Contemporary clinical trials最新文献

{"title":"System Interventions to Achieve Early and Equitable Kidney Transplants (STEPS): Protocol for STEPS, a randomized comparative effectiveness clinical trial","authors":"L. Ebony Boulware MD, MPH, FACP ,&nbsp;Patti L. Ephraim MPH ,&nbsp;Tariq Shafi MD, MHS ,&nbsp;Jamie A. Green MD, MS ,&nbsp;Teri Browne PhD, MSW ,&nbsp;Tara S. Strigo MPH, BS ,&nbsp;Sarah Peskoe PhD ,&nbsp;Jonathan Wilson MS ,&nbsp;Yuliya Lokhnygina PhD ,&nbsp;Aviel Alkon BS ,&nbsp;George L. Jackson PhD, MHA ,&nbsp;Matthew J. Ellis MD ,&nbsp;Debra Sudan MD ,&nbsp;Blake Cameron MD ,&nbsp;Pradeep K. Vaitla MD ,&nbsp;Ashley Cabacungan BS ,&nbsp;Lauren Brubaker MLS, ASCP, MPH ,&nbsp;Emily L. Obermiller MEd ,&nbsp;Clarissa J. Diamantidis MD, MHS","doi":"10.1016/j.cct.2025.107911","DOIUrl":"10.1016/j.cct.2025.107911","url":null,"abstract":"<div><div>The System Interventions to Achieve Early and Equitable Kidney Transplants Study (STEPS) is an ongoing pragmatic clinical trial investigating the effectiveness of an equitable and patient-centered approach to kidney care on equitable access to early kidney transplants for individuals with chronic kidney disease not on dialysis. The STEPS intervention combines active electronic health record surveillance to equitably identify all potentially eligible kidney transplant candidates in three health systems (‘STEPS Surveillance’) with a ‘STEPS Outreach Program’ (comprised of equity-conscious patient-centered transplant social worker and transplant coordinator outreach and navigation activities). Identified eligible participants are randomly assigned to receive either (a) Augmented Usual Kidney Care (routine care plus electronic surveillance and best practice alerts), or (b) the STEPS Health System Surveillance and Outreach Intervention plus Augmented Usual Kidney Care to improve access to kidney transplants overall as well as among Black and rural residing individuals. STEPS recruited all planned 1168 participants from March 2022 to March 2024. Outcomes will quantify differences between the study arms in progress toward and completion of kidney transplant evaluations, assessed via medical records, and patient-reported outcomes.</div><div><strong>Registration of clinical trials</strong></div><div>This study is registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> under the identifier <span><span>NCT05014256</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107911"},"PeriodicalIF":2.0,"publicationDate":"2025-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and methods of a cluster-randomized pragmatic trial of post-discharge stroke care","authors":"Patricia Commiskey ,&nbsp;D. Leann Long ,&nbsp;Virginia J. Howard ,&nbsp;Jeri Braunlin ,&nbsp;George Howard ,&nbsp;David Cochran ,&nbsp;Barry Jackson ,&nbsp;Desiree Bell ,&nbsp;Debbie Hill ,&nbsp;Amy E. Callahan ,&nbsp;Kenneth Gaines","doi":"10.1016/j.cct.2025.107890","DOIUrl":"10.1016/j.cct.2025.107890","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;Stroke is the 5th leading cause of death and a leading cause of adult disability in the United States (US). One in four strokes are recurrent events. Stroke patients experience persisting physical and cognitive impairments long-term, and their caregivers/family also experience psychological and health quality impacts. The current standard for stroke care in the US utilizes hospital certifications based on level of available care and includes proven acute and in-hospital care processes and offers limited post-discharge care coordination of risk factor management, secondary prevention, and early and continued rehabilitation that have been shown beneficial for recovery. The Joint Commission (TJC) Comprehensive Stroke Care (CSC) certification is awarded to hospitals that provide the most advanced level of stroke care. Another model of care in use in the US is a patient-centered, technology-enabled Integrated Stroke Practice Unit (ISPU) that incorporates team-based care components across the continuum. While risk factor management and early rehabilitation occur during hospitalization, these become the focus and are facilitated in the ISPU post-discharge. While both models have shown effectiveness, understanding which model yields better outcomes is critical scientific information for the stroke community.