Tip:
Highlight text to annotate it
X
>> James Alexander: Hello,
and welcome
to our Multicultural Media
Outreach webinar
on clinical research
in minority populations
sponsored by the Office
of Communications and Education.
I'm James Alexander
with my colleagues,
Jill Bartholomew
and Dr. Harry Kwon.
When it comes
to cancer health disparities,
clinical research is one
of the most talked
about subjects,
both in the research community
and among laypeople.
While participation
in a clinical study may not be
right for everybody,
we all agree
that clinical research awareness
should be increased
in communities of color.
In fact, it may help address
cancer disparities.
Today, we have
with us three outstanding
researchers
who have all dedicated their
work to addressing
cancer disparities.
Today, they will present
for about 10 minutes each,
and then we'll take questions
at the end.
And, so I'd like to begin
by introducing our first
presenter, Dr. Lauren Wood, MD.
Dr. Wood is head
of the clinical trials team
within the National Cancer
Institutes' vaccine branch.
In this position,
she oversees the implementation
and clinical translation
of research studies
investigating vaccines
and immune-based therapies
for both cancer
and *** infection.
Prior to this,
Dr. Wood helped physicians
in increasing responsibility
within the pediatric ***
and AIDS malignancy branch
of the NCI.
She is board certified
in allergen immunology,
pediatrics and internal
medicine, and she's also a
captain in the US Public
Health Service.
Dr. Wood, welcome.
>> Lauren Wood, MD:
Thank you very much, James.
I hope to provide some insight
into how minority participation
in clinical trials can be very,
very important
in maximizing cancer outcomes
for all individuals.
Clinical trials are very
important because they play a
critical role
in our understanding
of cancer biology,
cancer prevention
and cancer treatment.
Specifically, to understand
from epidemiologic studies
of cancer biology
that cancers can behave
differently in different people
and in different populations.
Some of these differences
include cancers
that are more frequent
in certain populations compared
to others.
Examples include the high rate
of prostate cancer among
African-American men,
as well as triple negative
breast cancer among young
African-American women.
We also know that gastric,
liver and bile duct cancers are
more common among Asian American
and Pacific islanders,
and cancer of the *** is very
high among Hispanic
and Latino women.
In addition,
we know that there are large
variations in cancer survival
by race and ethnicity.
As a matter of fact,
African Americans have the
highest death rate
from all cancer sites combined
from malignancy of the lung,
colon, ***, female breast
and *** of all racial
and ethnic minority groups
in the United States.
Importantly, the death rate
from cancer among
African-American males is
about 1.4 times higher
than that among white males
and among African-American women
is 1.2 times higher
than white females.
Variation in cancer outcomes
and survival can reflect
differences in response
to standard treatments,
as well as differences in access
to standard treatments
in healthcare in general.
And, it's important to know
that while the differences
in socioeconomic factors
and disparities and access
to care definitely play a major
role in many
of the observed differences
that we see in cancer survival.
There also maybe reasons
in underlying cancer biology
that explain why certain groups
of individuals don't fare
as well.
Examples of this can be
differences
in how the body handles
and metabolizes chemotherapy
drugs, often know
as pharmacokinetics
and pharmacodynamics.
And there are also biologic
differences
in tumor characteristics
that can be prevalent --
more prevalent
in one population compared
to another.
Clinical trials also give us
very, very important information
about cancer prevention.
We know that the frequency
of underlying risk factors
for some cancer is different,
vary dramatically
and significantly among
different racial
and ethnic groups.
For example,
there's a higher rate
of stomach cancer among Hispanic
and Latinos as well
as Asian Americans,
and this is thought to be due
to the fact that many
of them have chronic infection
with the bacteria known
as Helicobacter pylori.
We know that Helicobacter pylori
infection leads
to chronic inflammation
of the stomach
and that ultimately leads
to ulcers and potentially
down the line, stomach cancer.
Similarly, high rates
of liver cancer among Asian
Americans reflect the higher
frequency of another chronic
infection due
to hepatitis B infection among
recent immigrants.
We know that hepatitis B
infection is usually cleared
by most individuals,
but in individuals
who don't clear the infection
and have chronic active
hepatitis, that chronic
inflammation can then lead
to liver cancer
after a prolonged period
of time.
Finally, we know
that there's a higher incidence
of cervical cancer among Latino
women, and we believe
that this is due
to a very high frequency
of certain types
of human papilloma virus,
another infection that can lead
to chronic persistence,
chronic inflammation,
and the development
of precancerous
and cancerous lesions
of the ***.
There are other modifiable
cancer risk factors
that can also vary greatly
by race and ethnicity,
as well as socioeconomic status.
These include cigarette smoking
or tobacco use of other kinds,
physical inactivity,
which also closely tied --
relative to obesity.
We know that excess body weight
is directly associated
with the risk of cancer
at several organ sites.
That includes colon cancer,
breast cancer
and postmenopausal women,
uterine cancer, esophageal
and kidney cancer.
And we know
that there's a very tremendous
differentiation among races
in terms of the incidence
and frequency
of obesity among
African-American populations,
Hispanic populations,
Native-American populations,
which may all contribute
to differences and incidences
in cancer disparities.
We also know that in the area
of cancer prevention,
there are challenges with access
to screening technologies
that allow early detection
of cancer.
This is related to the ability
or inability of populations
to access very effective
screening interventions
including mammography,
colonoscopy, Pap smears
and HPV DNA testing.
Clinical trials also play a
critical role
in our understanding
of cancer treatment.
A measure of the quality
of cancer treatment is the
five-year survival for a patient
at the same stage of diagnosis.
African Americans have lower
stage-specific survival
than whites for many cancers.
