Strategies for Cancer Clinical Trials Education and Awareness: Lessons from the Field

1
Strategies for Cancer Clinical Trials Education
and Awareness Lessons from the Field
2
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

3
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.

4
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

5
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

6
Widespread 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)
8
Barriers To Clinical Trial Participation
9
General 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

10
Healthcare 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

11
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)
12
How 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.

13
Barriers for Ethnically Diverse Populations

• Fear and skepticism due to past abuses
• Lack of invitation/awareness
• Cultural barriers
• Language/Literacy

14
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?

15
Minnesota Cancer Clinical Trials Education and
Awareness Network (MCCTEAN)2002 - 2005
16
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.

17
Recruitment of patients to trials
Recruitment of healthy subjects to studies
EDUCATION
Public
Physicians
Allied health workers
Community leaders
18
(No Transcript)
19
(No Transcript)
20
4 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

29
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

30
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

31
Considerations 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

32
Barriers for Specific Populations
33
Asian Americans

• Different Values
• Decisions by consensus
• Group welfare
• Family centrality
• Saving face
• Degree of acculturation
• Language barriers

34
Native Americans

• Past discrimination
• Tribal taboo -loss of body parts
• Different communication styles
• Traditional gender roles
• Language barriers
• Other co-morbidities

35
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)

36
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

37
Whats 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

38
Whats 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.

39
Other MCCTEAN Activities
40
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.

41
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).

42
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

43
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

44
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
• NCIs Clinical Trials Homepage
  http//www.cancer.gov/clinicaltrials

45
Questions?