Factors Affecting Older African American Women's Decisions to Join the PLCO Cancer Screening Trial
http://www.100md.com
《临床肿瘤学》
the Graduate School of Public Health at University of Pittsburgh and University of Pittsburgh Cancer Institute, Pittsburgh, PA
ABSTRACT
PURPOSE: The purpose of this study is to describe the factors associated with the decisions of older African American women to join the PLCO (Prostate, Lung, Colorectal and Ovarian) Cancer Screening Trial when recruited.
METHODS: African American women between ages 55 and 74 years who were never diagnosed with a PLCO cancer were eligible for our study. Two methods of recruitment were used. First, mailings were sent to a random sample of women describing the PLCO followed by a telephone call to determine interest in the PLCO. If women were not interested in PLCO but consented to participate in our study, they were interviewed immediately. Second, we followed up with African American women who responded to mass mailings sent out before the start of our study by the Pittsburgh PLCO office. Women completed an interview about their cancer and clinical trial knowledge, attitudes, beliefs, and behaviors. The responses of women who joined the PLCO Trial are contrasted with the responses of women who did not join.
RESULTS: Numerous factors were associated with the decision of older African American women to join the PLCO, including perceptions of cancer prevention and detection, the experience of having a loved one with cancer, knowledge of and experience with clinical trials, and beliefs regarding the benefits and risks of clinical trial participation.
CONCLUSION: Minority recruitment to cancer clinical trials could be increased by designing interventions focused on individual, organizational, and community needs.
INTRODUCTION
Cancer incidence and mortality rates have declined in the past decade, but minority populations in the United States continue to bear a disproportionate share of the nation’s cancer burden.1,2 African Americans as a group have high cancer incidence and mortality rates3,4 and lower 5-year relative survival rates than whites.3,5 Cancer incidence and mortality rates for colorectal cancer are higher for African American women than for white women—that is, an incidence of 52 v 45 cases per 100,000 persons and 24.2 v 16.4 deaths per 100,000 persons.6 By contrast, the incidence and mortality rates for lung/bronchus and ovarian cancers are lower for African American women than for white women.6
Disparities in cancer incidence and mortality are a major concern, but their etiology is uncertain. One possibility is the inadequate representation of minorities in clinical research. Lack of adequate participation in clinical trials by diverse populations has limited the differences among groups and the generalizability of trial results and our ability to analyze subgroup differences.3
The National Institutes of Health Revitalization Act of 1993 mandates the inclusion of women and minorities in all National Institutes of Health–funded research, if appropriate.7 Since then, there has been a greater effort to recruit women and minorities into clinical research. In recent years, participation by African American women in cancer treatment trials has increased.8 However, cancer prevention trials continue to have difficulty recruiting women and minorities.3,8
Participation of African Americans in cancer clinical trials is likely shaped by a number of factors: structural barriers such as lack of health insurance coverage,9-14 cultural attitudes and beliefs, including mistrust of the health care system,15-25 lack of experience with clinical trials,3,26-30 and failure of physicians to refer patients.28-31 In general, much of what is known about factors affecting willingness of African Americans to participate in clinical trials has come from focus group studies29 and surveys where individuals have been asked general, hypothetical questions about their support for and willingness to participate in medical research.32,33 In addition, other studies focus on barriers to recruitment of African American cancer patients to treatment trials.34 By contrast, this study describes the factors affecting willingness of generally healthy, older African Americans to participate in a cancer screening trial, and does so in the context of an actual recruitment.
METHODS
This study examines accrual of older African American women to a randomized trial of cancer screening technologies—the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial—at the Pittsburgh, PA, site during 1997 and 1998. The PLCO is a 16-year, multisite randomized trial funded by the National Cancer Institute to determine whether screening decreases mortality from these cancers among adults aged 55 to 74 years. The purpose of our study was to describe the factors associated with the decision of older African American women to join the PLCO.
Eligibility Criteria
Women who met the basic eligibility requirements of the PLCO Trial were eligible for inclusion in our study. Our inclusion criteria were: African American women between the ages of 55 and 74 years, who had never been diagnosed with lung, colon/rectal, or ovarian cancer, and who were not currently being treated for any other cancer. Ethnicity was determined through individual self-identification.
Participant Recruitment and Data Collection
The recruitment process used at the Pittsburgh site of the PLCO Trial is illustrated in Figure 1. Two recruitment methods were used. First, to understand the decisions of women who had no interest in the PLCO Trial (Fig 1, box 1), a random sample of 604 age and race eligible women was drawn from a PLCO recruitment mailing list of licensed drivers and registered voters in Allegheny County, PA. We mailed the standard PLCO introductory letter and brochure explaining the trial (ie, why it is being conducted, eligibility criteria, what participants are asked to do, and how to learn more about the study). Forty-two mailings were sent in waves of 10 to 15 letters per mailing to ensure timely follow-up by our interviewers. These women may have received a prior mailing inviting them to participate in the PLCO study. Women were contacted within 5 to 7 days after receipt of our mailing. Only women who decided that they weren’t interested in the PLCO were interviewed immediately. If women expressed any interest, they were thanked and recontacted and interviewed after they had made their decision. Interviews were conducted either face-to-face or by telephone, whichever was more convenient for the respondent.
