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Correspondence: Address correspondence to Dr. Marvella E. Ford, Department of Medicine and Section of Health Services Research, Baylor College of Medicine, Veterans Affairs Medical Center (152), 2002 Holcombe Boulevard, Houston, TX 77030. E-mail: mford{at}bcm.tmc.edu
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Abstract |
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 TOP Abstract AAMEN Project Research Design...ResultsDiscussionReferences |
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Key Words: Recruitment • Cancer screening • African American men • Older adults
The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial is a 16-year, multisite randomized cancer screening trial funded by the National Cancer Institute (Gohagan, Prorok, Hayes, & Kramer, 2000; Prorok et al., 2000; Stallings et al., 2000). The primary objective of the PLCO Cancer Screening Trial is to determine whether screening for the four PLCO Cancer Screening Trial cancers decreases mortality from these cancers in adults aged 55–74 years at entrance to screening. PLCO Cancer Screening Trial participants must be generally healthy and asymptomatic for any of the study cancers at the time of enrollment.
The AAMEN Project, an ancillary study of the PLCO Cancer Screening Trial, is a randomized trial designed to increase the participation of African American men in the PLCO Cancer Screening Trial at the Henry Ford Health System site in Detroit, Michigan. The long-term objective of the AAMEN Project, which began in September 1996, is to identify a method for increasing the participation of older African American men in cancer screening trials. The AAMEN Project is funded by the Centers for Disease Control and Prevention and the National Cancer Institute.
The Need to Recruit African American Men to Cancer Screening Trials
Despite their higher incidence and mortality of cancer relative to their Caucasian counterparts (Baquet & Commiskey, 1999; Collins, 1997; Cooper, Yuan, Landefeld, & Rimm, 1996; DeAtoni et al., 1996; Demers, Severson, Schottenfeld, & Lazar, 1997; Guo, Sigman, Borkowski, & Kyprianou, 2000; Ndubuisi, Kofie, Andoh, & Schwartz, 1995; Platz et al., 1999; Powell et al., 2000; Powell, Heilbrun, Sakr, et al., 1997; Powell, Schwartz, & Hussain, 1995; Smith, DeHaven, Grundig, & Wilson, 1997; Tilley et al., 1997), African American men are not well-represented in cancer screening programs (Ballard, Nash, Raiford, & Harrell, 1993; Bateman et al., 1993; Blumenthal, Sung, Coates, Williams, & Liff, 1995; Chavez, Hubbell, McMullin, Martinez, & Mishra, 1995; Demark-Wahnefried, Catoe, Paskett, Robertson, & Rimer, 1993; Gelfand, Parzuchowski, Cort, & Powell, 1995; Gregg & Curry, 1994; Kang & Bloom, 1993; Millon-Underwood, Sanders, & Davis, 1993; Nelson, 1994; Paskett, DeGraffinreid, & Tatum, 1994; Paskett, DeGraffinreid, Tatum, & Margitic, 1996; Powe, 1995; Roberson, 1994; Smith, DeHaven, Grundig, & Wilson, 1997; Stallings et al., 2000; Thomas, Pinto, Roach, & Vaughn, 2001; Underwood, 1992; Vernon, et al., 1992). On a national level, cancer early detection programs have typically not had high levels of participation among African American men (Lovato, Hill, Hertert, Hunninghake, & Probstfeld, 1997; Powell, Heilbrun, Littrup, et al., 1997; Powell, Gelfand, Parzuchowski, Heilbrun, & Franklin, 1995; Weinrich et al., 1998).
