Introduction Despite safety and benefits of physical activity during treatment of localised breast cancer, successful exercise strategies remain to be determined. The primary objective of the ‘dispositif connecté’, that is, connected device in English trial is to evaluate the efficacy of two 6-month exercise interventions, either single or combined, concomitant to adjuvant treatments, on the physical activity level of patients with breast cancer, compared with usual care: an exercise programme using a connected device (activity tracker, smartphone application, website) and a therapeutic patient education intervention. Secondary objectives are to evaluate adherence to interventions, their impact at 6 and 12 months, representations and acceptability of interventions, and to assess the cost-effectiveness of the interventions using quality-adjusted life-years. Methods and analysis This is a 2×2 factorial, multicentre, phase III randomised controlled trial. The study population (with written informed consent) will consist of 432 women diagnosed with primary localised invasive breast carcinoma and eligible for adjuvant chemotherapy, hormonotherapy and/or radiotherapy. They will be randomly allocated between one of four arms: (1) web-based connected device (evolving target number of daily steps and an individualised, semisupervised, adaptive programme of two walking and one muscle strengthening sessions per week in autonomy), (2) therapeutic patient education (one educational diagnosis, two collective educational sessions, one evaluation), (3) combination of both interventions and (4) control. All participants will receive the international physical activity recommendations. Assessments (baseline, 6 and 12 months) will include physical fitness tests, anthropometrics measures, body composition (CT scan, bioelectrical impedance), self-administered questionnaires (physical activity profile (Recent Physical Activity Questionnaire), quality of life (European Organization for Research and Treatment of Cancer Quality-Of-Life Questionnaire-30, EQ-5D-5L), fatigue (Piper Fatigue Scale-12), social deprivation (Evaluation of Deprivation and Inequalities in Health Examination Centres), lifestyle, physical activity barriers, occupational status) and biological parameters (blood draw). Ethics and dissemination This study was reviewed and approved by the French Ethics Committee. The findings will be disseminated to the scientific and medical community via publications in peer-reviewed journals and conference presentations. Trial registration number NCT03529383; Pre-results.
Since the first description of Kasabach-Merritt syndrome (KMS) in 1940, many treatments have been proposed combining pharmacologic and non-pharmacologic approaches, which can be effective on the pathology but can have adverse and unpredictable side-effects with long-term use. Herein we describe the solely surgical treatment of Kasabach-Merritt syndrome in a neonate with a severe and rapidly progressive thrombocytopenia. The patient's condition normalized at 7 days postoperatively, with rapid increase in platelet count and normalization of d-dimer concentration.
Background Lack of physical activity (PA) and sedentary behaviors are leading risk factors for noncommunicable diseases (NCDs). Web- and smartphone-based interventions are effective in increasing PA in older adults and in patients with NCD. In many countries, spa therapy, commonly prescribed to patients with NCD, represents an ideal context to initiating lifestyle changes. Objective This study aimed to evaluate, in patients attending spa therapy, the effectiveness of an intervention combining a face-to-face coaching and, when returning home, a web- and smartphone-based PA program on the achievement of PA guidelines (PAG) 12 months after the end of spa therapy. Methods This was a 12-month, prospective, parallel-group randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received PA usual advice. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants were assessed by phone every 2 months. Primary outcome was meeting PAG (PA ≥600 metabolic equivalent of task) at 12 months. Secondary outcomes were meeting current PAG at 6 months; sedentary time, weight, waist circumference, PA, and quality of life at 6 and 12 months. Objective use data of the web- and smartphone-based PA program were collected. Analytic methods included intention to treat and constrained longitudinal data analyses. Results The study sample included 228 participants (n=176, 77.2% females) with a mean age of 62.4 (SD 6.7) years and a mean BMI of 28.2 (SD 4.2) kg/m2. Approximately 53.9% (123/228) of the participants were retired. No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group than in the control group (81% vs 67% respectively, odds ratio 2.34, 95% CI 1.02-5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight, and waist circumference at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in the intervention group than in the control group (mean difference: 4.1, 95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 (SD 4.5) months. Attrition rate during the first 2 months was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. Conclusions PA increased in both the intervention group and the control group. However, at 12 months, more participants met PAG in the intervention group compared with the controls. This indicates that the web- and smartphone-based program could have maintained PA in the intervention group. In addition, a spa therapy seems to be an ideal time and framework to implement PA education. Trial Registration ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796
BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.
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