Background: Chemoradiotherapy (CRT) for head and neck cancer (HNC) induces side-effects, including trismus, which impairs quality of life by causing difficulty to eat, speak, and maintain good oral hygiene, and by altering social life. Given the wide variation of reported trismus prevalence and as a first mandatory step for the preventive physiotherapy OPEN program (NCT03979924) this study evaluated trismus occurrence and its link with radiation doses. Methods: Study population was non-larynx HNC patients with epidermoid carcinoma treated with CRT, with or without surgery. A physiotherapist measured maximal interincisal distance before, during and after CRT, at 10 weeks and 6 months. The proportion of patients with trismus (with a 95% confidence interval) was estimated. Irradiation doses were analyzed between patients with and without trismus using non-parametric Kruskal-Wallis test. Results: We included 45 patients (77.8% male), median age 61 years (range 41-77). The proportion of trismus at baseline was 24.4%, 26.8% at 10 weeks and 37.1% at 6 months. During radiotherapy, it was 27.9% at week 3 and increased to 41.9% at week 6. Trismus occurrence at 10 weeks was higher when the radiation dose to the ipsilateral lateral pterygoid muscle was above the median value, that is, 36.8 grays. Conclusion: Trismus occurrence differed according to radiation dose and cancer location. These findings highlight the necessity of early preventive physiotherapy programs to reduce trismus occurrence. The second step, of the interventional multicenter OPEN program, is currently evaluating the impact of preventive physiotherapy and patient education on trismus in a sample of 175 patients.
BackgroundIn France, the issue of youth smoking remains a major challenge for public health. School failure, socio-economic and socio-cultural backgrounds influence the initiation and maintenance of smoking behavior in adolescents. Vocational students are at particularly high risk of using psychoactive substances, including tobacco. One of the most important factors is the environment, whether family, friends or peers. Therefore, peer education has a positive potential to change smoking behavior of adolescents. It has also been demonstrated that the Theory of Planned Behavior (TPB) has yielded the best prediction of intentions and behavior, in several health domains, including on tobacco. However, it is usually confined to the measurement of processes by which interventions change behavior, rather than to the development of these interventions. The objective of this paper is to describe the protocol for a randomized controlled trial of a peer intervention based on the TPB on a highly exposed young population.Methods/designsThis is a cluster randomized controlled trial comparing an intervention group to a control group, randomized into clusters (professional schools and classes) and stratified in three departments (Hérault, Aude and Gard) in the Languedoc-Roussillon region. The primary issue is the prevalence of daily smoking at 24 months, defined by a daily tobacco use of at least 1 cigarette, validated by CO levels in exhaled air. The primary hypothesis is that intervention will lead to decrease the daily smoking prevalence of 10% between the intervention group and the control group during a 2-year follow-up.DiscussionThe results from this trial will provide evidence on the effectiveness of an innovative peer-to-peer intervention based on the TPB.Trial registrationISRCTN: 37336035, Retrospectively registered 11/12/2015.
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