To understand the decisions of women who expressed an interest in the PLCO (Fig 1, box 2), two different groups of women were interviewed. First, the 35 women who were scheduled to attend an informational meeting and cancelled at least three appointments during the data collection period (Fig 1, box 3) were contacted and asked to participate in our study. Second, the 74 women who attended an informational meeting (Fig 1, box 4) to learn about the trial (ie, study purpose, length, eligibility criteria, risks and benefits, and participant tasks) were approached immediately before the meeting and were asked if they would be willing to discuss their decision regarding participation after the presentation. Women who agreed were interviewed by telephone, usually later the same day, but no later than a week after the meeting.
Interviews took approximately 45 to 60 minutes and were administered by trained interviewers. Interview data were collected between January 1997 and December 1998. Participants were paid $20 for completing the interview. This study was approved by the University of Pittsburgh institutional review board.
Instrumentation
The interview instrument consisted of 81 open- and closed-ended items. Women were asked about their prior cancer screening behavior, family history of cancer, conceptualization of cancer, cancer detection, and cancer prevention, perceived susceptibility to lung, colorectal, and ovarian cancers, their knowledge, attitudes, beliefs, and prior experience with clinical trials, and a set of demographic questions. Women were also asked selected items from the Powe Fatalism Inventory, a 15-item tool designed to assess fatalistic beliefs regarding cancer.35 After pilot testing, we used a modified 12-item version. Finally, women were asked a unique set of seven questions on the basis of whether or not they joined the PLCO. All of the responses to open-ended questions were recorded by the interviewers and were then collapsed into categories for analysis.
Statistical Analyses
The responses of the 206 women with no interest in the PLCO were combined with those of the 22 women who scheduled and cancelled three appointments and the two women who attended an informational meeting but declined participation. These women are labeled as nonjoiners (n = 230) in the analysis and are contrasted with the responses of women who attended a PLCO informational meeting and joined the trial (n = 69)—referred to as joiners.
Because of the dearth of information regarding factors affecting the willingness of African Americans to participate in a prevention trial when recruited, the analysis focuses on a descriptive examination of the data to provide contextual information rather than provide an explanatory model. Frequency data were generated to describe the characteristics of the women who participated in our study. Odds ratios were calculated to explore potential differences between women who joined the PLCO and those who did not. Logistic regression analysis was performed to identify those significant between-group differences that remained after we controlled for age, marital status, living arrangement, education, income, and employment status.
RESULTS
Table 1 provides a summary of the consent rate of contacted participants. Demographic characteristics are reported in Table 2.
Perceptions of Cancer Prevention and Detection
When describing cancer, most women provided similar responses regardless of whether or not they joined the trial. However, joiners’ conceptualization of cancer (on the basis of responses to an open-ended question) differed in two areas. Joiners were more likely to say that cancer is characterized by "cells taking over, or spreading throughout the body" and that "early detection increases the possibility of a cure or survival" (Table 3).
When asked an open-ended question about cancer prevention, the majority of all women believed that eating a healthy diet prevented cancer. However, joiners tended to emphasize the additional prevention strategies of "smoking avoidance and exercise/weight control" (Table 3).
When describing early detection methods, approximately half of all women mentioned mammograms and about one third mentioned Papanicolaou tests, but fewer than 10% mentioned any type of colon cancer screening test. However, joiners were more likely than nonjoiners to mention other, specific early-detection strategies/tests (Table 3).
Cancer Experience and Screening Behavior
Approximately three quarters of all women said their doctor had recommended at least one of the following: mammogram, Papanicolaou test, fecal occult blood tests, and breast self examinations (in descending order of frequency). And, almost all women reported having at least one of these tests. In addition, joiners were more likely than nonjoiners to report having a close relative with cancer (Table 4). Many women made comments such as, "their loved ones’ experiences with cancer" made them realize that they were "getting older" and were "more vulnerable" and therefore, "should be getting screened for cancer."
Perceived Cancer Susceptibility
When asked about the likelihood of their getting lung, colorectal, or ovarian cancer, the majority of all women surveyed said it was unlikely (Table 4). When asked why, women volunteered the following open-ended responses. Fifty-nine women (20%) said they were unlikely to get ovarian cancer because they had either a partial or total hysterectomy. Forty-six women (15%) said they were unlikely to get lung cancer because they either "never smoked," "were a former smoker," or "were only exposed to second-hand smoke." (Thirty-six women [12%] volunteered that they were current smokers.) And, 21 women (7%) said they were unlikely to get colon cancer because they either "ate a proper diet" or "were tested as part of the PLCO study for colon cancer and everything was fine."
