The Importance of Clinical Research for Minority and Underserved Communities


>>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 HIV infection. Prior to this, Dr. Wood helped physicians in increasing responsibility within the pediatric HIV 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 cervix 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, rectum, female breast and cervix 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 cervix. 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.

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