This chemoprevention trial tests the efficacy of retinol and beta- carotene in preventing lung cancer in two related high-risk populations: (a) heavy smokers recruited from insurance-based sources, and (b) current and former workers with heavy occupational asbestos exposure recruited from workers' compensation and employment-based sources. The double-blind two-arm randomized protocol compares placebos with a daily combination of 30 mg beta-carotene plus 25,000 IU retinol. We will recruit eligible heavy smokers from the Kaiser Permanente membership in the Portland, Oregon metropolitan area. We will participate in implementing a cost-effective, well-integrated, multi-clinic strategy, with the Seattle-based coordinating center for project management and data analysis. During the first 3 years of the new grant period (1988-91) we will recruit and enroll 2200 subjects randomized according to the multi-center protocol. We will provide all necessary data to evaluate accrual, coordination, and costs in geographically-dispersed clinic sites to generate best estimates of the remaining needs for the full-scale enrollment and follow-up. Current assumptions and projections indicate that the full-scale Efficacy Trial will be capable of detecting significant reductions in lung cancer incidence in the high-risk groups combined, and in either subgroups alone, with 13,000 smokers and 4,000 asbestos-exposed subjects.
| Valanis, B; Blank, J; Glass, A (1998) Mailing strategies and costs of recruiting heavy smokers in CARET, a large chemoprevention trial. Control Clin Trials 19:25-38 |
