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Journal of Clinical Oncology, Vol 23, No 31 (November 1), 2005: pp. 7967-7973 © 2005 American Society of Clinical Oncology. DOI: 10.1200/JCO.2004.00.4952 Recruiting African American Women to Participate in Hereditary Breast Cancer ResearchFrom the Abramson Cancer Center, Department of Psychiatry, and Department of Medicine, University of Pennsylvania, Philadelphia, PA Address reprint requests to Chanita Hughes Halbert, PhD, University of Pennsylvania, 3535 Market St, Suite 4100, Philadelphia, PA 19104; e-mail: Chanita{at}mail.med.upenn.edu
PURPOSE: This study evaluated the process of recruiting African American women to participate in genetic counseling research for BRCA1 and BRCA2 (BRCA1/2) mutations with respect to referral, study enrollment, and participation in genetic counseling. PATIENTS AND METHODS: African American women (n = 783) were referred for study enrollment.
RESULTS: Of 783 referrals, 164 (21%) women were eligible for enrollment. Eligible women were most likely to be referred from oncology clinics (44%) and were least likely to be referred from general medical practices (11%; CONCLUSION: Despite receiving a large number of referrals, only a small subset of women were eligible for enrollment. Oncology settings were the most effective at identifying eligible African American women and general medical practices were the least effective. Factors associated with enrollment included having a stronger family history of cancer and being referred from oncology clinics and community oncology resources. Referral from oncology clinics was the only factor associated significantly with participation in genetic counseling. Education about hereditary breast cancer may be needed among primary care providers to enhance appropriate referral of African American women to genetic counseling for BRCA1/2 mutations.
Despite intensive efforts, African American participation in cancer research remains limited.1-4 In addition, African American enrollment in research on BRCA1 and BRCA2 (BRCA1/2) mutations is low.5,6 Recruitment for these studies is a complex process that begins with identifying potentially eligible participants from referral sites, inviting eligible individuals to enroll onto the study, and completing enrollment and study procedures.7,8 Little is known about the process of recruiting African Americans to participate in clinical research for BRCA1/2 mutations or factors that influence outcomes at each stage of the process. The goals of this study were to determine the proportion of women who are referred to a BRCA1/2 genetic counseling research program who were eligible for participation; determine the proportion of eligible women who enroll onto the study; determine the proportion of women who participate in genetic counseling; and evaluate the role of referral site and participant characteristics on each phase of the recruitment process.
Study Population This study was approved by the Institutional Review Board at the University of Pennsylvania. To be eligible for participation, women had to self-identify as being African American or black, be at least 18 years of age, and have a minimum 5% to 10% prior probability of having a BRCA1/2 mutation. Participant recruitment was initiated in February 2003. To be included in the analysis of study enrollment, potential participants had to have a defined eligibility status, and if eligible, had to have been contacted about enrollment.
Procedures After referral, eligibility was determined by the study genetic counselor (L.K.) and enrollment was initiated by mailed invitation. Specifically, eligible women were mailed an invitation letter that described the study purpose and procedures. Women who did not opt out of enrollment by returning a reply card were contacted by telephone to complete the baseline interview. Before completing the baseline interview, verbal consent for study enrollment was obtained by a trained research assistant using a standardized consent script that described the study purpose and procedures, and possible risks and benefits. After women gave consent and enrolled onto the study, the baseline interview was completed. At the end of the baseline interview, women were invited to participate in pretest genetic counseling. For women who accepted the invitation, a genetic counseling appointment was scheduled for a convenient time, including evenings and weekends. Women were not offered a financial incentive for study enrollment and costs for transportation expenses were paid by grant funds. Genetic testing expenses were paid by participant’s insurance company or by institutional funds at the Abramson Cancer Center (Philadelphia, PA).
