Prospective, multicenter, randomized trial of a new organizational modality for providing information and support to cancer patients.

PURPOSE: No structured modality for providing information and support to patients in oncology wards has been validated in clinical trials. METHODS: This is a pragmatic, two-arm, cluster randomized trial, with the oncology ward as random assignment unit. Centers were allocated to implement a Point of Information and Support (PIS) or to a control group. The PIS included a library for cancer patients and a specifically trained oncology nurse. End points, measured at patient level, were psychological distress and satisfaction with received information. Both intent-to-treat and per-protocol analyses considering clustering were performed. RESULTS: Thirty-eight Italian cancer centers were randomly assigned, and 6 months after PIS creation, 3,286 unselected, consecutive cancer patients were surveyed (1,654 in the experimental group and 1,632 in the control group). Three thousand one hundred ninety-seven (97%) questionnaires were collected and deemed valid. Fifty-two percent of centers (11 of 21 centers) in the experimental arm did not implement the PIS in accordance with the protocol. Overall, 34% of patients showed moderate to severe psychological distress, and only 9% declared dissatisfaction. Intent-to-treat analysis did not yield significant differences. Although the per-protocol analysis did show a reduction in psychological distress (28.9% for functioning PIS v 33.3% for no PIS) and dissatisfaction (6.4% for functioning PIS v 9.3% for no PIS), differences did not reach significance. CONCLUSION: This is the first cluster randomized trial aiming to demonstrate that a structured modality of providing information reduces psychological distress. We did not find this, but we believe results should be interpreted cautiously, particularly because of the low compliance with PIS implementation. Context analysis preceding such interventions is essential.

Prostate cancer and exposure to pesticides in agricultural settings.

Our study evaluates the association between prostate cancer and exposure to pesticides in agricultural settings in Italy. The data were derived from a hospital-based multi-site case-control study carried out in 5 rural areas between 1990-92. In our study, 124 new cases of prostate cancer were ascertained and interviewed, along with 659 cancer controls. A team of agronomists assessed past exposure to pesticides by using a checklist of 100 chemical families and 217 compounds applied from 1950-85 in the areas considered. The association between prostate cancer and different occupational risk factors was measured by maximum likelihood estimation of the odds ratio, controlling for potential confounders. "Ever been employed in agriculture" was associated with a 40% increased risk (OR = 1.4, 95% CI = 0.9-2.0). Prostate cancer was also related positively to food and tobacco (OR= 2.1, 95% CI = 1.1-4.1), and chemical products (OR = 2.2, 95% CI = 0.7-7.2) industries. The analyses carried out to estimate the association between different types of pesticides and prostate cancer showed increased risks among farmers exposed to organochlorine insecticides and acaricides (OR = 2.5, 95% CI = 1.4-4.2), more specifically to the often contemporary used compounds DDT (OR = 2.1, 95% CI = 1.2-3.8), and dicofol (OR = 2.8, 95% CI = 1.5-5.0), whose effects could not be well separated.