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Recruiting African American Women to Participate in Hereditary Breast Cancer Research

From 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

	ABSTRACT

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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%; ² = 96.80; P = .0001). Overall, 62% of eligible women enrolled onto the study and 50% of enrollees completed genetic counseling. Women with a stronger family history of cancer (odds ratio [OR] = 3.18; 95% CI, 1.36 to 7.44; P = .01) and those referred from oncology clinics and community oncology resources (OR = 2.97; 95% CI, 1.34 to 6.58; P = .01) were most likely to enroll onto the study. Referral from oncology clinics was associated significantly with participation in genetic counseling (OR = 5.46; 95% CI, 1.44 to 20.60; P = .01).

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.

	INTRODUCTION

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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.

	PATIENTS AND METHODS

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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
Potential participants were identified through a referral network that included seven clinical institutions and community oncology resources (eg, breast cancer support groups, health fairs) located in Philadelphia, PA. At all clinical referral sites, the following information was provided in brochures and flyers given to all African American women by physicians and clinic staff: a new research program specifically for African American women was available, and eligible women would receive counseling and education about hereditary cancer. At community oncology resources, study brochures and flyers were distributed by research staff. It is important to note that some women (n = 19) were referred to the study while participating in an epidemiologic protocol designed to identify genetic risk factors for breast cancer or learned about the study through another breast cancer risk counseling program at the University of Pennsylvania (n = 14). However, these women did not receive genetic counseling or clinical genetic testing for BRCA1/2 mutations before being referred; thus, there was no overlap with the genetic counseling research program. Furthermore, enrollment was not significantly different among women referred from the epidemiologic study and counseling program (² = 1.20; P = .27). Referral forms were completed by women interested in learning more about genetic counseling and included the following information: racial background, address, birth date, and personal and family history of cancer.

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
Eligibility. Women who had a 5% to 10% prior probability of having a BRCA1/2 mutation were eligible for study enrollment. Women who did not have a 5% to 10% prior probability were ineligible.

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 site. Women were categorized as being referred from oncology resources (eg, oncology clinics [ONCs], mammography facilities), general medical resources (eg, internal medicine, obstetric/gynecology practices), or community oncology resources based on the setting from which they were referred.

Referral personnel. Women were categorized as having been referred to the study by physicians or clinic/research staff.

Eligibility Variables
Clinical factors. Age, personal history of breast and/or ovarian cancer, and family history of cancer were obtained by self-report at referral. Because it is standard practice in genetic counseling to construct a three-generation pedigree,^9,10 we calculated the total number of first-, second-, and third-degree relatives affected with breast and/or ovarian cancer. Women were categorized as having two or more, or less than two affected relatives.

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
Sociodemographics. Marital status, education level, employment status, and income were obtained by self-report at the baseline interview.

Risk perception. Perceived risk of having a BRCA1/2 mutation was evaluated at baseline using one previously validated Likert-style item^3,15,16 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.

	RESULTS

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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.

View larger version (28K): [in this window] [in a new window]   Fig 1. Overview of study procedures. *Women pending contact for study enrollment (n = 7) were excluded from the analysis of study enrollment. **Women undecided about genetic counseling (n = 3) were excluded from the analysis of participation in genetic counseling.

Predictors of Study Enrollment
The enrollment rate equaled the number of women who enrolled onto the study divided by the total number of eligible women. Of 157 eligible women, 98 (62%) enrolled onto the study. As listed in Table 1, family history was associated significantly with enrollment. Women who had two or more affected relatives were most likely to enroll. Study enrollment was also significantly greater among women referred from ONCs and COMs compared with GMPs. There was also a trend for affected women to be more likely to enroll onto the study compared with unaffected women. No other factors were associated significantly with study enrollment.

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
The rate for participation in genetic counseling equaled the number of women who participated in genetic counseling divided by the number of eligible study enrollees. Overall, 48 (50%) of eligible study enrollees (n = 95) participated in genetic counseling (30% of all eligible women [n = 157] contacted for study enrollment). (Three women who enrolled onto the study were undecided about participation in genetic counseling and were excluded from the analysis of genetic counseling participation; therefore, the denominator for this analysis is 95 women.) As listed in Table 2, women with greater education and those at high risk for having a BRCA1/2 mutation were most likely to participate in genetic counseling. Women referred from ONCs were also most likely to participate in genetic counseling. Affected women were also more likely to participate in genetic counseling compared with unaffected women; however, this effect was not statistically significant (P = .07). No other factors were associated significantly with participation in genetic counseling.

	DISCUSSION

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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 research^20,21 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 reported^6,24; 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.

	Authors' Disclosures of Potential Conflicts of Interest

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The authors indicated no potential conflicts of interest.

	Acknowledgment

 
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.

	NOTES

 
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.

	REFERENCES

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Submitted November 9, 2004; accepted July 25, 2005.

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