Community
Health Workers and Cancer Clinical Trials:
Experiences, Knowledge and Concerns
A report by
Russell K. Schutt, Ph.D.
&
Jessica Santiccioli,
Jennifer Maniates1, M.A.,
Silas Henlon
&
Lidia Schapira, M.D.
Research funded by National Cancer Institute grant to JudyAnn Bigby1, MD (Massachusetts Secretary of Health and Human Services, formerly Brigham & Women’s Hospital and Harvard Medical School), Lidia Schapira, MD, Russell K. Schutt, Ph.D, as part of U56 project, University of Massachusetts Boston and Dana-Farber/Harvard Cancer Center.
Executive Summary
· Members of some racial and ethnic minority groups increasingly are underrepresented as participants in clinical trials concerning some types of cancer.
· Community health workers are key participants in the health care system who can help to understand and address disparities in clinical trial participation.
· Information was collected from Boston-area community health workers using focus groups (N=15), intensive interviews (N=11) and a structured survey (N=76).
· Survey respondents were ethnically diverse, mostly female, one-fifth spoke Spanish as their primary language, and half had completed college.
·
Survey respondents rated the quality of health
care in the
· Interview respondents remarked that they had an important role to play in reducing health disparities and also noted behaviors and orientations of community members that undermined their health care.
· Survey respondents were very aware of the importance of cancer research, but had less favorable attitudes toward medical researchers than toward health care providers. Some were skeptical about medical research and distrusted medical researchers; some believed that researchers were not interested in community needs.
· Interview respondents perceived little interest in health care research in their communities and many were very interested in increasing that level of interest. Potential barriers to community members’ research participation that were perceived as “very important” by all or almost all interview respondents included inadequate transportation, lack of understanding and fear of research, lack of trust of researchers, limited English language ability and immigration issues.
·
Most interview respondents were aware of the
· Most community health workers felt that their level of understanding of cancer clinical trials was inadequate and that access to cancer clinical trials in their communities was even less adequate. There were many incorrect answers in the survey on a quiz about clinical trials. Most respondents were generally aware that clinical trials test a new treatment and that the informed consent process is supposed to protect human subjects.
Table of Contents
The
Importance of Community Health Work
The
History of Medical Research
Knowledge
about Medical Research
Knowledge
about Informed Consent
Introduction
Disparities in cancer between
subpopulations in the
Participation of minority populations in cancer clinical
trials tends to be less common than participation of whites--although this
difference varies with type of cancer---and the overall trend for black
enrollment declined between 1996-1998 and 2000-2002 (Murthy 2004). Community health workers (CHWs) can play an
important role in reversing this decline:
As increasingly important members of the health care delivery sytem, CHWs
(also called outreach workers, patient navigators, health educators, lay case
managers, health ambassadors) connect the formal health care system to
underserved communities by providing critical health care information and
resources. This report summarizes the
results of research to investigate community health workers’ knowledge of,
experience with, and attitudes toward cancer clinical trials and other types of
health-related research.
Methodology
We
collected information from community health workers in the
We recruited participants
for our focus groups and interviews through outreach efforts to programs
that employ CHWs throughout the greater
We interviewed eleven
community health workers (CHWs). All
participants were female. All spoke
English, but Spanish was the primary language of five and Polish, of one. Two interviewees had earned Master’s degrees,
three had a Bachelor’s degree and one an Associate’s degree; the rest were high
school graduates—most with additional training related to health care. About equal numbers of respondents were in
their 30s, 40s and 50s. Five interviewees
identified as
We
administered our survey in collaboration with the Community Health Education
Center (CHEC), a training organization funded by the City of
All
procedures were reviewed and approved by the Institutional Review Boards at the
Dana Farber/Harvard Cancer Center and the
Our
primary findings are presented in four sections: the importance of community health work,
attitudes about current medical research, concerns about the history of medical
research, knowledge about medical research and suggestions for training. Survey results are used to provide an
overview of many attitudes; details are added with quotes from the interviews
and focus groups.
The Importance of Community Health Work
The eleven community health workers who participated in interviews worked with diverse populations. Their clients were primarily black and Hispanic, but usually included some who were white and Asian. Six of the 11 had many clients who did not speak English. Many of their clients were elderly and most were poor, as reflected in participation in MassHealth. The interviewees were devoted to their clients:
I love my job, … it's personal.
This is something that I would like to stop, the breast cancer. I would really, really like to see that one
day we can stop it. And so I'm very
passionate, and when I talk to a client, I'm like trying to put my mind in
their minds, in making sure that they understand that this is something that we
can prevent.
Educating community members about health and health care was a key commitment:
I'm sort of out there, trying to make sure that other people know
more.
