Find below the revised version of the article that was sent to Dr. Wallington on June 18, 2010.

The effects of cancer information exposure through mass media channels on

                           clinical trial awareness and willingness to participate among Latinos/Hispanics:

                           Results from the 2005 “Your Voice, Your Health Survey: Su Voz, Su Salaud”

Sherrie Flynt Wallington, PhD

Assistant Professor

Georgetown University School of Medicine & Lombardi Comprehensive Cancer Center

Anne-Michelle Noone, MS

Biostatistician

Georgetown University School of Medicine & Lombardi Comprehensive Cancer Center

Gheorghe Luta, PhD

Assistant Professor

Georgetown University School of Medicine & Lombardi Comprehensive Cancer Center

Maria Lopez-Glass, Ph.D.

Assistant Professor

Georgetown University School of Medicine &  Lombardi Comprehensive Cancer Center

Vanessa Sheppard, PhD

Assistant Professor

Georgetown University School of Medicine & Lombardi Comprehensive Cancer Center

Larisa Caicedo, MA

Director

Nueva Vida, Incorporated

Cherie Spencer, MS

XXXX[jad2] 

Howard University Cancer Center

Elmer Huerta, MD, MPH

XXXX

Washington Cancer Institute and Washington Hospital Center

Jeanne Mandelblatt, MD, MPH

 Professor

Georgetown University School of Medicine & Lombardi Comprehensive Cancer Center

Address correspondence to:  Sherrie Flynt Wallington, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Research Building, W326A, 3970 Reservoir Rd, N.W., Washington, D.C. 20057; Telephone: 202-687-4378; fax:202-687-6402; email: slw49@georgetown.edu.________________________________________________________________________________

This research was funded by a grant from the National Cancer Institute (U01 CA114593‐03S3) as part of the Latin American Cancer Research Coalition (LACRC).

Abstract

Objective:

We evaluated relationships among demographic and health variables, exposure to mass media, social-psychological variables, clinical trial awareness, and willingness to participate in clinical trials of Latinos/Hispanics.

Methods: We conducted a cross-sectional Spanish survey of 1,351 adult Latino men and women who attended low-cost clinics. Logistic regression procedures were used to assess effects on awareness of clinical trials and rates of participation in a clinical trial of demographic variables, media exposure variables, and social-psychological variables.

Results:

Marriage (OR = 1.45, p = .03), 12 years of education (OR = 1.83, p = .001), more than 12 years of education (OR = 1.96, p = .001), use of Internet for health news and services (OR = 2.33, p = .001), likelihood of developing cancer (OR = -1.42, p = .03), and trust in health information from health sources (OR = 1.33, p = .001) predicted the likelihood that a respondent was aware of clinical trials. Contacting the Cancer Information Service (CIS) (OR = 2.49, p = .05), attending health fairs (OR = 1.47, p = .03), worrying about developing cancer (OR = 1.91, p = .005), self-efficacy (OR = 1.14, p = .01), trust in health information from health sources (OR = 1.20, p = .03), and knowledge of a clinical trial (OR = 1.57, p = .003), predicted the willingness of respondents to participate in a clinical trial.

Limitations:

Measures of Internet use and likelihood of developing cancer were self-reported. More objective measures of these variables would lead to more reliable results.

Conclusions: 

Demographic variables predicted awareness of cancer clinical trials but did not predict rates of participation. Behavioral measures (i.e., contacting the CIS, attending health fairs, and awareness of clinical trials) predicted participation rates. Internet use predicted each outcome.

 

 

 

Key Words: Clinical trial awareness, clinical trial participation, Latinos/Hispanics, mass media


Introduction[s3] 

It is well-documented that despite the steady improvements in the overall health of Americans, some racial and ethnic minority populations as well as members of lower socioeconomic groups experience a lower quality of health services, are less likely to receive routine medical procedures, and have higher rates of morbidity and mortality than non-minorities and people of higher socioeconomic status (SES) 33. For example, even as the overall burden of cancer is steadily falling, the decline in both incidence and mortality are greater for Whites than for African-Americans, Hispanics/Latinos, American Indians, and Alaskan Natives33. A difference in transmission of scientific knowledge to various sectors of the public could explain these disparities76. This difference could also exacerbate the lack of awareness of and participation in randomized clinical trials among racial and ethnic groups 2, 32, 79[jad4] .

Many clinical trials have improved health care for many diseases, including cancer. However, less than 5% of adult cancer patients enroll in clinical trials; in fact, only 3% of U.S. adults with cancer participate in clinical trials—far fewer than the number needed to address the most critical cancer issues quickly 50, 51, 79. Moreover, enrollment in cancer clinical trial [jad5] is much lower for minorities, the elderly, and underserved communities 5, 24, 61. This is particularly true for Latinos/Hispanics. they represent 15% of the U.S. population and cancer is their second-leading cause of death. However, they comprise only 3% of the enrollees in cancer clinical trials 4, 49, 70. A National Cancer Institute study 49 of clinical trials found that the number of trial enrollees relative to estimated U.S. cancer rates was significantly lower for Latinos/Hispanics and African-Americans than for Whites.