In general,
the poor survival appears
to be due to more disparity
than access and care and quality
of cancer treatment.
However, the types
of standard treatments
that are ultimately offered
to patients are usually based
on data from clinical trials.
However, a vast array
of current data shows
that many racial
and ethnic minorities remain
severely underrepresented
in the clinical trials
that we have.
A lot of people don't know
exactly what clinical
trials are.
They are research studies
that involve people,
and they help physicians
and healthcare providers find
ways to improve health
and cancer care
and our final stop
in a long process that begins
with research in a lab
and among animal testing.
Most of the standard treatments
that we use today are the result
of past clinical trials,
which is why it is critically
important that underrepresented
minorities, and racial
and ethnic minorities
participate
in these clinical trials
so that we know
that the results are going
to be generalizable
to all the US populations
that need them.
An individual study can be
designed to answer scientific
questions about new ways
to either treat cancer,
find and diagnose a cancer,
prevent cancer,
or even manage symptoms
of cancer or the side effects
from the treatment.
The important thing
for many patients to know is is
that clinical trials follow
strict guidelines.
A studied protocol explains
exactly what's going
to happen during the trial,
how the study will be carried
out, and why each part
of the study is necessary
and includes information
about the reason
for doing the study,
who can join the study,
how many people are needed
for the study, any drugs
or vaccines they're going
to take during this study,
the dose of those drugs
or vaccines,
and how often they will be
taking them,
what medical tests they're going
to have to have
and how often these tests are
going to be done,
and also what information will
be gathered about them
and their response to treatment.
The trials can involve many
types of treatments
such as new drugs or vaccines,
new ways to do surgery
or give radiation therapy,
or even combinations
of treatments
such as chemotherapy
plus vaccines.
It's also important for people
to understand
when they're considering a
clinical trial
that clinical trials occur
in different phases.
So, some patients may have
interests in participating
in trials that are
in more advanced stages
of a development,
whereas other patients might be
willing to participate in trials
that are still
in the earliest stage
of development.
The clinical trials take place
in phases with each phase having
different goals and objective.
Phase one trials are
first-in-human trials
where drugs, vaccines
or interventions are being
conducted in human beings
for the very first time.
The goal of these trials is
to find a safe dose,
decide how a treatment should be
given and see how the new
treatment affects the body.
Phase two trials,
try and determine
if the new treatments have an
effect on a certain cancer,
and also to see how the new
treatment affects the body.
Phase three trials are often
much larger,
involve many patients
and are conducted
at multiple sites.
We understand
in phase three trials really how
much of the dose to give,
we have a better understanding
of what the effect is
on the body,
as well as what the potential
drug effect is on the treatment.
During phase three trials,
the goal is
to compare a new treatment,
or a new use of a treatment
with current standard treatment
or chemotherapy drugs.
Phase four studies are the final
studies that allow us
to assess the long-term safety
and effectiveness
of a new treatment,
and are usually conducted
by the pharmaceutical
manufacturer and sponsor
of a new drug or a vaccine.
An example of an early phase one
trial is our TARP peptide
vaccine trial.
This is an early phase cancer
vaccine trial.
TARP is a novel tumor protein
that's expressed in about 90
to 95% of prostate cancers
and 50% of breast cancers.
It is over-expressed
on tumor cells compared
to normal cells,
and that makes it a very good
target to use
in the vaccine platform.
The goal of using a therapeutic
cancer vaccine is basically
to stimulate
and train the patient's own
immune system to better fight
and attack and hopefully
ultimately control their own
prostate cancer.
The science
of why we're using a TARP
peptide vaccine, well, briefly,
I told you that TARP is a
protein that's over-expressed
in prostate cancers,
and the analogy is is
that proteins are
like a long sentence.
Peptides are like words
in a sentence.
So, short peptides are the
equivalent of small words
and they are 9
to 11 amino acids in length.
Long peptides are big words
and they are 15
to 20 amino acids in length.
Amino acids are actually the
letters in the words that are
in the sentence.
We are using peptides
that are short
in the vaccine platform,
and we've done something
to these peptides.
We've done what we call
epitope enhancement.
That means that we substitute a
single letter for another letter
within that short peptide
within the word and it results
in better stimulation
of the immune system.
That's the science behind why
we're doing this clinical trial.
So, this clinical trial is
in men with stage D0
prostate cancer.
They're men
who have had primary treatment
for their prostate cancer,
but their PSA levels have
started to come back
and are now detectable
but they have no evidence
of any metastatic disease
anywhere in their visceral
organs, such as their liver
and lungs, or in their bones.
These peptides are being given
to men to stimulate their immune
system, and the goal is is that,
hopefully, we can slow the rate
in which their PSA is rising,
or even cause the PSA levels
to decrease.
We measure the rate
at which the PSA is going
up by a measure called PSA
doubling time.
Again, because this is a first
in human study,
our primary goals are
to make sure
that the vaccine is safe,
that it first does no harm
to the patients,
we look to see whether
or not there are any adverse
effects from the vaccine
and also to see whether
or not it indeed stimulates the
immune system.
The secondary objective
of this trial was to find
out whether
or not we could indeed alter how
fast the PSA is rising
by impacting the PSA
doubling time.
Importantly, one of the things
that we shown
with this preliminary trial is
that TARP peptide vaccination is
indeed safe
and it actually does slow the
prostate cancer tumor growth
rate and slows the rate
at which the PSA is rising
in these men.
Finally, why is participation
in clinical trials so important?
Again, we've already talked
about -- we have a desire
to improve cancer prevention,
diagnosis and treatment
for all populations,
and ensure that the results
of these clinical trials are
applicable to all patients,
especially those
that are disproportionately
affected by the cancer.