Although cancer screening trial participation is of major importance for all individuals, it is of particular importance for African American men. Valid epidemiological and clinical research is predicated on the proper sampling of a heterogeneous population to ensure sample representativeness (Patrick, Pruchno, & Rose, 1998; Robinson, Ashley, & Haynes, 1996). Important scientific questions such as racial differences in prostate cancer prevalence and severity of disease can only be answered effectively if sufficient numbers of African American men are included in cancer screening trials. The participation of African American men in disease-specific clinical trials does not match the prevalence of these diseases in the African American male population (Bonner & Miles, 1997; Brawley & Tejeda, 1995; El-Sadr & Capps, 1992; Fitzgibbon et al., 1998; Gauthier & Clarke, 1999; Icard, Zamora-Hernandez, Spencer, & Catalona, 1996; Morse, Simon, Besch, & Walker, 1995; Robinson, Ashley, & Haynes, 1996; Thomas, Pinto, Roach, & Vaughn, 2001; Thompson, Neighbors, Munday, & Jackson, 1996; Weinrich et al., 1998; Wright et al., 1996). Without adequate numbers of African American men in clinical trials, the generalizability of study results to members of this population is in question. Further, the scarcity of data regarding African American men could result in inappropriate treatment guidelines for members of this population (Mohiuddin & Hilleman, 1993).
Conceptual Framework of the AAMEN Project
Swanson and Ward (1995) have developed a conceptual framework encompassing barriers related to the recruitment of members of minority groups to clinical trials. This framework includes four barriers. These are sociocultural barriers, economic barriers, individual barriers, and barriers inherent in study design. The AAMEN Project was designed to address each of these types of barriers. The following sections of this article describe these barriers and the manner in which the AAMEN Project addresses them. As shown in Table 1, Arm A consists of an enhanced recruitment letter followed by a telephone eligibility interview conducted by trained African American interviewers and a mailed baseline questionnaire/consent-form packet. Arm B consists of the enhanced recruitment letter followed by the telephone eligibility interview conducted by trained African American interviewers, during which the baseline questionnaire is administered, followed by a mailed consent packet. Arm C includes the enhanced recruitment letter followed by the telephone eligibility interview conducted by trained African American interviewers, followed by a church-based project session, during which the baseline questionnaire is administered and the consent form is completed. The control group, Arm D, consists of standard PLCO Cancer Screening Trial recruitment procedures: an introductory mailing, followed by the telephone eligibility interview conducted by trained African American or Caucasian interviewers, and a mailed baseline questionnaire/consent-form packet that is completed and returned by study participants.
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As another means of addressing sociocultural barriers in the AAMEN Project, research team members include persons whose racial, ethnic, and language backgrounds are similar to those of the potential study participants, which has been found to help establish a greater sense of trust among potential study participants (Ballard, Nash, Raiford, & Harrell, 1993; Henderson & Lee, 1995; Powell, Gelfand, et al., 1995; Roberson, 1994; Swanson & Ward, 1995). In Arms A–C of the AAMEN Project, African American interviewers make the follow-up telephone calls to potential participants, following their receipt of the initial contact letter. Curry, Moen, Morris, and Scheivelhud (1994) noted the importance of including follow-up telephone calls in minority recruitment processes.
Sociocultural barriers are also addressed in the AAMEN Project through the inclusion of local African American churches. Arm C, which includes church-based project sessions, was designed to increase a sense of community partnership between study staff and local community members. Culturally appropriate medical and psychosocial interventions have been found to be more effective than other types of interventions in increasing minority participation in clinical trials (Henderson & Lee, 1995).
African American churches may be defined as African American congregations whose decision-making is controlled by African American individuals (Taylor & Chatters, 1986). These churches often form the focal points for community activities and may be the only institutions in the African American community controlled and run by African Americans. Taylor and Chatters (1986) described African American churches as functioning as "omnipresent and important institutions" for African Americans of all ages. Historically, African American churches have functioned to provide for the educational, nutritional, psychological, and employment needs of African Americans (Taylor & Chatters, 1986). According to Morrison (1991) and Walls and Zarit (1991), African American churches are a natural site for the provision of formal services, as they tend to be used by many community members.