Under-representation of Latinas in breast cancer clinical trials is particularly pronounced; Latinas account for less than 2% of participants41,43. These findings remain problematic and illustrate an urgent need to ameliorate low accrual [jad6] rates among Latinos/Hispanics. If under-representation of Latinos/Hispanics in cancer clinical trials continues, it may in turn pose yet another constraint on access to care choices for this group, as clinical trials can be a viable and promising treatment option 49, 61. Another concern regarding under-representation of Latinos’/Hispanics in clinical trial increases the paucity of data of this group’s response to certain scientific developments, such as particular drug therapies 36. The response of minority groups to certain drug regimens has become an important part of pharmacogenomic studies. A better understanding is needed of variation in the response of genetic subgroups to certain drug agents 36, 80. By 2050, Latinos/Hispanics will represent almost a quarter of the country’s population—98.2 million70 and cancer is second only to cardiovascular disease as the leading cause of death among Latinos/Hispanics4. Consequently, greater rates of participation of Latinos/Hispanics in clinical trials is imperative to ensure generalizability of research results and to ensure that they benefit more equitably from scientific knowledge and discovery 5, 15,79.

To address the overwhelming concern regarding rates of participation of minorities in clinical trials, several research collaborations and educational and community-focused initiatives are now targeted toward improving this situation. For example, the National Institutes of Health (NIH) Revitalization Act of 1993 52 represents one important attempt to address under-representation; the act mandates that women and minorities must be recruited into trials to ensure valid conclusions on subpopulations. However, from the perspective of the patient, little is known about factors that influence the decision to enroll in clinical trials 22. According to a Harris Interactive survey 29, most individuals with cancer were either unaware or unsure that they could participate in a clinical trial. In addition, most of them indicated that they would have been willing to enroll.. These findings represent important progress in identifying barriers to participation of Latino/Hispanics in clinical trials but more work is needed to better understand Latinos/Hispanics participation in clinical trials and to increase rates of participation.

To address the problem of low participation in clinical trials among Latinos/Hispanics, researchers have noted the need to evaluate effectiveness of communication strategies, including the best approaches to delivering information about clinical trials, both at the community and individual levels; in addiction, they have recommended further evaluation of media-based and communication technology strategies24, 73. Some media-based interventions are effective in increasing accrual to clinical trials43, 69. Furthermore, a media-based strategy utilizing English and Spanish newspaper advertisements effectively communicated information regarding on cancer prevention and Latina women12. Thus, a media-based approach seems likely to be helpful in the recruitment of other low-income groups to clinical trials. Further, new communication technologies can deliver information in a format that is more convenient for prospective participants. Consequently, such technologies facilitate access to knowledge of cancer and health-related support services, including information regarding cancer clinical trials.

Technologies such as the Internet could enhance consumers’ knowledge of health-care and thereby increase the awareness and participation of consumers in clinical trials. However, these technologies have not adequately reached socioeconomic groups at greatest risk for poor health 7, 74, 77. Understanding communication and communication inequalities, particularly the role of the mass media and communication technologies, in increasing awareness of clinical trials and ultimately, recruitment of Latinos/Hispanics, is an understudied area. It presents an enormous opportunity to heighten awareness, to increase participation in clinical trials and to serve as a foundation for future communication initiatives and strategies. We must pay attention to closing the gap in clinical trial participation, particularly between the information “haves” and “have-nots,” and work to eliminate the knowledge gaps with Latinos/Hispanics regarding clinical trials74.

To help in further elucidating these issues, this study uses Tichenor, Donohue, & Olein’s (1970) 67 seminal knowledge gap hypothesis as a theoretical foundation. The hypothesis is a means to assess and emphasize social and structural influences on knowledge gaps to evaluate effects of differential exposure to mass media at group (e.g., socioeconomic groups) and community levels 68,72. The knowledge gap hypothesis suggests that populations with higher socioeconomic status (SES) tend to acquire information from the media at a faster rate than do segments with a lower SES. Such differences could lead to variation in the prevention, screening, and treatment, thereby exacerbating cancer health disparities.

Hypotheses

Aims

In this current research, we explore relationships among demographic and health variables, exposure to mass media channels, social-psychological variables, clinical trial awareness, and willingness of Latinos/Hispanics to participate in clinical trials. We advance the following hypotheses:

H1: Demographic variables (such as age, gender, marital status, and level of education) will predict awareness of clinical trials and willingness to participate in clinical trials.

H2: The perceived likelihood of developing cancer predicts (1) awareness of clinical trials and (2) willingness to participate in clinical trials.

H3: Types of media used to transmit information influence (1) and (2) above.

H4: Internet use increases (1) and (2). H5: Cell phone use predicts (1) and (2).

H6: Acculturation predicts (1).

H7: Self-efficacy predicts (1).

H8: Trust in health information source predicts (1) and (2).

H9: Knowledge of clinical trials predicts (1).

Methods

            We evaluated the information needs, information-seeking styles, and knowledge of cancer of Central and South American Latinos in the District of Columbia (DC) metropolitan area to fill key gaps in current knowledge of cancer treatments. The study was conducted as part of the Latin American Cancer Research Coalition (LACRC). The LACRC is a National Cancer Institute-funded regional Community Network Program (CNP). The goal of the LACRC is to use community-based participatory research to promote cancer control in Latinos in the greater metropolitan DC region. The LACRC includes six community clinics, two community hospitals, one comprehensive cancer center, a local Spanish-language health radio program, a cancer support network, local universities, and numerous advocacy organizations. The LACRC community clinics serve Latinos almost exclusively and provide primary care regardless of ability to pay. All study procedures were approved by the Institutional Review Board.

Setting and Population

            A cross-sectional convenience, quota sample of individuals (n=???[jad1] ) attending the LACRC primary care sites between June 2007 and November 2008 were selected for participation. To evaluate the relationship between communication and screening behaviors and selected health behaviors, we stratified our sample by age and gender. In each of the nine sites, 25 participants were enrolled in each of four gender-age categories: 21-29, 30-39, 40-54, and 55+. Participants were (1) clinic users or individuals accompanying a registered patient, (2) self-identified as Latinos, (3) 21 years of age or older, and (4) not enrolled in the Women Infants and Children (WIC) program. We also enrolled a convenience sample of Latinos attending health fairs sponsored by the LACRC clinics. We obtained informed consent (in Spanish) from each participants; each participant received a $10 gift card.