We also want to try and identify
through clinical trials
which cancer treatments may work
best for different
subpopulations of patients based
on tumor characteristics,
also known as molecular markers,
and also to avoid treatments
that are unlikely to work
for certain cancers
and certain populations
of patients.
There are a lot of barriers
to participation, particularly
for African Americans
and other ethnic minorities
in clinical trials.
These barriers include
structural barriers,
that instances
of that are health insurance,
or other financial support,
geographic distances
that patients have to travel
to actually go
to a cancer treatment facility
to access even cancer care
or clinical trials,
access to transportation,
general lack
of community awareness
of clinical trials
and potential benefits
of participation.
There are also
physician barriers.
There are sometimes different
recommendations
from healthcare providers
for patients of different races
and ethnicities,
or socioeconomic status even
when the stage
of cancer disease is the same.
We also know
that sometimes healthcare
providers have different
perceptions
of a patient's willingness
or ability to be able to comply
with treatment recommendations
or participation
in clinical trials.
Oftentimes, physicians fail
to even mention
or discuss clinical trials
as a treatment option
with their patients.
And, there are also other
personal preferences and biases
that physicians
and healthcare providers may
have about clinical trials.
In addition,
patients experience barriers
based on decisions
that they have to consider
as well as cultural barriers.
Sometimes there's often distrust
of conventional medical care
and specifically research.
This is a major issue
for African-American
populations, who,
in the United States,
have experienced past research
[inaudible] that has made
in general the community
mistrustful of participating
in clinical research.
There is sometimes inability
to navigate the medical system.
Other populations experience
language barriers,
as well as barriers related
to differing cultural
perspectives on health,
and how best to achieve
and maintain health.
Oftentimes,
there is often fatalism among
different populations.
And sometimes it simply boils
down to the lack
of having a trusted healthcare
provider in which patients can
really vent their decisions
about whether or not
to participate
in a clinical trial.
Fortunately, there are a lot
of information resources on how
to find clinical trials.
They include the National
Cancer Institute.
There is a 1-800
for cancer telephone line
that can be called,
as well as websites
that people can access,
as well as exchange email
and chat live.
And the NIH also has a very
informative website called NIH
Clinical Research Trials and You
that provides a host
of other web links
to very informative documents.
>> James Alexander:
Thank you so much
for that great presentation,
Dr. Wood.
I really have
to [inaudible] today,
especially as you explain how we
can identify
and understand the barriers
to clinical research
participation about minorities,
and especially
in this case African Americans.
So, thank you very much.
And now, we'll move
on to Dr. Grace X. Ma, PhD.
Dr. Ma is a nationally
and internationally renowned
behavioral health scientist.
She focuses on research --
her research
on community-based participatory
interventions, early detection,
chronic illnesses,
smoking cessation,
access and quality of healthcare
in underserved
and in high-risk
Asian Americans.
Dr. Ma founded Temple University
Center for Asian Health
which is dedicated
to reducing health disparities
among Asians in the US
and Asian countries.
She is a professor
of public health and a director
at the Center for Asian Health
at Temple University's College
of Health Professions
and Social Work.
Dr. Ma, thank you welcome.
>> Grace Ma, PhD:
Thank you, James.
Okay, yeah.
Okay. Thank you, James.
Good afternoon.
I would like to thank NCI
for inviting me
to address the topic
on cancer clinical trials
in Asian-American communities.
This is such an important issue.
I would like to approach this
topic from a
multilevel perspective.
Most people understand the
meaning and the benefits
of clinical trials.
Volunteerism
in the US is a common behavior
and it's taught at a young age.
In times of crisis,
people are known
to risk their lives
to save others.
But, volunteering
for clinical trials
is different.
This kind of volunteerism is
at variance with our perception
of behavior for the common good.
So, what are the clinical
trials, and why we conduct
cancer clinical trials,
and why they're important
for Asian Americans.
And as Dr. Wood already
explained it,
clinical trials are studies
to find better ways to prevent,
detect, and treat cancer,
and also help doctors find
better ways
to improve cancer care among
different populations.
And clinical trials oftentimes
compare standard care
to a standard care plus new
approaches to care,
specifically,
that might be effective
to certain cancer conditions
in certain age groups,
or ethnic populations.
And why is it important
to conduct clinical trials?
Because we all benefit
from more effective cancer
prevention, early detection,
and treatment options.
And, for example,
we have all benefited
from the clinical trials,
the breast cancer screening
and in the early days
in the 1970s.
We do not have regular routine
testing for breast cancer.
They're very limited
treatment options.
However, today,
we have regular mammography.
You could detect breast cancer
at an early stage.
There are also variety
of treatment options.
So, these are all the
contributions
of the clinical trials.
And why is it important
for Asian Americans
to participate
in cancer clinical trials?
Asian Americans is a very
diverse population originating
more than 50 different countries
and speaking more
than 100 languages.
And the dominant research
literature tends
to aggregate these groups
as Asians.
So, the major problem is
that most of the data available
is reported as Asian as a whole
and the needs
and the health conditions
of many Asians,
some populations are overlooked
because of the use
of aggregated total Asian data.
And the other reason why we
study Asian-American populations
and why it's important
for Asian Americans
to be participating
in clinical trials.
Because Asian Americans is one
of the fastest growing
populations in the United States
and this population grows faster
than any other racial ethnic
groups in the US
over the past decade.
By 2050, US will be home
to 34 million Asian Americans.
And also, other reasons
for why it is important
to have Asian Americans
participating
in clinical trials --
because Asian Americans
experiencing some unusual
and unique cancer disparities.
