Contemporary Clinical Trials Communications最新文献_第4页

Design and rationale for the VICTRIVA study: A randomized, double-blind, phase 3b study of vedolizumab in combination with upadacitinib in Crohn's disease VICTRIVA研究的设计和基本原理：vedolizumab联合upadacitinib治疗克罗恩病的随机、双盲、3b期研究

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101574

Silvio Danese , Bruce E. Sands , Brian G. Feagan , Vipul Jairath , Remo Panaccione , Laurent Peyrin-Biroulet , Peter M. Irving , Stefan Schreiber , Iris Dotan , Marc Ferrante , Geert R. D'Haens , Stephen Jones , Marcelo Freire , Dirk Lindner , Shashi Adsul , Pooja Oberai , Jean-Frédéric Colombel

Introduction

Remission rates in patients with Crohn's disease (CD) suggest a therapeutic ceiling with one advanced targeted treatment, representing an unmet need. Dual targeted therapy may provide a more effective treatment approach.

Methods

The primary objective of VICTRIVA (NCT06227910), a randomized, double-blind, phase 3b trial in biologic-experienced and biologic-naïve adults with CD, is to assess whether vedolizumab combined with upadacitinib induction improves rates of clinical remission and endoscopic response at week (W)12 vs. vedolizumab alone. Patients will be randomized 1:1 to vedolizumab (300 mg at W0, W2, W6, and W10) and either upadacitinib 45 mg or placebo daily. W12 responders will enter the maintenance arm up to W52 (vedolizumab monotherapy every 8 weeks [Q8W] from W14 to W52; Q4W escalation if needed). Patients who lose response during maintenance treatment despite dose escalation will enter the rescue substudy (vedolizumab Q4W plus upadacitinib 45 mg for 12 weeks, then vedolizumab monotherapy in patients who regain response). Assessments include patient-reported outcomes (PROs), CD activity index (CDAI), and Simple Endoscopic Score for CD (SES-CD). Globally, 396 patients (198 in each group) will be enrolled. Of these, a minimum of 50 and maximum of 50 % will be biologic-naïve. Co-primary endpoints are CDAI clinical remission and SES-CD endoscopic response at W12. Key secondary endpoints include PRO2 clinical remission at W12, and CDAI clinical remission, SES-CD endoscopic response, and PRO2 clinical remission at W52. Safety endpoints include the incidence of treatment-emergent adverse events.

Conclusion

VICTRIVA will evaluate the efficacy and safety of combined vedolizumab and upadacitinib induction therapy relative to vedolizumab monotherapy, aiming to break the current therapeutic ceiling.

Clinical trials registration

ClinicalTrials.gov, NCT06227910.

克罗恩病（CD）患者的缓解率表明一种高级靶向治疗的治疗上限，这代表了一种未满足的需求。双重靶向治疗可能提供更有效的治疗方法。VICTRIVA （NCT06227910）是一项随机、双盲、3b期临床试验，在有生物学经验的biologic-naïve成年CD患者中进行，主要目的是评估vedolizumab联合upadacitinib诱导是否在第12周(W)时比单独使用vedolizumab提高临床缓解率和内镜下反应率。患者将以1:1的比例随机分配至维多单抗（300 mg, W0, W2， W6和W10）和更新他替尼45 mg或安慰剂每日。W12应答者将进入维持组直至W52 （vedolizumab单药治疗每8周[Q8W]从W14至W52；如果需要Q4W升级）。尽管剂量增加，但在维持治疗期间失去反应的患者将进入拯救亚研究（vedolizumab Q4W + upadacitinib 45mg，持续12周，然后对恢复反应的患者进行vedolizumab单药治疗）。评估包括患者报告的结果（PROs）、CD活动指数（CDAI）和简单内镜下CD评分（SES-CD）。在全球范围内，将招募396名患者（每组198名）。其中，最少50%和最多50%将是biologic-naïve。共同主要终点是W12时CDAI临床缓解和SES-CD内镜下反应。关键次要终点包括W12时PRO2临床缓解、CDAI临床缓解、SES-CD内窥镜反应和W52时PRO2临床缓解。安全性终点包括治疗中出现的不良事件的发生率。结论victriva将评估vedolizumab联合upadacitinib诱导治疗相对于vedolizumab单药治疗的有效性和安全性，旨在打破目前的治疗天花板。临床试验注册：clinicaltrials .gov, NCT06227910。