Cancer Fatalism
Women were asked about their attitudes toward cancer and, overall, there were no significant differences between joiners and nonjoiners (Table 4).
Knowledge and Experience With Clinical Trials
Joiners were more likely than nonjoiners to report having participated in a prior study (eg, hypertension/high blood pressure, osteoporosis, and weight studies) and had a tendency to know at least one other person who had participated in a clinical trial. However, almost all women said that their doctor had never talked to them about participating in a clinical trial (Table 5).
Benefits and Risks of Clinical Trial Participation
When asked about the benefits and risks of clinical trial participation (Table 5), joiners were more likely to say they believed they could personally benefit than nonjoiners. The most frequent reasons given were: "by early detection of a disease" and/or "to gain knowledge or information about their health."
When asked whether African Americans benefit as much as whites from clinical trial participation, joiners were more likely than nonjoiners to say "yes." However, joiners gave somewhat different reasons (from open-ended responses) than nonjoiners. Joiners said African Americans benefit as much as whites because, "we’re all equal," "we all get the same diseases, so we all benefit." Joiners who said that African Americans do not benefit as much as whites, said so because first, African Americans "do not participate" and second, because African Americans "are not informed" and/or "not contacted about studies" as much as whites. Similarly, nonjoiners who said that African Americans don’t benefit as much as whites, said so because first, "they are not informed" and/or "not contacted" and second, because "African Americans are skeptical" or "lacking in trust because of Tuskeegee" and "the [medical] system is unfair to blacks."
The majority of all women said that there are risks to participation (Table 5). However, when asked to describe the types of risks, both joiners and nonjoiners most frequently mentioned the "risks of taking medications, radiation, side effects, and shots." The second most frequent risk mentioned by joiners was that "treatments or procedures may cause other problems" or "the treatment may help one disease but cause problems in other parts of the body." The second most frequent risk cited by nonjoiners was "the risk of being used as a guinea pig" or "being deliberately injected with a disease" and the "lack of faith/distrust" that is engendered.
Characteristics of Clinical Trial Participants
Women were asked about the characteristics of clinical trial participants (ie, the sick, healthy, rich, poor, white, African American). There were no significant differences in beliefs regarding who joins a clinical trial with the exception of beliefs regarding poverty and race (Table 5).
Beliefs Regarding Clinical Trials Study Design
Participants were questioned about how clinical trials are designed and executed (Table 5). Joiners were more likely than nonjoiners to believe that clinical trial participants are always told that they’re enrolled and about possible risks and benefits. Women were also asked, "When people participate in a treatment clinical trial, they’re assigned to a group to receive treatment. How do you think that the person’s medical treatment is chosen? Do you think the physician chooses, the participant chooses, or the treatment is assigned at random—like flipping a coin?" Joiners were more likely to reply that treatment is assigned at random. However, approximately one third of joiners stated that a person’s physician assigns treatment. These women frequently commented that, "I hope the person’s physician is assigning his/her treatment and not leaving it to chance."
Willingness to Participate in Treatment Clinical Trials
Women were asked about the circumstances under which they would be willing to participate in a clinical trial that focused on the study of a new treatment for a disease of interest to them. Joiners were more likely to say they would take part in such a study for an ongoing health problem that either they or a loved one had or any disease of importance to them (Table 5).
DISCUSSION
Participants who joined the PLCO Trial were younger, better educated, and had higher household incomes than women who declined participation. The median household income of African Americans in Allegheny County, PA, at the time of this study was $22,130.36 Approximately 50% of joiners versus 40% of nonjoiners reported household incomes above the median. However, after controlling for age, education, income, and employment status, significant differences remained between joiners and nonjoiners in knowledge; attitudes; beliefs; and perceptions regarding cancer, prevention, screening, and clinical trials. Joiners had a better understanding of cancer and the role of early detection and screening in successfully treating and/or surviving cancer than nonjoiners. These women communicated to the researchers that acquiring information about their health was a priority. Perhaps their assimilation of health information accounts for the observed differences.
Although both joiners and nonjoiners alike reported having prior cancer screening tests, nevertheless, some joiners said one of their reasons for joining the PLCO was "to have one of the cancer screening tests being evaluated." Studies have shown that participation in a clinical trial is an opportunity for some African Americans to receive information and care that may not otherwise be readily available (eg, flexible-sigmoidoscopy or chest x-ray).3,29,30,37 Perhaps the joiners, being more knowledgeable, utilized the trial to obtain additional information about their health.