For example,
Asian Americans experiencing
high prevalence
in the incidence rate
of hepatitis B infection ranges
from 6 to 15%
versus 3% among the
mainstream population.
So, as a result,
Asian Americans have the highest
incidence in the mortality rate
of hepatitis B-related
liver cancer.
And, also, Asian Americans
experiencing high incidence,
and prevalence,
and mortality rates
of stomach cancer.
For example,
Korean men experiencing the
highest rate
of stomach cancer among all
racial ethnic groups,
and it's five times higher
than white males.
We also observed similar high
incidence rates
of cervical cancer among
different Asian women.
And this chart indicates
that breast cancer incidence
rates among Asian subgroups
such as Korean, Filipino,
Chinese, and Japanese have
increased substantially compared
to non-Hispanic white,
Black and Hispanic populations.
And the incidence rates
of non-Asians either declined
or remained steady.
And experiencing
with these unusual cancer
disparities,
it is very important
for Asian Americans
to participate
in cancer clinical trials.
These trials can lead
to better prevention, detection
and treatment options.
However, in reality,
the participation rate
of ethnic minorities
in cancer clinical trial is low.
For Asian-American participation
rate, it is much lower.
As a result
of low participation,
we have observed slower progress
in prevention, detection,
and treatment for the cancers
that are prevalent
in these populations.
With underrepresentation
in cancer clinical trials,
it would be extremely
challenging
to develop personalized care
for these populations.
Regardless of racial ethnic
background, all populations
in the community should be
included in the cancer
clinical trials.
And through this
clinicaltrial.gov we have found
that -- which are supported
by NIH and other US federal
agencies, as well
as the industries.
So, about 150,000 clinical
trials were found
in this database.
There are only 239 clinical
trials that are focused
on Asian Americans.
So, this population has a low
participation
and underrepresentation,
so it is important for them
to participate in.
So, in response
to this low issue,
so our team conducted a series
of studies and to seek answers
to this question why there's a
low participation
and underrepresentation
of Asian Americans participating
in the cancer clinical trials.
So, in our early study,
we have focused
on their awareness level
in terms of clinical trials,
and we found that 78%
of the participants did not know
or have never heard
of clinical trials,
77% of them were not willing
to participate.
In our early --
in our recent studies,
we began to look at attitudes
of the Asian Americans
about clinical trials.
So, we -- the purpose
of the study is
to identify barriers,
facilitators
and the culture factors
that influence their decisions
in participating
in clinical trials,
especially among the three Asian
Americans subgroups, Chinese,
Vietnamese, and the Koreans.
So, we have focused
on four major research
questions why.
Why not participate
in cancer clinical trials?
What are the major concerns
about these trials?
What are the factors
that really determining their
decision to be or not to be
in these trials?
And what are the best approaches
to promote cancer clinical
trials among those populations?
In terms of recruitment,
we really got a mixed reaction
in terms of participating
in clinical trials,
some of them think making a
contribution
to the science would give some
hope for a better future
and this has to be related
to the disease
that they're familiar with
or they have among their family
members or the
community members.
And also, we have seen other
answers such as
if there's a little risk
involved that they would be more
willing to participate.
And if doctors recommend them
to participate,
they would probably more likely
to participate.
And so, the risk factor becomes
a bit of concern among this
population,
so this needs assessment study.
We're also identifying concerns
that are various among these
Asian populations in terms
of their low participation
which are related to mistrust
in the healthcare system;
concerns about the foreclosure,
disclosure and the privacy
and their information;
struggled with idea
of a health risk
by participating
in cancer clinical trials.
Language barrier is also one
of the major factors;
lack of support
from family members,
communities, or resources;
culture and social barriers
in terms of the perception
and the means in participating
in is not necessary and the lack
of knowledge
of cancer clinical trial is also
a major barrier.
I wanted to share quickly a
personal story.
A few years ago we identified a
couple of trials that focused
on the disease that are relevant
to Asian-American populations.
So, we reviewed the criteria
and recruited some participants
who were interested in one
of the trials.
Then we approached the study
site, the response was negative.
The reasons for refusing
to take our Asian patients is
that they do not have the
instruments or consent forms
in Asian languages.
Even I offered to help
with the translation
or the adaption of the protocols
of these materials,
the response is, "No, thank you.
We already have
enough improvement.
It is just too complicated
to include your
Asian participants."
So, this incident was really a
wakeup call for me and the --
for my colleagues,
and so we having really tried
different ways to respond
to this barrier.
So, we're trying
to use multilevel approaches
and emphasize the importance
of clinical trial
in this population,
especially education among all
levels, not only the
participants
but also the community leaders,
healthcare providers
and the health system,
promoting altruism
and also promoting
recommendations
from trusted individuals
such as physicians, relatives,
friends and the
community leaders.
And I emphasized the benefits
and the incentives
for participating
in the cancer clinical trials.
We're also trying
to encourage people
to be the advocate
for participation
in clinical trial
and to create environment
of [inaudible] for people
to be more accessible
to these studies
and as clinical trials
that are available
in the mainstream.
The other area we're trying
to improve is language access,
and we're trying
to make sure different studies
have translated the consent
forms, the consent forms should
have been a simple language
and a much shorter form
and interpreter services
in person or by phone should
be available.
So, these are the areas
that we have been working
on over the past years.
So, I would
like to briefly introduce how we
have handled this
and what program
that we have been trying
to implement at the Center
for Asian Health in terms
of clinical trial education.
Before I move into this program,
I would like to quickly give a
brief overview of the Center
for Asian Health
which was established in 2000,
and the major focus
of the center is
to review cancer
and the health disparities among
the ethnic minorities
and Asian populations.