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引用次数: 0

Evaluating continuous identity cognitive therapy for veterans with a recent suicidal episode: An open-label group pilot study 评估最近有自杀倾向的退伍军人的持续身份认知疗法：一项开放标签小组试点研究

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101576

Yosef Sokol , Sofie Glatt , Sarah Andrusier , Chynna Levin , Caroline Boucher , Josephine Ridley , Clayton H. Brown , Yulia Landa , Shirley Glynn , Marianne Goodman

Introduction

There is a gap in effective recovery-oriented treatments for Veterans experiencing suicidal thoughts and/or behaviors, particularly those recovering from a suicidal episode. This study aimed to evaluate the feasibility and acceptability of Continuous Identity Cognitive Therapy (CI-CT), a novel recovery-oriented psychotherapy for Veterans with a history of a recent suicidal episode, and to refine the intervention through an iterative development process. CI-CT integrates theories of personal identity and selfhood within a cognitive therapy framework. It aims to repair personal identity through the construction of a coherent, meaningful self-narrative connecting the present to a clear, detailed, realistic, and desired future self.

Method

Three one-arm trials of CI-CT were conducted to evaluate feasibility and acceptability of the therapy. Trials were conducted iteratively, with each trial incorporating lessons and modifications from the previous one. Participants (N = 15 consented, with N = 12 initiating therapy and 11 completing the full intervention) were U.S. Veterans with a history of a suicide attempt or plan with intent within the past two years.

Results

CI-CT had high levels of feasibility and acceptability based on recruitment rates, attendance rates, low dropout rates, high completion rate of follow-up assessments, and participant feedback. In addition, there were high levels of measured client satisfaction and positive qualitative feedback.

Discussion

The high attendance and retention rates and positive Veteran feedback support further exploration and testing of CI-CT in a randomized clinical trial.

Clinical trial registration

NCT04731519.

对于经历过自杀想法和/或行为的退伍军人，特别是那些从自杀事件中恢复过来的退伍军人，有效的康复导向治疗存在差距。本研究旨在评估持续身份认知疗法（CI-CT）的可行性和可接受性，并通过迭代开发过程来完善其干预措施。CI-CT是一种面向近期有自杀倾向的退伍军人的新型康复导向心理治疗方法。CI-CT在认知治疗框架内整合了个人同一性和自我的理论。它旨在通过构建一个连贯的、有意义的自我叙述来修复个人身份，将现在与一个清晰、详细、现实和期望的未来自我联系起来。方法采用CI-CT单臂试验，评价其治疗的可行性和可接受性。试验是迭代进行的，每次试验都结合了前一次试验的经验教训和修改。参与者（N = 15名同意，N = 12名开始治疗，11名完成完整干预）是在过去两年内有自杀企图或自杀计划的美国退伍军人。结果从招募率、出勤率、低辍学率、高随访评估完成率和参与者反馈来看，sci - ct具有较高的可行性和可接受性。此外，有高水平的测量客户满意度和积极的定性反馈。高出勤率和保留率以及积极的退伍军人反馈支持在随机临床试验中进一步探索和测试CI-CT。临床试验注册号nct04731519。

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引用次数: 0

A Bayesian model with seasonal effects for predicting accrual in clinical trials: Application to HOBIT and BOOST-3 trials for severe traumatic brain injury 具有季节效应的贝叶斯模型预测临床试验中应计收益：应用于严重创伤性脑损伤的HOBIT和BOOST-3试验

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101586

Mohammod Mahmudur Rahman , Md Saiful Islam Saif , Jonathan Beall , Renee’ L. Martin , Gaylan L. Rockswold , William G. Barsan , Frederick K. Korley , Robert Silbergleit , Valerie Stevenson , Byron Gajewski

Background

Accurate accrual prediction is essential for initial planning and ongoing monitoring of clinical trials. Slow accrual can compromise statistical power, increase costs, or lead to premature trial termination. Traditional Bayesian approaches typically assume constant accrual rates and often fail to capture real-world seasonal fluctuations, which can reduce predictive accuracy.