Many families have not even finished sixth grade, so even health itself
is something that they don’t know too much about.
…there are a lot of people, just the basics, they don’t know. …there were only two out of 28 women doing
breast self exams. That is
ridiculous. And just simple things. You know, people don’t understand that they
are poisoning their body by smoking cigarettes.
I mean, come on?
Survey
respondents perceived considerable disparities in the quality of health care in
the
Figure 1
Some community health workers also focused attention on their role in improving communication with their communities.
I think it relates a lot to knowing the culture, coming from the
culture, and the community having this certain expectation from you that you
will not cross over cultural boundaries like someone who’s not part of that
culture.
Most of [our clients] don’t speak English…sometimes they come to us and
explain what they wanted or what they needed…
Other community health workers made it clear that they view the behaviors and orientations of health care recipients as contributing to inequities in health care.
It's just...let's say for some populations they don't go to get
preventive care at all until they feel sick and...so we know the answer, you
know, it's just trying to educate them so they can go for the preventive care.
[Clients] don’t even like to take the medicine when they have a
problem.
I mean, I know some of the reasons for [disparities in health] but
-- public health benefits get taken
away from the immigrants who are legally here.
There's one reason. Then you have
to access services or -- just don't access services because they can't afford
to pay for it. There are some institutions
that can't work with them financially or aren't willing.
Current Medical Research
Survey respondents were very aware of the importance of cancer research: all believed that cancer research is extremely or very important to finding better ways to prevent, diagnose or treat cancer and many expressed a strong interest in learning more about health care research and encouraging others to participate in cancer research (Figure 2). Specifically, between 70% and 80% rated as extremely or very important: increasing awareness about cancer clinical trials, encouraging those with a cancer diagnosis or high risk of cancer to participate in cancer clinical trials, and learning more about health care research. About 60% believed that the community can benefit form participation in cancer clinical trials and that improving awareness of health care research is very or extremely important.
Because I really believe that in research, a lot of thought is being given to the problem, to the implementation of the planning and the implementation of it, like getting funds to do it. I think that they are very serious people, who although they might be thinking about money, like for example, specifically pharmaceuticals, but I think that they want to help people. So the benefit is more for the community.
Figure 2
In spite of this recognition of the value of cancer research, community health workers who were surveyed had less favorable attitudes toward medical researchers than toward doctors and other health care providers (Figure 3). A majority of survey respondents trusted doctors and other health care providers to protect their rights and safety” at least “most of the time,” compared to just one-third who accorded at least this much trust to medical researchers or to federal laws and regulations.
Figure 3
The interviewees reported little interest in the community in health care research. Five of the eleven interview respondents had spoken to people in the community about health care research at least three times, but only one of the interviewees reported that community members were interested in participating in health care research. Some of the community health workers expressed a strong desire to improve the level of interest.
I think this is not only for one person, this is to improve. This is when they find something, to stop a
type of illness is not only going to benefit that person that is using their
bodies, it's going to benefit the whole world.
A lot of patients don't have any information at all, and there's not
enough work in terms of providing that information for them. There's a lot of education that needs to be
done in that area, because they don't understand what research is.
They need to hear more testimony of personal experience…clinical trials
are a hard sell.
The eleven community health workers who participated in interviews responded to 15 statements about health care research (Table 1). Their responses indicated that all recognized the importance of health care research but many had some level of distrust of medical researchers.
Table 1
|
Statement |
# Agree |
|
Health care research has led to many improvements in health care for some populations. |
11 |
|
There should be more health care research occurring in minority communities. |
9 |
|
Patients’ rights are protected in health care research. |
9 |
|
More research is needed to determine why some racial and ethnic groups have worse health than others. |
9 |
|
The history of health care research in minority communities is very troubling. |
8 |
|
Patients should benefit directly from participating in health care research. |
8 |
|
Patients don’t have enough information to decide if participating in a research study is right for them. |
6 |
|
Health care researchers have no connection to community health workers like me. |
5 |
|
Doctors don’t know how to talk to patients about research. |
5 |
|
It only makes sense to participate in health care research if you’re sick. |
3 |
|
Health care research benefits researchers, not the community. |
2 |
|
Health care researchers are just using our bodies. |
2 |
|
Patients enrolled in research studies receive better health care than other patients. |
1 |
|
Most health care research is not really necessary. |
1 |
|
Research funding just helps the researchers. |
0 |
Many comments in the interviews expressed the same recognition of the value of medical research that was evident in the most commonly endorsed statements in the survey.
We need to understand that the only way for us to progress into the
future is to know that what works, what doesn’t work and the only way to do
that is through clinical trials.
I believe that research always needs to be done. There’s always something cropping up and
there’s always something that has not yet been addressed.