Data Collection

Survey Development

            We developed a survey entitled “Your Voice, Your Health: Su Voz, Su Salud” using community participatory principles. We identified topics of interest to the LACRC community clinics and discussed the data that would be most useful in developing education campaigns and interventions to address the cancer control needs of their populations. We then used the National Cancer Institute (NCI) Health Information National Trends Survey (HINTS) to guide the selection of  domains and topics identified by the partnership 53. We identified existing, validated Spanish-language instruments, including items that had been successfully administered in the Spanish-language version of the HINTS survey 53.

Pre-Test

            We conducted a pre-test with a sample of 30 clinic users to assess the reliability of our measurement scales. Scales that were not reliable (Cronbach’s alpha < .6) were dropped or revised. Our final survey included sources of cancer information, factors that influence choice of medium, general knowledge of cancer, family history, information-seeking styles, information self-efficacy, medical trust, acculturation, socio-demographics, and history of cancer screening.

Survey Administration

            Trained bicultural and bilingual cancer-control coordinators conducted face-to-face interviews at our nine community-clinic, partner sites and health fairs. All interviews took place in a private location to maintain confidentiality; interviews lasted about 30 minutes. These interviews were conducted in the language of the participant’s choice. The interviewer used a laptop with the survey on-screen to administer the survey and to record responses. If a participant was not comfortable with the computer, then the interviewer entered responses on a hard copy of the survey. XX% of surveys were completed using the laptop. [jad2] The laptops were password protected. All data were transferred to one computer for analysis. [jad3] Sites and participants were identified by number only.

Measures

Primary Outcomes     

The outcome variables for our analyses were the magnitudes of the awareness and participation in cancer clinical trials. These items were assessed using two survey items containing the following statements:  

            Clinical trial awareness. “Please tell me which one of the four definitions you think describes a clinical trial? Response options were “A project in a clinic, a test in an MD’s office, a research project in which some patients are selected to try new treatments medications while others receive different medications or none at all, a group of medical students, unsure (DO NOT READ), refused (DO NOT READ).”

            Clinical trial participation. “In the future, if you developed a health problem like cancer, would you consider joining a clinical trial that was testing a new cancer treatment that could help you?” Response options were “I would not participate, I might participate, I probably would participate, I definitely would participate, Not sure/haven’t thought about it, and Refused (DO NOT READ).”

Independent Variables

            Demographic variables. Standard demographic information was obtained from each participant, including age, gender, marital status, and country of origin. To assess the knowledge gap hypothesis, we also included highest grade or level of schooling completed. To assess information-seeking behavior, participants were asked how often (not at all, very little, somewhat, quite a bit, always) they sought health information from the following sources: newspapers, magazines, radio, television, the Internet, health professionals (such as doctors and nurses), health educators/navigators, community leaders/priests, health fairs, and “Charlas de Salud” in the waiting room area at community clinics/church/community centers. Participants were also asked how much they trusted the information from each source.

            Personal cancer risk. Two questions were asked to assess the each participant’s perception of their own cancer risk: (1) “In your opinion, how likely is it that you will develop cancer?” (hereafter referred to as “risk”), with possible responses ranging from “not at all likely” to “definitely” on a five-point scale; and (2) “In the past month, how often have you worried about your own chances of getting cancer?” (hereafter referred to as “worry”), with possible responses ranging from “not at all or rarely” to “a lot” on a four-point scale.

            Acculturation. Acculturation is always measured by proxy variables, which include questions about an individual’s use in various settings of English or Spanish31. We measured acculturation by asking participants four questions about language preference: (1) “In general, what language(s) do you read and speak?” (2) “In which language do you think?” (3) “What language do you speak at home?” and (4) “What language do you speak with friends?” For each question, there were five possible responses: (1) only Spanish, (2) Spanish more than English, (3) both equally, (4) English more than Spanish, or (5) only English. The responses to these four questions were averaged to create an overall measure of acculturation. Participants were also asked how many years they had lived in the United States, which was used as an additional measure of acculturation.

            Self-efficacy. An eight-question scale, modified from the Seeking and Understanding Medical Information Subscale from the Cancer Behavior Inventory, was used to measure self-efficacy47. Participants were asked to choose a number between 1 and 9, where 1 represents “not at all confident” and 9 represents “totally confident” in response to phrases such as “How confident are you that you can ask nurses questions about cancer.” (See Appendix # for details.) Responses to these questions were then averaged to create a composite score; individuals were given a score if they answered all eight items.           

Data Analysis

            We evaluated effects of independent variables on each outcome using t-tests and chi-square tests. We reviewed the functional form of each independent variable to determine whether a continuous or categorical variable was more appropriate. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were estimated using logistic regression for each outcome. For each model, each independent variables was selected based on a test of the significance of the OR. Except for certain factors such as age and acculturation, independent variables were retained in the model only if its OR was significantly (p<0.05) greater than zero.

 

Results

Descriptive Statistics

            Two-thirds (65%) of the respondents were from Central America and two-thirds (66%) were married. The proportion of males and females was approximately equal. Most (75%) respondents had 12 or fewer years of education. Half (51%) of the respondents indicated that they were not likely to develop cancer. More than a third (38%) indicated reported that they were likely to develop cancer.

            For most respondents (66%), their health care provider was their primary source of health information (Table 2); this was followed by the media (27%). The Internet was inaccessible to more than half of the respondents (59%) but most respondents had a cell phone (77%).

