Minority recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT).
BACKGROUND
Previous large chemoprevention studies have not recruited significant numbers of minorities. The Selenium and Vitamin E Cancer Prevention Trial (SELECT) is a large phase III study evaluating the impact of selenium and vitamin E on the clinical incidence of prostate cancer. Over 400 SELECT study sites in the USA, Canada, and Puerto Rico recruited men to this trial. The SELECT recruitment goal was 24% minorities, with 20% black, 3% Hispanic, and 1% Asian participants. The goal for black participants was set at 20% because of their proportion in the United States population and their prevalence of prostate cancer.


METHODS
The minority recruitment strategies in SELECT were to: 1) consider minority recruitment during site selection; 2) expand the eligibility criteria by lowering the age criterion for black men and including men with controlled co-morbid illnesses; 3) develop a national infrastructure; 4) give additional funds to sites with the potential to increase black enrollment; and 5) provide resources to maximize free media opportunities to promote SELECT.


RESULTS
SELECT recruitment began in August 2001 and was intended to last five years, but concluded two years ahead of schedule in June 2004. Of the 35 534 participants enrolled, 21% were minorities, with 15% black, 5% Hispanic, and 1% Asian.


CONCLUSIONS
Careful planning, recruitment of large numbers of clinical centers and adequate resources accomplished by the combined efforts of the National Cancer Institute (NCI), Southwest Oncology Group (SWOG), SELECT Recruitment and Adherence Committee (RAC), SELECT Minority and Medically Underserved Subcommittee (MMUS), and the local SELECT sites resulted in attainment of the estimated sample size ahead of schedule and recruitment of the largest percentage of black participants ever randomized to a cancer prevention trial.
Cook
Elise D
ED
Department of Clinical Cancer Prevention, Unit 1360, The University of Texas M D Anderson Cancer Center, Houston 77230-1439, USA. edcook@mdanderson.org
Moody-Thomas
Sarah
S
Anderson
Karen B
KB
Campbell
Russell
R
Hamilton
Sandra J
SJ
Harrington
Joseph M
JM
Lippman
Scott M
SM
Minasian
Lori M
LM
Paskett
Electra D
ED
Craine
Stephen
S
Arnold
Kathryn B
KB
Probstfield
Jeffrey L
JL
D001741:Black or African American; D000368:Aged; D000975:Antioxidants / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000208:ethnology; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D014810:Vitamin E / Q000627:therapeutic use
D000975:Antioxidants; D014810:Vitamin E