…there’s just certain advances [in research] that have been able to be
made. AIDS or HIV, when it first came on
the scene was, for a lot of people, a death sentence. Now it’s considered a chronic disease, and
that’s because of all the research and the funding, and the new drugs that have
come out.
And they have really been making a…lot of advances with, you know,
heart disease, and just cervical cancer, breast cancer. There is…significant contribution to this
trial. This is like stem cell
research. And I think it’s exciting that
we have this available for us.
Some interview respondents also focused specifically on the importance of reducing disparities in participation in medical research in order to lessen ethnic disparities in health care.
Well I know for a fact that let’s say the breast cancer in Black women
is more aggressive and more deadly than it is in other women. So, the research that’s being done in that
area is not just benefiting the researchers.
It will benefit the community… I think research helps the community, and
it’s been more impactful in some communities than others.
It’s important to figure out the variables why, you know, one racial or
ethnic group is not as healthy as another, considering that overall, we have
the same access to health care.
… more efforts need to be put forth.
I think once you start thinking of [research] with a different
population, people can get frightened of how much work it’s going to be or how
difficult it’s going to be, and that can sometimes be discouraging and,
therefore, it doesn’t take place. So that’s
detrimental to the welfare of the diverse communities.
The majority of the studies are really based on white communities and
then there are just certain ones that – there are very few that are African
American, Latino, or Asian Specific…there’s just minimal research, and the
research that’s done is just a couple of diseases like diabetes, heart disease.
Other community health workers balanced positive feelings about medical research with a degree of skepticism.
Because I have heard
stories that point to telling me that patients’ rights are not protected. But on the other hand, I see many advances in
terms of research. So I’m kind of
divided.
For the most part I
think I have a very positive opinion about healthcare research because I think
that there’s plenty to learn and definitely we could eliminate most of this –
diseases that plague us. But on the
other hand, I am very skeptical about how researches are being done…Like what
are the intentions behind it, what are the motives behind it, who’s doing it
and what – and for what reason…I don’t think that most clinical trials are very
inclusive.
That one I’m kind of tied between.
There are some patients, like cancer patients, they go through trials
and studies and if it kind of just ends there and you leave them hanging,
that’s wrong. So, on the other hand,
just healthcare research is just taking your survey and getting some kind of –
I kind of think it depends on the situation.
Success is the advantage of clinical trials, but the disadvantage is
that people might be having shifty experimentation done on them for a research
project’s ulterior motives.
Participating in research is and isn’t safe, it depends on the
research.
Some accepted the
value of research only in certain circumstances.
Clinical trials are only worthwhile if a new medication can do things
that an old medication can’t.
Especially if you have to undergo treatment or something, you can get
sick rather than helping. So I, for
example, if I am sick, I want to help them, but if not I think it is a risk to
the person that is healthy.
They are only appropriate if something in standard care isn’t
functioning.
Expressions of distrust in medical researchers were sometimes quite blunt.
People don’t trust that researchers will be honest, or the research
isn’t being done to benefit them, it is being done to benefit the
researcher. That makes people not want
to participate.
Sometimes I feel that this research is focused on just trying to prove
something… sometimes I think that they are just using our bodies.
…the results need to come back too, and that doesn’t happen…the
deliverance system is bad, researchers don’t bother to know the areas that they
research.
…they don’t trust research, that when they get to some things, they
want to do it for the money that they are going to get from the medication, to
be lucrative for them.
Other critical comments about medical researchers focused on medical researchers’ perceived lack of concern with community needs.
Researchers don’t care about what the community needs.
Health care researchers have no connection to community health workers.
I don’t want to tell people to participate in research because I think
that the researchers are benefiting but my community isn’t.
We need to be asked what we think our communities need. It isn’t right to do research that isn’t
needed in the community.
Researchers are ignorant and they have a lot of opinions about who they
think the community is.
Interview respondents were also asked to indicate the importance of 17 possible barriers to participation by community members in health care research (Table 2). Most of these barriers were related as “very important” reasons for non-participation by at least 6 of the 11 interview respondents.
Table 2
|
Barrier |
# Very Important |
|
Inadequate transportation |
11 |
|
Don't understand research |
10 |
|
Lack of trust in researchers |
9 |
|
Limited English language ability |
9 |
|
Fear of participating in research |
9 |
|
Immigration/Visa issues |
9 |
|
Limited knowledge about health |
8 |
|
Time/scheduling constraints |
8 |
|
Objections of family, friends |
8 |
|
Believe research doesn't help |
7 |
|
Confused by consent forms |
7 |
|
People don't hear about research |
7 |
|
Bad experiences with doctors |
6 |
|
Think their information won't be kept confidential or private |
6 |
|
Doctors don't offer research to them |
6 |
|
Loss of control over their health care |
6 |
|
Expect inferior care |
5 |
|
Other |
2 |
Several comments explained why transportation presented problems for community members who might otherwise participate in medical research.