            The mean age of the respondents (Table 3) was 41 (SD = 13). On a scale from 1 to 9 self-efficacy scores averaged 6.7 (SD = 1.6). English was rarely spoken by respondents in this sample: on a scale from 1 to 5, acculturation scores averaged 1.5 (SD = 0.7). On a scale from 1 to 5, [jad1] Many respondents trusted health information: the mean score for trust in health information was 4 (SD = .9).

Predictors of Knowledge of  Clinical Trials

            Demographic variables. Region, marital status, level of education, and likelihood of developing cancer predicted a prior knowledge of clinical trials but gender did not (Table 4). Respondents from South America had better knowledge than their counterparts in North and Central America (p = .03). Married respondents had better knowledge than unmarried respondents (p = .004). Knowledge of clinical trials increased with level of education (p = .001). Respondents had better knowledge if they were not likely to develop cancer (p = .005).   Media exposure variables. The primary source of health information of respondents and their use of the Internet significantly predicted knowledge of clinical trials. Respondents who received health information from the media and other sources had better knowledge than respondents who received health information from their health care provider and significant people in their lives (p = .001). Respondents who used the Internet to obtain health information had better knowledge than respondents who did not (p = .001).

            Social-psychological variables. Acculturation and trust in health information were associated with knowledge of clinical trials  but age and self-efficacy did not (Table 6). Knowledge increased with the mean acculturation score of respondents[jad2]  mean trust scores.

            Multivariable model of the extent of knowledge of clinical trials. Combined effects of marital status, level of education, Internet use for health searches, likelihood of developing cancer, and trust in health information predicted knowledge of clinical trials (Table 7). After controlling for each of the remaining independent variables, the odds that a respondent had a prior knowledge of clinical trials was 1.45 times greater for a married respondent than for an unmarried one. The odds that a respondent had a prior knowledge of clinical trials increased with his/her level of education. Thus, if the respondent had 12 years of education, then the odds that he/she had a prior knowledge of clinical trials was doubled. The odds of a respondent’s prior knowledge was doubled again if he/she also had more than 12 years of education. Similar the odds that a respondent had a prior knowledge of clinical trials also was doubled if he/she used the internet to gather health information. The odds was 1.45 times smaller (p<0.03) for a respondent who believed that he/she was likely to develop cancer than for a respondent who did not. The odds was increased slightly if a respondent trusted health information (OR = 1.33, p = .001).

Predictors of Willingness to Participate in a Clinical Trial

            Demographic variables. We found no evidence (Table 8) that the willingness of respondents to participate in a clinical trial varied with region, gender, marital status, or level of education. However, willingness was greater for respondents who worried about developing cancer.

            Media exposure variables. Willingness to participate in clinical trials was greater if a respondent had called the CISor if a respondent had attended health fairs (Table 9). We found no evidence that a respondent’s willingness to participate was associated with his/her source of health information, use of the internet, or use of a cell phone.

            Social-psychological variables. Mean scores for self-efficacy and trust in health information were slightly greater for respondents who were willing to participate in a clinical trial (Table 10). We found no evidence that willingness was related to age or acculturation.

            Multivariable model for the probability of joining a clinical trial. A willingness to participate in cancer clinical trials was clearly associated with the combined effects of contacting the CIS, attending health fairs, worry about developing cancer, knowledge of clinical trials, self-efficacy, and trust in health information (Table 11). However, self-efficacy (OR = 1.14, p = 0.01) and prior knowledge of clinical trials (OR = 1.20, p = 0.03) were only weakly associated with a willingness to participate whereas contact with CIS and worry about cancer were strongly associated.  The likelihood that a respondents was willing to participate was greatly increased if he/she had called the CIS (OR = 2.49, p = .05), or if he/she worried about cancer ((OR = 1.91, p = .005). The strength of the associations between willingness to participate and attendance at health fairs or prior knowledge of clinical trials was intermediate. The odds that a respondent was willing to participate was increased if he/she attended health fairs (OR = 1.47, p = .03), and if he/she had a prior knowledge of clinical trials (OR = 1.57, p = .003).

 

Discussion

Knowledge of clinical trials varies widely and is associated with low rates of participation in clinical trials and disparities in cancer treatment. This present study highlights the importance of closing existing gaps in knowledge of clinical trials and increasing rates of participation of Latinos/Hispanics in clinical trials. Mass media are an important source of information about human health72, including information about clinical trials.42, 69 We used data from the 2005 “Your Voice, Your Health Survey: Su Voz, Su Salaud” to test the premise that exposure to information regarding cancer through mass media channels is associated with an awareness of clinical trials and with rates of participation of Latinos/Hispanics in clinical trials.

            Clinical Trial Awareness. We expected that demographic variables (e.g., age, gender, marital status, and education level) would be strongly associated with a prior knowledge of clinical trials. However, in our study, that prior knowledge was associated with marital status and education level but not  age and gender. In a previous study of cancer patients, a prior knowledge of cancer clinical trials was not associated with marital status37 but the respondents included non-Latinos/Hispanics. . In a more recent study13, a prior knowledge of cancer clinical trials was related to race, ethnicity, income, education, and family history of cancer. In addition, familiarity of Latinos/Hispanics with clinical trials depended on education level. Thus, variation in socioeconomic status could be more important than racial or ethnic differences; within racial and ethnic groups rather than mask them by treating them as one monolithic group76.