Methods

We developed a Bayesian seasonal accrual model that extends the traditional homogeneous model by incorporating quarter-specific priors to account for seasonal variation. The model combines prior knowledge with observed data up to the monitoring point to obtain accrual predictions using the Bayesian posterior predictive distribution. We applied this approach to quarterly accrual data from two ongoing trials: the Hyperbaric Oxygen Brain Injury Treatment (HOBIT) trial and the Brain Oxygen Optimization in Severe TBI Phase-3 (BOOST-3) trial. Along with the Deviance Information Criterion, model performance was evaluated using RMSE, bias, and standard deviation, calculated from internal predictions of total accruals within observed seasonal quarters. Posterior predictive distributions of accrual after 36 and 30 quarters were also generated.

Results

Both trials exhibited seasonal trends, with the highest accrual rates in summer. The seasonal model yielded lower DIC in both trials. In HOBIT, internal prediction accuracy did not improve, likely due to uniformly low accrual rates. In contrast, the seasonal model outperformed the homogeneous model in BOOST-3 trial, yielding substantially lower RMSE, bias, and SD.

Conclusion

Incorporating seasonal effects into accrual modeling can enhance prediction accuracy, particularly in larger trials with high enrollment, and supports more accurate trial forecasting and resource allocation.

准确的权责发生制预测对于临床试验的初始计划和持续监测至关重要。缓慢的累积可能损害统计能力，增加成本，或导致试验过早终止。传统的贝叶斯方法通常假设恒定的应计利率，往往无法捕捉到现实世界的季节性波动，这可能会降低预测的准确性。方法我们开发了一个贝叶斯季节权责发生制模型，该模型扩展了传统的同质模型，通过纳入季度特定先验来考虑季节变化。该模型将先验知识与监测数据结合起来，利用贝叶斯后验预测分布获得应计收益预测。我们将这种方法应用于两项正在进行的试验的季度应计数据：高压氧脑损伤治疗（HOBIT）试验和重度TBI脑氧优化3期（BOOST-3）试验。与偏差信息标准一起，使用RMSE、偏倚和标准偏差来评估模型的性能，标准偏差是根据观察到的季节性季度内总应计收益的内部预测计算出来的。36个季度和30个季度后应计收益的后验预测分布也被生成。结果两项试验均表现出季节性趋势，夏季累计发病率最高。季节性模型在两项试验中均产生较低的DIC。在HOBIT，内部预测的准确性没有提高，可能是由于统一的低应计率。相比之下，在BOOST-3试验中，季节性模型优于均匀模型，产生更低的RMSE、偏倚和SD。结论在权责发生制模型中加入季节效应可以提高预测精度，特别是在大型、高入组的试验中，并支持更准确的试验预测和资源分配。

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引用次数: 0

Retraction notice to “Filipinos Fit and trim - A feasible and efficacious DPP-based intervention trial” [Contemporary Clinical trials Communications 12 (2018) 76–84] 撤回“菲律宾人健康和修剪——可行有效的dpp干预试验”的通知[当代临床试验通讯12 (2018)76-84]

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101573

Melinda S. Bender , Bruce A. Cooper , Elena Flowers , Raymond Ma , Shoshana Arai

引用次数: 0

The Bud App: A protocol for a randomized controlled trial with an internal pilot phase targeting modifiable risk and protective factors for suicide among international students Bud应用程序：一项针对国际学生自杀的可修改风险和保护因素的内部试点阶段随机对照试验协议