…a lot of people don’t have transportation. You make a lot of assumptions. I mean, even though I have a car and my
husband has a car and my daughter has a car, I wish they had the taxi ride
program when I was doing chemo and radiation, because it was door to door. For me, it was parking your car and walking
to the door, or parking your car and then getting on the bus. So even if you have transportation it’s still
a pain.
Transportation is a barrier, a huge barrier.
Interview and focus group respondents also explained how low levels of knowledge create a barrier to participation in research.
I don’t think they understand the process and, you know, the real
meaning. Like, let’s say the real
meaning to research… they just hear that, OK, they’re using my body, and that’s
it…
Well, I think people just don’t know enough. They don’t know enough to ask – even what
questions to ask.
…I think that’s part of the reason why minority communities…don’t
participate, because they don’t know about it.
The other part, I think, is there’s a skepticism. Some of them are skeptical, but I think most
of the time, that they don’t know about it, and I think there’s different
reasons why they don’t know about it.
It has to do with the mystification of research. I think that it’s another world, and it’s not
linked to the regular healthcare issues.
It’s like oh, that’s something on Mars, and we’re here on Earth. So a connection is not established. When you say research, I think that most
people do not link it to their health.
Like I don’t think OK, I will ask my doctor the next time, about if
there is a research on cancer.
Interviews provided additional comments to explain problems such as fear, lack of trust, and language.
Again, I think it’s because of the negative stuff that’s out there, and
people’s preconceived notions about research or what are they going to do, and
what kind of medicine am I going to be taking.
Is it going to do me any good?
You know, that kind of thing. I
think the fear factor is a big part of it.
Well people make generalizations.
They had one bad experience with a doctor or a couple of bad
experiences, so anybody working in the health field was no good.
…research is like kind of separate from itself, alien to us, the
providers, and to the clients too. At
least that’s how I perceive it.
Well the language barrier [to participation in medical research] is
only part of it because it’s lack of education…everyone’s not at that level.
Also, the language that researchers use is ignorant. Like “African American Women” – it makes people
not want to participate. I am black
Some community health workers suggested that the level of distrust could be lessened by ensuring that community members help to plan the research, receive benefits from the research, and communicate with researchers “in their own [the community members’] language.”
And after the research is completed, where do the resources go back to
from your – your findings of your research.
And, you know, you came in and we – we assisted in the studies that you
were looking for and proving the information.
But are those resources going back into that community that you just,
you know, performed a study or research assistance on?
…a lot of distrust, individuals not looking like them coming in to the
community trying to do research, the community not being involved in the
beginning processes of research, not just when you need us – our bodies to test
on. But actually being involved in
planning what that research project will look like.
The History of Medical Research
Many community
health workers identified the history of healthcare research as a barrier to
research participation by community members.
Most comments about this history referred to the infamous
…that's one of the reasons why we have just black people in general being
very wary of the government…
Just -- the population
I deal with is the African-American population or people who identify as from
African descent, and a lot of people have the
When you look at the African American and African community you have to
look at the history of – that medical providers have had with those communities
and it’s not very – it’s not positive at all.
And I think that plays a huge part in not only individuals participating
in research but individuals also getting care for anything.
Some of those who pointed to this problem also suggested that it could be lessened through community involvement.
The sharing of resources is an issue when you’re looking at research.
So I think, you know, with the African and African-American community,
recognizing that there’s a bad history between the medical providers and the
community and seeing how -- involving this community -- involving the community
can sort of lessen that.
I mean you know, people always talk about the
I don’t need to go through the documentation of it or the history of
it. But how medical so-called under the
title of research has been done in Africa, and has been done here in
I mean, I think in the Black community, people are very suspicious of
research studies. So you know, we have
to put the past behind us and sort of start fresh and really evaluate, just
like if you had a bad experience with a doctor, well that doesn’t mean that all
doctors are, you know, not qualified.
Knowledge about Medical Research
In spite of their own interest in medical research, most community health workers felt that their current level of knowledge was inadequate (Figure 4). More than half reported that they were no more than somewhat aware of medical research in their community and almost half felt that they little or no access to information about cancer clinical trials in their community (Figure 4).
Figure 4
About half of the community health workers also described their level of understanding of clinical trials as only “somewhat,” “a little” or not “at all.” (Figure 5) About one-quarter felt they understood clinical trials “very well.” (Figure 5)
Figure 5
The average score correct on a 19-item quiz about clinical trials that was included in the community health worker survey was 50%, with many receiving even lower scores (Figure 6). Only one respondent answered more than one-third of the questions correctly.