We also anticipated that perceived likelihood of developing cancer would predict awareness of clinical trials. An individual’s perceived cancer risk (PCR) predicts his/her likelihood of engaging in preventive health behaviors 35, 71. We found that those with a lower perceived likelihood of developing cancer surprisingly had better prior knowledge of clinical trials than those who had a higher perceived likelihood of developing cancer. It seems more plausible that having a low PCR would contribute to less attentiveness to clinical trial communication through mass media, and thus a poorer knowledge of clinical trials. The significance of the association between low PCR and better knowledge about clinical trials is unclear and warrantsfurther research. Some recent work54 suggests that low PCR among Latinos/Hispanics and other minority groups may be related to difficulties in reporting on a family history of cancer, cancer risk salience (people basing their cancer risk perceptions on the experiences and beliefs of their same race, ethnic group, or social network), and whether PCR even represents a meaningful concept for a given group. Thus, low PCR may then be a barrier among Latinos/Hispanics to screening and other cancer prevention behaviors and even awareness of and participation in clinical trials.

Our findings also support the notion that mass media have been ascribed a great deal of power in influencing both individual and population health74. The belief in the media’s power to influence individual and population health stems in part from the immense amount of time people spend with the media 72. We found that mass media plays a greater role in awareness of clinical trials than a respondent’s health care provider or significant people in a respondent’s life. Specifically, the extent of internet use was positively related to a better knowledge of clinical trials.

Recent research has led to improved knowledge of the effectiveness of Web-based strategies for education and recruitment for cancer clinical trials.20, 45, 48 However, more effort is needed to increase Internet usage by Latinos/Hispanics. The Pew Hispanic Center and Pew Internet Project56 report that although Latinos/Hispanics comprise approximately 14% of the U.S. adult population, only half (56%) of this growing group goes online. By comparison, 71% of non-Hispanic Whites and 60% of non-Hispanic Blacks use the Internet. Our finding represents a growing shift away from the earlier and stark digital divide issues, that is the perceived gap between those who have access to the latest information technology and those who do not19.

We found that acculturation (based on language) was significantly associated with knowledge of clinical trials. Acculturation has become a popular construct in research on health disparities among ethnic minorities. It presumes that individuals choose or reject behaviors based on their cultural beliefs and that such choices are prime factors affecting their health31. Although little is known about how acculturation affects clinical trial awareness and participation, increasing acculturation among Latinos/Hispanics has been shown to influence knowledge, attitudes, and behaviors related to awareness of genetic tests, adherence to mammography scheduling, and utilization of cervical cancer screening 28, 66, 64.

Trust in health information gained from a variety of sources is an important driver of information seeking, which may lead to in increased knowledge of health and positive health behaviors 57. We found that trust in health information from health sources was significantly associated with knowledge of clinical trials. This finding may be supported by the fact that many Latino/Hispanic groups receive health care from clinics that predominately serve Latinos/Hispanics and have bilingual administrative and medical staff. Consequently, Latinos/Hispanics may experience less discrimination and have a higher satisfaction with patient-provider relationships 63. Moreover, the value of having a Latino/Hispanic health provider for achieving patient-physician cultural concordance 34 may in turn lead to greater trust and better health discussions, including discussions about clinical trials.

Clinical Trial Participation. We expected that our socio-demographic variables would be associated with willingness to participate in clinical trials. However, in contrast to our expectations, the findings show that none of our socio-demographic variables was associated with willingness to participate. Brown and Moyer (2010)13 suggest that motivations and disincentatives for potential research participants may differ by socio-demographic factors and particularly by race and ethnicity. For example, among Latinos/Hispanics, factors associated with under-representation in cancer clinical trials are multi-factorial6. Such factors include a particular emphasis regarding obstacles of socio-cultural beliefs about health care, diminished social resources, learned helplessness, economic disparity, language barriers, educational differentials, lack of provider cultural competency, lack of perceived value and involvement in clinical trials of Latino/Hispanic physicians, and poor community readiness to promote trial participation 22, 40, 9, 58.

Compared with other groups, higher levels of education and positive beliefs about the medical risks of research predicted willingness to participate among Whites 62. Among Blacks, awareness of the infamous Tuskegee Syphilis Study (in which poor Black men were denied treatment for syphilis from 1932-1972 26 has been heavily cited as the singular reason behind the under-representation of Blacks in clinical trials and mistrust of medical and health providers.11, 27 However, Brandon, Isaac, and LaViest10 suggest the Tuskegee study has less of a role in engendering distrust among Blacks and other minority groups. They point to other multiple and complex explanatory factors. These factors could include the lack of physicians’ awareness and referrals to clinical trials,  personal mistreatment by health and medical establishments,  perceived costs or lack of health insurance,  geographic and personal constraints (e.g., child care, inflexible work hours, transportation), language and health literacy concerns, lack of minority investigators in the trial research design and implementation, lack of family or peer support, inclusion and exclusion eligibility criteria, and unavailability of an appropriate trial.1, 16, 18, 22, 25, 30, 59, 79  In spite of these barriers, research is providing evidence that, when asked to participate in clinical trials, Latinos/Hispanics and other minority groups, are willing to do so and enroll at the same rates as non-Hispanic Whites.17, 40, 79

We expected that the type of media, particularly the Internet, would predict willingness to participate in clinical trials. However, the Internet and other media types were not associated with clinical trial participation. In contrast, contact with the National Cancer Institute’s (NCI) CIS and attendance at health fairs were significantly associated with likelihood of joining a clinical trial. NCI’s special efforts to promote the CIS, particularly among minority and underserved populations, has increased awareness of this service among Latinos/Hispanics and other minority groups 65. Established in 1975 and with some recent changes, the CIS exists to help the public obtain the latest, most accurate scientific information about cancer-prevention behaviors and practices, screening recommendations and procedures, and the most recent advances in cancer treatment 65. In one CIS study, Squiers et al. 65 found that although overall awareness of CIS was low (32%), African-Americans and Latinos/Hispanics were significantly more aware of the CIS than Whites. This may have increased clinical trial awareness and participation of members of minority groups. More research is needed to determine if awareness of CIS by Latino/Hispanics CIS increases their use of CIS. In addition, health fairs are ideal venues for community outreach and have been shown to be quite effective in promoting screening for various cancers. 14