So, the goal of this center is
to build healthy Asian
communities
and through various
interventions, so we --
our goal is
to targeting the underserved
Chinese, Vietnamese, Cambodian,
South Asians, Filipino,
and the underserved
Asian population.
So, our geographic area,
primarily, is
in the East Coast --
Virginia, Maryland, DC,
Delaware, Pennsylvania,
New Jersey and New York City,
with headquarters
in Philadelphia
and with a branch office
in New York City.
So, in response
to the health disparity --
cancer disparity needs
in the Asian communities,
over the past 14 years,
the center has developed several
major domains in terms
of intervention
on cancer chronic disease,
tobacco, and translation
of health especially related
to clinical trial education.
That's the area I'm going
to focus on the next slides.
So, we have used multilevel
approach to educate
at a different settings
to promote clinical trial
participation among the
Asian-American populations.
First, we have used the TOT
training model
which is the training
of the trainers.
So, in collaboration
with the ENACCT
and the Asian community leaders,
we developed a culturally
tailored cancer clinical trial
education curriculum
for Asian community lay people.
So we trend community leaders
as clinical trial educators
and navigators.
Then, they provide education
to community members
at the large scale.
So, this program has become very
successful and we have a
publication coming out to look
at the impact and outcome
of this intervention.
The other programs
that we created is focused
on clinical trial education
for physicians.
So, we developed an online
clinical trial course tailored
for physicians
who see a large number
of Asian patients
and they encourage them
to make recommendations
for Asian patients
to participate
in cancer clinical trials.
Then, when they finish the
program, they receive the CME
credits from Temple University
Medical School.
So, this program,
we're also follow
up to see the impact,
to see if they have been
improved their recommendations
in their daily practice.
And we are also trying
to provide large scale media
campaign and dissemination
at the multi-levels,
especially at the two levels;
one is to promote local ethnic
media venues, newspapers,
magazines and other local social
media; and the second is
to disseminate this cancer
clinical trial
through scientific community
of peer reviewed refereed
journals, as well
as professional conferences.
So, by ending this presentation,
I would like to acknowledge the
support of NCI,
the collaboration for --
from ENACCT,
Asian Community Health
Coalition, and the Asian
Physician Network.
Thank you.
>> James: Dr. Ma,
thank you so much
for that wonderful presentation
and especially
for establishing the connection
between personalized medicine
and [inaudible] participation
in cancer clinical trials.
And as you pointed out,
that's very important
to the Asian-American community
which has very low participation
rates, so thank you again.
And now, we're moving
on to our next presenter,
Dr. Amelie G. Ramirez, PhD.
She's an internationally
recognized expert
in Latino health disparities
research and health promotion.
She's made tremendous strides
to reduce cancer
and chronic diseases,
to increase screening rates
and clinical trial approval,
as well as improve healthy
lifestyles among Latinos.
Dr. Ramirez directs both Redes
En Accion and its headquarters
at the Institute
for Health Promotion Research,
and the UT Health Science Center
at San Antonio.
Dr. Ramirez was elected
to the Institute of Medicine
of the National Academies
in 2007.
Dr. Ramirez, thank you.
>> I don't know.
>> [Inaudible].
>> She's talking
but I don't hear her.
>> James Alexander: [Inaudible].
>> Amelie G. Ramirez,
PhD: I'm sorry.
Can you hear me now?
>> Yes.
>> James Alexander: Yes.
>> Amelie G. Ramirez,
PhD: Oh, okay.
I just wanted to thank James
and the NCI
and my former panel members
for being on --
giving me the opportunity to be
on this webinar.
And I'm really excited
to be here with all of you.
I wanted to share a little bit
about, you know, Hispanics,
first of all in terms
of the different --
types of groups of Latinos
that we have here
in the United States,
even though we may share a
common language, there's a lot
of variability
within our population group.
Mexican Americans has the
largest ethnic group
within the Hispanic population
followed by Puerto Ricans
and Cubans, but we have Central
and South Americans and each
of these population groups are
from different regions
and bring different cultural --
you know, uniqueness
to our community here
in the United States.
And Hispanics now are the
largest minority
in the United States.
And I'm based here
in San Antonio
where we've been told
that San Antonio is what Texas
is going to be like in 10 years
and what the United States is
going to be
like in the next 20 years.
So, the growth
of the Latino community is
becoming very, very important,
yet we continue
to be underrepresented
in a large number of studies.
And such studies
as clinical trials,
it's really important for us
to make sure
that our populations are
representative
so as new opportunities
for new drug developments
and so forth that we make sure
that they are acceptable
within our population.
For example, right now,
we have -- in our children,
we have high rates of leukemias
and current traditional methods
for treating leukemia
in our Hispanic
or Latino children are not
as effective,
so that means we need new drugs
to get our population treated
and get them to live longer,
because this is one of the areas
where we've made a lot
of progress in treating leukemia
in children, but not necessarily
with the Hispanic population.
So with that, I'd like to kind
of start my presentation
and share a few demographics
with you.
As I mentioned earlier,
that 16% of the US population
is Hispanic.
It is the largest minority
population today,
and cancer impacts Hispanics
by 21% and 15% of our kids,
and just recently,
cancer became the leading cause
of death among our
Hispanic populations.
And similar to some
of our Asian colleagues,
we have higher rates
of cervical cancer, gastric,
liver, and gallbladder cancers,
as well.
And, again,
very few Latinos participate
in clinical trials.
The best we know is that less
than 5% actually participate
in current clinical trials.
So, why do we think there are
so few Latinos participating
in clinical trials?
We [inaudible] some research
particularly looking
at early phase clinical trials,
and some of those things
that Lauren
and Grace have mentioned already
also came out in our own
research and that there's two
levels of barriers --
barriers from a physician
standpoint and barriers
from the patient standpoint.