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101578

Samuel McKay , Christina Ng , Jennifer Nicholas , Vivienne Browne , Gina Chinnery , Isabella Choi , Bailey Nation-Ingle , Kristal Alison , Ella Perlow , Michelle Lamblin , Elise Carrotte , Ellie Brown , Gregory Armstrong , Jocelyn I. Meza , Madhavan Mani , Jo Robinson

International students face elevated risk for mental health problems and suicide, yet encounter multiple barriers to accessing timely and culturally responsive treatments. Key challenges include high rates of psychological distress, low mental health literacy, and reduced help-seeking, often compounded by perceived burdensomeness, a lack of belonging, and difficulties with emotion regulation. Bud is a self-guided, co-designed mobile app developed to address these challenges through an accessible digital intervention. This paper outlines a protocol for a randomized controlled trial evaluating the effectiveness, acceptability, engagement, and safety of Bud among international students enrolled at Australian tertiary institutions. The trial also includes an internal pilot phase to ensure the feasibility of the trial procedures, with benchmarks for recruitment, retention, and engagement. A community sample of 302 participants will be randomly assigned to either the intervention group (Bud app) or the active control group (online mental health fact sheets) for four weeks. Assessments will be completed online at baseline, two weeks, and four weeks post-baseline. The primary outcome is psychological distress, with secondary outcomes including help-seeking intentions, perceived burdensomeness and belonging, emotion regulation, mental health literacy, and suicidal ideation. Acceptability and engagement will be assessed using self-report and objective measures. Interviews will be conducted with a subset of 20 participants to explore their views on Bud further. This trial will provide the first evaluation of a suicide prevention tool specifically for international students. If effective, Bud could offer a scalable and culturally relevant solution to improve student mental health and reduce service access barriers.

Trial registration

ACTRN12625000584437.

国际学生面临较高的心理健康问题和自杀风险，但在获得及时和符合文化要求的治疗方面遇到多重障碍。主要的挑战包括心理困扰率高、心理健康素养低、寻求帮助的人数减少，往往还伴随着感到负担、缺乏归属感和情绪调节方面的困难。Bud是一款自我引导、共同设计的移动应用程序，旨在通过可访问的数字干预来解决这些挑战。本文概述了一项随机对照试验的方案，该试验评估了在澳大利亚高等院校就读的国际学生中使用Bud的有效性、可接受性、参与度和安全性。该试验还包括一个内部试点阶段，以确保试验程序的可行性，并制定招聘、留任和聘用的基准。302名参与者的社区样本将被随机分配到干预组（Bud应用程序）或积极对照组（在线心理健康情况说明书），为期四周。评估将在基线、基线后两周和基线后四周在线完成。主要结局是心理困扰，次要结局包括求助意向、感知负担和归属感、情绪调节、心理健康素养和自杀意念。可接受性和参与度将使用自我报告和客观措施进行评估。我们将与20位参与者进行访谈，进一步探讨他们对Bud的看法。这项试验将首次对专门针对国际学生的自杀预防工具进行评估。如果有效，Bud可以提供一个可扩展的、与文化相关的解决方案，以改善学生的心理健康，减少获得服务的障碍。registrationACTRN12625000584437审判。

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引用次数: 0

The effect of combined rhythmic breathing and aromatherapy on pain intensity and anxiety in patients with unstable angina 节奏呼吸联合芳香疗法对不稳定型心绞痛患者疼痛强度和焦虑的影响

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101575

Sahar Nouri, Nasrin Hanifi, Farhad Ramezani-Badr

Background

Unstable angina is a serious heart condition characterized by intense chest pain and anxiety, which substantially reduces patients’ well-being.

Objective

This study examined the combined effects of rhythmic breathing and aromatherapy on pain and anxiety in unstable angina.

