Download Strategies for Cancer Clinical Trials Education and Awareness

Strategies for Cancer
Clinical Trials Education
and Awareness:
Lessons from the Field
Why should we care?
• Cancer affects all of us
• Each year in the U.S.A:
− More than half a million people die of cancer —
more than 1,500 people a day
− People of color are disproportionately affected by
cancer
Cancer Disparities Defined
NCI defines "cancer health disparities" as
• “. . . adverse differences in
• cancer incidence (new cases),
• cancer prevalence (all existing cases),
• cancer death (mortality),
• cancer survivorship,
• and burden of cancer or related health conditions
that exist among specific population groups in the
United States.”
Who participates in cancer clinical
trials?
• Less than 5% of all
eligible people with cancer
• Few over age 65
• Ethnically diverse
populations
− Even fewer in many large
prevention trials
Inclusion of women and minorities
•1986 inclusion of women encouraged
•1987 inclusion of minorities encouraged
•1993 NIH Revitalization Act
•1994 NIH revised inclusion policy to
mandate that women & minorities MUST
be included in all clinical research studies
“Widespread access to clinical
trials and racial and ethnic
proportionality is less a matter of
scientific necessity than of social
justice” - Brawley, 2004.
Barriers To Clinical Trial
Participation
General Barriers to Participation in
Clinical Trials
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Many do not know what a CT is
Fear of research – historical abuses
Fear treatment will be withheld
Lack of access to CTs
Personal and practical obstacles (language)
Cost and insurance concerns (out of pocket costs)
Cultural influences
Unwilling to go against doctor
Study design eligibility criteria (i.e. co-morbidities)
Low health literacy
Healthcare Provider Barriers
• Unaware of clinical trials
• Unwillingness to “lose control” of patient’s care
• Belief that standard therapy is the best
• Administrative burden
• Not enough time to discuss option with patients
• Judge that patient would not be interested
Role of Physician in Clinical
Trials Participation
Source: A Quantitative Survey of Public Attitudes Toward Cancer Clinical Trials
R.L. Comis, C.R. Aldige, E.L. Stovall, L.U. Krebs, P.J. Risher, H.J. Taylor (2000)
35
Told patient about trials
77
14
Made "great effort" to
educate patient
64
9
Made "great effort" to
help patient find trial
62
Made "great effort" to
persuade patient to
participate
4
32
0
20
40
60
80
Patients who do not participate in clinical trials
Patients who participate in clinical trials
100
How Do People Find Out About
Clinical Trials?
• Their physicians
– Inform them clinical trials are an option they
might look into
– Refer them to specific clinical trials
– Conduct trials as part of their own practices
• They hear about them from trusted sources
– family, friends, community leaders, etc.
• They search out options on their own.
Barriers for Ethnically Diverse
Populations
• Fear and skepticism due to past abuses
• Lack of invitation/awareness
• Cultural barriers
• Language/Literacy
A Tale Of Two Approaches
• Promoting clinical trials broadly among
populations that have cancer disparities.
• Promoting specific clinical trials that
address high priority cancer needs
expressed by populations/communities with
cancer disparities.
• What are the pros and cons of each of
these?
Minnesota Cancer Clinical
Trials Education and
Awareness Network
(MCCTEAN)
2002 - 2005
MCCTEAN
• A statewide network with a goal of creating
awareness about cancer clinical trials and
providing educational opportunities for
health professionals, the public and
individuals/families with a cancer diagnosis.
Recruitment
of patients to
trials
Recruitment of healthy
subjects to
studies
EDUCATION
4 Leaders – 2 Approaches
• Focus on health professional education
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Training on NCI’s CTES materials
Assessment
Integration of the topic at cancer/health conferences
Community clinic trainings (FQHC)
• Focus on community education
– Tour of research labs, cancer centers, etc.
– Integration of clinical trials at community events and
health fairs
– 1:1 navigation; education classes; DVD
• Ongoing activities at home institution and with
regional partners
• Over 20 resources
 Brochures, Workbooks, Web site, Slide shows, Videos, DVD, CD,
and Booklets
 Created as a train-the-trainer program
 Targeted education and outreach to health professionals and the
community
Importance of Community Outreach
•Informing your community about clinical trials
can…
– Overcome barriers to enrollment in trials
– Help people make informed decisions about
cancer treatment and prevention options
– Make community aware of the option of
participation in a clinical trial
Considerations for Community Outreach
• Be familiar with communities you are serving:
– Decision making
– Gate Keepers/Leaders
– Informed Decision making is the message not recruitment
• Address potential risks of trials, in addition to benefits:
– Involve those who help with decision making
– Provide ample opportunities for questions
– If you sense hesitation, address it head on; use this as an opportunity to
for dialogue
– Stress patient rights to withdrawal – at any time
• Avoid conducting outreach that will disrupt work and home
schedules.