Women who joined the PLCO Trial also appeared to be motivated by the experience of having a loved one with cancer. In addition, they tended to be willing to take the next step and take part in a study of a new treatment for an ongoing health problem that either they or a loved one had or any disease of importance to them. These women were positive in their outlook about cancer and believed that early detection and treatment made a difference in health outcomes. A number of studies have reported that African American women have fatalistic attitudes toward cancer.3,15,35 Powe (1995) found that cancer fatalism was predicted by education, income, ethnicity, and sex. However, in the current study, looking only at African American women, we found no difference in fatalistic attitudes between the joiners and nonjoiners, even though joiners were better educated and had higher incomes.35
Women who joined the PLCO were clearly more knowledgeable about clinical trials and reported prior experience with them. However, all the women in our study reported that their doctor/health care provider had never talked to them about joining a clinical trial. The lack of physician communication regarding this issue appears to be a major missed opportunity for recruitment. Given that participants reported following their physicians’ recommendations regarding cancer screening, it seems reasonable to assume that physician discussion and endorsement of clinical trials would have a positive impact on patients’ decisions.38
Ultimately, women who joined the PLCO Trial believed that they would personally benefit from participation and that any potential risks were outweighed by the benefits. These women said that "early detection of disease" and "gaining information about their health" were their main reasons for joining the trial. Although most of the joiners believed that African Americans benefit as much as whites from participation in clinical trials, those who did not—both joiners and nonjoiners alike—said it was primarily because African Americans don’t participate and/or aren’t informed and secondly, because they are skeptical of research and lacking in trust.
While the findings suggest that a level of mistrust of clinical trials and researchers exists among all women, and especially among the nonjoiners, the risk of taking medications and the complications from various procedures/treatments seems to be a greater concern. Perhaps a recruitment strategy should place an emphasis on providing education and information about the potential risks of taking various study medications and their side effects and how to manage them. Having this type of information in advance would empower minority participants and may help to dispel attitudes of being treated as a "guinea pig."
The results of this research suggest that the recruitment of more African American women to cancer clinical trials will be dependent on a number of different intervention efforts at multiple levels. First, a study must provide women with a perceived benefit(s)—that is, something that they want. For example, diagnostic or screening tests, as in the case of the PLCO Trial, as well as educational information and skills that they deem to be valuable and that empower them to make informed decisions with respect to their health.
At an organizational level, registries of African Americans interested in participating in various types of clinical trials need to be established. The findings indicate that joiners were more likely to have participated in prior studies and tended to know others who have done so. In addition, cancer survivor networks could be utilized to assist with recruitment to cancer prevention, screening, and treatment trials. Finally, various systems must be put into place to inform physicians about and encourage them to refer appropriate patients to clinical trials. Physicians, especially primary care physicians, must also be rewarded in some manner for their efforts.
Finally, the findings suggest that there is a clear need to engage in a dialogue with members of the African American community to facilitate recruitment. First, there is a need to dispel the misperception that only the poor or minorities participate in clinical trials. The nonjoiners overestimated the extent to which these groups participate. Perhaps because African Americans are not well-informed because of ineffective recruitment strategies, they lack the first-hand experience with clinical trials that the joiners have, which may perpetuate misperceptions regarding who participates. Second, there is a need to distinguish the different types of cancer clinical trials available and how they are designed and implemented. This could include a discussion of the concept of randomization, the circumstances under which a placebo might be given to participants in a clinical trial, and the informed consent process. Those who engage in a community dialogue must be trained and sensitive to how their engagement of the community may affect the willingness of African Americans to participate.
There were several limitations to the study. First, data were collected at only one site and, therefore, may not be generalizable. However, we believe the data are unique and shed light on an issue of great concern—namely, an in-depth look at the factors influencing the decisions of older, African American women regarding participation in a cancer screening trial. Second, the sample was drawn from lists of licensed drivers and registered voters in Allegheny County and, therefore, not every African American household was included. However, the sample for our study was representative of the population being recruited to the PLCO Trial. Finally, some of the differences found in joiners’ knowledge of clinical trials could be attributed to attendance at the PLCO informational meeting rather than as a result of level of education. However, after controlling for level of education significant differences in knowledge, attitudes, beliefs, and behaviors regarding clinical trials exist that weren’t influenced by attendance at the PLCO presentation.
We used the PLCO as an opportunity to learn about the general attitudes of joiners and nonjoiners toward clinical trials in general and screening trials in particular. We conclude that minority accrual to cancer clinical trials could be increased by designing interventions focused on individual, organizational, and community needs.
Authors' Disclosures of Potential Conflicts of Interest
The authors indicated no potential conflicts of interest.
NOTES
Supported by Grant No. NCI-5 RO3CA73340 from the National Cancer Institute.
