Contemporary Clinical Trials Communications最新文献

{"title":"Evaluation of an emotion regulation and healthy lifestyle program (HealthTRAC) for adolescents with obesity: a randomized controlled trial protocol","authors":"Wendy Hadley, David Barker, Christopher Houck, Alex Foster, Kimberly Reynolds, Katherine Darling, Jennifer Warnick, Elissa Jelalian","doi":"10.1016/j.conctc.2026.101671","DOIUrl":"10.1016/j.conctc.2026.101671","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"52 ","pages":"Article 101671"},"PeriodicalIF":1.5,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13393701/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148580313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to “Evaluating continuous identity cognitive therapy for veterans with a recent suicidal episode: An open-label group pilot study” [Contemp. Clin. Trials Commun. 48 (2025) 101576]","authors":"Yosef Sokol, Sofie Glatt, Sarah Andrusier, Chynna Levin, Caroline Boucher, Josephine Ridley, Clayton H. Brown, Yulia Landa, Shirley Glynn, Marianne Goodman","doi":"10.1016/j.conctc.2026.101662","DOIUrl":"10.1016/j.conctc.2026.101662","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"52 ","pages":"Article 101662"},"PeriodicalIF":1.5,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13419472/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148632110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A family navigator model for foster parents to promote youth mental health wellness: Study development and protocol","authors":"Christina L. Boisseau ,&nbsp;Heather Risser ,&nbsp;Miguel A. Herrera ,&nbsp;Clara Law ,&nbsp;Zoran Martinovich ,&nbsp;Spencer St. Jean ,&nbsp;Yufan Wang","doi":"10.1016/j.conctc.2026.101651","DOIUrl":"10.1016/j.conctc.2026.101651","url":null,"abstract":"<div><h3>Background</h3><div>Children in foster care experience disproportionately high rates of mental illness, yet most do not receive timely or evidence-based mental health treatment. Foster parents play a critical role in treatment engagement but face substantial structural and informational barriers to accessing care.</div></div><div><h3>Objective</h3><div>This study describes the development, human-centered design, open and pilot randomized controlled trial of <em>Family Navigator Plus (FN+)</em>, a telehealth-delivered family navigation intervention designed to increase foster parent activation and reduce barriers to mental health treatment access for children in foster care.</div></div><div><h3>Methods</h3><div>FN+ is a 5-week, manualized intervention delivered via telehealth by trained community health workers. The study includes three phases: 1) human-centered design interviews with foster parents, caseworkers, and providers; 2) an open trial (<em>N =</em> 12) to refine the intervention; and 3) a pilot randomized controlled trial (<em>N</em> = 60) comparing FN + to an attention control condition focused on youth civic engagement. The primary outcome is foster parent activation in the child's mental health care.</div></div><div><h3>Conclusions</h3><div>This study will provide critical feasibility, acceptability, and preliminary effectiveness data for a scalable, cost-effective approach to improving mental health care access for children in foster care.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"51 ","pages":"Article 101651"},"PeriodicalIF":1.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148230608","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":"Expressive writing to reduce depressive and anxiety symptoms among sexual minority veterans: Study design for a pilot randomized controlled trial","authors":"Kelly L. Harper ,&nbsp;Katherine Kelton ,&nbsp;Nicholas A. Livingston ,&nbsp;Katherine M. Iverson ,&nbsp;Colleen A. Sloan ,&nbsp;Abigail Batchelder ,&nbsp;Brian P. Marx","doi":"10.1016/j.conctc.2026.101650","DOIUrl":"10.1016/j.conctc.2026.101650","url":null,"abstract":"<div><h3>Background</h3><div>Sexual minority veterans (e.g., gay, lesbian, bisexual) are at increased risk for depression and anxiety due in part to the experience of sexual minority stressors. However, few interventions target distress related to sexual minority stressors, and even fewer have been tested in Veterans Health Administration (VHA). Brief, easy to implement interventions, such as expressive writing-based interventions, that target distress related to sexual minority stressors are needed to reduce disparities in depression and anxiety.</div></div><div><h3>Method</h3><div>We describe the design of a two-phase study consisting of an open trial and a pilot randomized controlled trial (RCT) comparing Expressive Writing on Minority Stressors (EWMS) and a neutral writing condition among sexual minority veterans. The EWMS protocol will be iteratively refined in a case series (n = 10) and then tested in a pilot randomized control trial (RCT; n = 54). Aims of the pilot RCT are to: 1) demonstrate feasibility and acceptability of study procedures and EWMS using quantitative and qualitative data; and 2) examine preliminary trends in depressive and anxiety symptoms to inform the design of a future, fully powered efficacy trial. Participants will be assessed at baseline, posttreatment, and 3 months after treatment. Qualitative exit interviews will be conducted to inform refinements to the intervention with an eye towards usefulness, satisfaction, and implementation.