Recruiting Black Men to a Clinical Trial to Evaluate Prostate Cancer Screening -- Detroit, Michigan, 1998

In 1998, an estimated 184,500 cases of prostate cancer will be diagnosed and approximately 39,200 men will die from this disease (1). Black men have higher prostate cancer incidence and mortality rates than white men (2). Representation of blacks in clinical trials that investigate the treatment of cancer is proportional to the burden of this disease in the black population (3). However, blacks have generally been underrepresented in clinical trials of preventive interventions (4). To determine the effect of socioeconomic status (SES) on the enrollment of black men in a trial that includes screening for prostate cancer, the African American Men (AAMEN) project in Detroit, Michigan, analyzed data from local recruitment efforts. This report summarizes preliminary results of this analysis, which indicate that SES was not an important factor in refusal to participate in the screening trial.

The Prostate, Lung, Colorectal, and Ovarian Cancer Screening (PLCO) Trial, sponsored by the National Cancer Institute (NCI), is a 16-year, multisite, randomized trial initiated in 1993 to determine whether screening and early detection of these four cancers decrease mortality among healthy, asymptomatic adults aged 55-74 years (5). The trial includes annual screening with prostate-specific antigen (PSA) and a digital rectal examination. Potential participants are ineligible for the study if they have received more than one of the screening tests being evaluated in the trial, have been diagnosed with or are being treated for any of the PLCO trial cancers, or if they have been prescribed finasteride.

The AAMEN project was initiated in October 1996 at the Henry Ford Health System, Detroit, Michigan, as a supplement to the PLCO trial. The AAMEN project, a collaborative effort between CDC and NCI, was designed to evaluate the effectiveness of strategies aimed at increasing recruitment of black men into clinical trials of preventive services. Potential study participants were identified by using commercial and public mailing lists containing the names and addresses of black men aged 55-74 years who lived in metropolitan Detroit.

The enhanced recruitment strategies being evaluated in this study include a direct-mail recruitment packet that contains the picture and signature of a prominent black sports celebrity, a community leader, and a successful Detroit businessman who is approximately the same age as the men targeted for recruitment. Other strategies include follow-up telephone calls by trained black interviewers to determine eligibility to participate in the PLCO trial and recruitment sessions held at local black churches.

The study population was assigned SES codes using census block group information (6). Low and moderate-to-high SES levels were based on annual income and federal poverty guidelines adjusted for household size. * Of the 31,954 potential participants in AAMEN, final recruitment determinations were completed for 19,862 (62.2%). Of the participants who completed the recruitment process, 3691 (18.5%) could not be contacted, resulting in 16,171 potential participants available for analysis.

Through July 1998, the proportion of black men from moderate-to-high SES areas who refused to participate was similar to the proportion from low SES areas. However, a greater proportion of black men from moderate-to-high SES areas were ineligible than were those from low SES areas (p less than 0.01) (Table_1). Comprehensive data about reasons for ineligibility were available only for 2047 (39.4%) of the 5190 ineligible men. Of these, 47% percent were ineligible because of having received more than one PSA test during the preceding 3 years.

Reported by: ME Ford, PhD, S Havstad, MS, Henry Ford Health System, Detroit, Michigan. Epidemiology and Health Svcs Research Br, Div of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, CDC.

Editorial Note

Editorial Note: The goal of clinical trials is to provide science-based information that can be used by health-care providers in making treatment decisions and by policy makers in setting health-care policy. For clinical trials to achieve this goal, persons participating in trials should reflect the diverse composition of the population in which trial results will be applied. The factors that influence blacks to participate in clinical trials are complex and are affected by publicity surrounding ethical abuses in past studies, cultural differences in perceptions about health care, and disparities in access to quality health care (7). These barriers to study participation by black men must be addressed because the incidence of prostate cancer and associated mortality among black men is high and the onset is unusually early compared with the overall U.S. population; such differences cannot be adequately evaluated without sufficient enrollment of blacks in the trial.