In summary, demographic variables predicted knowledge of clinical trials in the current study but they did not predict the willingness to participate in clinical trials. Likewise, use of the Internet predicted knowledge of clinical trials but it did not predict a willingness to participate. In contrast, self-efficacy predicted a willingness to participate but not a knowledge of clinical trials. Moreover, factors that predicted willingness to participate entailed more “involvement” and efficacy on the part of respondents. For instance, calling the CIS, attending health fairs, and knowledge of clinical trials each suggest an increased involvement of a respondent.

            Limitations. We note some limitations of the current study. Due to the cross-sectional nature of this study, none of the variables were controlled or manipulated. Thus, causality could not be established. Further, we can only generalize to the areas where respondents were recruited from. Finally, more objective measures of perceived risk of cancer and likelihood of having cancer are needed as these measures were based on self-reports.

            Strengths. Cross-sectional studies can make valuable contributions insofar as they set the stage for subsequent hypothesis-driven research 78. Therefore, an important strength of this study involves our ability to develop priorities for future work regarding increasing clinical trial awareness and participation among Latinos/Hispanics. Also, this study is unique in its in-depth assessment of communication and mass media constructs specifically among Latinos/Hispanics as it relates to clinical trial awareness and participation.

            Conclusions. The challenge of minority accrual in clinical trials is well recognized, and recruiting and retaining Latinos/Hispanics poses even greater complexities 3, 21, 44. Given that Latinos/Hispanics represent one of the fastest growing ethnic populations and have poor cancer outcomes, it is critical that they be aware and participate in clinical trials to ensure generalizability of cancer research results and to ensure that they benefit equitably from cancer scientific knowledge and discovery. These efforts will not only help to ameliorate low participation rates but will also assist with the important goal of reducing and eliminating cancer health disparities among Latinos/Hispanics.  While our study raises some intriguing questions for future research related to clinical trial awareness and participation, it also gives us some important insights into health communication and the use of various mass media channels. Among Latinos/Hispanics, there is a critical need to provide, through multiple channels (i.e., patient-physician encounters, mass media, and community encounters such as health fairs and other community forums), targeted (group) and tailored (individual) 39 information to increase clinical trial awareness and participation.

 

 

REFERENCES

  1. Adams-Campbell, L., Ahaghotu, C., Gaskins, M., Dawkins, F.W., Smoot, D., Polk, O., et al. (2004). Enrollment of African American onto clinical treatment trials: Study design barriers. Journal of Clinical Oncology, 22(4), 730-734.

  1. Allmark, P. (2004). Should research samples reflect the diversity of the population? Journal of Medical Ethics, 30(2), 185-19.

  1. Alvarez et al, 2006

  1. American Cancer Society. (2006). Cancer facts & figures for Hispanics/Latinos 2006-2008.          American Cancer Society, Atlanta, Georgia. Retrieved December 15, 2008 from http://www.cancer.org/docroot/home/index.asp.

  1. Baquet, C., Henderson, K., Commiskey, P., & Morrow, J.N. (2008). Clinical trials: The art of enrollment. Seminars in Oncology Nursing, 24(4), 262-269.

  1. Beverage, J.N., & O’Brien, D.G. (2008). Latino participation in cancer clinical trials. Cancerpact. Retrieved December 14, 2008, from http://www.cancerpact.org/Latinos%20in%20Cancer%20Clinical%20Trials.pdf.

  1. Birru, M., & Steinman, R.A. (2004). Online health information and low literacy African Americans. Journal of Medical Internet Research, 6(3), e.26.

  1. Blake, K.D., Flynt Wallington, S., & Viswanath, K. (in press). Health communication channel preferences by class, race, and place. In G. Kreps (Ed.), Health communication: Building the evidence base in cancer control. New Jersey: Hampton Press.

  1. Borrayo, E.A., et al. (2007)

  1. Brandon, D.T., Issac, L.A., & LaViest, T.A. (2005). The legacy of Tuskegee and trust in medical care: Is Tuskegee responsible for race differences in mistrust of medical care? Journal of National Medical Association, 97(7), 951-956.

  1. Braunstein, J.B., Sherber, N.S., Schulman, S.P., Ding, E.L., & Powe, N.R. (2008). Race, medical, researcher distrust, perceived harm, and willingness to participate in cardiovascular prevention trials. Medicine (Baltimore), 87(1), 1-9.

  1. Brewster, W.R., Anton-Culver, H., Ziogas, A., Largent, J., Howe, S., Hubbell, F.A., et al. (2002). Recruitment strategies for cervical cancer prevention study. Gynecologic Oncology, 85(2), 250-254.

  1. Brown and Moyer (2010)

  1. Chiu, Anderson, Corbin, 2005

  1. Christian, M.C., & Trimble, E.L. (2003). Increasing participation of physicians and patients from underrepresented racial and ethnic groups in National Cancer Institute-sponsored clinical trials. Cancer Epidemiology, Biomarkers, & Prevention, 12(3), 277s-283s.

  1. Colon-Otero, G., Smallridge, R.C., Solberg, Jr., L.A., Keith, T.D., Woodward, T.A., Willis, F.B., et al. (2008). Disparities in participation in cancer clinical trials in the United States:       A symposium of a healthcare system in crisis. Cancer, 112(3), 447-454.

