Community Leaders andPatient Advocates

Advocating for Cancer Clinical Trials: Strategies That Work

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Course Objectives

» Review common barriers to trial participation» Dispel common myths about what cancer clinical trials are

and how they work» Review how messages for taking action may vary according to

one’s current awareness and experiences with cancer and clinical trials

» Discuss select community groups’ effective approaches for community education and outreach

» Review lessons learned in launching community education and outreach activities

» Develop your own plan of action to advocate for cancer clinical trials in your community

How You Can Be an Advocate for Cancer Clinical Trials in Your Community

» Clinical trials are the way we make progress in cancer care

» There are different types and phases of cancer clinical trials

» There are federal regulations in place to protect research participants

» Cancer clinical trials are an option in quality cancer treatment

» Everyone should ask their doctor about cancer clinical trials

Take-home messages:

Current State of Clinical Trials Participation

» Although 20% of cancer patients are eligible for clinical trials, only 3% participate…and an even smaller percentage of minorities do*

» 85% percent of cancer patients surveyed were unaware that clinical trials were a treatment option, but 75% would have been willing to participate†

» Minorities may be as willing to participate in research, but they are less likely to be asked‡

* GPO Access Web site: http://www.gpoaccess.gov/congress/index.html (2007); http://oversight.house.gov; Sateren WB et al. J Clin Oncol (2002); Christian MC, Trimble EL. (2003); 2006 from NCI Web site: www.cancer.gov/clinicaltrials/resources/outreach-education-advocacy; http://cancer.gov/clinicaltrials/digestpage/boosting-trial-participation; Brawley O. J Clin Oncol (2004); Murthy VH, Krumholz HM, Gross CP. JAMA (2004); Stewart et al. Ann Surg Oncol† Comis RL. J Clin Oncol (2000)‡ Wendler D et al. PLoS Med (2006)

Barriers to Cancer Clinical Trials

Patient Barriers» Distrust/fear

» Believe the myths

» Have a different cultural perspective

» Don’t qualify

» Don’t have insurance

» Face other problemsComis (2000, 2003)

Provider/ CCT Staff Barriers» May not feel suited to

discuss the topic with patients

» May lack awareness of appropriate local clinical trials

» May assume ethnic/radial minority patients are either: – Unwilling. Uninterested or

likely to be noncompliantNational Cancer Institute Outreach Guide

Cancer Clinical Trials:What’s Myth? What’s Fact?

» Cancer clinical trials are only for people who have no other options. – This statement is a Myth. Clinical trials are not only for

those with the most advanced disease.

» Cancer patients get a “sugar pill” if they go on a clinical trial. – This statement is a Myth. Patients always receive

appropriate treated for their cancer; placebos, or “sugar pills,” are almost never used in cancer treatment trials.

Cancer Clinical Trials:What’s Myth? What’s Fact?

» What’s being tested is always better than the currently accepted treatment. – This statement is a Myth. This is not known at the time of the trial.

It’s the reason the trial is done—to determine which approach is more effective.

» Doctors will always suggest cancer trials as a treatment option for patients who are eligible. – This statement is a Myth. Eighty-five percent of cancer

patients surveyed were unaware that clinical trials were a treatment option, but 75% would have been willing to participate if they had known about them.** Comis RL J Clin Oncol (2000)

» Most people participate in Phase III trials within a community practice setting. – This statement is a Fact. Trials are not just offered at

large academic centers.

» Patients on a clinical trial are closely followed by doctors and nurses. If the patient is not doing well on the trial, he or she will be taken off the study. – This statement is a Fact.

Cancer Clinical Trials:What’s Myth? What’s Fact?

» Rogers’ Diffusion of Innovation Theory promotes adoption of an innovation (i.e., new clinical trial messages) over time which influences others (community leaders, health care providers, cancer clinical trial staff) to make changes in cancer care

» Bandura’s Social Cognitive Theory promotes knowledge acquisition, modeling, and enhanced self-efficacy to change behaviors

Cancer Clinical Trials:Knowledge + A Call to Action

» Community education efforts cannot rely on knowledge alone.

» Must be combined with action messages

» One message does not fit all

Cancer Clinical Trials:Knowledge + A Call to Action

Simple Messages You Can Share with Others About Clinical Trials

» The only way we can make progress in fighting cancer is through clinical trials

» Taking part is voluntary—you cannot be a part of study without giving permission

» There are regulations in place to protect research participants

I read in the paper that they’re doing more cancer research—turning people into guinea pigs!

Simple Messages You Can Share with Others About Clinical Trials

» Most people with cancer aren’t told that clinical trials are a quality treatment option

» Every research study is not appropriate for everyone

» Ask questions to help make an informed decision

If a clinical trial was available for me, wouldn’t my doctor tell me about it?

