Effectiveness of a standardized patient education program on therapy-related side effects and unplanned therapy interruptions in oral cancer therapy: a cluster-randomized controlled trial.

PURPOSE: Oral agents for cancer treatment are increasingly prescribed due to their benefits. However, oral cancer medications are difficult to handle and have a considerable potential for side effects. This type of therapy requires a high level of self-management competence by the patient. A standardized patient education program provided by physicians and oncology nurses may positively influence the handling of oral agents. The aim of the study was to evaluate the impact of a standardized patient education program provided by specially trained oncology nurses on therapy management regarding side effects and unplanned therapy interruptions. METHODS: One hundred sixty-five patients from 28 office-based oncology practices from all over Germany participated in this cluster-randomized controlled study. Patients of both intervention (n = 111) and standard care groups (n = 54) received the usual oncologist counseling; in addition, the patients from the intervention group (k = 17 practices) received an education from specially trained oncology nurses. The time of observation was 3 months per patient. RESULTS: The patients of the intervention group reported fewer side effects (skin rash, pain, fatigue, nausea, vomiting). Patients in the standard care group interrupted the therapy more frequently without informing their oncologist, compared to the intervention group. CONCLUSIONS: Patients benefit from a standardized patient education program provided by specially trained oncology nurses. They tend to handle side effects and critical situations better.

The response of soil organism communities to the application of the insecticide lindane in terrestrial model ecosystems.

The EU plant protection regulation 1107/2009/EC defines the requirements for active ingredients to be approved, specifically including the assessment of effects on biodiversity and ecosystems. According to that, semi-field methods are expected to be more important in the near future. Therefore, a higher-tier experiment suitable to assess the risk for soil organisms was conducted to further develop the TME (terrestrial model ecosystems) methodology in a dose-response design with the persistent insecticidal model compound lindane (gamma-HCH). The effects of lindane on soil communities such as collembolans, oribatid mites, nematodes, soil fungi and plant biomass were determined in 42 TME. Intact TME-soil cores (diameter 300 mm, height 400 mm) from undisturbed grassland were stored outdoor under natural climatic conditions. Lindane was applied in five concentrations between 0.032 mg active ingredients (ai)/kg dry soil and 3.2 mg ai/kg dry weight soil, six-fold replicated each. Twelve TME served as untreated controls. Abundance and community structures of oribatids, collembolans, enchytraeids, nematodes and fungi were recorded. Oribatid mites' community responded 3 months after treatment, although they were not significantly affected by the overall treatment regimen. Collembolans in total and species-specific abundance as well as the community endpoints (principal response curves, diversity measures) were adversely affected by moderate dosages of lindane. Effects were transient between 3 and 5 months after treatment with a recovery within 1 year. No significant effects could be detected for enchytraeids, nematodes and fungi. The study design and the obtained results allow for calculations of no observed effect concentrations below the highest treatment level for populations and for soil communities as defined entities, as well as effective concentrations. The paper discusses the limits of effect detection in the light of achievable coefficients of variation and by means of minimum detectable differences. Outdoor TME are useful to analyze and assess functional and structural endpoints in soil organisms' communities and their possible recovery after pesticide treatment within 1 year.