Outcomes Study enrollment. Women who consented for study enrollment, completed the baseline interview, and accepted the invitation for pretest genetic counseling were categorized as study enrollees. Women who consented for study enrollment, completed the baseline interview, and declined genetic counseling were also categorized as study enrollees if they agreed to participate in follow-up telephone interviews. Women who actively declined study enrollment and those who passively declined enrollment by not responding to multiple attempts to complete the baseline interview were categorized as nonenrollees. Participation in genetic counseling. Women who completed pretest genetic counseling were categorized as counseling participants. Women who enrolled in the study but declined genetic counseling and those who did not complete counseling after accepting the invitation were categorized as counseling nonparticipants.
Recruitment Variables Referral personnel. Women were categorized as having been referred to the study by physicians or clinic/research staff.
Eligibility Variables BRCA1/2 prior probability. Probability of having a BRCA1/2 mutation was estimated based on the individual's personal and family history of breast and/or ovarian cancer using prior probability models and mutation prevalence tables.11-14 Women were categorized as being at moderate (5%) or high (10% or higher) risk of having a BRCA1/2 mutation.
Participant Characteristics Risk perception. Perceived risk of having a BRCA1/2 mutation was evaluated at baseline using one previously validated Likert-style item3,15,16 that asked women to indicate how likely it was that they had a BRCA1/2 mutation (1 = not at all likely to 4 = definitely). We recoded this item into a dichotomous variable (likely v not likely) based on the distribution of responses.
Eligibility for Study Participation As shown in Figure 1, since initiating recruitment in February 2003 to August 2004, 783 African American women were referred to the study. Most women 492 (63%) were referred from general medical practices (GMPs), 200 (25%) were referred from oncology clinics (ONCs), and 91 (12%) were referred from community oncology resources (COMs). All women referred to the study self-identified as being African American or black.
The referral rate equaled the number of eligible women divided by the total number of women referred to the study. Of the 783 women referred, 164 (21%) were eligible for participation and 619 (79%) were ineligible because their personal or family history of cancer was not suggestive of hereditary disease. Eligible women were most likely to be referred from ONCs (44%) compared with COMs (23%) and GMPs (11%;  2 = 96.80; P = .0001). Ineligible women and those who were eligible for participation but pending contact for enrollment were excluded from subsequent analyses; thus, the data presented below evaluate study enrollment among 157 eligible women (95% of the 164 eligible women).
Predictors of Study Enrollment
We used logistic regression analysis to identify factors having independent associations with study enrollment. Because study enrollment was not significantly different among women referred from ONCs and COMs, we combined these groups into one category and evaluated referral site as a two-level variable (ONC/COM v GMP) in the regression model. Referral site was not associated significantly with family history of cancer ( 2 = 0.74; P = .69) but was related to personal history of disease (2 = 29.83; P = .001); however, this association did not result in multicollinearity (r for the coefficients = –0.41). Therefore, variables that had a bivariate association of P < .20 with enrollment (referral site, cancer history, and family history) were included in the regression model. Only referral site and family history had significant independent associations with study enrollment. Women who had two or more affected relatives were three times more likely to enroll onto the study compared with those who had fewer affected relatives (odds ratio [OR] = 3.18; 95% CI, 1.36 to 7.44; P = .01). Compared with women referred from GMPs, those referred from ONCs and COMs were about three times more likely to enroll (OR = 2.97; 95% CI, 1.34 to 6.58; P = .01). The effect for cancer history was not significant (OR = 2.00; 95% CI, 0.78 to 5.14; P = .15). We reran the logistic regression model excluding women referred from the epidemiologic protocol and the other risk counseling program; the results were unchanged (family history: OR = 3.34, 95% CI, 1.23 to 9.11, P = .02; referral site: OR = 2.93, 95% CI, 1.24 to 6.90, P = .01).
