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This study aimed to evaluate the impact of a physical-sport education pilot programme on adolescents’ subjective well-being (health-related quality of life, positive affect and negative affect), trait emotional intelligence and social anxiety. The programme was based on the pedagogical sport education model within a quality physical education framework, and approached from the perspective of social and emotional learning. Participants were 113 compulsory secondary education students aged 12–15 years that were assigned to a control group (n = 44) and an experimental group (n = 69). A quasi-experimental design with repeated pre-test and post-test measures was used. Bonferroni correction was applied for multiple comparisons. The preliminary results obtained in this investigation revealed that the physical-sport education pilot programme promoted significant improvements in a specific indicator of subjective well-being and trait emotional intelligence in the experimental group. These encouraging findings support the pedagogical efficiency of the programme with regard to the programme aim. The findings also highlight the feasibility and appropriateness of the programme in terms of an innovative teaching proposal.

PurposeThis study aims to determine the incidence of nausea and vomiting (CINV) after moderately emetogenic chemotherapy (MEC), under medical practice conditions and the accuracy with which physicians perceive CINV.MethodsChemotherapy-naive patients receiving MEC between April 2012 and May 2013 were included. Patients completed a diary of the intensity of nausea and number of vomiting episodes. Complete response and complete protection were assessed as secondary endpoints.ResultsOf 261 patients included, 240 were evaluated. Median age was 64 years, 44.2 % were female and 11.2 % were aged less than 50 years; 95.3 % of patients received a combination of 5-hydroxytryptamine 3 (5-HT3) antagonist + corticosteroid as antiemetic treatment. Vomiting within 5 days of chemotherapy administration occurred in 20.8 %, nausea in 42 % and significant nausea in 23.8 % of patients. An increase in the percentage of patients with significant nausea (from 9.4 to 21.7 %) and vomiting (from 9.2 to 16.5 %) was observed from the acute to the delayed phase. Complete response was 84.2 % in the acute phase, 77 % in the late phase and 68.9 % in overall period. Complete protection was 79.5 % in the acute phase, 68.8 % in the late phase and 62.4 % throughout the study period. Physicians estimated prophylaxis would be effective for 75 % of patients receiving MEC, compared with 54.1 % obtained from patients’ diary.ConclusionDespite receiving prophylactic treatment, 31 % of patients did not achieve a complete response and 38 % complete protection. In general, nausea was worse controlled than vomiting. The results also showed the late phase was worse controlled than the acute phase in all variables. Healthcare providers overestimated the effectiveness of antiemetic prophylaxis.Electronic supplementary materialThe online version of this article (doi:10.1007/s00520-015-2809-3) contains supplementary material, which is available to authorized users.

Background The value of neoadjuvant chemotherapy in soft tissue sarcoma (STS) is not completely understood. This study investigated the benefit of neoadjuvant chemotherapy according to prognostic stratification based on the Sarculator nomogram for STS. Methods This study analyzed data from ISG‐STS 1001, a randomized study that tested 3 cycles of neoadjuvant anthracycline plus ifosfamide (AI) or histology‐tailored (HT) chemotherapy in adult patients with STS. The 10‐year predicted overall survival (pr‐OS) was estimated with the Sarculator and was stratified into higher (10‐year pr‐OS < 60%) and lower risk subgroups (10‐year pr‐OS ≥ 60%). Results The median pr‐OS was 0.63 (interquartile range [IQR], 0.51‐0.72) for the entire study population, 0.62 (IQR, 0.51‐0.70) for the AI arm, and 0.64 (IQR, 0.51‐0.73) for the HT arm. Three‐ and 5‐year overall survival (OS) were 0.86 (95% confidence interval [CI], 0.82‐0.93) and 0.81 (95% CI, 0.71‐0.86) in lower risk patients and 0.69 (95% CI, 0.70‐0.85) and 0.59 (95% CI, 0.51‐0.72) in the higher risk patients (log‐rank test, P = .004). In higher risk patients, the 3‐ and 5‐year Sarculator‐predicted and study‐observed OS rates were 0.68 and 0.58, respectively, and 0.85 and 0.66, respectively, in the AI arm (P = .04); the corresponding figures in the HT arm were 0.69 and 0.60, respectively, and 0.69 and 0.55, respectively (P > .99). In lower risk patients, the 3‐ and 5‐year Sarculator‐predicted and study‐observed OS rates were 0.85 and 0.80, respectively, and 0.89 and 0.82, respectively, in the AI arm (P = .507); the corresponding figures in the HT arm were 0.87 and 0.81, respectively, and 0.86 and 0.74, respectively (P = .105). Conclusions High‐risk patients treated with AI performed better than predicted, and this adds to the evidence for the efficacy of neoadjuvant AI in STS. Lay Summary People affected by soft tissue sarcomas of the extremities and trunk wall are at some risk of developing metastasis after surgery. Preoperative or postoperative chemotherapy has been tested in clinical trials to reduce the chances of distant metastasis. However, study findings have not been conclusive. This study stratified the risk of metastasis for people affected by sarcomas who were included in a clinical trial testing neoadjuvant chemotherapy. Exploiting the prognostic nomogram Sarculator, it found a benefit for chemotherapy when the predicted risk, based on patient and tumor characteristics, was high.