Economic barriers include the costs associated with participating in a research study (Swanson & Ward, 1995). These costs can include transportation and parking costs, child care costs, and lost wages. Economic barriers are addressed in the AAMEN Project. For men who require it, transportation to the church project session sites is provided (Arm C). A contractual agreement was entered into with a local transportation company that has a fleet of well-maintained, plushly outfitted luxury cars that pick up potential participants at their homes and take them to the meeting locations of the church-based project sessions. In addition to providing transportation for participants who would not otherwise be able to come to the project sessions, the use of the luxury cars apparently conveys to the participants the esteem in which they are held by study staff. As one participant stated on his arrival at a church-based project session, "When I saw that car pull up and got into it, I knew I must be important to this study or you (study staff) would not have sent a limousine to pick me up!" In addition, the church-based project sessions are held on Saturday mornings, when the majority of the potential participants do not have to work. Thus, an attempt has been made to hold the church project sessions during times that do not compete with wage earning. Participants were periodically asked whether Saturday mornings were suitable meeting days and times. The overwhelmingly affirmative response from study participants indicated that Saturday mornings were a better time to meet than weekdays or weekday evenings.
Individual barriers include denial of disease or feelings of disease invulnerability (Swanson & Ward, 1995). In Arms A–C of the AAMEN Project, individual barriers are addressed through the use of the enhanced recruitment letter, which focuses on the vulnerability of African American men to major health problems.
Barriers inherent in study design include barriers that are intrinsic to the design of research projects (Swanson & Ward, 1995). For example, at the Henry Ford Health System site of the PLCO Cancer Screening Trial only 50% of the mailed baseline packets are returned, which is a requirement for enrollment. The AAMEN Project was designed to overcome this barrier to participation. In Arm B baseline information is gathered via telephone interview, and in Arm C this information is gathered during church-based project sessions. However, in Arm B it has been discovered that the consent forms, which still need to be mailed to participants for their completion and return, are only returned at a 50% response rate.
Another example of a barrier inherent in study design is the fact that in many multisite, longitudinal studies, participants never see each other face to face. This barrier is addressed in the AAMEN Project in Arm C, which includes church-based project sessions during which participants are given the opportunity to have lunch with each other at no cost to themselves. This allows the men in the study the chance to see the other participants face to face and to develop a sense of group identity and mutual bonding and support. Kaufman and Rodriguez-Trias (1995) stressed the importance of incorporating informal sources of social support into the design and conduct of studies, such as through the church-based project sessions that are part of Arm C.
During the church-based project sessions, the potential participants take part in an interactive forum during which information related to the health status of African American men is presented and discussed. At the end of the forum, the participants enroll in the PLCO Cancer Screening Trial by completing the study forms and receive copies of a booklet entitled "Challenge of a lifetime: Improving the health of African American men in Michigan." The booklet was developed by the Michigan Department of Community Health (MDCH). The presentation based on the information contained in the booklet is typically made by staff from MDCH. This is an example of partnership between the AAMEN Project staff and a state-run community health agency.
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AAMEN Project Research Design and Methods |
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TOPAbstractAAMEN Project Research Design...ResultsDiscussionReferences |
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The specific aims of the AAMEN Project are to evaluate the efficacy of three increasingly intensive recruitment interventions and a control arm in recruiting African American men to the PLCO Cancer Screening Trial (Table 1). Study outcomes related to eligibility status are as follows: (a) eligible and interested in participating, (b) eligible but refused to participate, (c) ineligible to participate (as determined by PLCO Cancer Screening Trial or AAMEN Project criteria), and (d) no contact (unable to contact participant through phone or mail).
Protocol Revision for Those With Unlisted Telephone Numbers
A significant number of African American men in southeastern Michigan ages 55–74 were found to have unlisted telephone numbers. However, the 1990 Census data indicated that a high percentage (95%) of households in southeastern Michigan do have working telephones. Therefore, in the majority of cases in which a listed telephone number is not available, it is likely that the potential participants have working telephones. As a consequence, mailing lists containing the names of African American men ages 55–74 residing in southeastern Michigan are now purchased regardless of whether there is a listed telephone number. A postcard and a prepaid return envelope are included with the introductory mailing sent to everyone. Potential participants are asked to provide a telephone number where they can be reached or a telephone number where they can receive a message. If the postcards are not returned, AAMEN Project staff search for a listed telephone number using the following four Internet person locator sites: (a) infospace, http://www.infospace.com; (b) whowhere, http://www.whowhere.com; (c) switchboard, http://www.switchboard.com; and (d) theultimates, http://www.theultimates.com. If a telephone number is identified, the study protocol is followed.