The findings of this analysis suggest that when special efforts are made, including use of culturally appropriate approaches, SES status does not influence the willingness of black men to participate in clinical trials. The data also show that many black men were ineligible for the trial because of a high prevalence of prior PSA testing. A recent assessment by the U.S. Preventive Services Task Force recommended against the use of this test for screening because treatment of early stage prostate cancer can have deleterious side-effects, and the impact of screening and treatment on mortality has not been demonstrated definitively (8). However, the American Cancer Society (ACS) recommends that both the PSA test and the digital rectal examination be offered annually, beginning at age 50, to men who have a life expectancy of at least 10 additional years and to younger men who are at high risk for prostate cancer (e.g., men aged 45 years with a strong family history of prostate cancer or who are black) (1). ACS guidelines also emphasize the need to provide patients information about the risks and benefits of screening.

The data presented in this report may not be generalizable to black men residing in other areas of the country. In particular, the high rate of ineligibility attributable to having received a recent PSA test may be secondary to a local community effort (the Detroit Education and Early Detection program) that provides information about prostate cancer and early detection and offers PSA tests and prostate examinations to black men in metropolitan Detroit.

This study underscores that involvement of minority and underserved populations in studies of cancer prevention and control interventions requires state and federal agencies and professional and community groups to 1) support recruitment of blacks and other minority groups into clinical trials; 2) support capacity building necessary for conducting clinical trials at institutions accessible to and trusted by targeted minority populations; and 3) ensure greater involvement of study staff with culture, attitudes, beliefs, and experiences similar to those of populations targeted for clinical trial enrollment.

References

1. Landis SH, Murray T, Bolden S, Wingo PA. Cancer statistics, 1998. CA Cancer J Clin 1998;48:6-29.

2. Ries LAG, Miller BA, Kosary CL, et al, eds. SEER cancer statistics review, 1973-1994: tables and graphs. Bethesda, Maryland: National Institutes of Health, 1997; NIH publication no. 97-2789.

3. Tejeda HA, Green SB, Trimble EL, et al. Representation of African-Americans, Hispanics and whites in National Cancer Institute cancer treatment trials. J Natl Cancer Inst 1996;88:812-6.

4. Eastman P. NCI hopes to spur minority enrollment in prevention and screening trials. J Natl Cancer Inst 1996;88:236-7.

5. Gohagan JK, Prorok PC, Kramer BS, Cornett JE. Prostate cancer screening in the Prostate, Lung, Colorectal and Ovarian Screening Trial of the National Cancer Institute. J Urol 1994;152:1905-9.

6. Krieger N. Overcoming the absence of socioeconomic data in medical records: validation and application of a census-based methodology. Am J Public Health 1992;82:703-10.

7. Brawley OW. The study of untreated syphilis in the negro male. Int J Radia Oncl Biol Phys 1998;40:5-8.

8. US Preventive Services Task Force. Screening for prostate cancer. In: US Preventive Services Task Force: Guide to clinical preventive services. 2nd ed. Baltimore: Williams & Wilkins, 1996:119-34.

* Low SES was defined as an annual income less than 1.5 times the poverty level, and moderate-to-high SES was defined as an annual income greater than or equal to 1.5 times the poverty level.

TABLE 1. Number and percentage of recruitment and eligibility status of black men in the Prostate, Lung, Colorectal, and Ovarian Cancer
Screening Trial, by socioeconomic status (SES)* -- Detroit, Michigan, 1996-1998
==============================================================================================================================================
                            Refused              Ineligible             Deceased               Eligible and interested         Total
                       ------------------    ------------------    -------------------     ------------------------------ -----------------
SES category              No.       (%)        No.        (%)        No.       (%)              No.               (%)      No.       (%)
----------------------------------------------------------------------------------------------------------------------------------------------
Low SES                  2,707    (46.7)      1,597     (27.6)        806    (13.9)              676            (11.7)     5,786   (100.0)
Moderate-to- high SES    4,880    (47.0)      3,593     (34.5)      1,039    (10.0)              873            ( 8.4)    10,385   (100.0)

Total                    7,587    (46.9)      5,190     (32.1)      1,845    (11.4)            1,549            ( 9.6)    16,171   (100.0)
----------------------------------------------------------------------------------------------------------------------------------------------
* Low SES was defined as an annual income <1.5 times the poverty level, and moderate-to-high SES was defined as an annual income>= 1.5 
  times the poverty level.
==============================================================================================================================================

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