Methods

This two-arm randomized controlled trial involved 56 participants, who were equally allocated to an intervention group (n = 28) and a control group (n = 28). The intervention group received rhythmic breathing exercises combined with aromatherapy using 40 % diluted damask rose essential oil, administered in three sessions per hour over a 3-h period. Pain and anxiety were measured using Visual Analog Scales at baseline and at 1-, 2-, and 3-h post-intervention.

Results

Repeated measures ANOVA indicated a significant time-based decrease in pain and anxiety within the intervention group, contrasting with the control group (P < .001).

Conclusion

Pain and anxiety were effectively reduced in unstable angina patients through a combined intervention of rhythmic breathing and aromatherapy. These results highlight the promise of non-drug methods for treating the mental and physical effects of heart disease.

不稳定型心绞痛是一种严重的心脏疾病，其特征是剧烈的胸痛和焦虑，这大大降低了患者的幸福感。目的探讨节奏呼吸联合芳香疗法对不稳定型心绞痛患者疼痛和焦虑的影响。方法56例受试者被随机分为干预组（n = 28）和对照组（n = 28）。干预组接受有节奏的呼吸练习，同时使用40%稀释的大马士革玫瑰精油进行芳香疗法，每小时进行三次，持续3小时。疼痛和焦虑在基线和干预后1、2和3小时使用视觉模拟量表进行测量。结果重复测量方差分析显示，干预组与对照组相比，疼痛和焦虑在时间上有显著的减少（P < .001）。结论节奏呼吸与芳香疗法联合干预可有效减轻不稳定型心绞痛患者的疼痛和焦虑。这些结果强调了非药物方法治疗心脏病的精神和身体影响的前景。

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引用次数: 0

The REST (randomised evaluation of sleeping with a toy or comfort item) trial: a protocol for an online, randomised trial of comfort item use on sleep quality in children REST（带着玩具或舒适物品睡觉的随机评估）试验：一项在线随机试验方案，用于研究儿童使用舒适物品对睡眠质量的影响

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101580

Simone Lepage , Laura Flight , Nikki Totton , Declan Devane

Randomised controlled trials (RCTs) are the gold standard for evaluating healthcare interventions. Participatory research, in which the public is engaged in research activities, enhances their understanding of trials but requires innovative strategies to reach diverse populations, particularly children. This article outlines the design of the REST (Randomised Evaluation of Sleeping with a Toy or comfort item) trial, a child-led study investigating whether sleeping with a comfort item affects sleep quality in children compared to not using one.

The REST trial was created with children aged 7 to 12 through The Kid's Trial, an online initiative where children co-design and co-conduct a randomised trial. The REST trial is a two-arm, pragmatic, superiority RCT. Children worldwide participate from home and are randomly assigned (1:1) to either sleep with or without a comfort item for 7 nights. The primary outcome is sleep-related impairment (SRI), measured using the PROMIS Pediatric Short Form v1.0 Sleep-Related Impairment 4a questionnaire. The secondary outcome is sleep quality, evaluated using a single-item Sleep Quality Scale. Data are collected via online self-reported questionnaires at baseline and eight days post-randomisation. Recruitment is global, targeting caregivers through online media, with study materials available on a dedicated website.

The REST trial aims to enrol 292 participants to achieve 80 % power to detect a 3-point difference in SRI. Findings will explore the impact of comfort items on sleep and demonstrate the feasibility and benefits of child-led participatory research, fostering scientific literacy and critical thinking.

