Search results for "Study protocol"
showing 10 items of 114 documents
Internet-based perioperative exercise program in patients with Barrett’s carcinoma scheduled for esophagectomy [iPEP - study] a prospective randomize…
2017
Abstract Background Patients undergoing surgery for esophageal cancer have a high risk for postoperative deterioration of lung function and pulmonary complications. This is partly due to one-lung ventilation during thoracotomy. This often accounts for prolonged stay on intensive care units, delayed postoperative reconvalescence and reduced quality of life. Socioeconomic disadvantages can result from these problems. Physical preconditioning has become a crucial leverage to optimize fitness and lung function in patients scheduled for esophagectomy, in particular during the time period of neoadjuvant therapy. Methods/Study design We designed a prospective multicenter randomized-controlled tria…
EORTC-1203-GITCG - the “INNOVATION”-trial: Effect of chemotherapy alone versus chemotherapy plus trastuzumab, versus chemotherapy plus trastuzumab pl…
2019
10–20% of patients with gastric cancer (GC) have HER2+ tumors. Addition of trastuzumab (T) to cisplatin/fluoropyrimidine-based chemotherapy (CT) improved survival in metastatic, HER2+ GC. When pertuzumab (P) was added to neoadjuvant T and CT, a significant increase in histopathological complete response rate was observed in HER2+ breast cancer. This study aims to investigate the added benefit of using both HER2 targeting drugs (T alone or the combination of T + P), in combination with perioperative CT for localized HER2+ GC. This is a prospective, randomized, open-label, phase II trial. HER2 status from patients with resectable GC (UICC TNM7 tumor stage Ib-III) will be centrally determined.…
The Norwegian healthy body image programme: study protocol for a randomized controlled school-based intervention to promote positive body image and p…
2018
Body dissatisfaction and disordered eating raise the risk for eating disorders. In the prevention of eating disorders, many programmes have proved partly successful in using cognitive techniques to combat such risk factors. However, specific strategies to actively promote a positive body image are rarely used. The present paper outlines a protocol for a programme integrating the promotion of a positive body image and the prevention of disordered eating. Using a cluster randomized controlled mixed methods design, 30 high schools and 2481 12th grade students were allocated to the Healthy Body Image programme or to a control condition. The intervention comprised three workshops, each of 90 min…
The effectiveness and applicability of different lifestyle interventions for enhancing wellbeing : the study design for a randomized controlled trial…
2014
Background: Obesity and stress are among the most common lifestyle-related health problems. Most of the current disease prevention and management models are not satisfactorily cost-effective and hardly reach those who need them the most. Therefore, novel evidence-based controlled interventions are necessary to evaluate models for prevention and treatment based on self-management. This randomized controlled trial examines the effectiveness, applicability, and acceptability of different lifestyle interventions with individuals having symptoms of metabolic syndrome and psychological distress. The offered interventions are based on cognitive behavioral approaches, and are designed for enhancing…
Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol f…
2017
Background Emotional disorders (ED) are among the most prevalent mental disorders. However, less than 50% of people suffering from ED receive the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which tries to address the underlying processes common to ED. Most of these programs focus primarily on down-regulating negative affectivity, rather than increasing strengths and up-regulating positive affectivity. The data suggest the existence of disturbances in positive affectivity in these disorders, and so new interventions focusing on these problems are greatly needed. It is also essential to provide assist…
In-home versus hospital preoperative balance and proprioceptive training in patients undergoing TKR; rationale, design, and method of a randomized co…
2017
Abstract Background Severe knee osteoarthritis, as well as the surgical procedure of total knee replacement that aims to reduce its symptoms, cause great deterioration on the proprioceptive system. Taking this fact into account, and considering that balance abilities positively influence the capacity to perform basic functional tasks, this trial aims to find the short and mid-term effects of a preoperative balance and proprioceptive training when conducted by patients undergoing total knee replacement. Along with the effects, it is intended to determine whether in-home based training can be as effective as hospital training. The results will help to conclude whether the possible benefits ma…
Colorectal cancer stage at diagnosis in migrants versus non-migrants (KoMigra) : study protocol of a cross-sectional study in Germany
2014
Background: In Germany, about 20% of the total population have a migration background. Differences exist between migrants and non-migrants in terms of health care access and utilisation. Colorectal cancer is the second most common malignant tumour in Germany, and incidence, staging and survival chances depend, amongst other things, on ethnicity and lifestyle. The current study investigates whether stage at diagnosis differs between migrants and non-migrants with colorectal cancer in an area of high migration and attempts to identify factors that can explain any differences. Methods/Design: Data on tumour and migration status will be collected for 1,200 consecutive patients that have receive…
Evaluation design of the Social Engagement Framework for Addressing the Chronic-disease-challenge (SEFAC): a mindfulness-based intervention to promot…
2019
Background The Social Engagement Framework for Addressing the Chronic-disease-challenge (SEFAC) project intends to empower citizens at risk of or with type 2 diabetes (T2DM) and/or cardiovascular disease (CVD) to self-manage their chronic conditions through the SEFAC intervention. The intervention combines the concepts of mindfulness, social engagement and information and communication technology support, in order to reduce the burden of citizens with chronic conditions and to increase the sustainability of the health system in four European countries. Methods A prospective cohort study with a 6-month pre-post design will be conducted in four European countries: Croatia, Italy, the Netherla…
Evaluation design of Urban Health Centres Europe (UHCE): preventive integrated health and social care for communitydwelling older persons in five Eur…
2017
BackgroundOlder persons often have interacting physical and social problems and complex care needs. An integrated care approach in the local context with collaborations between community-, social-, and health-focused organisations can contribute to the promotion of independent living and quality of life. In the Urban Health Centres Europe (UHCE) project, five European cities (Greater Manchester, United Kingdom; Pallini (in Greater Athens Area), Greece; Rijeka, Croatia; Rotterdam, the Netherlands; and Valencia, Spain) develop and implement a care template that integrates health and social care and includes a preventive approach. The UHCE project includes an effect and process evaluation.Meth…
The Norwegian Healthy Life Study: protocol for a pragmatic RCT with longitudinal follow-up on physical activity and diet for adults
2017
The Norwegian Directorate of Health recommends that Healthy Life Centres (HLCs) be established in primary health care to support behaviour change and reduce the risk of non-communicable diseases. The aim of the present study protocol is to present the rationale, design and methods of a combined pragmatic randomized controlled trial (RCT) and longitudinal cohort study of the effects of attending HLCs concerning physical activity, sedentary behaviour and diet and to explore how psychological well-being and motivational factors may mediate short— and long-term effects. The present study will combine a 6-month RCT with a longitudinal cohort study (24 months from baseline) conducted at six HLCs …