Statistical Methods
Means and standard deviations are presented for continuous variables such as age. Chi-square tests were used to test for differences in categorical variables such as income level. Student's t test was used to test for age differences between two groups, whereas analysis of variance (ANOVA) techniques were used for testing for age differences within three groups. Because of the large sample size there is very high power to detect even the smallest differences, such that even these differences may be statistically significant. Therefore, the emphasis on the results in this study should not be on significant p values, but on actual differences and their social meaning.
Individuals who were unable to be contacted in the AAMEN Project represent a special group that is regarded in some studies as "soft refusals." However, in the present study this group also contains a large number of participants for whom a correct telephone number was unavailable. Consequently, in this article we will first compare baseline characteristics between individuals who were unable to be contacted versus those who were contacted (i.e., included individuals who were eligible but refused to participate, those who were eligible and interested, and those ineligible to participate). The main focus, however, will be on age, income level, and telephone status differences in eligibility outcomes (refusals, eligible and interested, and ineligible groups).
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Results |
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TOPAbstractAAMEN Project Research Design...ResultsDiscussionReferences |
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Table 3 shows that the group that was most difficult to contact was, on average, younger than the group that was able to be contacted (p <.001). Table 3 also shows that the contact rate in the moderate-to-high income group was almost 6% higher compared with the contact rate in the low-income group (52.4% vs. 46.6%, respectively). The listing status of participants' telephone numbers (listed vs. unlisted) did not affect eligibility status outcome. The percentage of refusals, ineligible, and eligible and interested outcomes were similar for the participants regardless of whether their telephone numbers were listed (p =.08). Thus, once contacted, no differences in outcome were seen among participants, despite their original listed/unlisted telephone number status.
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Discussion |
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TOPAbstractAAMEN Project Research Design...ResultsDiscussionReferences |
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Although efforts have been made to include African American men who do not have telephones by asking them to provide a telephone number where they can be reached, the study is still telephone based in its design. In Wayne County, Michigan, the area from which most of the AAMEN Project participants are drawn, only 5% of the population are without working telephones. Therefore, it is not likely that a large number of men cannot participate due to the lack of a working telephone. However, although applicable to other telephone-based study designs, the results of the AAMEN Project may not be generalizable to studies that do not rely on this method of recruitment. Additionally, the study results indicate a large number of men who refused to participate. Finally, it is important to keep in mind the fact that the AAMEN Project is still underway. Although trends in the data may be observed, conclusive statements cannot yet be made.
Despite the study limitations noted above, the AAMEN Project, a randomized trial that aims to assess the outcomes of a four-arm recruitment effort aimed at recruiting older (aged 55–74 years) African American men to the PLCO Cancer Screening Trial, yields useful results. The telephone- and mail-based recruitment procedures used in the AAMEN Project represent a suitable alternative to face-to-face recruitment when financial resources for recruitment are limited.
The results of the AAMEN Project reflect a number of demographic differences in the characteristics of individuals with different eligibility status outcomes. For example, 38% of these men had low incomes and 62% had moderate-to-high incomes. Men with listed telephone numbers were contacted at a higher rate than men without listed telephone numbers (70% vs. 21%, respectively), in spite of using a number of Internet-based sources in an attempt to locate missing telephone numbers. However, it is interesting to note that once contacted, having a listed versus an unlisted telephone number did not in any way affect likelihood of actually participating in the study. That is, men with unlisted telephone numbers were as likely as men with listed telephone numbers to participate once contacted.
More older than younger men were able to be contacted by telephone, although a higher percentage of younger than older men were eligible and interested in participating. This finding may reflect the fact that a higher proportion of the older men had received a prostate specific antigen (PSA) test than had the younger men. The primary reason for PLCO Cancer Screening Trial ineligibility was having had more than one PSA test in the past 3 years. Because prostate cancer is associated with increased age in the general population, physicians of many of the older men may have conducted a PSA test as part of a yearly examination, thus rendering a substantial proportion of the older men ineligible to participate.