Presented in part at the American Public Health Association Annual Meeting, Boston, MA, November 15, 2000.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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Racial and ethnic patterns: Cancer facts and figures. Atlanta, GA, American Cancer Society publication 8620-R, 1997
Giuliano AR, Mokuau N, Hughes C, et al: Participation of minorities in cancer research: The influence of structural, cultural, and linguistic factors. Ann Epidemiol 10:S22-S34, 2000
Haunes MA, Smedley BD: The unequal burden of cancer - An assessment of NIH research and progress for ethnic minorities and the medically underserved. Institute of Medicine. Washington, DC, National Academy Press, 1999
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Price JH, Desmond SM, Slenker S, et al: Urban black women's perceptions of breast cancer and mammography. J Commun Health 17:191-204, 1992
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ABSTRACT
PURPOSE: The purpose of this study is to describe the factors associated with the decisions of older African American women to join the PLCO (Prostate, Lung, Colorectal and Ovarian) Cancer Screening Trial when recruited.
METHODS: African American women between ages 55 and 74 years who were never diagnosed with a PLCO cancer were eligible for our study. Two methods of recruitment were used. First, mailings were sent to a random sample of women describing the PLCO followed by a telephone call to determine interest in the PLCO. If women were not interested in PLCO but consented to participate in our study, they were interviewed immediately. Second, we followed up with African American women who responded to mass mailings sent out before the start of our study by the Pittsburgh PLCO office. Women completed an interview about their cancer and clinical trial knowledge, attitudes, beliefs, and behaviors. The responses of women who joined the PLCO Trial are contrasted with the responses of women who did not join.
RESULTS: Numerous factors were associated with the decision of older African American women to join the PLCO, including perceptions of cancer prevention and detection, the experience of having a loved one with cancer, knowledge of and experience with clinical trials, and beliefs regarding the benefits and risks of clinical trial participation.
CONCLUSION: Minority recruitment to cancer clinical trials could be increased by designing interventions focused on individual, organizational, and community needs.
INTRODUCTION
Cancer incidence and mortality rates have declined in the past decade, but minority populations in the United States continue to bear a disproportionate share of the nation’s cancer burden.1,2 African Americans as a group have high cancer incidence and mortality rates3,4 and lower 5-year relative survival rates than whites.3,5 Cancer incidence and mortality rates for colorectal cancer are higher for African American women than for white women—that is, an incidence of 52 v 45 cases per 100,000 persons and 24.2 v 16.4 deaths per 100,000 persons.6 By contrast, the incidence and mortality rates for lung/bronchus and ovarian cancers are lower for African American women than for white women.6
Disparities in cancer incidence and mortality are a major concern, but their etiology is uncertain. One possibility is the inadequate representation of minorities in clinical research. Lack of adequate participation in clinical trials by diverse populations has limited the differences among groups and the generalizability of trial results and our ability to analyze subgroup differences.3
The National Institutes of Health Revitalization Act of 1993 mandates the inclusion of women and minorities in all National Institutes of Health–funded research, if appropriate.7 Since then, there has been a greater effort to recruit women and minorities into clinical research. In recent years, participation by African American women in cancer treatment trials has increased.8 However, cancer prevention trials continue to have difficulty recruiting women and minorities.3,8
Participation of African Americans in cancer clinical trials is likely shaped by a number of factors: structural barriers such as lack of health insurance coverage,9-14 cultural attitudes and beliefs, including mistrust of the health care system,15-25 lack of experience with clinical trials,3,26-30 and failure of physicians to refer patients.28-31 In general, much of what is known about factors affecting willingness of African Americans to participate in clinical trials has come from focus group studies29 and surveys where individuals have been asked general, hypothetical questions about their support for and willingness to participate in medical research.32,33 In addition, other studies focus on barriers to recruitment of African American cancer patients to treatment trials.34 By contrast, this study describes the factors affecting willingness of generally healthy, older African Americans to participate in a cancer screening trial, and does so in the context of an actual recruitment.
METHODS
This study examines accrual of older African American women to a randomized trial of cancer screening technologies—the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial—at the Pittsburgh, PA, site during 1997 and 1998. The PLCO is a 16-year, multisite randomized trial funded by the National Cancer Institute to determine whether screening decreases mortality from these cancers among adults aged 55 to 74 years. The purpose of our study was to describe the factors associated with the decision of older African American women to join the PLCO.
Eligibility Criteria
Women who met the basic eligibility requirements of the PLCO Trial were eligible for inclusion in our study. Our inclusion criteria were: African American women between the ages of 55 and 74 years, who had never been diagnosed with lung, colon/rectal, or ovarian cancer, and who were not currently being treated for any other cancer. Ethnicity was determined through individual self-identification.