Predictors of Participation in Genetic Counseling
To identify factors having independent association with participation in genetic counseling, we used logistic regression analysis. Because participation in genetic counseling differed among women referred from ONCs, COMs, and GMPs, we used dummy variables to evaluate the effect of referral site; women referred from GMPs were used as the reference group. As listed in Table 3, clinical factors and sociodemographics were not associated significantly with participation in genetic counseling. The addition of referral site improved the overall fit of the model (likelihood ratio test = 14.23; P = .001); however, only the effect for the comparison of the ONCs to GMPs was significant. We reran the logistic regression model excluding women referred from the epidemiologic study and the other risk counseling program, and the results were unchanged (OR = 5.09, 95% CI, 1.27 to 20.45, P = .02 for the comparison of ONCs to GMPs and OR = 2.54, 95% CI, 0.47 to 13.83, P = .28 for the comparison of COMs to GMPs).
To our knowledge, this is the first empirical study to evaluate the process of recruiting (eg, determination of the proportion of eligible women referred to the study and rates of study enrollment and participation in genetic counseling) African American women to genetic counseling research for BRCA1/2 mutations. Despite receiving a large number of referrals, only 21% of women referred to the study were eligible for enrollment; eligible women were most likely to be identified from oncology resources. This finding is not surprising given the fact that hereditary breast cancer is rare and BRCA1/2 mutations account for only approximately 5% to 10% of all breast cancer occurrences.17-19 Thus, most women in the general population, including those receiving care in oncology settings, are not likely to have a personal and family history cancer that is suggestive of hereditary disease and be eligible for enrollment onto genetic counseling research. Overall, 62% of eligible women enrolled onto the study and of the eligible enrollees, 50% participated in genetic counseling. Although prior studies have shown that African Americans report concerns about genetics research20,21 and may not participate in genetic registries,4 our enrollment and participation rates are similar to those reported for hereditary breast cancer studies conducted with predominantly white populations.22,23 It is important to note that only half of eligible women participated in genetic counseling. This may indicate that acceptance of genetic testing may be even lower among African American women than previously reported6,24; however, participation in genetic counseling and testing may be greater among women who are specifically seeking these services. Future studies should evaluate reasons for participating and not participating in genetic counseling among African American women. We found that women who had a stronger family history of cancer were most likely to enroll onto the study. However, family history was not associated with participation in genetic counseling. This suggests that family history may motivate participation in the initial aspects of hereditary breast cancer research, but may not translate into completion of study procedures. Despite this, collecting information on family history from African American women in clinical settings is important to ensure that women with an increased risk for BRCA1/2 mutations are informed about the availability of programs designed to provide education and counseling, and are referred for participation. Participation in genetic counseling may be beneficial to African American women to increase knowledge about breast cancer risk factors and to provide information about options for cancer prevention and control. We also found that referral site was associated significantly with study enrollment and participation in genetic counseling. An important consideration, however, is that eligible women were most likely to be identified from ONCs. However, previous studies have shown that African American participation in cancer prevention and control research and treatment trials is limited, even though participants are identified from oncology settings and may have a vested interest in study enrollment to obtain cancer treatment or support services.1,2,15,25 Our findings suggest that even though recruitment from oncology settings has not translated into high rates of African American participation in most types of cancer research, African American women who are referred from oncology settings may be willing to enroll onto hereditary breast cancer research studies and participate in genetic counseling. It is possible that women referred from oncology settings were most likely to participate in genetic counseling because of increased knowledge about hereditary breast cancer or greater perceived value of genetic risk information.6 Thus, oncology settings can be an effective resource for identifying African American women who are eligible to participate in hereditary breast cancer research, and referral from these settings may translate into completion of study procedures. Future studies are needed to identify motivations for participating in genetic counseling among women referred from different settings. In considering the results of this study, some limitations should be noted. First, we were not able to evaluate the effects of sociodemographics