Contemporary Clinical Trials Communications最新文献

{"title":"Evaluating a negotiation training program for family caregivers of older people using a Multiphase Optimization Strategy (MOST) design and protocol","authors":"Charlie Olvera ,&nbsp;Vanessa Ramirez-Zohfeld ,&nbsp;Alaine Murawski ,&nbsp;Angela Fidler Pfammatter ,&nbsp;Lee A. Lindquist","doi":"10.1016/j.conctc.2026.101596","DOIUrl":"10.1016/j.conctc.2026.101596","url":null,"abstract":"<div><div>Traditional clinical trial designs such as the isolated two-arm randomized controlled trial (RCT) do not offer robust solutions for evaluating and optimizing delivery of complex, multi-component behavioral interventions. A recent alternative design, the Multiphase Optimization Strategy (MOST), addresses many shortcomings of the isolated two-arm RCT. The MOST framework for trial design provides researchers opportunities to perform independent evaluations of intervention content, dosage levels, delivery formats, and potential intra-intervention interactions. Results from factorial trials which implement MOST frameworks are used to optimize ongoing interventions.</div><div>Herein, we describe the protocol for a MOST RCT which evaluates NegotiAge, an artificial intelligence-based negotiation and dispute resolution training program for family caregivers of older adults. Many family caregivers experience conflicts as they support older adult care recipients. Teaching negotiation skills to family caregivers has potential to improve communication and resolve conflicts more efficiently. The trial evaluation of NegotiAge eschews traditional two-arm RCT design and instead employs the MOST framework. Our MOST trial tests eight treatment combination packages against one another and evaluates associations between specific treatment combinations and user-centered outcomes.</div><div>This research is the first to apply the MOST framework in geriatrics and family caregiving. Our use of the MOST framework to evaluate and optimize NegotiAge enables us to identify which components are most effective for family caregivers and isolate the interactional effects of each component. The protocol and eventual results of our MOST trial will demonstrate how to optimize an intervention to be efficient and potent for busy family caregivers of older adults.</div></div><div><h3>Trial registration ID</h3><div>NCT04837937.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101596"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Healthy eating and active living to reverse diabetes (HEAL Diabetes-USA): a randomized controlled pilot study protocol to assess the feasibility of a weight loss intervention for diabetes remission","authors":"Alexandria M. Boykins ,&nbsp;Asos Mahmood ,&nbsp;Mona N. Wicks ,&nbsp;Satya Surbhi ,&nbsp;Santos A. Martinez ,&nbsp;Frankie B. Stentz ,&nbsp;James E. Bailey","doi":"10.1016/j.conctc.2026.101597","DOIUrl":"10.1016/j.conctc.2026.101597","url":null,"abstract":"<div><h3>Background</h3><div>Intensive lifestyle programs promoting weight loss have been shown to induce long-term remission of early Type 2 diabetes (T2D). Further, multicomponent weight loss interventions are recommended for all patients with obesity, but these programs are largely unavailable for people living in low-income and medically underserved areas in the United States (US) and little is known about the benefits, feasibility, and costs of such interventions in community settings.</div></div><div><h3>Objective</h3><div>To assess the feasibility, preliminary effectiveness, and costs of a multicomponent intensive healthy eating and weight-loss program designed to support diabetes remission.</div></div><div><h3>Study design</h3><div>The US-based Healthy Eating and Active Living to reverse diabetes (HEAL Diabetes-USA) is a pragmatic randomized controlled pilot study conducted in Memphis, Tennessee (data collection: August 2023–August 2025), independent of and not affiliated with the UK-based HEAL-D program. Adults (≥18 years) with early T2D (&lt;6 years), HbA1c ≥ 6.5%, and overweight/obesity (n = 60) are randomized to either Enhanced Care (EC) or Intensive Care (IC). EC includes printed materials and standard health coaching. IC is the multi-component intervention arm which includes grocery delivery, nutrition education, biweekly group sessions, and ongoing health coaching. Primary outcomes include changes in body weight and HbA1c, and proportion of patients who achieved diabetes remission at 6 and 12 months. Secondary outcomes include changes in random blood glucose, self-efficacy, diabetes self-care activities and program cost analyses.