Participant Recruitment and Data Collection
The recruitment process used at the Pittsburgh site of the PLCO Trial is illustrated in Figure 1. Two recruitment methods were used. First, to understand the decisions of women who had no interest in the PLCO Trial (Fig 1, box 1), a random sample of 604 age and race eligible women was drawn from a PLCO recruitment mailing list of licensed drivers and registered voters in Allegheny County, PA. We mailed the standard PLCO introductory letter and brochure explaining the trial (ie, why it is being conducted, eligibility criteria, what participants are asked to do, and how to learn more about the study). Forty-two mailings were sent in waves of 10 to 15 letters per mailing to ensure timely follow-up by our interviewers. These women may have received a prior mailing inviting them to participate in the PLCO study. Women were contacted within 5 to 7 days after receipt of our mailing. Only women who decided that they weren’t interested in the PLCO were interviewed immediately. If women expressed any interest, they were thanked and recontacted and interviewed after they had made their decision. Interviews were conducted either face-to-face or by telephone, whichever was more convenient for the respondent.
To understand the decisions of women who expressed an interest in the PLCO (Fig 1, box 2), two different groups of women were interviewed. First, the 35 women who were scheduled to attend an informational meeting and cancelled at least three appointments during the data collection period (Fig 1, box 3) were contacted and asked to participate in our study. Second, the 74 women who attended an informational meeting (Fig 1, box 4) to learn about the trial (ie, study purpose, length, eligibility criteria, risks and benefits, and participant tasks) were approached immediately before the meeting and were asked if they would be willing to discuss their decision regarding participation after the presentation. Women who agreed were interviewed by telephone, usually later the same day, but no later than a week after the meeting.
Interviews took approximately 45 to 60 minutes and were administered by trained interviewers. Interview data were collected between January 1997 and December 1998. Participants were paid $20 for completing the interview. This study was approved by the University of Pittsburgh institutional review board.
Instrumentation
The interview instrument consisted of 81 open- and closed-ended items. Women were asked about their prior cancer screening behavior, family history of cancer, conceptualization of cancer, cancer detection, and cancer prevention, perceived susceptibility to lung, colorectal, and ovarian cancers, their knowledge, attitudes, beliefs, and prior experience with clinical trials, and a set of demographic questions. Women were also asked selected items from the Powe Fatalism Inventory, a 15-item tool designed to assess fatalistic beliefs regarding cancer.35 After pilot testing, we used a modified 12-item version. Finally, women were asked a unique set of seven questions on the basis of whether or not they joined the PLCO. All of the responses to open-ended questions were recorded by the interviewers and were then collapsed into categories for analysis.
Statistical Analyses
The responses of the 206 women with no interest in the PLCO were combined with those of the 22 women who scheduled and cancelled three appointments and the two women who attended an informational meeting but declined participation. These women are labeled as nonjoiners (n = 230) in the analysis and are contrasted with the responses of women who attended a PLCO informational meeting and joined the trial (n = 69)—referred to as joiners.
Because of the dearth of information regarding factors affecting the willingness of African Americans to participate in a prevention trial when recruited, the analysis focuses on a descriptive examination of the data to provide contextual information rather than provide an explanatory model. Frequency data were generated to describe the characteristics of the women who participated in our study. Odds ratios were calculated to explore potential differences between women who joined the PLCO and those who did not. Logistic regression analysis was performed to identify those significant between-group differences that remained after we controlled for age, marital status, living arrangement, education, income, and employment status.
RESULTS
Table 1 provides a summary of the consent rate of contacted participants. Demographic characteristics are reported in Table 2.
Perceptions of Cancer Prevention and Detection
When describing cancer, most women provided similar responses regardless of whether or not they joined the trial. However, joiners’ conceptualization of cancer (on the basis of responses to an open-ended question) differed in two areas. Joiners were more likely to say that cancer is characterized by "cells taking over, or spreading throughout the body" and that "early detection increases the possibility of a cure or survival" (Table 3).
When asked an open-ended question about cancer prevention, the majority of all women believed that eating a healthy diet prevented cancer. However, joiners tended to emphasize the additional prevention strategies of "smoking avoidance and exercise/weight control" (Table 3).
When describing early detection methods, approximately half of all women mentioned mammograms and about one third mentioned Papanicolaou tests, but fewer than 10% mentioned any type of colon cancer screening test. However, joiners were more likely than nonjoiners to mention other, specific early-detection strategies/tests (Table 3).
Cancer Experience and Screening Behavior
Approximately three quarters of all women said their doctor had recommended at least one of the following: mammogram, Papanicolaou test, fecal occult blood tests, and breast self examinations (in descending order of frequency). And, almost all women reported having at least one of these tests. In addition, joiners were more likely than nonjoiners to report having a close relative with cancer (Table 4). Many women made comments such as, "their loved ones’ experiences with cancer" made them realize that they were "getting older" and were "more vulnerable" and therefore, "should be getting screened for cancer."