Figure 6
Answers to questions in the interviews also reflected variable levels of understanding about clinical trials. When asked to define the term “clinical trial,” most respondents knew in a general way that this involves a test of a new treatment.
Clinical trial. Well clinical
means that it's health related. It's
going to be supervised by doctors.
You're in good hands. And trial
means that it's a test. You know, I
don't think they're making any promises to you, that they can cure you. I think they can fairly well assure you that
you're not going to be any sicker than you already are, but it's a trial. It's a test to see if this particular drug or
process or procedure is going to make any difference in your case.
It means trying something that hasn't fully been -- it's testing
things, it's something that hasn't fully been approved yet maybe. They're still exploring the possibilities as
to whether or not this is going to work.
Is it going to be effective treatment?
Is this going to be effective? If
it's going to maybe eradicate whatever it is.
So it's a time of uncertainty, unknown.
Basically it’s – well for me I would say that it’s something that’s
being tried out, to see what the benefits of it would be, in working with a
particular population or with different populations.
However, many respondents also thought that clinical trials routinely involve a comparison of a new treatment with a placebo, rather than with the current standard treatment.
A trial of medication that is being tested for reliance to give it out
to the general public, and while you are on that clinical trial, you can take
placebos and hazardous to your health substances.
For example, if we worked for pharmaceuticals and it were a cancer
patient, they would get a couple of groups going, where some get a placebo,
some get the actual drugs, and they compare peoples' reactions.
For example like we do – for…breast cancer…some women might get a
placebo or a Tamoxifen to reduce their cancer reoccurrence.
Some only had a general recognition that clinical trials can help to identify new treatments:
Means, hopefully, that using this type of study, we can – we can find
cures for the diseases.
For me, it means the future, you know, better outcome in different
diseases.
You know, sometimes I think that we use our body to try something, and
sometimes that's the only way that they can find cures for cancer or any other
ailment, so I think to me, it means a lot, even though I don't like to
participate, but I understand that it's really important. So that's the only way that we can improve or
stop cancer or any other illness.
The percentage of correct answers to the true/false statements in the knowledge quiz varied markedly between questions (Table 3). Most community health workers were aware of an informed consent requirement and of the role of clinical trials in developing new treatments for cancer. However, at least one-third were unclear about the particular information included in consent statements, about the extent to which participants’ rights are protected. Depending on the specific explanation tested, between one-third and three quarters misunderstood some aspects of the logic behind random assignment to the treatment group.
Table 3
|
Question |
% Correct |
|
The
“Consent Form” must be signed before a patient can participate in a clinical
trial |
92% |
|
Those who
participate in a clinical trial are helping others with cancer |
84% |
|
People
that agree to enter clinical trials have the right to withdraw from it at any
time |
83% |
|
Participating
in a clinical trial is a way of being involved in developing new treatments
for cancer |
82% |
|
The
“Consent Form” provides the Doctor’s contact phone number if there are ever
any problems with the clinical trial |
72% |
|
A
“Consent Form” outlines the important risks and potential benefits of
entering a clinical trial |
68% |
|
The
random assignment of treatment ensures that the groups of patients involved
in a clinical trial are as similar as possible |
67% |
|
Patients
who agree to enter a clinical trial and then do not get the treatment they wanted,
can usually change it |
65% |
|
If a
clinical trial is about a very important clinical question, a doctor can
force a patient to enter the trial |
63% |
|
A person
in a clinical trial is required to complete a lot more tests or
questionnaires |
57% |
|
While in
a clinical trial, a patient will be informed of any new clinical information
that relates to his or her cancer |
57% |
|
The
treatment being tested in a clinical trial is always better |
53% |
|
Once a
person is in a clinical trial he or she cannot receive other necessary
treatments |
51% |
|
In a
randomized clinical trial the treatment you get is decided by chance |
50% |
|
People
are asked to enter clinical trials to compare the effectiveness of different
treatments, or techniques of care |
50% |
|
Patients
may be randomized into a clinical trial without knowing it |
44% |
|
Patients
get no financial compensation for entering a clinical trial |
39% |
|
You get
the best medical care when you participate in a clinical trial |
38% |
|
In a
randomized clinical trial the doctor picks the best treatment to give to the
patient |
25% |
Knowledge about Informed Consent
Explanations by interviewees about the process of eliciting informed consent revealed general awareness of the process. Some felt that this process worked well:
…research studies give enough information. They talk and talk and – what can be – what
can happen wrong, what can happen right.
I think they give enough information.
All information is given to the patient, basically looking out for the
patient themselves, and that has been very clear within many settings and
hospitals and health centers.