</div></div><div><h3>Conclusions</h3><div>This pilot RCT will inform the first fully powered clinical trial to test an individually delivered intervention for sexual minority veterans to reduce depressive and anxiety symptoms associated with minority stress.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"51 ","pages":"Article 101650"},"PeriodicalIF":1.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148167664","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":"The design of a small Bayesian hybrid-controlled trial utilizing time-to-event data from six published sources that used best alternative care to treat liver-predominant metastasis from primary ocular melanoma","authors":"David Zahrieh ,&nbsp;Xiaofei Wang ,&nbsp;Svetomir N. Markovic ,&nbsp;Vera J. Suman","doi":"10.1016/j.conctc.2026.101653","DOIUrl":"10.1016/j.conctc.2026.101653","url":null,"abstract":"<div><h3>Background</h3><div>Time-to-event endpoints, such as progression-free survival (PFS), are used to evaluate clinical activity in early-phase RCTs in cancer research. Because the power to detect a reduction in the hazard rate depends on the number of events observed, recruiting enough patients with a rare cancer can be difficult. Bayesian designs that leverage historical control data to augment the control arm are sought in rare cancers because there is a practical and ethical willingness to trade modest increases in bias and Type 1 error, particularly under prior-new data conflict, for meaningful reductions in variance and improved feasibility.</div></div><div><h3>Purpose</h3><div>The purpose is to provide a real-world, from beginning to end application to design a time-to-event hybrid-controlled trial for a rare cancer with best alternative care (BAC) as the control that uses robust borrowing from six BAC PFS data sources and explicitly evaluates the operating characteristics across degrees of prior-new data conflict.</div></div><div><h3>Methods</h3><div>A simulation-based approach for Bayesian sample size determination was used and calibrated to possess good frequentist Type 1 and 2 error properties.</div></div><div><h3>Results</h3><div>A Bayesian hybrid-controlled RCT resulted in a 28% reduction in the number of participants needed to detect a 50% reduction in the hazard rate compared with a traditional frequentist design with the same power.</div></div><div><h3>Conclusions</h3><div>Utilizing historical BAC PFS data from 309 patients with liver-predominant metastasis from primary ocular melanoma can enhance trial efficiency by assigning fewer subjects to the control arm and potentially lead to the earlier availability of effective therapies to patients with this rare cancer.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"51 ","pages":"Article 101653"},"PeriodicalIF":1.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148230610","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":"Evaluating the substitutability of fruit versus menthol and tobacco-flavored e-cigarettes on combustible cigarette cessation: Randomized clinical trial protocol","authors":"Olivia Klapec ,&nbsp;Andrew A. Strasser ,&nbsp;E. Paul Wileyto ,&nbsp;Janet Audrain-McGovern","doi":"10.1016/j.conctc.2026.101652","DOIUrl":"10.1016/j.conctc.2026.101652","url":null,"abstract":"<div><div>While regulations have restricted the sale of pod-style fruit-flavored e-cigarettes, observational and clinical data suggest that their use is associated with smoking cessation among adults. Surprisingly, no randomized clinical trials have tested whether fruit flavors affect smoking outcomes compared with those authorized for sale, and, if so, why. Adults who smoke cigarettes daily, who have had multiple prior unsuccessful quit attempts, and who are interested in quitting smoking by switching to an e-cigarette will be recruited. Eligible adults will be randomized to fruit, menthol, or tobacco-flavored e-cigarettes. The baseline smoking rate will be established on days 1-5. Laboratory visits on days 6 and 7 will assess flavor-associated subjective reward and the reinforcing value of flavored e-cigarettes relative to combustible cigarettes. Participants will then receive an e-cigarette device and a 6-week supply of nicotine pods (5% nicotine) in their assigned flavor, and a structured action plan to quit smoking by switching to the e-cigarette. The primary outcome is the longitudinal daily cigarette count from baseline through the end of the six-week switch period (primary endpoint) and at the 26-week follow-up (secondary endpoint). Complete switching will be verified with a carbon monoxide value &lt; 5 ppm. Secondary outcomes include subjective reward, relative reinforcing value, and positive affect. This trial will determine if fruit-flavored e-cigarettes facilitate initial and sustained switching more than menthol or tobacco, whether greater rewarding and positively reinforcing effects drive switching, and if the unavailability of fruit-flavoring may foster continued smoking for those unable to quit with FDA-approved medication.</div><div>This trial was registered at <span><span>CT.gov</span><svg><path></path></svg></span> (NCT06264154) <span><span>https://clinicaltrials.gov/study/NCT06264154</span><svg><path></path></svg></span> on February 16, 2024.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"51 ","pages":"Article 101652"},"PeriodicalIF":1.