaluates how a new drug should be given, how often and at what dose. A phase I trial usually enrolls a small number of patients.

Phase II: A phase II trial provides preliminary information about the effectiveness of a new drug or procedure against a particular cancer. If a treatment proves effective in phase II testing, it moves on to phase III.

Phase III: A phase III trial compares a promising new drug, new combination of drugs or new procedure with the best prevailing standard treatment. Phase III studies usually involve large numbers of patients, usually hundreds or thousands. A patient in a phase III trial is randomly assigned to receive either the new treatment or the best existing treatment. Cancer clinical trials rarely use placebos.

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In a pair of studies he conducted before and after passage of SB-37, Lara showed that the law appeared to have reduced the number of patients who cited insurance constraints as a primary reason for declining to enroll in a cancer clinical trial. And participation in cancer clinical trials increased.

With his new grant, Lara will mount a multimedia ad campaign to further raise awareness of SB-37 among patients and physicians. At the same time, the campaign will increase awareness of the importance of cancer clinical trials. The campaign will take place in the nine-county region surrounding UC Davis Cancer Center. San Diego County will serve as a control. Public surveys will be conducted before and after the ad campaign in both regions to measure changes in awareness of SB-37. Enrollment in cancer clinical trials will be tracked as well.Young & Rubicam, a Madison Avenue-based global advertising agency that has handled Burger King and Dr. Pepper accounts, is designing the ads.

Lara's goal: to increase participation in cancer clinical trials at UC Davis Cancer Center to 32 percent of adult patients in two years, double the Cancer Center's current rate.

The cancer specialist has reason to be optimistic. Past media campaigns have proved effective in changing health-related behaviors — for better and worse. In 1921, R.J. Reynolds Tobacco Company spent $8 million on its now-legendary "I'd walk a mile for a Camel" campaign. Within two years, Camel had captured 45 percent of the cigarette market in the United States.

But Lara takes his inspiration from the American Legacy Foundation's current anti-tobacco "Truth" campaign. Through creative advertising and promotions, the campaign delivers a clear, consistent message that has helped to reduce smoking rates nearly 18 percent among high school students.

"The American Legacy Foundation did a fantastic job in focusing attention on tobacco cessation and simplifying complex issues," he says. "We're aiming for a similar approach."

Confronting barriers

In addition to the media campaign, Lara's study will examine communication gaps among patients, family members, health care providers and researchers that may act as barriers to clinical trial participation. Debora Paterniti, an assistant professor in the UC Davis Center for Health Services Research in Primary Care, leads this arm of the study. The sociologist will spend six months observing the process of recruitment, consent and participation in early phase trials. She will also conduct focus group interviews to assess perception and understanding of the research process among patients of different ages and ethnic groups.

In previous studies, Paterniti learned that all players — community doctors, researchers, project coordinators, patients and family members — view the cancer research process from different perspectives. Patients tend to be concerned about how a cancer study might affect their health — if they will be in pain, for example, or whether they'll actually receive what may be a promising new treatment. Family members wonder how long the trial will last and whether they have the appropriate resources at home to support the patient. Researchers have other concerns, ranging from whether a patient is physically well enough to complete a trial to whether sufficient numbers of patients can be recruited to a study to allow meaningful results in a timely manner.

"Sometimes it can be as if they are all speaking different languages," Paterniti says. "The reality is that different groups have different understandings as well as different things at stake."

Based on her observations and focus-group findings, Paterniti will design, implement and evaluate an intervention that she hopes will reduce communications barriers that discourage participation in early phase cancer clinical trials. She will make a special effort to include minority patients in her study, in hopes of finding an effective way to increase minority participation. Nationwide, minorities are poorly represented in early phase trials, often leaving clinicians with no alternative but to generalize results from one group to another.

Paterniti's ultimate intervention may be as simple as a list of questions for patients and family members to ask their doctors.

Like Lara's media campaign, Paterniti's intervention, if it proves successful, could be adopted by cancer centers around the country.

"We're interested in the welfare of all cancer patients," Lara says. "We're in the business of finding and developing the best new anti-cancer drugs — and getting these into the clinic and marketplace as quickly as possible."

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  "We're interested in the welfare of all cancer patients. We're in the business of finding and developing the best new anti-cancer drugs — and getting these into the clinic and marketplace as quickly as possible." — Primo "Lucky" Lara  
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Sacramento, CA 95817

cancer.center@ucdmc.ucdavis.edu

© 2004 UC Regents. All rights reserved.

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