Background: Prophylaxis for chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) is essential. Four-drug antiemetic therapy, consisting of a neurokinin-1 receptor antagonist (NK1RA), a 5-hydroxytryptamine type 3 receptor antagonist (5-HT3RA), dexamethasone (DEX), and olanzapine (OLZ), is currently recommended for HEC. However, the efficacy, optimal dosing schedule, and appropriate dosage of OLZ remain unclear when combined with a highly selective NK1RA, fosnetupitant (FosNTP).
Objective: This study aimed to evaluate the efficacy and safety of a four-drug antiemetic regimen including FosNTP and OLZ for prophylaxis of CINV in patients receiving anthracycline-based (neo)adjuvant chemotherapy for early breast cancer (EBC) and to explore outcomes with OLZ dose adjustments in the second cycle.
Methods: This single-institution, prospective observational study will enroll 100 patients with EBC who undergo HEC. All patients will receive a four-drug antiemetic regimen consisting of FosNTP, 5-HT3RA, DEX, and the guideline-recommended dose of OLZ administered orally from days -1 to 4. During the second cycle of treatment, OLZ dosing may be adjusted based on tolerability and patient preference. The primary endpoint is the proportion of patients who experienced no nausea during the overall phase (0-120 h) of the first cycle, as assessed using the daily visual analog scale. A sample size of 86 was calculated to assess the efficacy of the four-drug antiemetic regimen, including OLZ, assuming an expected no nausea rate of 42%, a threshold no nausea rate of 27% based on historical data, 90% power, and a 1-sided significance level of 5.0%. A single-sample z-test with a normal approximation will be used for the analyses.
Results: This study was approved by the Ethics Committee of the National Hospital Organization Kyushu Cancer Center, and participant recruitment and data collection commenced in May 2024. As of September 2025, approximately 70 participants have been recruited. Data collection is expected to continue until April 2026, and both data collection and analyses are anticipated to be completed in 2027.
Conclusions: This study will provide real-world evidence on the effectiveness and safety of a four-drug antiemetic regimen, including FosNTP and OLZ, in patients receiving anthracycline-based HEC and may inform optimal OLZ dosing strategies.
Background: Internationally, physical activity is successfully integrated into academic lessons in primary schools, showing promising results on cognition and student engagement. However, there is a lack of knowledge about its effects and feasibility for individual situated learning processes in upper secondary school.
Objective: This protocol describes the design and methods of the Physically Active Academic Lessons (PAAL) study, a mixed methods, cluster randomized, individual crossover trial. The PAAL study aims to examine the acute effects of physically active academic lessons on cognitive prerequisites of learning (alertness and executive functions) and situational engagement (behavioral, cognitive, and emotional engagement; disaffection; competence experiences; and help seeking), as well as factors modifying these effects (physical and mental load and perceived physical and academic competence). Further, subject teachers' and students' experiences and perceptions of physically active academic lessons in general upper secondary school will be explored.
Methods: The first part of the PAAL study involves exploring subject teachers' experiences of facilitators, barriers, usefulness, and the meaning of physically active academic lessons for the situational learning process through semistructured interviews with 14 teachers. The second part consists of a cluster‑randomized individual crossover trial including 168 students in mathematics and foreign language lessons, followed by interviews with 30 students.
Results: Funding for the study was obtained in May 2023. Ethical approval for the teacher interviews was granted in September 2023, and for the student trial in December 2023. Data collection was completed between October 2023 and November 2024. Data analysis is ongoing. The findings of the study will provide essential evidence-based information on physically active classroom practices that support teachers and schools in implementing pedagogical methods that enhance student learning and well-being in upper secondary schools.
Conclusions: The background, design, content of the intervention, and methods of the PAAL study are presented. This study aims to address a gap in the literature regarding the feasibility and effectiveness of physically active methods during academic lessons in upper secondary school.
Background: National birth rates among adolescents have consistently decreased since 1991, yet substantial disparities remain, particularly among youth in foster care, who experience higher risks of unintended pregnancies and sexually transmitted infections. Few sexual health programs rarely address the specific needs of foster youth or incorporate youth perspectives into their design, development, and implementation.
Objective: This study aims to refine, pilot-test, and evaluate Next4You, a fully mobile, youth-centered sexual health education platform tailored specifically for adolescents in or transitioning from foster care. The program intends to reduce sexual risk behaviors and related psychosocial outcomes by promoting healthy relationships, sexual wellness, contraception use, communication skills, self-respect, and wellness education.
Methods: Next4You is a fully mobile, self-paced, 4-week intervention evaluated using an individual-level randomized controlled trial involving a target sample of 500 youths aged 16-19 years with current or previous foster care experience in California. Participants are randomly assigned to either the intervention group, which receives access to Next4You modules, or the comparison group, which accesses general health materials through a similar web platform. Both groups complete baseline, 3-month, and 9-month follow-up surveys. Immediately following the 9-month follow-up survey, participants in each group receive access to the platform they were not initially assigned. Data collection assesses contraceptive behaviors, sexual communication, consent self-efficacy, and knowledge related to health rights and financial literacy. Intervention engagement is tracked through platform analytics, and qualitative interviews supplement data collection. Data analysis will adhere to intent-to-treat principles, using multilevel regression models to assess impacts.
Results: Funding was awarded in 2021, with institutional review board approval in October 2022. Intervention development lasted approximately 7 months, engaging foster youth in a co-design process to ensure relevance and cultural competence. Study recruitment began in September 2023, continuing until May 2025. Final data collection is anticipated by March 2026, followed by data analysis.
Conclusions: Next4You presents an innovative approach to sexual health education by addressing critical gaps in sexual health education for foster youth through mobile technology. If effective, Next4You could provide another evidence-based option for promoting sexual health among foster youth, guiding policymakers and practitioners in adopting similar trauma-informed and youth-centered interventions.