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148230603","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":"Electronic clinical outcome assessments and the European Union's clinical trial regulation: Smoothing the path to friction?","authors":"Pierre Mermet-Bouvier ,&nbsp;Pierre-Frederic Omnes ,&nbsp;Valdo Arnera ,&nbsp;Scottie Kern","doi":"10.1016/j.conctc.2026.101623","DOIUrl":"10.1016/j.conctc.2026.101623","url":null,"abstract":"<div><div>The European Union's Clinical Trial Regulation 536/2014 (EU-CTR) sought to harmonize clinical trial rules, ensure high standards of safety, and streamline processes through its new Clinical Trials Information System (CTIS). However, confusion remains regarding submission requirements for “patient-facing documents” in Parts I and II of clinical trial applications (CTAs). Misinterpretations—particularly around what qualifies as written information—have led to unnecessary submissions of materials like eCOA or ePRO “screenshots,” which are not legally required.</div><div>The EU's EUDRALEX Volume 10 Q&amp;A (notably Question 1.24) clarified that only patient-facing documents linked to trial endpoints, such as questionnaires, diaries, or patient cards, need inclusion in Part I alongside the protocol. There is no legal basis to demand all patient materials or their translations in Part II. Despite this clarification, member states retain autonomy under Article 26 to set national translation and document requirements, leading to inconsistent practices and continued administrative burden.</div><div>Recent initiatives, including CTR Collaborate (under the Accelerating Clinical Trials in the EU program) and MedEthics EU, seek to promote harmonization and efficient assessment. Empirical studies show that Ethics Committees (ECs) generally do not expect ePRO screenshots—most require only translated questionnaires.</div><div>EU-CTR's success depends on collective awareness and streamlined processes. With ICH E6 Revision 3 and global efforts by organizations like the WHO, there is an opportunity to balance regulatory rigor with practical efficiency—reducing redundant submissions and emphasizing participant protection as the core ethical priority.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101623"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147386261","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":"Tobacco cessation intervention for individuals with severe mental illness in Bangladesh, India, and Pakistan: protocol for a multi-country feasibility randomised controlled trial (SCIMITAR-SA)","authors":"Garima Bhatt ,&nbsp;Kousar Ishaq ,&nbsp;Aatik Arsh ,&nbsp;Omara Dogar ,&nbsp;Justin Fenty ,&nbsp;Cath Jackson ,&nbsp;Muqaddas Asif ,&nbsp;Jothisha C ,&nbsp;Shannon Halmkan ,&nbsp;Fahmida Islam ,&nbsp;Krishna Prasad Muliyala ,&nbsp;Venkata Lakshmi Narasimha ,&nbsp;Steve Parrott ,&nbsp;Rebecca R ,&nbsp;Fahmidur Rahman ,&nbsp;Faraz Siddiqui ,&nbsp;Heather Thomson ,&nbsp;Han-I Wang ,&nbsp;Rumana Huque ,&nbsp;Imran B. Chaudhry ,&nbsp;Pratima Murthy","doi":"10.1016/j.conctc.2026.101620","DOIUrl":"10.1016/j.conctc.2026.101620","url":null,"abstract":"<div><h3>Background</h3><div>Tobacco is consumed by two-thirds of individuals with severe mental illness (SMI). Despite a high tobacco-related disease burden, there is a lack of evidence-based cessation interventions for individuals with SMI living in low- and middle-income countries. This study aims to evaluate the feasibility and acceptability of a culturally adapted behavioural intervention for tobacco cessation (SCIMITAR-SA) delivered in mental health services in Bangladesh, India, and Pakistan.</div></div><div><h3>Methods</h3><div>A two-arm, parallel-group, individually randomised, multi-country feasibility trial will be conducted across six mental health facilities in urban centres. All trial participants will receive Very Brief Advice (VBA) and an educational leaflet from their clinical team. Additionally, those in the intervention arm will receive up to seven structured behavioural support sessions. Salivary cotinine and anabasine will be used to biochemically verify abstinence at seven months post-randomisation. Quantitative outcomes will assess feasibility of conducting a definitive trial, including recruitment and retention rates, session attendance, completeness of baseline assessments and outcome measures at four and seven months and use of health resources. An embedded process evaluation will explore the feasibility and acceptability of trial processes, and of the delivery and receipt of the VBA and SCIMITAR-SA interventions. Economic outcomes will assess the feasibility of collecting cost and resource-use data to inform a future definitive trial.</div></div><div><h3>Discussion</h3><div>The SCIMITAR-SA trial will provide essential evidence on the feasibility of delivering culturally adapted cessation support for people with SMI in South Asia and inform scalable integration into routine psychiatric care across low- and middle-income settings.</div></div><div><h3>Registration</h3><div>ISRCTN registry (ISRCTN91038721)</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101620"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147386240","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":"Relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation: A randomized controlled trial in young adult females","authors":"Fumitake Yamaguchi ,&nbsp;Miho Kuroki ,&nbsp;Naoki Yoshinaga ,&nbsp;Michikazu Nakai ,&nbsp;Yasuji Arimura","doi":"10.1016/j.conctc.2026.101613","DOIUrl":"10.1016/j.conctc.2026.101613","url":null,"abstract":"<div><h3>Background</h3><div>Shikuwasa (<em>Citrus depressa</em> Hayata) essential oil, rich in limonene and γ-terpinene, produces calming effects, but its psychological and physiological relaxation effects in humans remain unclear. This study examined the short-term relaxation effects of inhaling Shikuwasa essential oil compared to odor-free air among young adult females.