As a community health worker, the folks you work with, they trust
you. You know, you answer their
questions as best as possible and make sure they don’t have anything really
unanswered about the research and help put them more at ease so they could
better understand the goal and the outcome and how people could benefit.
I gave the information to the patient and just let them know that this
would be their decision but it’s something that, going forward, they could be a
part of in the future of, you know, getting better answers for the future and
new drugs.
Several interviewees felt that the lack of problems they had encountered in the consent process was due to their clients simply giving their consent to research participation on the basis of trust, rather than understanding.
They will sign anything you want… many people are not well educated so
that they can truly understand what’s going on.
They have to just trust that you have their best interests at
heart. That’s really what they’re
signing. They’re telling you that they
trust your best interests in their care.
Most of the people that I deal with, they really pretty much go on
trust. I have them sign all sorts of
forms and they could be signing their entire lives away to me (laughter) and
yet they sign them because they trust what it is...the services I’m giving them
and it’s just that trust between me and the patient and they’re trusting me and
they’re signing these forms and I know that they have no idea what they’re
signing.
Reports of problems and misunderstandings involving consent forms were more common among the community health workers who were interviewed or who participated in a focus group.
If the consent form has… too many conditions…and it has so many layers,
it may be harder for some of the
participants to understand… the legalese rather than down to earth as I say…If
they don’t understand research…they may not fully comprehend what they’re
getting themselves involved in, where it may be something that they are
interested in.
It’s a process that’s not common and definitely new to them.
…you have so many papers to sign, you don’t know what you’re signing…if
you’re only a high school graduate, if you made it to high school, I mean…you
go to the hospital and…you’re not sure what you’re signing then.
…we [CHWs] understand what informed consent is but I think the
difficulty in explaining that to the community is you’re signing a piece of
paper, you’re saying, “OK, yes,” but it’s something like – it’s the distrust of
the medical system…That’s basically what it is.
OK, I might say it’s OK to take my organs. Or I might say it’s OK for me to participate
and for you shoot me with some – shoot something in my body…But like what
really happens?...What does that really mean?
I think that’s what we’re trying to say.
I mean, informed consent is what’s on paper.
Half of informed consent people will not understand.
Respondents identified low literacy levels and language barriers that interfered with effective communication as special problems in the consent process.
It also has to be on the level of like the participants…For example, if
you’re Spanish speaking then, you know, have it in Spanish…if they’re low
literacy, then have it in low literacy.
And this has to be meeting where they’re at.
Understanding the IRB process, understanding confidentiality is very
huge…that’s sometimes confusing.
I feel comfortable if I knew, you know, as much information and I was
comfortable and had a good understanding of it and I can articulate it back to
the community that I’m serving. But if I
have questions then I would be hesitant to relay that information to the
community that [researchers] are trying to recruit…if I’m not fully
understanding what it is that you’re trying to get to the community or take
from the community then I would be hesitant to pass the information on or even
assist with a group.
I never talk to people directly [about cancer clinical trials]. But there are organizations that we partner with
that would…mail us brochures…or flyers regarding their research and they’re
even calling us, letting us know exactly what it is. And I don’t feel comfortable putting it on my
table.
I think that we – we are, you know, we would play a good role just because
we are very familiar with the community that we work with. They have trust us and we have their best
concern at heart. So as long as we are
provided with the right materials and we’re abreast of exactly what’s going on
with the trial, I think that it would be o – you know, we’d do well at
recruiting people if it’s something that we believed in.
Several respondents highlighted the additional difficulties faced by immigrants.
If people are immigrants, they’re not really 100% sure that their name
and information is not going to be shared.
And especially when you’re dealing with immigrants. Migration is something that’s very... I mean, they move – move around.
So when you want them to stick around for six months, not saying that
they’re not going to be there if they have a family but you never know, you
know, especially if they’re undocumented.
They’re just going to be skipping around and just wherever they can, you
know, go make money, so...
So there’s questions around safety like…what are you going to do with
my body. But then there’s safety –
there’s questions around safety like the sister was saying earlier around
immigration. What does that mean? Am I going to come and sit in a focus
group? OK…what’s going to happen? Like do I have to sign papers and
documentation? Do I have to go into a
facility once a month…what type of information are you going to need from me,
and then, when you get that information, where does it go?
Training
Suggestions
Community health workers who participated in interviews and focus groups were eager to increase their understanding of medical research and other health issues. This interest in further training was reflected both in their frequent participation in training, in their interest in further training, and in the many suggestions they made for improving training of community members.
All of the
interview and focus group participants had participated in a variety of
workshops and courses, from HIV prevention to basic nutrition, to navigating
the healthcare system. They had received
this training through a variety of media (Figure 7).
