Title: Strategies for Cancer Clinical Trials Education and Awareness: Lessons from the Field
1Strategies for Cancer Clinical Trials Education
and Awareness Lessons from the Field
2Why 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
3Cancer 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.
4Who 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
5Inclusion 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
6Widespread access to clinical trials and racial
and ethnic proportionality is less a matter of
scientific necessity than of social justice -
Brawley, 2004.
7(No Transcript)
8Barriers To Clinical Trial Participation
9General Barriers to Participation in Clinical
Trials
- 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
10Healthcare Provider Barriers
- Unaware of clinical trials
- Unwillingness to lose control of patients 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
11Role 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)
12How Do People Find Out AboutClinical 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.
13Barriers for Ethnically Diverse Populations
- Fear and skepticism due to past abuses
- Lack of invitation/awareness
- Cultural barriers
- Language/Literacy
14A 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?
15Minnesota Cancer Clinical Trials Education and
Awareness Network (MCCTEAN)2002 - 2005
16MCCTEAN
- 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.
17Recruitment of patients to trials
Recruitment of healthy subjects to studies
EDUCATION
Public
Physicians
Allied health workers
Community leaders
18(No Transcript)
19(No Transcript)
204 Leaders 2 Approaches
- Focus on health professional education
- Training on NCIs 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 - 11 navigation education classes DVD
- Ongoing activities at home institution and with
regional partners
21(No Transcript)
22(No Transcript)
23(No Transcript)
24(No Transcript)
25(No Transcript)
26(No Transcript)
27(No Transcript)
28- 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
29Importance 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
30Considerations 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
31Considerations for Community Outreach
- Present clinical trials information in a way
that - complements the audiences 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
32Barriers for Specific Populations
33Asian Americans
- Different Values
- Decisions by consensus
- Group welfare
- Family centrality
- Saving face
- Degree of acculturation
- Language barriers
34Native Americans
- Past discrimination
- Tribal taboo -loss of body parts
- Different communication styles
- Traditional gender roles
- Language barriers
- Other co-morbidities
35Latinos/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)
36African 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
37Whats 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
38Whats 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.
39Other MCCTEAN Activities
40Cancer 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.
41Cancer 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).
42Strategies - 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
43Final 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
44Resources
- 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 - NCIs Clinical Trials Homepage
http//www.cancer.gov/clinicaltrials
45Questions?