随机对照试验（RCTs）是评估医疗保健干预措施的黄金标准。公众参与研究活动的参与性研究提高了他们对试验的理解，但需要创新的战略来接触不同的人群，特别是儿童。这篇文章概述了REST（带着玩具或舒适物品睡觉的随机评估）试验的设计，这是一项由儿童主导的研究，调查与不使用相比，带着舒适物品睡觉是否会影响儿童的睡眠质量。REST试验是由7至12岁的儿童通过“儿童试验”（The Kid’s trial）创建的，这是一个在线倡议，儿童共同设计和共同实施一项随机试验。REST试验是一项两臂、实用、优势的随机对照试验。世界各地的儿童在家参与，并随机分配（1:1），在7个晚上有或没有舒适的物品睡觉。主要结果是睡眠相关障碍（SRI），使用PROMIS儿童短表v1.0睡眠相关障碍4a问卷进行测量。第二个结果是睡眠质量，使用单项睡眠质量量表进行评估。在基线和随机化后8天通过在线自我报告问卷收集数据。招聘是全球性的，通过在线媒体针对护理人员，并在专门的网站上提供学习材料。REST试验旨在招募292名参与者，以达到80%的能力来检测SRI的3点差异。研究结果将探讨舒适物品对睡眠的影响，并展示儿童主导的参与性研究的可行性和益处，培养科学素养和批判性思维。

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引用次数: 0

What works for men? Participant perspectives from a mixed-gender weight-management trial with incentives 什么对男人有效？一项有激励机制的混合性别体重管理试验的参与者观点

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-11-15 DOI: 10.1016/j.conctc.2025.101570

Katya Garza , Hisham Ahmad , Bhabna Pati , Corrine I. Voils

Background

Men are underrepresented in behavioral weight-loss trials, limiting the generalizability of findings. While gender-tailored programs have shown success, most research and community-based weight management programs remain mixed-gender. Little is known about men's experiences in these settings or how to best adapt mixed-gender programs to improve their relevance to men.

Purpose

To explore men's experiences regarding weight management and to qualitatively evaluate their experiences in the Log2Lose trial.

Methods

Semi-structured interviews were conducted with men who participated in the Log2Lose trial, a randomized study evaluating the effects of financial incentives on weight loss. Interviews explored motivations for enrolling, satisfaction with program components, and suggestions for improvement. Data were analyzed using conventional content analysis.

Results

Nineteen men completed interviews. Most self-identified as White, were middle-aged, married, and college educated. Six themes emerged: 1) Prior weight loss efforts were self-directed and hard to sustain; 2) Rising health concerns prompted men to seek support; 3) Higher-engagers framed weight loss as a personal responsibility, whereas lower-engagers preferred more external accountability; 4) Traditional social roles influenced dietary changes; 5) Peer relatability defined group experiences more than gender composition; 6) Men valued practical content but wanted more tailored support.

Conclusions

Men valued their participation in the Log2Lose trial and identified ways to improve relevance and engagement. This study provides participant-informed guidance to support the development of mixed-gender behavioral interventions that appeal to men and promote more equitable representation in weight loss research.

男性在行为减肥试验中的代表性不足，限制了研究结果的普遍性。虽然针对不同性别的体重管理项目取得了成功，但大多数研究和基于社区的体重管理项目仍然是男女混合的。人们对男性在这些环境中的经历知之甚少，也不知道如何最好地适应混合性别项目，以提高它们与男性的相关性。目的探讨Log2Lose试验中男性在体重管理方面的经验，并对其经验进行定性评价。方法对参加Log2Lose试验的男性进行半结构化访谈。Log2Lose试验是一项评估财务激励对减肥效果的随机研究。访谈探讨了入学的动机、对课程组成部分的满意度以及改进建议。数据分析采用常规内容分析。结果19名男性完成访谈。大多数自认为是白人的人都是中年人，已婚，受过大学教育。出现了六个主题：1)之前的减肥努力是自我导向的，难以持续；2)越来越多的健康问题促使男性寻求支持；3)高参与度者将减肥视为个人责任，而低参与度者更倾向于外部责任；4)传统社会角色影响饮食变化；5)同伴相关性比性别构成更能定义群体经历；6)男性看重实用内容，但希望得到更有针对性的支持。结论：男性重视他们对Log2Lose试验的参与，并确定了提高相关性和参与度的方法。本研究提供了参与者知情的指导，以支持对男性有吸引力的混合性别行为干预的发展，并促进减肥研究中更公平的代表性。

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引用次数: 0

Designing trials with multiple objectives with graphical approach for multiple scenarios 设计试验与多目标与图形方法，为多种情况

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-11-10 DOI: 10.1016/j.conctc.2025.101569

A. Adam Ding , Yulin Li , Samuel S. Wu

Clinical trials with multiple objectives require careful control of the overall error rate through adjustments for multiple hypothesis testing. Design optimization must account for these adjustments across various plausible scenarios. This paper introduces a framework for optimizing trial designs in multiple scenarios using graphical approaches. The method is demonstrated in a pain study trial, highlighting improvements in overall performance across multiple scenarios.