Figure 7
The interview respondents described a variety of locations and methods in these training experiences.
I consider myself always a learner.
So, I am constantly in workshops, training, conferences. I've taken continuing education courses at
CHEC and also UMass. I have credits, and
that's for me a value, to keep going.
Fairs. They [The
My trainings usually last a day.
Usually it's a day, a whole day, but it can last like two or three
days. My supervisor is very in tune with
that growth, professional growth.
I've had CPR training. I've had
some management training. I'm taking an
online class now, to become a certified tobacco cessation specialist.
Mass Law Institute, I think it was.
It's in downtown
Monthly, I go to the CHEC meetings, and some of the trainings that they
offer, like around substance abuse, domestic violence. The last one I went to was substance
abuse.
Respondents made suggestions for training programs that ranged from regular updates and speakers to entire courses.
Just recent updates…just to keep abreast of the recent developments in
Mass health and insurance laws.
…having somebody from outside the hospital coming in and speaking about
for example, policy. We’ve found that
that would be extremely helpful, you know, to save somebody from a lawyer
coming in and helping as far as, you know, explaining some of the legal sort of
terms, or just sort of like the legal jargon or how it applies to families and
how it affects them, and how you can help them without compromising the welfare
of the family…Or just having, for example, different services coming in that
are available, which we may not know about.
… getting more information as far as other services that are available
that we may not be aware about, sort of keeping up to date on what those might
be, so that we can serve like that bridge, to help those families learn about
what other services are out there. Free
legal aid is also something that a lot of them are very interested in. So where can you get free legal aid.
…that they would talk about more of the actual intervention that you
had yourself and, you know, you know how in some trainings they give you these
scenarios that someone had like 25 years ago that don't really match up. You know, it would have been nice if some of
the people had had their own scenarios, you know what I mean --to work out
different situations on the personalities of people that you run into.
The only thing that’s always good to have like the slides, a copy of
the slides, either in paper or, you know, or by sending it to you through the
e-mail…Because like that, you’ll always have it there and you can back as a
reference.
The only thing I would love to see is, you know, a continued refresher
course because if you don’t use it, you lose it, especially with languages.
…I’ve given them some suggestions for improvement. I think they need a glossary of terms. They’ve used a lot of terms that they just
assume people know …I think they should pare down the technology. I don’t think it has to be that
complicated. But I’ve enjoyed it. I’ve gotten a lot out of it and I’m looking
forward to it. People think I would be a
good counselor.
Respondents also identified a number of content areas that should be included in training sessions.
Clinical trial jargon…Medical jargon.
…we want to know -- how -- to be -- how to interpret to them and
explain to them what the benefits of their participation and what is their
actual role and responsibility. How much
time. Is there any kind of... I don’t want to say compensation but, you
know, any incentives that go –
…it would be good to see how invasive the trials could, you know, would
be to the participants.
We need to be trained on what a clinical trial is.
Yeah, we need to know about the successes, the failures – the history
of clinical trials. We need to know
about data, databases, how to do data analysis, and the history of
research. There is so much diversity.
During the interviews and focus groups we asked community health workers for suggestions concerning our planned training for community health workers about medical research. Their responses emphasized the importance they attached to improving their own knowledge as a prelude to effective training in the community.
It has to be made sure that we know all of the things going on about an
issue. We need to look educated. That is so important.
Training needs to be comprehensive…It can’t just be some one or two day
workshop. It needs to go over
everything, and they need to spend weeks and money to make sure that we have
the classes and the knowledge that we need.
Clinical trials needs to have training for us, and it also needs
commitment from the other end too – protocol time we need to have a copy, and
the researchers need to be committed to the communities they are researching.
Our respondents suggested a range of techniques for effective training, ranging from role plays to including researchers and cancer survivors who have participated in clinical trials.
Probably do some role plays, you know, have some of the classic
hecklers hanging around…and probably have people to ask them questions that are
a little more technical, that maybe they can't answer, that they have to say,
I've got to research that and come back to you.
I've got to look into it and get back to you, because that comes up a
lot, even just with regular stuff that I do, I have to tell the person, give me
your name and number, and I'm going to have to look that up and get back to
you.
Definitely a diversity of AV material, products. Some people are really good at learning by
seeing, some people are really good at learning by doing, where you would take
them out into the field, and some people, for reasons I don't know, just like
books (laughter). No, it's always good
to have text, I'm just kidding, but not just relying so much on the text that
that's your primary tool. Definitely
need visuals and hands-on for community health workers to do their work. Having them do some more independent projects
too is helpful… Probably speaking you
know, with professionals in the field who have done it, as well as any
subjects.