Our patient -- Latino patients,
some of them prefer
to see a doctor who is
of Latino descent
yet we have very few Latino
physicians in the United States
and even fewer
who are oncologists
and who are familiar
with clinical trials.
So, that's a major barrier
overall, but to those physicians
that we did talk to, you know,
they say that,
particularly our community
physicians and oncology
physicians that it takes a lot
of extra time and work
to be able to provide a trial
out in the community,
that the protocols are very
detailed, and so sometimes it's
difficult for them to apply them
in a community setting and that
from a personnel perspective,
it's really hard
to sometimes explain
these trials.
And that they worry
about losing the control
and the care of their patients
when they enroll in the trial.
So -- but we all know
that when you come
to a cancer center that's been
designated by NCI,
you're more than likely
to get some
of the highest treatments
and the best treatments
available so that we really try
to encourage our communities
to look for NCI-designated
cancer centers,
and to ask about
clinical trials.
From a patient perspective,
some of the barriers
that we found is that,
they truly have a lack
of knowledge.
When we first started some
of our work, a trial --
the word "trial" have been --
was more of a legal term,
you know, versus a study trial.
And so we used the word clinical
studies when we tried
to explain clinical trials.
And, again, the cultural,
the literacy issue making sure
that our messages are available
in Spanish are
extremely important.
And most of them said, you know,
the doctor never told them
about it or discussed
that they had this
particular option.
And then, other things came
into play, so sometimes clinical
trials are not available
in their local communities.
If they qualify, they would have
to travel, so there was cost
involved and sometimes their
insurance would not cover these
particular trials.
So, those are some
of the patient barriers
that we found.
And then, some of the things
that we talked
about from an enabling
standpoint though that they felt
that if they trusted the doctor
and the doctor recommended a
trial and that the trial was
near them, they would be more
than likely to participate.
They felt that joining the trial
gave them hope and that hope,
you know, helping the
future generations.
And having clear information
in the steps were very
important, and also getting
encouragement
from their family was something
that was critical to them.
They felt it had to be a kind
of a family decision
versus the patient-only decision
in terms of moving forward
with their trials.
But overall, we still see a lack
of information regarding
effective strategies
to recruit minorities
into clinical trials
and even more specifically,
the Latino community.
So, I'd like to share
with you some examples and some
of the work that we've done here
in San Antonio
and to help improve the clinical
trial approval.
One of the first studies
and we partnered
with the National Cancer
Institute on this
and their cancer information
service was
to develop some public service
announcements that were both
in English and Spanish
and we did a lot
of focus group research
to make sure
that our messages were targeting
the needs of our community,
and we share these
across seven television
and radio stations
across the United States.
And even today,
we sometimes see them airing
which is to our surprise, but,
again, we promoted the 1-800
number where they could
information and we got hundreds
of calls that came
from about 30 different states,
you know, requesting information
about trial, and screening,
and preventative information.
These public service
announcements that delved
with the topics of faith,
you know -- that faith --
and it was important
to take care of your body
and if there was an opportunity
to fight cancer
that you should fight it.
So, we had one again
from the faith base perspective.
We had another one
that was a boxer that resonated
with Hispanic males
that if they had prostate cancer
that, you know --
that they should ask
about a clinical trial
that they were in it
for the fight of their life.
So, it's very appealing.
We had another one that was
on a wedding where a daughter --
a father said, "I'm not ready
to give my daughter up.
She's enrolled
in a breast cancer clinical
trial," trying to get some
of the younger Hispanic women
that are impacted
by the triple negative
breast cancer.
So, this was one way,
but one of the things
that we found
in this particular study
that it is hard to get this type
of message out to a general
Hispanic audience.
Most people are only going
to listen if they've had cancer
in the family
or if they themselves
have cancer.
So, your audience becomes a
little bit more narrow.
So, how to focus
and target our messages,
I think, still requires
more research.
Another study was --
okay, so we have a
cancer registry.
How can we get people to enroll
in a cancer registry
so that we know they're there
in case something comes up
and we can contact them
for later, you know,
participation?
So, we did a randomized control
trial in which we had
three conditions.
One was the normal letter
that a physician reaches
out to you and tells you
"I've got a trial
that I think you might be
interested in.
Come in to the office and see
if you qualify."
So, the other one was we tried,
the second condition was the
letter plus the bilingual
brochure that actually describes
what were clinical trials,
what were the benefits
of clinical trials,
what kinds of questions you
should ask your provider
about clinical trials.
And then the third was the
letter, the bilingual brochure,
but actually having someone
follow up to see
if you would be interested
in enrolling for the registry.
And the end result was
that the third condition is the
one that had the highest yield
that people actually signing
up that having the ability
to talk to someone
in person really made a
difference and helped them
understand a little bit more
about the importance
of being part of a registry
that could connect with them
in the future
if the files were available
to them.
And then another study was we
actually conducted this
in South Texas
in the Lower Rio Grande Valley
to try to make sure
that we were getting a 100%
participation of our children
in clinical trials.
And so, what we did is we
actually placed a clinic patient
navigator in the clinic system
and she worked hand in hand
with the nurse
and with the physician
to make sure
that the parents knew
about the trials,
if they were interested
that they were consented
that they got the appropriate
information for the trials
that they were able
to call the parents
up to remind them
when they needed to come in,
you know, to get
their treatments.
So a lot of money is spent,
the treatments are delivered.
But oftentimes the patients
wouldn't come
in to get the treatment,
and so we wanted to make sure
that all of this was done
in a timely fashion.