Simple Messages You Can Share With Others About Clinical Trials

» Ask your doctor about all your treatment options, including clinical trials

» In most cancer treatment studies, you will get either the most accepted treatment for your cancer or a new treatment that doctors hope will be better

» No one gets a placebo (sugar pill) instead of appropriate treatment

» Cancer clinical trials are not always covered by insurance

Being an Advocate for Cancer Clinical Trials: Strategies That Work

Strategies That Work:Community Education

» Spread the word in one-on-one and group settings

» Communicate key messages to share with cancer patients and the public at large

Community Education Activities of ENACCT’s Pilot Education Program

(PEP)

Margo Michaels, MPH Executive DirectorENACCT

ENACCT Educational Approach:Pilot Education Program (PEP)

Trained “peer trainers” and “provider trainers” lead interactive workshops

in their community

National expert leads “Enhancing Recruitment

and Retention Efforts“ for CCT teams

Knowledge + Action

» Based on NCI CTES

» Messages of social justice and access to care

» Tests at 8th grade level

» Available in Spanish and Korean

» Videos

» Slides

» Trainer and Trainee Guides

» Curricula changed 3 times from ongoing trainer feedback

Quotes from the Field:Community Leaders

» Some people come with all kind of reservations [about CCTs], and then they hear, number one, we’re not selling it. They’re hearing both sides of it—then they’re open.”

» “The knowledge base that I had before coming to this program was such that I wouldn’t have recommended anyone [to CCTs] because of what had happened regarding African Americans and treatment of African Americans as a result of clinical trials. “

Generating CCT Profiles Through PEP Community “Palm Cards”

To date, 49,000+ palm cards similar to these have been distributed

PEP Impact on Community Leader Trainee Knowledge, Attitudes, and Behaviors

BOSTON SITE Mean score before training: 14.1After training: 14.6 Difference: 0.5 ± 2.69 (t = 2.35; P = 0.02)

Survey subscale Nurse practitioners Physicians

Trial regimen P = 0.45 P = 0.33

Provider preference P = 0.63 P = 0.03

Provider knowledge P = 0.0008 P = 0.0001

Access P = 0.02 P = 0.03

Provider behavior P < 0.0001 P = 0.05

Patient preference P = 0.14 P = 0.95Survey subscales with a P value < 0.05 were significant for predicting referral to a cancer clinical trial by a primary care provider (PCP) within the past year. Gender, race, practice setting, practice location, and employment status (full vs part time) made no significant difference in PCP behavior pre and post training.

APHA Presentation, November 2009

On PEP community education activities in Decatur, IL:

“There were certain times where they’d ask me to come back and talk about clinical trials, or right then and there I was allotted a certain amount of time, say 10–15 minutes, [and] the conversation would extend into half-hour conversations….”

Abbey Britton, BSPEP Local Site CoordinatorDecatur Memorial Hospital

On PEP community education activities in Tacoma, WA, through the Cross Cultural Health Collaborative:

“Each group has their own belief and way of understanding [clinical trials] information.”

Samantha Yeun, BAPEP Local Site CoordinatorTacoma-Pierce County Health Department

On PEP community outreach strategies in Tacoma, WA:

“Encourage patients and families to make sure they ask the doctor that they see: Is there a clinical trial available for me to participate in as part of my treatment?”

Jay Zatzkin. MDMedical OncologistTacoma, WA

On clinical trial awareness activities at Vanderbilt:

“[The Community Outreach Research Nurse] uses an educational approach to reach out to folks not only about clinical trials, but cancer prevention and cancer screening information.”

Debra Wujcik, RN, PhDDirector of Clinical Trials at Meharry Associate Professor of NursingVanderbilt University School of NursingNashville, TN

On clinical trial awareness through the Community Bridges project:

“One of the key messages…was the need for the education process to be fluid, for it to be flexible and for it to be attentive to some of the specific concerns related to trust of the medical community”.

Melissa Green, MPHProject Coordinator, Community Bridges University of North CarolinaCecil G. Sheps Center for Health Services ResearchChapel Hill, NC

On clinical trial awareness through the Community Bridges project:

“I think [African Americans] would be more apt to partake in a cancer clinical trial…knowing that if they do so, that it could save generations. It could save family members. It could save friends.”

Odetta PorterCommunity Activist, SurvivorCrossworks and We Care Support

On clinical trial awareness through the Community Bridges project:

“You have to be informed of the risks and the benefits of everything that could potentially happen to you and as a part of that informed consent process, that you have the right to leave the study at any time that you wish if you feel uncomfortable at any time about any part of it.”

Bill RobinsonFounder and DirectorBlack Men’s Health Initiative

Community Education:Steps to Implement

» Identify groups that are willing to accommodate an educational workshop or presentation

» Prior to delivery, learn what the audience’s current awareness, misconceptions, and concerns are about clinical trials

» Use resources, such as www.cancer.gov, to help prepare and distribute related handouts

» When possible, include past trial participants and cancer trial staff in education activities

Lessons Learned

» Develop take–away messages in formats that are portable, long lasting

» Deliver messages that reflect the needs and concerns of the diverse communities you encounter

» Community engagement and capacity-building among community leadership take time to develop

» Brief presentations, rather than longer workshops, may be appropriate for some audiences and venues

In Summary…

» Debunk myths about cancer clinical trials with easy-to-understand facts

» Cancer clinical trials education messages should include a call to action

» Be flexible in setting the length and focus of education activities for diverse audiences

» Be prepared to address difficult questions or locate resources for additional information

Next Steps:Action Planning

Critical Thinking Activity

» What strategies discussed can you apply to your community?

» Which strategies did you find particularly intriguing?

» How might your approach be different?

What’s Next?

Action Planning Worksheet

Thank you!