  1. Comis, et al, 2001

  1. Comis, R.L., Miller, J.D., Aldige, C.R., Krebs, L., & Stoval, E. (2003). Public attitudes toward participation in cancer clinical trials. Journal of Clinical Oncology, 21(5), 830-835.

  1. DiMaggio, P.E., Hargittai, E., Neuman, W.R., & Robinson, J.P. (2001). Social implications of the Internet. Annual Review of Sociology, 27, 307-336.

  1. Dolinksy, C.M., Wei, S.J., Hampshire, M.K., & Metz, J.M. (2006). Breast cancer patients’ attitudes toward clinical trials in the radiation oncology clinic versus those searching for trial information on the Internet. The Breast Journal, 12(4), 324-330.

  1. Eakin et al., 2007

  1. Ellington, L., Wahab, S., Sahami Martin, S., Field, R., & Mooney, K.H. (2006). Factors that influence Spanish- and English-speaking participants’ decision to enroll in cancer randomized clinical trials. Psychooncology, 15(4), 273-284.

  1. Eng, T. R. (2001). The eHealth landscape: A terrain map of emerging information and communication technologies in health and health care. Retrieved December 12, 2008, from http://www.rwjf.org/app/rw_publications_and_links/publicationsPdfs/eHealth.pdf.

  1. Ford, J.G., Howerton, M.W., Bolen, S., Gary T.L., Lai, G.Y., Tilburt, J., et al. (2005). Knowledge and access to information on recruitment of underrepresented populations to cancer clinical trials. Evidence Report/Technology Assessment No. 122. Johns Hopkins University Evidence-based Practice Center, (Contract No. 290-02-0018.) AHRQ Publication No. 05-E019-2. Rockville, MD: Agency for Healthcare Research and Quality.

  1. Ford, J.G., Howerton, M.W., Lai, G.Y., Gary, T.L., Bolen, S., Gibbons, M.C., et al. (2008). Barriers to recruiting underrepresented populations to cancer clinical trials: A systematic review. Cancer, 112(2), 228-242.

  1. Gamble, 1993

  1. Gamble, V.N. (1997). Under the shadow of Tuskegee: African Americans and health care. American Journal of Public Health, 87(11), 1773-1778.

  1. Graves et al., 2008

  1. Harris Interactive. (2001). Misconceptions and lack of awareness greatly reduce recruitment for cancer clinical trials. Health Care News, 1(3). Retrieved December 14, 2008, from http://harrisinteractive.com/about/healthnews/HI_HealthCareNews2001Vol_iss3 .pdf.

  1. Howerton, M.W., Gibbons, M.C., Baffi, C.R., Gary, T.L., Lai, G.Y., Bolen, S., et al. (2007). Provider roles in the recruitment of underrepresented populations to cancer clinical trials. Cancer, 109(3), 465-476.

  1. Hunt, Schneider, & Comer, 2004

  1. Hussain-Gambles, M. (2003) Ethnic minority under-representation in clinical trials: Whose responsibility is it anyway? Journal of Health Organization & Management, 17(2), 38–143.

  1. Institute of Medicine. (2002). Committee on communication for behavior change in the 21st century: Improving the health of diverse populations: Speaking of health: Assessing health communication strategies for diverse populations. Washington, DC: National Academies Press.

  1. Julliard, Vivar, Delgado, Cruz, Kabak, & Sabers, 2008

  1. Katapodi, Lee, Facione, & Dodd, 2004

  1. Katzung, B.G. (2004). Basic and clinical pharmacology (9th ed.). New York: McGraw-Hill.

  1. Kim et al., 2008

  1. Kreuter, Farrell, Olevitch, & Brennan, 2000

  1. Jr., Lara, P.N., Paterniti, D.A., Chiechi, C., Turrell, C., Morain, C., Horan, N.,et al. (2005). Evaluation of factors affecting awareness of and willingness to participate in cancer         clinical trials. Journal of Clinical Oncology, 23(6), 9282-9289.

  1. Larkey, L.K., Ogden, S.L., Tenoria, S., & Ewell, T. (2008). Latino recruitment to cancer prevention/screening trials in the Southwest: Setting a research agenda. Applied Nursing Research, 21(1), 30-39.

  1. Lawsin, C.R., Borrayo, E.A., Edwards, R., & Belloso, C. (2007). Community readiness to promote Latinas’ participation in breast cancer prevention clinical trials. Health & Social Care in the Community, 15(4), 369-378.

  1. Lewis, C.E., George, V., Fouad, M., Porter, V., Bowen, D., & Urban, N. (1998). Recruitment strategies in the women’s health trial: Feasibility study in minority populations. WHT: FSMP investigators group. Women’s health trial: Feasibility study in minority populations, Controlled Clinical Trials, 19(5), 461-476.

  1. Mandelblatt, J., Kaufman, E., Sheppard, V., Pomeroy, J., Kavanaugh, J., Canar, J., et al. (2005). Breast cancer prevention in community clinics: Will low-income Latina patients participate in clinical trials? Preventive Medicine, 40, 611-618.

  1. Mann, Hoke, Williams, 2005

  1. Markman, M., Petersen, J., & Montgomery, R. (2008). An examination of the influence of patient race and ethnicity on expressed interest in learning about cancer clinical trials. Journal of Cancer Research and Clinical Oncology, 134(1), 115-118.

  1. Mediamark Research Inc. (2000). Multimedia audiences’ summary. Retrieved December 15, 2008, from http://www.mediamark.com.