And as you can see
over the years,
our total enrollment increased
in some 38 to 118
and we were told by the Office
of Clinical Trials there at NCI
that we had one
of the highest rates of accrual
for children
on these particular trials.
So, definitely,
that interpersonal relationship,
the individual,
the patient navigator was
bilingual, you know.
She knew how
to connect the patient
with different resources
that if they didn't have
transportation, you know,
she assisted them
in getting them there
when the treatment, you know --
medications became available
and those kinds of things
and became another support
person for the family.
Because you can only imagine
having a child with cancer
and doing all that you can
to make sure the things turned
out all right.
And then, we also right now
under -- through the support
of Susan G. Komen for the Cure,
we have a multimedia program
that is going on in
which we've developed culturally
tailored messages with regards
to clinical trials.
We -- randomizing
of the three conditions.
Again, we have a control
and then they're randomized
by their stage
of knowledge whether they've
never heard
about a clinical trial;
they've heard about a trial
but have never participated
in a trial; and then, thirdly,
they know about the trial,
they -- and they want more
information and are interested
in participating.
And so, they actually see this
computer-based module
that we have developed.
When they answer a few
questions, they're --
it determines what they level
they're in, they get randomized
for that condition,
and then they go
through a series
of role model scenarios
to help them understand what are
clinical trials,
what is randomization, you know,
what kinds of questions they
should ask their physicians.
And, it's called choices
and they also take home a
brochure with the questions
that they want to ask the doctor
to see if they qualify.
The individuals that we get
for this trial are individuals
with breast cancer and we find
out from the doctor
if they're going
to be offered a trial or not,
but the patient does not know
that at that time.
And so we're able
to randomize them
into these two conditions,
the control
and the intervention condition,
and we're trying to see
if by giving them this
information earlier,
are we reducing some of the fear
that the patient may have.
Are they better able
to make a more informed decision
about participating in the trial
when they come to the doctor,
for their second visit,
where they're being told what
type of cancer they have
and that they may qualify
for a particular trial.
So, as I mentioned,
that study is still ongoing
and we hope to complete it
within this coming year.
So, what can we do with regards
to helping people
understand trials?
We have found
that the social role modeling
based on the social cognitive
theory has been really important
and that we take care of a lot
of the cultural sensitivity,
the cultural appropriateness
when we have an individual
from the Latino community
actually expressing what their
needs are.
This is one situation
where a grandfather says,
"My father and brother had
cancer, so I wanted
to do everything possible
to stay healthy.
When my doctor told me that I'm
at risk for cancer,
I participated
in a clinical trial
to set a good example
for my grandchildren."
So, again, you know,
it's not necessarily doing it
for themselves
but helping the future
generation that's important.
And, you've already heard
of some wonderful resources
that are available
through the National Cancer
Institute with learning more
about how to participate
in the clinical trial.
But, you know,
if you want to use the web
and go and find those resources,
you can find it at nci.gov
and look under Clinical Trials.
You can find
out about what's going
on in your own community,
if you're near a cancer center
and find out what trials those
are, speak to one
of the nurse clinical
coordinators and see
if you might be eligible
for a trial, also,
an opportunity to discuss ahead
of time what are some
of the risks and benefits
and if it's --
a trial is right for you.
And most of all,
they have information to discuss
with your family,
because as I said
in our Latino community,
they really feel it's a family
decision whether they're going
to be, you know --
if they should join a trial
or not.
And, most of all,
understanding the informed
consent, and all the requests
that are needed.
Oftentimes, Latinos are left
out of clinical trials
because physicians feel, "Oh,
they won't come.
They won't show
up for their appointment.
There's too many issues."
And part of it is that,
if their insurance does cover
it, some of our patients go in
and out of coverage
for health insurance.
So, they do need a little bit
more support in making sure
that they stay enrolled
in the trial and making sure
that they complete the trial.
And, the other thing
that we're finding and working
with the Center
to Reduce Cancer Health
Disparities there at NCI,
is that we need to be more
from the area
of biospecimen recruitment.
Again, our community does not
give necessarily biospecimens,
so we're trying
to educate what is biospecimen.
It's not just always blood,
but you can, you know,
donate strands of your hair, or,
you know, your little scrapes
from your skin, saliva,
urine and that, you know,
donating is entirely voluntary,
but that, you know,
establishing these databanks
are critical.
And, again,
we have a tremendous
underrepresentation
of the Latino community
in these particular databanks.
So, with that, again,
I'm extremely thankful
to the National
Cancer Institute.
They have some,
just tremendous amount
of valuable resources
with regards to clinical trials
that we can access,
but also wanted
to promote our cancer centers.
If listeners are
from South Texas that we here
at the Cancer Therapy
and Research Center would be
glad to help you.
And we're also very grateful
to the support from our grants
that have allowed this type
of work to continue
from the National Cancer
Institute and the Susan G. Komen
for the Cure.
So, thank you all very much
and I'll be glad
to take any questions.
>> James Alexander:
Thank you so much,
Dr. Ramirez
for a great presentation,
and especially
for enlightening us
on the communication aspect
of clinical trials research
and participation, which,
as we all know,
is especially important
to minority populations
and also especially
to the Latino population.
But, we want to thank all of you
for three really great
presentations, Dr. Wood,
Dr. Ma and Dr. Ramirez.
And now we thought what we would
do is that we would take a few
minutes here at the end
of the webinar
to just ask a couple
of follow-up questions
that will help all
of us understand this issue a
little bit better.
So, we'll just throw
out a couple of questions
and then just feel free
to answer here for us
as we close out.
Number one,
we thought we would --
that there would be some
interest in this question.