具有多个目标的临床试验需要通过调整多个假设检验来仔细控制总体错误率。设计优化必须考虑到各种可能情况下的这些调整。本文介绍了一个框架，以优化试验设计在多种情况下使用图形方法。该方法在一项疼痛研究试验中得到了证明，强调了在多种情况下整体性能的提高。

引用次数: 0

The culturally adapted cognitive behavioral stress management program for enhancing psychological well-being and self-management of postoperative breast cancer patients: A randomized controlled study protocol in China 提高乳腺癌术后患者心理健康和自我管理的文化适应性认知行为压力管理方案：中国随机对照研究方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-11-02 DOI: 10.1016/j.conctc.2025.101567

Linzhi Jiang , Rongrong Liu , Xingqun Tan , Fan Wang , Liyuan Sun

Introduction

Breast cancer patients often face mental health challenges after prolonged treatment. High incidence and mortality rates, coupled with a shortage of healthcare professionals and heavy clinical workloads, frequently lead to the neglect of psychological care. Developing a targeted and effective psychological intervention for breast cancer patients is therefore crucial. This study aims to evaluate the efficacy of a culturally adapted cognitive behavioral stress management (CBSM) program on postoperative psychological well-being, disease-related symptoms, and self-management among breast cancer patients in China.

Methods and analysis

A total of 72 postoperative breast cancer participants will be randomly assigned to either the intervention group or the control group. This study adopts a randomized controlled design with repeated post-test measurements. Key outcome variables, including benefit finding (primary outcome), social support, perceived stress, self-management, and quality of life (secondary outcomes), will be assessed at four time points: baseline, 1 month, 3 months, and 6 months after the intervention.

Discussion

This study provides a structured psychological intervention tailored to postoperative breast cancer patients in China, offering a theoretical basis for clinical psychological care in oncology settings. The findings are expected to clarify the role of the culturally adapted CBSM program in enhancing benefit finding, improving social support and self-management, and alleviating stress while boosting quality of life. By testing the adapted CBSM in the Chinese cultural context, with implications for refining cross-cultural psychological support strategies for breast cancer patients.

Trial registration

Chinese Clinical Trial Registry: ChiCTR2500101510; registration date: April 25, 2025.

乳腺癌患者在长期治疗后经常面临心理健康挑战。发病率和死亡率高，加上保健专业人员短缺和临床工作量大，经常导致忽视心理护理。因此，为乳腺癌患者制定有针对性和有效的心理干预措施至关重要。本研究旨在评估文化适应性认知行为应激管理（CBSM）项目对中国乳腺癌患者术后心理健康、疾病相关症状和自我管理的疗效。方法和分析总共72名乳腺癌术后患者将被随机分配到干预组和对照组。本研究采用随机对照设计，重复试验后测量。主要结果变量，包括获益发现（主要结果）、社会支持、感知压力、自我管理和生活质量（次要结果），将在四个时间点进行评估：基线、干预后1个月、3个月和6个月。本研究为中国乳腺癌术后患者提供结构化的心理干预，为肿瘤学临床心理护理提供理论依据。该研究结果有望阐明文化适应性CBSM项目在增强发现利益、改善社会支持和自我管理、减轻压力和提高生活质量方面的作用。通过在中国文化背景下测试适应的CBSM，为完善乳腺癌患者的跨文化心理支持策略提供启示。中国临床试验注册中心：ChiCTR2500101510；报名日期：2025年4月25日。

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