• Stress importance of equal access to highest quality care
–Incorporate clinical trials information in all cancer-related programs
– Highlight the advances made clinically
Considerations for Community Outreach
• Present clinical trials information in a way that
– complements the audience’s values
– is respectful and easy to understand
– uses multiple approaches: publications, videos
―Testimonials, stories
― Small group discussions
– addresses fears and concerns
• Organize tours for community leaders and doctors
• Develop a mechanism for visits by patients
• Present clinical trials information in an unbiased way
Barriers for Specific
Populations
Asian Americans
• Different Values
–Decisions by consensus
–Group welfare
–Family centrality
• “Saving face”
• Degree of acculturation
• Language barriers
Native Americans
• Past discrimination
• Tribal “taboo” -loss of body parts
• Different communication styles
• Traditional gender roles
• Language barriers
• Other co-morbidities
Latinos/Hispanics
•Fatalism
•Use of folk remedies
•Delays seeking health care
•Fear
•History of past abuses
•Family/Work responsibilities
•Poor MD/pt communication
•Language barriers (regional dialects)
African Americans
• Lack of awareness
• History of past experiences
• Experiences with medical systems
• Fear
• Hopelessness, fatalism
• Lower priority
• Family and/or work responsibilities
• Researchers not giving back to community
What’s Wrong?
A cancer center has been working to build a
relationship with the local Indian tribal
community. At a recent meeting with Tribal
council leadership, a nurse talks about a new
clinical trial and hands out information
detailing how patients are randomized to arms
of the trial. She says, ‘If any of your members
are diagnosed with lung cancer, feel free to
pass this out…”
What’s Wrong?
A medical center puts an ad in the paper for
a breast cancer prevention trial. The team
makes sure to include ‘Se habla espanol’ in
the ad. When staff get a call from a Spanish
speaker, no one can find the Spanish
speaking nurse to help the caller.
Other MCCTEAN
Activities
Cancer Clinical Trials Conference
• To inspire communities of color, policy
makers and providers to establish and
strengthen partnerships and collaborative
relationships to reduce cancer health
disparities while understanding the barriers
that prevent the benefits of research from
reaching all populations in Minnesota.
Cancer Plan Minnesota 2005-2010
• Promote participation in prostate cancer screening and
prevention trials.
• Provide all cancer patients with information about clinical
trials.
• Conduct outreach programs in racial and ethnic minority
communities that communicate the results of clinical trials, as
well as the benefits of clinical trials to individuals and to
communities.
• Expand the clinical trial infrastructure into racial and ethnic
minority communities, including employment of culturally
diverse staff.
• Use community lay health educators to increase awareness of
clinical trials in community settings.
• Solicit participation from racial and ethnic minority
communities on Institutional Review Boards (IRB).
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Strategies - Institutional
Have community members be part of the IRB
Clinical Research Advisory with community members
Tours of facilities for community gatekeepers
Three “R” (Recruitment, Retention, Reporting back)
– Recruitment should not be the sole focus
– Studies should take into account or include co-morbidities
– Retention plan – learn about the experience, why they stay and
why they withdrawal
– Report back – send period letters to participants, referring
physicians and final report to community gatekeepers and
community papers
• Reduce literacy levels of informed consents
• System to identify and match newly diagnosed patients
with available clinical trials
– Clinical Trials navigator/coordinator
Final Lessons Learned
• For sustainability – have $$ and dedicate a staff
person to the project
• Keep in mind everyone is busy
• Measure knowledge/awareness, not recruitment
• Cast a wide net of partners
• Talk ahead of time with key contacts to
determine appropriate content and speakers
Resources
• Clinical Trials Education for Native Americans –
http://natamcancer.org/page147.html
• Education Network to Advance Cancer Clinical
Trials (ENACCT) – http://www.enacct.org/
• Eliminating Disparities in Clinical Trials (EDICT) –
http://www.bcm.edu/edict/home.html
• NCI’s Clinical Trials Homepage –
http://www.cancer.gov/clinicaltrials
Questions?