Another interesting study finding was that the proportion of individuals with low incomes who refused to participate was only slightly (3%) lower than the proportion of men with moderate-to-high incomes who refused to participate. It may be that men with fewer economic resources viewed participation in the trial as a means of obtaining free cancer screening exams, although the actual benefits of obtaining such exams has not yet been determined. This finding is supported by another study result that showed that a slightly (only 1.5%) higher proportion of men with moderate-to-high incomes were ineligible to participate, compared with men with low incomes. Again, the primary reason for PLCO Cancer Screening Trial ineligibility was having had more than one PSA test in the past 3 years. Perhaps men with higher incomes were able to purchase a PSA test either through the use of their health insurance coverage or out of pocket. In contrast, men of low income may not have had the same degree of access to PSA tests.
A similar finding was that the proportion of men with low incomes who were eligible and interested in participating was substantially higher (about 1.5 times higher) than the proportion of men with moderate-to-high incomes who were eligible and interested in participating. In summary, the AAMEN Project demonstrated success in recruiting a substantial proportion of men with low incomes, as well as men with moderate-to-high incomes.
Whereas the study results shed light on factors related to clinical trial participation among older African American men, the percentage of men eligible and interested in participating might have been higher had techniques other than mail- and telephone-based strategies been incorporated. For example, one study arm could have involved face-to-face recruitment, in which recruiters went to the homes of potential participants, reviewed the aims of the study, and assisted participants in completing the eligibility screener, and, if eligible to participate, the other study forms, including the consent form. Although this type of recruitment strategy would obviously be more time consuming and labor intensive than the strategies used in the present study, their results may have been more fruitful. Although a growing body of results from recruitment studies have been published, the majority of studies are not randomized trials, as the AAMEN Project is (Curry, Moen, Morris, & Scheivelhud, 1994; DeAtoni et al., 1996; Demark-Wahnefried, Catoe, Paskett, Robertson, & Rimer, 1993; Kang & Bloom, 1993; Myers, Wolf, Balshem, Ross, & Chodak, 1994; Patrick, Pruchno, & Rose, 1998; Powell, Heilbrun, Sakr, et al., 1997). Instead, these studies used nonrandomized designs to recruit community members to cancer screening programs. Therefore, the results of the AAMEN Project represent a substantial addition to existing research in this area.
Future studies could focus on specific arenas, such as gaining a better understanding of reasons for refusing to participate. Indeed, once final analyses of the AAMEN Project have been completed, the results will shed light on the effectiveness of specific recruitment strategies for men with different sociodemographic characteristics, such as age and income. In addition, the relative impact of various barriers to participation could be examined within these different sociodemographic groups.
In summary, the participation of African American men in cancer screening trials is critical to enhancing current understanding of cancer etiology and treatment efficacy in members of this group. The findings in this report suggest that efforts focused specifically on recruiting African American men are needed in order to increase their participation in cancer clinical trials. A high level of commitment to the inclusion of African American men in clinical trials is needed on a number of different levels. This commitment translates into making study sites more accessible to African American men, as well as funding and supporting investigators conducting clinical trials of recruitment studies.
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Footnotes |
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This research was supported by Centers for Disease Control and Prevention/National Cancer Institute Contract NO1-CN-25512, Department of Defense Grant DAMD 17-96-1-6246, and National Institute on Aging Grant P 30 AG 5286. We thank the AAMEN Project telephone interviewing staff for their support: Kevin Davis, Marilynn Drain, Helen Fink, Darnell Franks, Linda Hopkins-Johnson, Jo'Carroll Martin, Arenetra Morris, Timothy Osborne, Vernetta Randolph, Melissa Tracy, and Debbie Williams. 
1Henry Ford Health Sciences Center, Center for Research in Diverse Populations, Detroit, MI.
2>Henry Ford Health Sciences Center, Department of Biostatistics and Research Epidemiology, Detroit, MI.
3Department of Biometry and Epidemiology, Medical University of South Carolina, Charleston, SC.
Received for publication December 31, 2001. Accepted for publication April 15, 2002.
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