CHICAGOAdvances in cancer screening, prevention, and treatment
have led to decreased cancer incidence and mortality. However, the
benefits of new early detection measures and treatment options are
not shared equally among ethnic minorities and the medically
underserved, and disparities in cancer morbidity and mortality
For example, blacks have the highest overall incidence of cancer of
any racial or ethnic group in the United States and are 33% more
likely than whites to die of cancer.
Black women have the highest rates of colorectal and lung cancers and
have the highest mortality rates for breast, colorectal, and lung
cancer. Black men have the highest incidence of and mortality from
prostate, colorectal, and lung cancers. Blacks have low rates of
cancer screening and low rates of participation in cancer clinical
The IOM Report
The disproportionate burden of cancer led to the Congressional
request that the Institute of Medicine (IOM) review the National
Institutes of Healths research and programs for ethnic
minorities and the medically underserved. The IOMs report
has drawn attention to low rates of minority participation in cancer
screening and prevention studies.
Clinical trials play a crucial role in cancer research. Assuring that
new treatment and prevention approaches are effective and safe for
the general population requires large-scale, randomized, double-blind
clinical trials. However, recruitment is challenging, with less than
5% of eligible cancer patients being enrolled in clinical treatment
To ensure that research findings can be generalized to and are
applicable to diverse populations, clinical trials should include
adequate representation from minority populations.
Despite efforts to increase minority enrollment into cancer
prevention trials, however, minority participation rates remain low.
For example, in the ongoing Prostate Cancer Prevention Trial (PCPT)
and Breast Cancer Prevention Trial (BCPT), minority enrollment rates
did not reach 5%.[2,4]
In addition to increasing minority participation in prevention
trials, decreasing cancer incidence and improving cancer survival
requires successful implementation of new technologies for cancer
screening and early detection, some of which have only recently
become available to the public. (One such technology, genetic
screening for mutations in cancer susceptibility genes, will be
discussed in an upcoming article in this series.)
Low minority participation rates in cancer screening and prevention
trials suggest that barriers to participation have not been
adequately addressed. Targeted research and interventions are
necessary for decreasing cancer rates in ethnic minorities and the
This paper will address the work by Marvella Ford, PhD, of the Henry
Ford Health Care System, Detroit, on recruitment of blacks into
cancer chemopre-vention trials, as presented at the Robert H. Lurie
Comprehensive Cancer Centers Health Policy
SymposiumCancer: Reaching Medically Underserved Populations.
Minority Recruitment Goals
Successful cancer prevention trials require recruitment and retention
of large numbers of healthy asymptomatic participants. In addition,
lengthy trial periods of 10 years or more are often necessary to
detect any differences in tumor development between the intervention
and placebo arms.
Unlike treatment trials where participants receive high-quality
standard care and/or the experimental treatment, all participants in
prevention trials are healthy and therefore may not receive any
supplemental care. In addition, those who receive the intervention
may experience adverse effects they would not experience if not in
the trial, and those in the placebo arm may not experience any
Ongoing prevention trials have not met target minority recruitment
goals. For example, although black men over age 55 make up 8.2% of
the US male population over age 55, of the 18,882 men randomized into
the PCPT, 92% are white and only 4% are black.[4,5]
Disparities in minority recruitment in the BCPT are even more
pronounced. More than 95% of the 13,266 participants are white, and
only 2.1% are black, an accrual rate that is not representative of
the disease burden in this population.
In another NCI-sponsored prevention trial, the Prostate, Lung,
Colorectal, and Ovarian Cancer Screening Trial (PLCO), 89% of
participants were white, 4.4% black, 1.4% Hispanic, 4.3% Asian
American, and less than 0.5% other.
To achieve appropriate representation of minorities in prevention
trials, recruitment efforts must address barriers to minority
enrollment. Barriers to minority participation in clinical trials
include historical, sociocultural, economic, and individual
Blacks perceptions of clinical research have been influenced by
the Tuskegee Syphilis Study that began in the 1930s and was designed
to document the natural course of syphilis.
Although penicillin became standard treatment for syphilis in the
1940s, researchers did not provide information about or access to
antibiotics. The men were left untreated into the early 1970s, when
the study was disclosed and subsequently shut down.
Sociocultural, Economic Barriers
Sociocultural barriers include lack of access to information about
clinical trials, mistrust of the health care system, fear of being
used as a guinea pig, cultural beliefs about specific diseases or
illness in general, fatalism, or embarrassment.[8,9]
The largest economic barrier to participation of minority and
low-income persons is lack of health insurance. In most cases, access
to the health care system is a prerequisite for participation in
Other economic barriers include lack of transportation, the need for
child care, and lost wages because of missed work. Individual
barriers may include beliefs about personal invulnerability to disease.