</div></div><div><h3>Conclusions</h3><div>This protocol describes the design of HEAL Diabetes-USA, a community-based intensive lifestyle intervention for early T2D. Findings will inform the feasibility and cost-effectiveness of delivering multicomponent diabetes-remission programs in medically underserved US settings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101597"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of preoperative inspiratory muscle training combined with education course on postoperative pulmonary complications in high-risk patients with lung cancer after video-assisted thoracoscopic surgery: a randomized controlled trial","authors":"Ting Lu ,&nbsp;Zhixuan Shi ,&nbsp;Shuna Huang ,&nbsp;Lan Lv ,&nbsp;Xinyuan Chen ,&nbsp;Ke Ma ,&nbsp;Xu Li ,&nbsp;Fancai Lai ,&nbsp;Jun Ni","doi":"10.1016/j.conctc.2026.101600","DOIUrl":"10.1016/j.conctc.2026.101600","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Aims&lt;/h3&gt;&lt;div&gt;Surgery provides the best chance of survival for early-stage non-small cell lung cancer patients, resulting in a large number of patients requiring surgical resection each year. Preoperative inspiratory muscle training (IMT) is recognized as an important component of the preoperative management of lung cancer, although there is limited evidence for the delivery of a home-based IMT combined with preoperative education. We developed a programme combining short-term home-based IMT and preoperative physiotherapy education (\"the programme\") for lung patients with lung cancer. This study aims to evaluate the effectiveness of the programme in reducing postoperative pulmonary complications (PPCs) after video-assisted thoracoscopic surgery (VATs) compared to standard care.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;This randomized controlled clinical trial (RCT) called for 114 participants at a tertiary hospital to be randomized 1:1 to the control group (CG) and the intervention group (IG). All subjects in both groups received routine perioperative rehabilitation intervention and health education manual. Participants in the IG received a detailed education course plus at least seven-day inspiratory muscle training programme before VATs. Outcome assessments were obtained in person at baseline (T0), the day before surgery (T1) and hospital discharge (T2). Primary outcome measure was PPCs using the Melbourne Group Score (MGS) obtained at discharge. Secondary outcomes were health-related quality of life, maximal inspiratory pressure (MIP), Forced expiratory volume in the first second (FEV1), 6-min walk distance (6MWD), length of hospital stay (LOS), anxiety and depression levels, and hospital costs. SPSS 26.0 statistical analysis software was used for analysis, and bilateral tests were used according to statistical tests. When P &lt; 0.05, the difference was considered statistically significant.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;In accordance with the protocol, we performed interim unblinding after 50 % of the patients had been enrolled. At the interim analysis, the conditional power was calculated as 0.035 (futility index: 0.965; Supplementary 1), indicating this study should be stopped because there is little chance of achieving statistical significance. No safety concerns were identified. A total of 56 cases (27 cases in the IG and 29 cases in the CG) were finally included from March 2023 to March 2024. The incidence of PPCs between the two groups was not statistically significant (CG = 2/29, IG = 3/27, adjust RR was1.90 (0.29–12.82). One-week preoperative training programme increased MIP, but the results were not sufficient to make a significant difference (P = 0.208). Other secondary outcome measures were also assessed, but no significant between-group differences were found.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;Preoperative education combined with one-week IMT has no significant clinical significance in reducing the incidence of p","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101600"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of intermittent theta-burst stimulation (iTBS) on post-stroke depression (PSD): A study protocol for a single-center randomized controlled trial","authors":"Yanbiao Zhong ,&nbsp;Meng Ren ,&nbsp;Wenjing Wang ,&nbsp;Juanlian He ,&nbsp;Yonghui Zhong ,&nbsp;Jingjing Xu ,&nbsp;YuanLi Li ,&nbsp;Sicong Zhang ,&nbsp;Chunlei Shan","doi":"10.1016/j.conctc.2026.101599","DOIUrl":"10.1016/j.conctc.2026.101599","url":null,"abstract":"<div><h3>Introduction</h3><div>Intermittent theta-burst stimulation (iTBS) is a specific type of repetitive transcranial magnetic stimulation (rTMS) paradigm with long-lasting effects and a short session duration. Although randomized controlled trials have suggested that iTBS is effective for treating depression, few studies have investigated the effects of iTBS in treating post-stroke depression (PSD). The purpose of the present study is to investigate whether iTBS can be used to treat PSD. We will also investigate the corresponding mechanisms of iTBS via functional magnetic resonance imaging (fMRI).</div></div><div><h3>Methods and analysis</h3><div>We will recruit 36 PSD patients for this single-center, randomized, sham-controlled trial. Subjects will be randomly divided into the following two groups according to a 1:1 ratio: the active iTBS group and the sham iTBS group. The data will be collected at 0 and 10 d after the commencement of treatment. The primary outcome will be comprised of scores on the 17-item Hamilton Depression Rating Scale. The secondary outcomes will consist of MRI results and the results of neuropsychological tests, including the Brief 16-item Quick Inventory of Depressive Symptomatology Self-Report, Hamilton Anxiety Scale, Snaith-Hamilton Pleasure Scale for clinician administration, and Young Mania Rating Scale.