on study enrollment. This information was collected after enrollment; however, we did compare participants and nonparticipants in genetic counseling in terms of sociodemographics, and we also compared study enrollees and nonresponders in terms of some baseline variables. An additional limitation is that more than one type of referral personnel was used. Thus, it is possible that women heard about the study through multiple sources or received more detailed information about the study from clinic staff or physicians. However, referral source was not associated significantly with study enrollment; therefore, it is not likely that any potential variation in information received about the study influenced enrollment decisions. However, our study was not powered to detect differences in study enrollment or participation in genetic counseling based on referral from different types of personnel. Thus, experimental studies are needed to compare the effects of different referral sites and sources on African American enrollment in hereditary breast cancer research. Within these designs it will be especially important to evaluate the impact of race of the individual making the referral and completing enrollment procedures on participation decisions. Despite these limitations, this study highlights the importance of using multiple referral sites to identify African American women at increased risk for hereditary breast cancer. Our findings suggest that African American women at increased risk for having a BRCA1/2 mutation are receptive to enrolling onto genetic counseling research; however, one's family history of cancer and the referral site may influence decisions about study enrollment and participation in genetic counseling. Increasing awareness about the availability of hereditary breast cancer research among African American women in oncology settings and developing strategies to identify women at increased risk for hereditary disease may enhance African American participation in genetic counseling research. It may also be important to enhance knowledge about hereditary breast cancer and genetic counseling among physicians and clinic staff in GMPs. Although most African American women were referred from general medical practices, fewer eligible women were referred from these sites. Recent studies have shown knowledge about hereditary cancer is limited among primary care providers and most primary care providers believe that they are not qualified to provide genetic services.26,27 Educational efforts about hereditary cancer may enhance recognition of women at increased risk for BRCA1/2 mutations in settings where a greater number of African American women may be receiving health care.
The authors indicated no potential conflicts of interest.
Costs for genetic testing were paid by institutional funds at the Abramson Cancer Center. We thank all of the women who expressed an interest in this study and we are especially appreciative to those who participated in this research.
Supported by Department of Defense Grant No. DAMD17-00-1-0262. Authors' disclosures of potential conflicts of interest are found at the end of this article.
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17. Miki Y, Swensen J, Shattuck-Eidens D, et al: A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1. Science 266:66-71, 1994 18. Wooster R, Bignell G, Lancaster J, et al: Identification of the breast cancer susceptibility gene BRCA2. Nature 378:789-792, 1995[CrossRef][Medline] 19. Claus EB, Schildkraut JM, Thompson WD, et al: The genetic attributable risk of breast and ovarian cancer. Cancer 77:2318-2324, 1996[CrossRef][Medline] 20. Furr LA: Perceptions of genetics research as harmful to society: Differences among samples of African Americans and European Americans. Genet Test 6:25-30, 2002[CrossRef][Medline] 21. Thompson HS, Valdimarsdottir B, Jandorf L, et al: Perceived disadvantages and concerns about abuses of genetic testing for cancer risk: Differences across African American, Latina and Caucasian women. Patient Educ Couns 51:217-227, 2003[CrossRef][Medline] 22. Lerman C, Narod S, Schulman K, et al: BRCA1 testing in families with hereditary breast-ovarian cancer. JAMA 275:1885-1892, 1996[Abstract] 23. Cappelli ML, Surh L, Humphreys S, et al: Psychological and social determinants of women's decisions to undergo genetic counseling and testing for breast cancer. Clin Genet 55:419-430, 1999[CrossRef][Medline] 24. Hughes C, Fasaye GA, LaSalle VH, et al: Sociocultural influences on participation in genetic risk assessment and testing among African American women. Patient Educ Couns 51:107-114, 2003[CrossRef][Medline]
25. Sears SR, Stanton AL, Kwan L, et al: Recruitment and retention challenges in breast cancer survivorship research: Results from a multisite, randomized intervention trial in women with early stage breast cancer. Cancer Epidemiol Biomarkers Prev 12:1087-1090, 2003 26. Mouchawar J, Klein CE, Mullineaux L: Colorado family physicians' knowledge of hereditary breast cancer and related practice. J Cancer Educ 16:33-37, 2001[Medline] 27. Freedman AN, Wideroff L, Olson L, et al: US physicians' attitudes toward genetic testing for cancer susceptibility. Am J Med Genet 120:63-71, 2003 Submitted November 9, 2004; accepted July 25, 2005. This article has been cited by other articles:
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Copyright © 2005 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