I wonder if you guys could --
if you folks could expand upon
or highlight what is culturally
unique about each
of the populations we heard
about today when it comes
to clinical trials
and clinical
research participation.
>> Amelie G. Ramirez, PhD: Well,
this Amelie.
I just want to emphasize that,
again, the Hispanic community is
kind of like a mosaic
of cultures that, you know --
that we represent different
population groups, ethnicity,
culture, and origin
and that it's important
to provide the information
in a language that is understood
by our population there is,
even though we all use different
types of words,
there's the ability to have kind
of a -- I don't want
to call it this,
but I'll use the word
"generic Spanish"
that it can be --
they call it
"broadcast Spanish," that,
you know, it's a message
that can get
across to different audiences,
but that's really important.
And most of all
that what's unique
with our population,
we need to be very respectful
about the values
that our community holds very
close to themselves in terms
of their families
that they value interpersonal
relationships, so this,
you know, one-on-one
communication is extremely
important and that the providers
and healthcare takers are
very respectful.
Their communications,
we all know
that cancer is feared greatly
in our community,
so being sensitive to that fact
and not just treating it
as a regular disease,
but a disease
that requires a lot of support
from the community
and from the providers.
And most of all,
where their religion
or spirituality enters
into the decision
that they want to make.
>> Grace Ma, PhD: Well,
likewise -- this is Grace.
As I indicated
in my presentation,
Asian Americans confronting some
unusual and the unique
of cancer disparities,
and they're the least likely
to participate
in cancer clinical trials
because of a range of barriers
and challenges.
So, I think it is very important
to deal with these issues
from multilevel approaches
to overcome the barriers
at the individual level,
and use the value
of the community
and the diverse culture
to educate the community members
at the individual level,
as well as the community
and the social society level.
And most importantly,
we need to work
with community --
I mean, healthcare providers
and the health system
to overcome the systematic
and also structural barriers.
>> Lauren Wood, MD:
This is Lauren.
I would like to echo
that there are themes raised
by both Grace and Amelie
that also apply
to African Americans.
I think among all populations,
there is a common need
to have providers
that are respectful
and have a level
of cultural competency
in dealing with different racial
and ethnic minority populations.
All patients desire
to have providers
that are respectful to them
of their belief,
of their personal needs,
of their healthcare needs,
and are able to communicate
with them effectively regarding
the treatment decisions
that they may be facing.
Cancer strikes fear
in the hearts
of everyone no matter what their
race or ethnicity,
and being sensitive to be able
to effectively communicate
about those issues is critically
as important
as has been highlighted both --
by both Dr. Ma and Dr. Ramirez.
One of the things
that I think is additionally
important for African Americans
is is that this level
of trust regarding information
that is provided
from healthcare providers
about clinical trials has
to be addressed with a level
of contextual sensitivity
to the issue
that in the past there have been
historical research abuses.
Studies have clearly shown
though that when individuals
have had the time
where providers have taken the
time to explain the nature
of the clinical trial,
offer clinical trials,
explain what the studies involve
that people are potentially very
receptive to participating
in clinical trials
when they are offered.
>> James Alexander:
Thank you so much.
We really have learned a lot
today and I thought there was
one other thing
that we might want to throw
out to you and then we'll close.
I wonder if there --
we wonder if there's any
difference in the way
that minority populations
or underserved populations view,
cancer clinical research
as opposed to clinical research
[inaudible] diseases?
>> Lauren Wood, MD:
This is Lauren.
I'll weigh in there.
I think that this would be
actually a fascinating area
of research [laughter]
because I think
that there's very little
out there.
For those of us
who do clinical research,
we tend to be in silos
of research related
to our respective diseases.
We are all struggling
with the issue no matter what
the nature of our clinical trial
and what the disease
that we are attempting
to prevent, diagnose, or treat,
deal with --
deal and struggle with the issue
of underrepresentation
in clinical trials.
But, I'm not really aware
of research out there
that has looked among
populations to really look
at approaches as to whether
or not trials
for different diseases are
viewed differently
by different populations,
or even if you categorize trials
as being minimally invasive,
or therapeutic,
or just diagnostic, whether
or not there are differences
in how these clinical trials
might be viewed
by different communities.
And it would be important area
to move forward it in terms
of research.
>> Grace Ma, PhD:
I agree with Dr.
Wood's perspective.
For Asian Americans,
if they're familiar
with the diseases
and especially,
they have someone
in their family
or communities has the cancer
or a specific disease,
they would be very interested
in learning more about it
or more participating.
So, I think this area needs
further investigation.
>> Amelie G. Ramirez, PhD: Yeah.
And this is Amelie,
and I'm also supportive
of the two previous comments
and -- but I would think
within the Latino community,
they appear very late
for a diagnosis
so that we really need to talk
about prevention
and this is diagnosis
for any type
of disease whether it's
cardiovascular disease
or cancer.
But cancer definitely is the
most feared disease of all
in our community,
and so we really need to focus
on them by coming
in for screening
and still our most preventative
technique that we have,
you know, and if we could get
them in early that, you know,
doctors are still telling me,
you know, they're diagnosing
stage four breast cancer,
colon cancer, and so forth,
because they --
you know, they wait
and then they go
to the emergency room.
But, it's beyond the opportunity
to help in terms of some
of the current treatments
that we have.
So, anything that we can do
to really reach out to them
and educate them
on the subject matter
is critical.
>> James Alexander: Well, okay.
Thank you all again
so very much.
This has been very informative,
very educational,
and we look forward to talking
to you again about this subject.
Thank you very much
from the Office
of Communications and Education
at the National
Cancer Institute.
>> Grace Ma, PhD: Thank you.
>> Amelie G. Ramirez, PhD:
Thank you so much.