</div></div><div><h3>Ethics and dissemination</h3><div>Ethics approval has been granted by the Ethics Committee of Yueyang Integrative Medicine Hospital, an affiliate of Shanghai University of Traditional Chinese Medicine (Shanghai, China; Grant No. 2019-108). Written informed consent will be obtained from each participant before any procedures are performed. The findings will be published in peer-reviewed journals and presented at academic conferences.</div></div><div><h3>Trial registration number</h3><div>ChiCRT1900027686.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101599"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study design and protocol for a randomized clinical trial investigating a brief fear of uncertainty-focused intervention as an adjunct to project safe guard for military personnel","authors":"Samantha E. Daruwala ,&nbsp;Kayley Stratton ,&nbsp;Grace Y. Cho ,&nbsp;Michael D. Anestis ,&nbsp;Craig J. Bryan ,&nbsp;Nicholas P. Allan","doi":"10.1016/j.conctc.2025.101577","DOIUrl":"10.1016/j.conctc.2025.101577","url":null,"abstract":"<div><h3>Background</h3><div>In the United States (US), the proportion of firearm suicide deaths are higher among military personnel compared to the general population. Secure firearm storage practices (e.g., gun safe, unloaded) can reduce the risk of firearm suicide. A randomized controlled trial, called Project Safe Guard (PSG) found that providing lethal means counseling (LMC) to firearm-owning service members increased secure firearm storage practices; however, some still stored at least one firearm unsecurely. Intolerance of uncertainty (IU) may be a barrier to secure firearm storage that decreases the effectiveness of LMC. This study will examine the impact of a brief intervention that targets IU (i.e., Cognitive behavioral therapy for Uncertainty Enhanced; CUE) on improving the effectiveness of PSG-LMC on secure firearm storage practices among firearm-owning service members. In this protocol paper, we describe the rationale and methodology for this study.</div></div><div><h3>Methods</h3><div>This study uses a counterbalanced design with two conditions to test the acceptability, feasibility, and potential efficacy of both interventions with 100 current or recently discharged service members who report elevated IU and storing at least one firearm unsecurely. Participants are randomized to either receive CUE or PSG-LMC first, and then receive the second intervention approximately two weeks later. Participants will complete a baseline assessment, ecological momentary assessment (EMA) via their mobile devices, and follow-ups at 1-, 3-, 6-, 9-, and 12-months post-baseline. All interventions will be delivered remotely.</div></div><div><h3>Conclusions</h3><div>This study aims to inform how to improve firearm safety in military personnel with elevated IU.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101577"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Yogurt reintroduction and the circulating microbiome in healthy volunteers: protocol for a prospective, longitudinal, species-controlled crossover clinical trial (MAMI)","authors":"Junhong Su ,&nbsp;Bettina E. Hansen ,&nbsp;Zifang Wang ,&nbsp;Abylaikhan Sharmenov ,&nbsp;Xueshan Xia ,&nbsp;Michelle Broekhuizen ,&nbsp;Zhongren Ma ,&nbsp;Maikel P. Peppelenbosch","doi":"10.1016/j.conctc.2025.101579","DOIUrl":"10.1016/j.conctc.2025.101579","url":null,"abstract":"<div><h3>Background</h3><div>Although the gut microbiome plays a crucial role for maintaining overall host homeostasis and metabolism, it is significantly influenced by dietary changes, leading to substantial temporal variations in microbial composition within and between individuals. Despite this, incidental fecal sampling remains the standard method for microbiome assessment. Recently, the blood microbiome, defined by microbial DNA (cmDNA) circulating in the bloodstream, has emerged as a potentially more stable and integrated alternative. Preliminary data suggest that blood microbiome analysis may offer more consistent insights than fecal-based approaches, although the methodological validity of the approach has been questioned.</div></div><div><h3>Method/design</h3><div>This study aims to establish or rule-out cmDNA as a representative of the gut microbiome. In a prospective, single-arm crossover trial, effects of dairy product withdrawal and reintroduction of a yoghurt with a known consortium of bacteria will be assessed in healthy volunteers aged 18–65. Participants will first abstain from all dairy products, a phase expected to reduce yogurt-associated cmDNA in the bloodstream. Yogurt will then be reintroduced, during which reappearance of cmDNA of specific bacteria (especially LGG, LA-5 and BB-12) is anticipated. Shotgun metagenomic sequencing will be used to track cmDNA dynamics over time. This longitudinal sampling approach will provide experimental evidence supporting the existence and responsiveness of the circulating microbiome, while also revalidating the bioinformatic pipeline used for its analysis.