Perceived Cancer Susceptibility
When asked about the likelihood of their getting lung, colorectal, or ovarian cancer, the majority of all women surveyed said it was unlikely (Table 4). When asked why, women volunteered the following open-ended responses. Fifty-nine women (20%) said they were unlikely to get ovarian cancer because they had either a partial or total hysterectomy. Forty-six women (15%) said they were unlikely to get lung cancer because they either "never smoked," "were a former smoker," or "were only exposed to second-hand smoke." (Thirty-six women [12%] volunteered that they were current smokers.) And, 21 women (7%) said they were unlikely to get colon cancer because they either "ate a proper diet" or "were tested as part of the PLCO study for colon cancer and everything was fine."
Cancer Fatalism
Women were asked about their attitudes toward cancer and, overall, there were no significant differences between joiners and nonjoiners (Table 4).
Knowledge and Experience With Clinical Trials
Joiners were more likely than nonjoiners to report having participated in a prior study (eg, hypertension/high blood pressure, osteoporosis, and weight studies) and had a tendency to know at least one other person who had participated in a clinical trial. However, almost all women said that their doctor had never talked to them about participating in a clinical trial (Table 5).
Benefits and Risks of Clinical Trial Participation
When asked about the benefits and risks of clinical trial participation (Table 5), joiners were more likely to say they believed they could personally benefit than nonjoiners. The most frequent reasons given were: "by early detection of a disease" and/or "to gain knowledge or information about their health."
When asked whether African Americans benefit as much as whites from clinical trial participation, joiners were more likely than nonjoiners to say "yes." However, joiners gave somewhat different reasons (from open-ended responses) than nonjoiners. Joiners said African Americans benefit as much as whites because, "we’re all equal," "we all get the same diseases, so we all benefit." Joiners who said that African Americans do not benefit as much as whites, said so because first, African Americans "do not participate" and second, because African Americans "are not informed" and/or "not contacted about studies" as much as whites. Similarly, nonjoiners who said that African Americans don’t benefit as much as whites, said so because first, "they are not informed" and/or "not contacted" and second, because "African Americans are skeptical" or "lacking in trust because of Tuskeegee" and "the [medical] system is unfair to blacks."
The majority of all women said that there are risks to participation (Table 5). However, when asked to describe the types of risks, both joiners and nonjoiners most frequently mentioned the "risks of taking medications, radiation, side effects, and shots." The second most frequent risk mentioned by joiners was that "treatments or procedures may cause other problems" or "the treatment may help one disease but cause problems in other parts of the body." The second most frequent risk cited by nonjoiners was "the risk of being used as a guinea pig" or "being deliberately injected with a disease" and the "lack of faith/distrust" that is engendered.
Characteristics of Clinical Trial Participants
Women were asked about the characteristics of clinical trial participants (ie, the sick, healthy, rich, poor, white, African American). There were no significant differences in beliefs regarding who joins a clinical trial with the exception of beliefs regarding poverty and race (Table 5).
Beliefs Regarding Clinical Trials Study Design
Participants were questioned about how clinical trials are designed and executed (Table 5). Joiners were more likely than nonjoiners to believe that clinical trial participants are always told that they’re enrolled and about possible risks and benefits. Women were also asked, "When people participate in a treatment clinical trial, they’re assigned to a group to receive treatment. How do you think that the person’s medical treatment is chosen? Do you think the physician chooses, the participant chooses, or the treatment is assigned at random—like flipping a coin?" Joiners were more likely to reply that treatment is assigned at random. However, approximately one third of joiners stated that a person’s physician assigns treatment. These women frequently commented that, "I hope the person’s physician is assigning his/her treatment and not leaving it to chance."
Willingness to Participate in Treatment Clinical Trials
Women were asked about the circumstances under which they would be willing to participate in a clinical trial that focused on the study of a new treatment for a disease of interest to them. Joiners were more likely to say they would take part in such a study for an ongoing health problem that either they or a loved one had or any disease of importance to them (Table 5).
DISCUSSION
Participants who joined the PLCO Trial were younger, better educated, and had higher household incomes than women who declined participation. The median household income of African Americans in Allegheny County, PA, at the time of this study was $22,130.36 Approximately 50% of joiners versus 40% of nonjoiners reported household incomes above the median. However, after controlling for age, education, income, and employment status, significant differences remained between joiners and nonjoiners in knowledge; attitudes; beliefs; and perceptions regarding cancer, prevention, screening, and clinical trials. Joiners had a better understanding of cancer and the role of early detection and screening in successfully treating and/or surviving cancer than nonjoiners. These women communicated to the researchers that acquiring information about their health was a priority. Perhaps their assimilation of health information accounts for the observed differences.
Although both joiners and nonjoiners alike reported having prior cancer screening tests, nevertheless, some joiners said one of their reasons for joining the PLCO was "to have one of the cancer screening tests being evaluated." Studies have shown that participation in a clinical trial is an opportunity for some African Americans to receive information and care that may not otherwise be readily available (eg, flexible-sigmoidoscopy or chest x-ray).3,29,30,37 Perhaps the joiners, being more knowledgeable, utilized the trial to obtain additional information about their health.