Among patients with resected sporadic SSAs the risk of developing metachronous ANL is influenced by the presence of synchronous HRA on index colonoscopy. Patients with SSAs and synchronous HRA on index colonoscopy require closer surveillance, whereas those with synchronous LRA and those without synchronous adenomas may be followed up in the same way as those with LRAs.

IMPORTANCEActive therapeutic combinations, such as trabectedin and radiotherapy, offer potentially higher dimensional response in second-line treatment of advanced soft-tissue sarcomas. Dimensional response can be relevant both for symptom relief and for survival.OBJECTIVE To assess the combined use of trabectedin and radiotherapy in treating patients with progressing metastatic soft-tissue sarcomas.DESIGN, SETTING, AND PARTICIPANTS Phase 1 of this nonrandomized clinical trial followed the classic 3 + 3 design, with planned radiotherapy at a fixed dose of 30 Gy (3 Gy/d for 10 days) and infusion of trabectedin at 1.3 mg/m 2 as the starting dose, 1.5 mg/m 2 as dose level +1, and 1.1 mg/m 2 as dose level -1. Phase 2 followed the Simon optimal 2-stage design. Allowing for type I and II errors of 10%, treatment success was defined as an overall response rate of 35%. This study was conducted in 9 sarcoma referral centers in Spain, France, and Italy from April 13, 2015, to November 20, 2018. Adult patients with progressing metastatic soft-tissue sarcoma and having undergone at least 1 previous line of systemic therapy were enrolled. In phase 2, patients fitting inclusion criteria and receiving at least 1 cycle of trabectedin and the radiotherapy regimen constituted the per-protocol population; those receiving at least 1 cycle of trabectedin, the safety population.INTERVENTIONS Trabectedin was administered every 3 weeks in a 24-hour infusion. Radiotherapy was required to start within 1 hour after completion of the first trabectedin infusion (cycle 1, day 2). MAIN OUTCOMES AND MEASURESThe dose-limiting toxic effects of trabectedin (phase 1) and the overall response rate (phase 2) with use of trabectedin plus irradiation in metastatic soft-tissue sarcomas. RESULTSEighteen patients (11 of whom were male) were enrolled in phase 1, and 27 other patients (14 of whom were female) were enrolled in phase 2. The median ages of those enrolled in phases 1 and 2 were 42 (range, 23-74) years and 51 (range, 27-73) years, respectively. In phase 1, dose-limiting toxic effects included grade 4 neutropenia lasting more than 5 days in 1 patient at the starting dose level and a grade 4 alanine aminotransferase level increase in 1 of 6 patients at the +1 dose level. In phase 2, among 25 patients with evaluable data, the overall response rate was 72% (95% CI, 53%-91%) for local assessment and 60% (95% CI, 39%-81%) for central assessment. CONCLUSIONS AND RELEVANCEThe findings of this study suggest that the recommended dose of trabectedin for use in combination with this irradiation regimen is 1.5 mg/m 2 . The trial met its primary end point, with a high overall response rate that indicates the potential of this combination therapy for achieving substantial tumor shrinkage beyond first-line systemic therapy in patients with metastatic, progressing soft-tissue sarcomas.

Gemcitabine plus sirolimus exhibits satisfactory antitumor activity and safety in this osteosarcoma population, exceeding the prespecified 40% of 4-month PFSR. The significant correlation of biomarkers with clinical outcome encourages further prospective investigation.

The objective of the present study was to experimentally assess the effects of a mindfulness-based intervention (MBI) for the improvement of subjective well-being, trait emotional intelligence (TEI), mental health, and resilience in a sample of women with fibromyalgia (FM). The sample consisted of 104 women, between 29 and 77 years old (M = 47.59; SD = 5.93). The measures used were as follows: Satisfaction with Life Scale (SWLS), Positive and Negative Affection Scale (PANAS), Trait Emotional Intelligence Questionnaire Short Form (TEIQue-SF), Mental Health Questionnaire (MH-5), and Resilience Scale (ER-14). A quasi-experimental design of repeated measures with a control group (CG) was used: before and after the application of the treatment and a follow-up assessment 6 months after the completion of the intervention. In order to assess the effect of the program, the participants were randomly assigned to the experimental and control conditions. In the pretest evaluation, a multivariate analysis of variance (MANOVA) and analysis of variance (ANOVA) were carried out. In the post-test evaluation, a multivariate analysis of covariance (MANCOVA) of the study variables as a whole was performed. Then, descriptive analyses and analysis of covariance (ANCOVA) of the post-test scores (covariate pretest score) were performed. In the follow-up evaluation, a MANCOVA of the study variables as a whole was performed. Then, descriptive and ANCOVA analyses of the follow-up scores (covariate pretest score) were performed. In addition, the effect size was calculated using partial eta-squared (μ2). The post-test results confirmed statistically significant differences in satisfaction with life (SWL), positive affect (PA), mental health, and resilience. The follow-up results showed statistically significant differences in SWL, PA, TEI, mental health, and resilience. The study provides an effective intervention tool that has been validated experimentally. The general results allow the emphasis of the importance of the implementation of MBIs framed in non-pharmacological treatments in FM.