</div></div><div><h3>Conclusion</h3><div>This pilot study will test whether blood-derived microbial DNA can serve as a valid surrogate for gut microbiome composition. If successful, this approach may provide a more stable and integrative alternative to fecal sampling and support future biomarker development and mechanistic research.</div></div><div><h3>Clinical trial registration</h3><div>NCT06944002.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101579"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Frontier sites in clinical trials: Opportunities, challenges, and models","authors":"Andrea Bastek ,&nbsp;Amanda Zenere ,&nbsp;Heather Manley ,&nbsp;Camille Finkle ,&nbsp;Chad Jaeger ,&nbsp;Janet Matthews ,&nbsp;Kristie Moffett ,&nbsp;Megan Solomon ,&nbsp;Paula Underhill","doi":"10.1016/j.conctc.2025.101581","DOIUrl":"10.1016/j.conctc.2025.101581","url":null,"abstract":"<div><h3>Background</h3><div>The clinical trials industry faces a growing capacity gap driven by an increasing number of studies combined with site and staff shortages. The Site Enablement League (SEL) Task Force on Frontier Sites was established to explore the potential of non-traditional research sites—termed \"frontier sites\"—to address these issues by expanding access to underserved populations and embedding clinical research in community settings.</div></div><div><h3>Methods</h3><div>The task force defined frontier sites and conducted a survey to gather perspectives on their benefits, challenges, and support needs. Twenty-nine valid survey responses were collected. Respondents self-identified as having direct experience with frontier sites (“experienced respondents”) or answered based on their perception of working with frontier sites (“perception respondents”). Free-text responses were coded into categories and analyzed qualitatively and quantitatively.</div></div><div><h3>Results</h3><div>Access to new participant populations was the most cited benefit, and experienced respondents noted additional gains in site engagement and education. Operational infrastructure deficiencies were the primary challenge identified by both experienced and perception respondents. Experienced respondents highlighted greater concerns about compliance and community resistance. The primary support need identified was enhanced operational support and quality oversight. Differences between experienced and perception respondent groups suggested the need for broader industry education.</div></div><div><h3>Conclusion</h3><div>Frontier sites offer significant promise for increasing research capacity and diversity, but require substantial operational, educational, and community engagement support. These survey findings provide a foundation for shared understanding across the industry. From that foundation the industry can work to develop a playbook to guide the successful integration of frontier sites into clinical trial operations.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101581"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145690370","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Establishing a clinical trial site: A primer for aspiring principal investigators","authors":"John J. Sramek,&nbsp;Modesto S. Carrillo,&nbsp;Neal R. Cutler","doi":"10.1016/j.conctc.2025.101561","DOIUrl":"10.1016/j.conctc.2025.101561","url":null,"abstract":"<div><div>Establishing a private clinical trial site is an increasingly appealing but complex opportunity for physicians interested in becoming Principal Investigators (PIs) in FDA-regulated research. This article provides a comprehensive overview for aspiring PIs, detailing the critical requirements and best practices for launching and operating a successful site.</div><div>The topics covered include regulatory responsibilities, financial considerations, infrastructure needs, staffing roles, investigational product handling, standard operating procedures, IRB oversight, informed consent, and patient recruitment and retention strategies. Special emphasis is placed on compliance with FDA regulations and Good Clinical Practice (GCP) standards, ensuring data integrity and the protection of study participants.</div><div>The paper highlights the importance of robust infrastructure—from calibrated laboratory equipment and secure drug storage to electronic data capture systems—and the need for well-trained support staff, including clinical research coordinators and sub-investigators. The recruitment and retention of diverse participants is explored through ethical, patient-centered engagement strategies. Additionally, guidance is provided on navigating site feasibility assessments, sponsor negotiations, and the startup study process.