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Behavioral and Social Science: Recruitment/Retention/Adherence in Clinical Research

Demographics, co-morbidities, and adherence/retention record of a large African American cohort of cancer prevention trial participants.

Cook County Hospital, Chicago, IL; Jesse Brown VA Medical Center, Chicago, IL

Abstract

B49

Chicago West Side VA (Jesse Brown) Medical Center, a major component of the Universtiy of IIllinois Minority Based CCOP, has enrolled 745 subjects in the Selenium and Vitamin E Cancer Prevention Trial (SELECT), of whom 663 (89%) are African American. These 663 subjects, comprising 12.5% of the entire African American population in SELECT, were enrolled between October 15, 2001 and June 24, 2004, at a constant rate of 22.5 subjects/month. Enrollment age range was 50-86 (mean 59.7, median 57). 66% take hypertension medications. 39% take statins for hyperlipidemia. 26% are diabetic. 21% have symptomatic BPH. 21% have Post-Traumatic Stress Disorder. 39% are current smokers and 42% are former smokers. Since enrollment, 17 subjects have been diagnosed with prostate cancer and 22 with other cancers (lung 5, colon 5, bladder 2, pancreas 2, kidney 3, hepatocellular 2, and stomach, anal, and lymphoma 1 each). 33 have died (myocardial infarction 13, cancer 10, drug overdose 2, CVA 2, trauma 1, seizure 1, congestive heart failure 1, suicide 1, undetermined cause 2). 18 (3%) have been lost to follow-up. 4 participants have been transferred to other SELECT study sites. 118 (17%) have discontinued SELECT study supplements but remain in follow-up per protocol. 88% of on-supplement participants are "adherent" (>80% compliance by pill counts). 97% of the 626 remaining African American subjects are in contact per protocol. Median follow up is 3.25 years. 17 prostate cancers have been diagnosed to date, an annualized rate of 800/100,000. The compliance and retention record of this urban male African American US Veteran population which is a major component of the total SELECT African American enrollment has been excellent. .