As I said before, like the slides, a copy of the slides, like a
nice...or, if not the slides, then printed information that has the slides in
it but readable because sometimes they give it out and it's so like, black and
white and small print, very tiny, that you can't even read it. Because when we have like time off, like a
break, we can, you know, just use that to read and go through and study… making it convenient locations and times…
Examples and not too much written material. More, I would say definitely a video or
pictures… I don't know how possible
this is, but even if it's other members within their same community, other
members of the same community who have participated in, almost their feeling
about participating in the trial would be definitely very good for them.
The interviewees often stressed the importance of culturally sensitive training approaches and engaging community health workers as trainers.
It should include cultural barriers in it…
How to talk to people when they – religion comes up, or when – that the only
person that can make the decision is the male figure. How to go through that, first, to the husband,
and make this other person do the research study. You know, things like that. Convince people, barriers, I think. And definitely medical terminology…
interactions with the research person so we can ask questions, and
pamphlets. Form groups…talk about an
issue, and have the research person there answer – you know, answer these
questions.
I guess you would have to be culturally sensitive to how to get your idea across to certain populations… [For example]Asian women are just not used to touching their bodies and having that breast model out there for them, you know, is quite different from, you know, Americans. That's something that shows, you know, cultural sensitivity and it's a difference and you need to expect that…
You need to think about the population, the cultural beliefs and
religion beliefs and all that… health
fairs in schools and churches, things like that for the community… Participating in trainings and conferences,
things like that that we can learn in order to teach the community.
Training should be done by us – community health workers should help
make up the training.
We need to have all of the education materials and we need to be able
to bring them to our communities.
Some also emphasized the importance of training on health issues most relevant to their specific community:
Help them educate the community about healthcare research, what that
training should include... Well, I think it should include maybe some relevant
research that has been done that is of interest to that particular community. If you're going to be dealing with heart
disease research, you know, you might want to go up to a community that has --
you know, has members of -- experiencing a lot of heart problems or heart
disease, and you know, show them some research studies that have had positive
results, that was done and as a result of this research being done, this is
what was implemented. I think people
would like to see that research has come back and had a result that was brought
into their community... I think
community health workers should be educated about different studies that were
done, what the results of those studies were in the populations, and if they're
working with those populations, to share that information with them.
Training on the things that are in the community, that are needed in
the community. You know, that this
community is a large community with high blood pressure and diabetes and those
kinds of things would affect that community.
Do you know what I mean? I mean,
I'm not saying keep it in just those two things, but what's happening in that
community.
Some suggestions
focused on the importance of education about human subject protections and
about problems in the treatment of human subjects in past research, with a
particular emphasis on the
Side effects…I think also understanding the process…that researchers
have to go through in order to get a clinical trial…because I think that us, as
community workers, we don’t understand the IRB process. And knowing that there’s supposedly this very
formal, very -- supposedly, I guess, very strict process… in order for
individuals to study humans. So I think
as us understanding that process will sort of decrease the issue around
confidentiality, around abuse, around…information.
Well, I think people have to know the history. You've got to find some good novel or good
non-fiction about the
Conclusions
This assessment of community health workers’ experiences, knowledge and concerns about cancer clinical trials and other types of health care research confirms the extent of the difficulties identified in prior research and also identifies means for lessening these difficulties. Community health workers have many concerns about cancer research, but they recognize the importance of lessening disparities in research participation and they are eager to learn more about research so that they can provide more information to community members.
Community
health workers were aware of ethical violations in the past in health care
research—particularly the
All the community health workers we studied recognized the importance of medical research for improving health care, as well as the importance of reducing disparities in rates of participation in order to improve health care outcomes in all communities. They made many suggestions for improving trust and knowledge. First and foremost, community health workers were concerned that they be included as partners in planning and working on research projects. Although they were interested in helping to publicize clinical trials, they also stipulated that their support was contingent on believing that members of their community would receive some benefits from a clinical trial and that the researchers would inform them of the outcomes of the research.
Community health workers had learned about medical research from a variety of sources and they recommended that multiple modes be used for formal training efforts. Talks by experts, entire courses, informational booklets and videos were all suggested. Several respondents stressed the importance of cultural and community sensitivity.
Our research has identified both the potential for new training programs about cancer clinical trials targeted to community health workers and it has suggested specific content areas and methods that should be included in such programs. We have learned both that community health workers are very concerned about the potential benefits of cancer clinical trials to their communities and also very eager to increase their understanding of cancer clinical trials. Further research on community health workers and cancer clinical trials should use representative samples of geographically dispersed populations. Training programs themselves should be developed by culturally sensitive educators and accompanied by rigorous evaluations of their effectiveness.
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