There is intense disagreement in the medical community regarding the value of population based PSA screening for asymptomatic men, and the efficacy of aggressive treatment of screen-detected disease. In the midst of this controversy, professional groups are increasingly advocating fully informing men of the pros and cons of screening and allowing them to make a personal decision regarding whether to obtain screening. Although informed decision-making is rapidly becoming the """"""""standard of care"""""""" in this area, there is a paucity of information regarding how screening decisions are made in real world settings, and the best ways to promote an informed decision. This information gap is especially acute for ethnic minority men, who have not been systematically studied with respect to prostate cancer screening. Therefore, we propose to conduct a randomized clinical trial to evaluate the effect of an intervention designed to increase informed decision-making regarding prostate cancer screening in a community sample of Hispanic men. Hispanics constitute very large proportions of the Los Angeles and California populations, and prostate cancer is the most common form of cancer and the second leading cause of cancer death in this group. We will recruit 900 Hispanic men from multiple community-based organizations in the Los Angeles area, and administer an in-person baseline interview. Following this, subjects will be randomized to the two study arms. The Intervention Group (N=450) will be invited to attend a small group discussion session aimed at informing men about the nature of prostate cancer, pros and cons of screening, the controversy surrounding treatment of early stage disease, and the importance of making an active and informed decision regarding obtaining a PSA [prostate-specific antigen] test. They will also receive culturally tailored print materials summarizing the information presented in the intervention session. The Control Group (N=450) will be given a pre-existing, publicly available pamphlet, that mentions the availability of screening tests for prostate cancer but does not include details regarding the pros and cons of screening, or other elements of the intervention. Subjects in both groups will be re-contacted 12-months post baseline and administered a telephone interview to assess the impact of our intervention. The two main outcomes will include a composite measure of informed decision making (multidimensional construct including knowledge of prostate cancer and the pros and cons of screening, communication with physician or others regarding screening, and active participation in the screening decision) and receipt of PSA in the past 12 months.
| Crespi, Catherine M; Wong, Weng Kee; Mishra, Shiraz I (2009) Using second-order generalized estimating equations to model heterogeneous intraclass correlation in cluster-randomized trials. Stat Med 28:814-27 |
| Wong, Weng Kee; Zhu, Wei (2008) Optimum treatment allocation rules under a variance heterogeneity model. Stat Med 27:4581-95 |
| Moerbeek, Mirjam; Wong, Weng Kee (2008) Sample size formulae for trials comparing group and individual treatments in a multilevel model. Stat Med 27:2850-64 |