  1. (Merluzzi and Sanchez, 1997)

  1. Metz, J.M., Coyle, C., Hudson, C., & Hampshire, M. (2005). An internet-based cancer clinical trials matching resource. Journal of Medical Internet Research, 7(3), e24.

  1. Murthy, V.H., Krumholz, H.M., & Gross, C.P. (2004). Participation in cancer clinical trials: Race-, sex-, and age-based disparities. Journal of American Medical Association, 291(22), 2720-2726.

  1. National Cancer Institute. (2001). Cancer clinical trials: The basic workbook. Retrieved December 15, 2008, from http://www.cancer.gov/clinicaltrials/resources/basicworkbook.

  1. National Cancer Institute. (2006). Boosting cancer trial participation. Retrieved December 15, 2008, from http://www.cancer.gov/clinicaltrials.

  1. National Institutes of Health. (1993). NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Retrieved December 15, 2008, from http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.

  1. Nelson, 2004

  1. Orom, Kiviniemi, Underwood, Ross, & Shavers, 2010

  1. Peppercorn, J.M., Weeks, J.C., Cook, E.F., & Joffe, S. (2004). Comparison of outcomes in cancer patients treated within and outside clinical trials: Conceptual framework and structured review. Lancet, 363(9405), 263-270.

  1. Pew Hispanic Center and Pew Internet Project. (2007). Latinos online: Pew Internet & American Life Project. Retrieved December 15, 2008, from http://pewhispanic.org/files/reports/73.pdf.

  1. Ramanadhan, S., & Viswanath, K. (2006). Health and the information nonseeker: A profile. Health Communication, 20(2), 131-139.

  1. Ramirez, A.G., Wildes, K., Talavera, G., Napoles-Springer, A., Gallion, K., & Perez-Stable,          E.J. (2008). Clinical trials attitudes and practices of Latino physicians. Contemporary Clinical Trials, 29(4), 482-492.

  1. Robinson, J.M., & Trochim, W.M. (2007). An examination of community members’, researchers’ and health professionals’ perceptions of barriers to minority participation in medical research: An application of concept mapping. Ethnicity and Health, 12(5), 521-539.

  1. Robinson, T. N., Patrick, K., Eng, T. R., & Gustafson, D. (1998). An evidence-based approach to interactive health communication: A challenge to medicine in the information age. Journal of American Medical Association, 280, 1264-1269.

  1. Sateren, W.B., Trimble, E.L., Abrams, J., Brawley, O., Breen, N., Ford, L., et al. (2002). How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. Journal of Clinical Oncology, 20(8), 2109-2117.

  1. Shavers et al., 2002

  1. Sheppard et al., 2008

  1. Shuh, Zhu, & Potter, 2006

  1. Squiers, L., Bright, M.A., Rutten, L.J., Atienza, A.A., Treiman, K., Moser, R.P., Hesse, B. (2006). Awareness of the national cancer institute’s cancer information service: Results from the Health Information National Trends Survey (HINTS). Journal of Health Communication, 11 (S1), 117-133.

  1. Sussner et al., 2008

  1. Tichenor, Donohue, & Olien, 1970

  1. Tichenor, Donohue, & Olien, 1980

  1. Umutyan, A., Chiechi, C., Beckett, L.A., Paterniti, D.A., Turrell, C., Gandara, D.R., et al. (2008). Overcoming barriers to cancer clinical trial accrual: Impact of a mass media campaign. Cancer, 112(1), 212-219.

  1. U.S. Census Bureau. (2002-2006). American community survey demographic and housing estimates: 2005-2007: U.S. Census Bureau. Retrieved December 15, 2008. from

http://factfinder.census.gov.

  1. Vernon, 1999

  1. Viswanath, Wallington, & Blake, 2009

  1. Viswanath, K. (2005). The communications revolution and cancer control. Nature Reviews Cancer, 5, 828-835.

  1. Viswanath, K. (2006). Public communication and its role in reducing and eliminating health          disparities. In G. Thompson, F. Mitchell, & M. Williams (Eds.), Examining the health disparities research plan of the National Institutes of Health: Unfinished business (pp. 215-233). Washington, DC: National Academies Press.

  1. Viswanath, K., Ramanadhan, S., & Kontos, E. Z. (2007). Mass media and population health:        A macrosocial view. In S. E. Galea (Ed.), Macrosocial determinants of population health       (pp. 275-294). New York: Springer.

  1. Viswanath, K., Breen, N., Messiner, H., Moser, R.P., Rakowski, W. (2006). Cancer knowledge and disparities in the information age. Journal of Health Communication, 11 (S1), 1-17.

  1. Wallington, S.F. (2008). The Internet as an emerging patient education tool among African American men with prostate cancer: An exploratory study. American Journal of Men’s      Health, 2(2), 106-121.

  1. Weinstein 2005

  1. Wendler, D., Kington, R., Madans, J., Van Wye, G., Christ-Schmidt, H., Pratt, L., et al. (2006). Are racial and ethnic minorities less willing to participate in health research? PLoS Medicine, 3(2), e19.

  1. Wilkerson, G.R. (2005). Drug metabolism and variability among patients in drug response. New England Journal of Medicine, 352, 2211-2224.

  1. Wood, C.G., Wei, S.J., Hampshire, M.K., Devine, P.A., & Metz, J.M. (2006). The influence of race on the attitudes of radiation oncology patients towards clinical trial enrollment. American Journal of Clinical Oncology, 29(6), 593-599.

82.  Zarcadoolas, C., Pleasant, A. F., & Greer, D. S. (2006). Advancing health literacy: A framework for understanding and action. San Francisco: Jossey-Bass.