</div><div>Drawing from the authors’ experience establishing clinical trial sites and contract research organizations, this guide offers strategic insights on building sponsor relationships, evaluating protocol feasibility, and enhancing site performance metrics. The evolving clinical trial landscape—driven by new therapeutic developments and digital technologies—demands that PIs not only meet regulatory standards but also demonstrate leadership, operational excellence, and a commitment to scientific integrity.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101561"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rationale and protocol for a prospective clinical trial enrollment improvement hybrid study within a trial","authors":"Patrick Lewicki ,&nbsp;Sabrina Clark ,&nbsp;Elaina Shoemaker ,&nbsp;Bingkai Wang ,&nbsp;Jerison Ross ,&nbsp;Stephanie Daignault-Newton ,&nbsp;Noelle Carlozzi ,&nbsp;Adam Martin-Schwarze ,&nbsp;William Meurer ,&nbsp;Anne Sales ,&nbsp;Khurshid Ghani ,&nbsp;Casey Dauw ,&nbsp;Kristian Stensland","doi":"10.1016/j.conctc.2025.101548","DOIUrl":"10.1016/j.conctc.2025.101548","url":null,"abstract":"<div><h3>Introduction</h3><div>Enrollment to clinical trials is challenging, and few evidence-based interventions to improve enrollment exist. Provider-facing advertising campaigns could help increase enrollment, but this type of intervention has not been prospectively evaluated in a clinical trial.</div></div><div><h3>Methods</h3><div>We designed a randomized clinical trial to evaluate the effect of a month-long email advertising campaign on enrollment to a clinical trial. This hybrid implementation-effectiveness Study Within a Trial tested the effect of precision audit and feedback techniques enrollment effectiveness outcomes (enrollment) and measured implementation outcomes (email opens, link clicks). This design is an application of a Study Within a Trial (SWAT) to evaluate an intervention intended to improve enrollment. The goal of this study was to inform both this advertising campaign and refine SWAT methods for evaluating future trial improvement interventions.</div></div><div><h3>Discussion</h3><div>This Study Within a Trial provides preliminary data on the effectiveness of email advertising campaigns for improving clinical trial enrollment. Additionally, the infrastructure built through this SWAT will inform future studies of clinical trial enrollment improvement. This protocol can serve as a template for other investigators seeking to evaluate enrollment improvement interventions.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101548"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145119444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study protocol for Project SHINE (Sleep Health INitiative for Equity): A community-based pilot RCT to promote sleep and physical activity among Black/African American adults","authors":"Ivan HC. Wu ,&nbsp;Lorna McNeill ,&nbsp;Kristen Knutson ,&nbsp;Yisheng Li ,&nbsp;Diwakar Balachandran ,&nbsp;Rhonda Jones-Webb ,&nbsp;Pamela L. Lutsey ,&nbsp;Darin Erikson ,&nbsp;Shikha Bista ,&nbsp;Rachel Price ,&nbsp;Vanessa Anyanso ,&nbsp;Taylor Smith ,&nbsp;Rev Melvin Miller","doi":"10.1016/j.conctc.2025.101541","DOIUrl":"10.1016/j.conctc.2025.101541","url":null,"abstract":"<div><h3>Background</h3><div>Black/African American (AA) adults experience shorter sleep duration and poorer sleep quality compared to White counterparts, contributing to higher risks of chronic diseases. Project SHINE (Sleep Health INitiative for Equity) aims to address these sleep disparities by evaluating the feasibility, satisfaction, and plausibility (i.e., preliminary efficacy) of a culturally tailored sleep intervention designed to improve sleep duration and physical activity among AA adults with body mass index (BMI) ≥ 25 not meeting physical activity and sleep guideline recommendations.</div></div><div><h3>Methods</h3><div>This pilot community-based randomized controlled trial (RCT) includes two phases. Phase 1 involves qualitative interviews with AA adults to explore sleep-related sociocontextual factors to refine the intervention. Phase 2 is an RCT (n = 80) assigning participants to a four-week sleep extension intervention or a contact control. The sleep extension intervention aims to improve sleep duration and physical activity. Sessions occur via Zoom, with in-person baseline and follow-up visits. Primary outcomes include feasibility and satisfaction of the intervention. Secondary outcomes include self-reported and objective sleep and physical activity measures, plus exploratory biomarkers for cancer and cardiovascular risk. Additional self-reports assess sleep-related psychosocial factors and health behaviors.</div></div><div><h3>Discussion</h3><div>This study will assess the feasibility and implementation of a culturally tailored, virtual sleep intervention for AA adults. By integrating behavior change theories, cultural adaptation frameworks, and community-based participatory principles, <em>Project SHINE</em> aims to inform a larger-scale trial and support scalable behavioral interventions to improve sleep health and reduce disparities.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101541"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145050424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}