Women who joined the PLCO Trial also appeared to be motivated by the experience of having a loved one with cancer. In addition, they tended to be willing to take the next step and take part in a study of a new treatment for an ongoing health problem that either they or a loved one had or any disease of importance to them. These women were positive in their outlook about cancer and believed that early detection and treatment made a difference in health outcomes. A number of studies have reported that African American women have fatalistic attitudes toward cancer.3,15,35 Powe (1995) found that cancer fatalism was predicted by education, income, ethnicity, and sex. However, in the current study, looking only at African American women, we found no difference in fatalistic attitudes between the joiners and nonjoiners, even though joiners were better educated and had higher incomes.35
Women who joined the PLCO were clearly more knowledgeable about clinical trials and reported prior experience with them. However, all the women in our study reported that their doctor/health care provider had never talked to them about joining a clinical trial. The lack of physician communication regarding this issue appears to be a major missed opportunity for recruitment. Given that participants reported following their physicians’ recommendations regarding cancer screening, it seems reasonable to assume that physician discussion and endorsement of clinical trials would have a positive impact on patients’ decisions.38
Ultimately, women who joined the PLCO Trial believed that they would personally benefit from participation and that any potential risks were outweighed by the benefits. These women said that "early detection of disease" and "gaining information about their health" were their main reasons for joining the trial. Although most of the joiners believed that African Americans benefit as much as whites from participation in clinical trials, those who did not—both joiners and nonjoiners alike—said it was primarily because African Americans don’t participate and/or aren’t informed and secondly, because they are skeptical of research and lacking in trust.
While the findings suggest that a level of mistrust of clinical trials and researchers exists among all women, and especially among the nonjoiners, the risk of taking medications and the complications from various procedures/treatments seems to be a greater concern. Perhaps a recruitment strategy should place an emphasis on providing education and information about the potential risks of taking various study medications and their side effects and how to manage them. Having this type of information in advance would empower minority participants and may help to dispel attitudes of being treated as a "guinea pig."
The results of this research suggest that the recruitment of more African American women to cancer clinical trials will be dependent on a number of different intervention efforts at multiple levels. First, a study must provide women with a perceived benefit(s)—that is, something that they want. For example, diagnostic or screening tests, as in the case of the PLCO Trial, as well as educational information and skills that they deem to be valuable and that empower them to make informed decisions with respect to their health.
At an organizational level, registries of African Americans interested in participating in various types of clinical trials need to be established. The findings indicate that joiners were more likely to have participated in prior studies and tended to know others who have done so. In addition, cancer survivor networks could be utilized to assist with recruitment to cancer prevention, screening, and treatment trials. Finally, various systems must be put into place to inform physicians about and encourage them to refer appropriate patients to clinical trials. Physicians, especially primary care physicians, must also be rewarded in some manner for their efforts.
Finally, the findings suggest that there is a clear need to engage in a dialogue with members of the African American community to facilitate recruitment. First, there is a need to dispel the misperception that only the poor or minorities participate in clinical trials. The nonjoiners overestimated the extent to which these groups participate. Perhaps because African Americans are not well-informed because of ineffective recruitment strategies, they lack the first-hand experience with clinical trials that the joiners have, which may perpetuate misperceptions regarding who participates. Second, there is a need to distinguish the different types of cancer clinical trials available and how they are designed and implemented. This could include a discussion of the concept of randomization, the circumstances under which a placebo might be given to participants in a clinical trial, and the informed consent process. Those who engage in a community dialogue must be trained and sensitive to how their engagement of the community may affect the willingness of African Americans to participate.
There were several limitations to the study. First, data were collected at only one site and, therefore, may not be generalizable. However, we believe the data are unique and shed light on an issue of great concern—namely, an in-depth look at the factors influencing the decisions of older, African American women regarding participation in a cancer screening trial. Second, the sample was drawn from lists of licensed drivers and registered voters in Allegheny County and, therefore, not every African American household was included. However, the sample for our study was representative of the population being recruited to the PLCO Trial. Finally, some of the differences found in joiners’ knowledge of clinical trials could be attributed to attendance at the PLCO informational meeting rather than as a result of level of education. However, after controlling for level of education significant differences in knowledge, attitudes, beliefs, and behaviors regarding clinical trials exist that weren’t influenced by attendance at the PLCO presentation.
We used the PLCO as an opportunity to learn about the general attitudes of joiners and nonjoiners toward clinical trials in general and screening trials in particular. We conclude that minority accrual to cancer clinical trials could be increased by designing interventions focused on individual, organizational, and community needs.
Authors' Disclosures of Potential Conflicts of Interest
The authors indicated no potential conflicts of interest.
NOTES
Supported by Grant No. NCI-5 RO3CA73340 from the National Cancer Institute.
Presented in part at the American Public Health Association Annual Meeting, Boston, MA, November 15, 2000.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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