The AAMEN Project
The African American Men (AAMEN) project began in 1996 as a
collaboration between the Centers for Disease Control, the National
Cancer Institute, and the Henry Ford Health Care System. The
project is designed to supplement the PLCO trial by determining the
effectiveness of strategies to overcome participation barriers and
increase the enrollment of black men in prostate cancer prevention
The PLCO trial, which began in 1993, aims to determine if screening
for and early detection of prostate, lung, colorec-tal, and ovarian
cancer among healthy, asymptomatic adults aged 55 to 74 decreases
It is essential to include black men in such trials, since they have
the highest incidence of prostate cancer as well as the highest
mortality rate from this cancer. Black men also have the lowest
rates of participation in prostate cancer screening, such as digital
rectal exams and prostate-specific antigen (PSA) blood tests.
The AAMEN project builds on previous focus group studies indicating
that black men of low to middle socioeconomic status with greater
knowledge about prostate cancer and screening for the disease are
more willing to participate in prostate cancer clinical trials.
The project uses commercial and public mailing lists to identify the
names and addresses of black men aged 55 to 74 who live in the
Detroit metropolitan area, and randomizes potential participants to
one of three enhanced recruitment strategies.
Men in the first intervention are sent a packet of recruitment
materials containing the photograph and signature of a black sports
celebrity, a Detroit community leader, and a Detroit businessman
approximately the same age as the men targeted by the AAMEN program.
The second intervention strategy includes telephone calls by trained
black men to determine eligibility to participate in the PLCO trial.
The third intervention employs recruitment sessions at local black
Each of these interventions aims to overcome the recruitment barriers
of mistrust and lack of awareness by disseminating information about
the trial through individuals and institutions that the targeted
population might trust. At this time, no preliminary data are
available on the recruitment rates of the AAMEN project.
Another intervention targeting blacks has already yielded promising
results. Holcombe et al report success in recruiting black men into
cancer prevention trials by identifying and addressing barriers to
Researchers at Louisiana State University Medical Center-Shreveport
(LSUMC-S) have achieved recruitment of blacks above the nationwide
average through a variety of techniques:
- Using community-based recruitment approaches.
- Working through Louisianas Charity Hospital System to
avoid cost concerns.
- Providing alternatives to written information.
- Addressing suspicion and cultural concerns about clinical
research in peer education groups.
As a result of these concerted efforts, 11% of patients enrolled in
the PCPT through LSUMC-S are black, compared with 4% overall.
Persistent disparities in cancer incidence and mortality between
whites and ethnic minorities in the United States suggest a need for
targeted efforts to increase cancer screening and prevention measures
among ethnic minorities and the medically underserved.
Since current clinical trial recruitment strategies are not reaching
the diverse populations, cancer clinicians and other researchers may
need to look at the recruitment strategies of studies in other areas
of medicine that have successfully recruited large numbers of
For example, researchers exploring the effect of dietary patterns on
blood pressure among adults with mild hypertension in the DASH trial
used targeted mailings, mass mailings, community and worksite
screening, and mass media advertising to recruit ethnic minorities.
As a result of these efforts, two thirds of participants are
minorities, and 60% are black.
In another example of successful recruitment, the African American
Antiplatelet Stroke Prevention Study (AAASPS), blacks were recruited
by developing a community network involving community members, black
churches and community organizations, and mass media advertising to
spread information about the study.
1. American Cancer Society: Cancer Facts and Figures 2000. Atlanta,
American Cancer Society, 2000.
2. Haynes MA, Smedley BD (eds): The Unequal Burden of Cancer: An
Assessment of NIH Research and Programs for Ethnic Minorities and the
Medically Underserved. Washington, DC, National Academy Press, 1999.
3. Benson AB 3d, Pregler JP, Bean JA, et al: Oncologists
reluctance to accrue patients onto clinical trials: An Illinois
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4. Coltman CA Jr, Thompson IM Jr, Feigl P, et al: Prostate Cancer
Prevention Trial (PCPT) update. Eur Urol 35:544-547, 1999.
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Population by Age, Race and Hispanic Origin, and Sex. March 1999.
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Americans in oncology clinical trials: The Louisiana State University
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13. Vollmer WM, Svetkey LP, Appel LJ, et al: Recruitment and
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