</div></div><div><h3>Methods</h3><div>In this two-arm, parallel-group, open-label, randomized controlled superiority trial, healthy females aged 18–39 were randomly assigned to either the Shikuwasa essential oil group (n = 20) or the odor-free air group (n = 20). The primary outcome was subjective tense-arousal, measured using the Japanese version of the University of Wales Institute of Science and Technology Mood Adjective Checklist (JUMACL). Secondary outcomes included miosis rate, peripheral skin temperature, and cerebral blood flow. Due to measurement constraints, the experiment was divided into three 2-min inhalation phases.</div></div><div><h3>Results</h3><div>No significant between-group differences were observed in tense-arousal, miosis rate, or cerebral blood flow. Additional analyses of covariance, performed for each outcome variable using the Visual Analog Scale score and its interaction with the group as covariates, revealed a trend toward an interaction effect for the JUMACL tense-arousal subscale score, although the overall effects were not statistically significant.</div></div><div><h3>Conclusions</h3><div>Short-term inhalation of Shikuwasa essential oil did not significantly reduce tense-arousal or affect physiological indices in healthy, normal-to-low stress young adult females. However, aroma preference may influence psychological and neural responses. Future studies should consider pre-assessed aroma preference, longer inhalation durations, single-phase protocols, extended rest periods, and participants’ baseline mood.</div></div><div><h3><strong>Trial registration</strong></h3><div>This study was prospectively registered with the UMIN-CTR, UMIN000053914.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101613"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146154175","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":"Protocol for a pragmatic trial comparing navigator and automated virtual interventions for guaranteeing adherence to fecal immunochemical testing (NAVIGATE-FIT)","authors":"Emily Jansen ,&nbsp;Divya A. Shankar ,&nbsp;Tabitha Cherilus ,&nbsp;Emily Foster ,&nbsp;Lisa Ben-Horin ,&nbsp;Nicholas Cordella ,&nbsp;Nicholas A. Bosch ,&nbsp;Kirsten Austad","doi":"10.1016/j.conctc.2025.101546","DOIUrl":"10.1016/j.conctc.2025.101546","url":null,"abstract":"<div><h3>Background</h3><div>Fecal immunochemical testing (FIT) – a non-invasive colorectal cancer (CRC) screening method offers an opportunity to bridge CRC screening gaps in underserved settings. The effectiveness of FIT as a screening tool, however, is limited by low return rates of stool samples. Patient navigation has been demonstrated to successfully improve FIT return rates in randomized trial settings, however, in real-world settings, navigation may not achieve the same impact due to resource constraints. Text-based reminders offer a low-cost alternative to patient navigation to facilitate FIT test returns. In the NAVIGATE-FIT project, we seek to use rapid randomized testing to compare a text-based intervention to patient navigation in a quality improvement effort assessing if a text-based reminder program is non-inferior to patient navigation to improve FIT return rates in a safety-net hospital system.</div></div><div><h3>Methods</h3><div>We will randomize primary care patients (English- or Spanish-speaking) due for CRC screening at Boston Medical Center (BMC) with an unreturned FIT test (ordered 30-37 days prior) to either a text messaging system (Artera) or patient navigation. Artera is an artificial intelligence enabled system which has been programmed with conversation text flows to facilitate FIT test returns. The patient navigation arm will prioritize patients with overdue FIT tests for a navigation phone call the week of randomization. Outcomes will be assessed in accordance with the Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) framework, and the project has been powered based on the effectiveness outcome of percentage of patients with a completed FIT test within 30 days of randomization. We have selected a non-inferiority margin of 13% on the risk difference scale and anticipate 80% power with inclusion of 196 patients in each arm. Primary analysis will be intention-to-treat. The primary project goal is to generate local knowledge to select a strategy to improve screening at BMC.</div></div><div><h3>Conclusions</h3><div>The NAVIGATE-FIT project is well-positioned to test the hypothesis that a conversational text-based reminder and follow-up system is non-inferior to the current usual care patient navigation system at BMC, a large, academic, urban, safety-net hospital, for improving return rates of FIT screening tests. This protocol can serve as a model to other health systems seeking to undertake randomized quality improvement projects.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101546"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147378912","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}