Background: Hypertension and diabetes are very common, interrelated chronic conditions. Awareness, diagnosis, treatment, and control rates of these conditions remain low, and access to quality care-particularly in rural areas-is a persistent challenge in many low- and middle-income countries. Strengthening primary health care, including the use of digital tools, is important to improve management of these chronic conditions.
Objective: This study aims to assess the implementation and effectiveness of a multicomponent, decentralized primary care model in comparison with a digital health-only intervention and usual care in rural Bangladesh.
Methods: The study applies a type 2 hybrid effectiveness-implementation design, using a 3-arm quasi-experimental approach, comprising 2 intervention arms and 1 usual care comparison arm. The study is being conducted across 3 subdistricts in the Dinajpur district, Rangpur division, northern Bangladesh. Primary outcomes include blood pressure and blood glucose control rates, assessed by population-based repeated cross-sectional surveys with independent samples, supplemented by facility-based prospective cohort data. Additionally, a mixed methods process evaluation is being conducted to capture the quantity, fidelity, adaptations, reach, and context of the interventions.
Results: The baseline community survey was conducted between January and March 2024, enrolling 6849 participants distributed across 3 arms: 2262 in usual care, 2287 in the digital-only arm, and 2300 in the multicomponent intervention arm. Participants had a mean age of 55.9 (SD 10.6) years with equal sex distribution (female: 3432/6849, 50.1%). Educational attainment was low, with 39.5% (2704/6849) of participants having no formal schooling and only 12.1% (917/6849) attaining secondary or higher education. The majority (6316/6849, 92.2%) reported being either self-employed or homemakers. The age-standardized baseline blood pressure control rate among all participants with hypertension was 10.2% overall, while the glycemic control rate among those with diabetes was 14.9%. Awareness and treatment rates for hypertension were 35.3% and 23.0%, respectively, compared to 60.7% and 34.5% for diabetes.
Conclusions: The study findings will provide critical evidence on scalable models for decentralized noncommunicable disease care and will have important implications for improving the management of hypertension and diabetes in Bangladesh and similar low-resource settings globally.
Background: Older patients are frequent users of Z-hypnotics despite consensus recommendations against extended use. Inappropriate Z-hypnotic use among older patients is frequently reported, posing risks of side effects and dependence. Interventions have been mainly at the population level and through prescription regulations. There are few instruments helping general practitioners (GPs) deal with inappropriate use among individual patients.
Objective: Through a randomized controlled trial (RCT), we aim to test the effectiveness of a behavioral brief intervention (BI) method used by trained GPs for reducing inappropriate Z-hypnotic use among their patients.
Methods: We will conduct a double-blind RCT with a single crossover. Patients (aged >60 years) on participating GPs' lists who are using Z-hypnotics inappropriately, do not have serious mental or physical disorders, and can provide valid informed consent are eligible. GPs randomized to the BI arm will be trained to administer the BI, and those randomized to business as usual (BAU) will not receive training. GPs' patient lists will be screened for inappropriate Z-hypnotic users through an electronic questionnaire. The GP will be informed of patients who should be given an appointment and administered the BI. Untrained GPs will continue BAU. Randomization-blinded outcome evaluation will be conducted at 6 weeks, 6 months, and 1 year in both the study groups.
Results: The main outcome is the proportion of patients with inappropriate Z-hypnotic use, comparing BI versus BAU, after 6 weeks. Secondary outcomes are cognitive function, pain, self-reported sleep evaluation, sleep efficiency (actigraphy) and quality of life, and change compared to baseline. We will also report on the characteristics of the screened GP patient population. Other variables are other medication use or polypharmacy, anxiety and depression, severity of dependence, and mortality.
Conclusions: If RCT-level evidence demonstrates the effectiveness of the BI for reducing inappropriate Z-hypnotic use among older patients without worsening of secondary outcomes, this could be a simple, transferable intervention to implement on a larger scale among GPs, other physicians, and health workers.
International registered report identifier (irrid): DERR1-10.2196/75670.
Background: Worldwide, mechanical ventilation and ventilator weaning have been widely researched. Nevertheless, rates of weaning failure remain high. According to the Medical Research Council framework, ventilator weaning is a complex intervention. While there are various guidelines on this, there is no abstract theoretical understanding that organizes the interventions, outcomes, and their contexts.
Objective: This study aims to explore the interconnectedness of interventions, outcomes, and context in ventilator weaning of adult intensive care patients.
Methods: Using the approach of Funnell and Rogers, we develop a program theory for ventilator weaning in a multimethod study comprising 2 main steps. First, 3 literature reviews on interventions and outcomes, predictors of weaning failure, and patients' experiences were triangulated with stakeholder conversations. Using abduction, we then developed an initial program theory. Second, the initial theory will be revised in an iterative process. To this end, semistructured group discussions and workshops will be conducted, followed by a deductive thematic analysis and adaptation of our theory. This process will be repeated until stakeholder statements and data analyses are congruent with the program theory.
Results: The initial program theory developed in step 1 is presented in this protocol and serves as the basis for review and refinement in step 2. The results of this iterative process and the final program theory are expected in 2026.
Conclusions: Following the Medical Research Council framework, a program theory on ventilator weaning will be developed in this study. This may enable a differentiated understanding of ventilator weaning and more sustainable and comprehensive research. The program theory emphasizes the interdisciplinary nature of ventilator weaning and supports health care professionals in combining interventions appropriately and evaluating relevant outcomes.
Trial registration: Open Science Framework YGJ3T; https://doi.org/10.17605/OSF.IO/YGJ3T.
International registered report identifier (irrid): DERR1-10.2196/83342.
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