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;This paper reports the protocol for the &lt;em&gt;Coordinated, Collaborative, Comprehensive, Family-Based, Integrated, and Technology-Enabled Stroke Care (C3FIT)&lt;/em&gt;, including rationale, design, and methodology for the study. C3FIT is a pragmatic, multicenter, single masked, Phase III, cluster randomized clinical trial designed to determine effectiveness of two US stroke care models - TJC CSC care (CSC-Only; active control) compared to a model that layers the ISPU model on top of CSC care (ISPU+CSC; intervention). Up to 23 clinical sites were stratified by geographic region and patient admission volume and randomized at the site level. Participants included patients (or their Legally Authorized Representative) and their caregiver (if available). Participants in each treatment group were followed through in-person, virtual, or phone contact at 3-, 6-, and 12-months post-discharge; participants in the ISPU+CSC arm were also seen at 1-, 2-, 4-, 5-, 7-, 8-, 9-, 10- and 11-months post-discharge. Patient-centered primary outcomes were patient function and quality of life (measured using the simplified modified Rankin Scale and Stroke Impact Scale respectively) at 12-months post-stroke. Treatment differences were assessed using generalized linear mixed models incorporating assessments at 0, 3, 6 and 12 months, with the primary treatment differences evaluated by a contrast statement assessing the 12-month difference.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;Results from C3FIT will help to determine which model of care yields better outcomes for patients and their caregivers, which will build scient","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107890"},"PeriodicalIF":2.0,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unpacking the chain of change in group CBT and ACT for depression: A protocol for a randomized clinical trial","authors":"Anh Dao,&nbsp;Rachel A. Bernstein,&nbsp;Francisco N. Ramos,&nbsp;Brittany Beasley,&nbsp;Iony D. Ezawa","doi":"10.1016/j.cct.2025.107907","DOIUrl":"10.1016/j.cct.2025.107907","url":null,"abstract":"<div><h3>Background</h3><div>Cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT) are among our most effective treatments for depression, yet their efficacy remains modest. Prior research has not been able to improve these efficacy rates in part due to the limited insight into the processes of change in these treatments and which individuals may benefit more or less from different therapeutic processes.</div></div><div><h3>Method</h3><div>One hundred adults with a diagnosis of major depressive disorder will be randomized to receive eight weeks of group CBT (<em>n</em> = 50) or ACT (<em>n</em> = 50). We will use intensive longitudinal sampling methods to examine therapeutic skills use, theorized treatment mechanisms, and treatment outcomes throughout the course of treatment. The primary aim is to examine the mediational effect of theorized treatment mechanisms on the association between therapeutic skills use and treatment outcomes. Our secondary aim is to examine the combined moderating effects of treatment modality and client characteristics on the association between therapeutic skills use and activation of mechanisms of change.</div></div><div><h3>Conclusion</h3><div>This work has the potential to inform precision mental health care by closing in on the question of “what works and for whom” as it relates to data-driven psychotherapeutic interventions for depression.</div></div><div><h3>Trial registration number</h3><div>The study is registered at <span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06245096</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107907"},"PeriodicalIF":2.0,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Periurethral versus intravaginal application of vaginal estrogen for the prevention of urinary tract infections in postmenopausal women: Design of a randomized non-inferiority trial","authors":"Stephanie W. Zuo ,&nbsp;Megan Bradley ,&nbsp;Erin E. Mowers ,&nbsp;Halina M. Zyczynski ,&nbsp;Sharon L. Hillier ,&nbsp;Mary F. Ackenbom","doi":"10.1016/j.cct.2025.107893","DOIUrl":"10.1016/j.cct.2025.107893","url":null,"abstract":"<div><h3>Background</h3><div>Recurrent urinary tract infections (UTIs) disproportionately affect older women. Vaginal estrogen is the only non-antibiotic therapy with a Grade A recommendation for the prevention of UTIs in postmenopausal women, but it is associated with a high rate of non-adherence due to reported difficulties with vaginal application and concerns about exogenous hormone exposure. To alleviate these challenges, some women apply estrogen cream periurethrally, although evidence supporting this approach is lacking.</div></div><div><h3>Methods</h3><div>The <u>T</u>echniques of <u>AP</u>plying Vaginal <u>E</u>strogen for Prevention of <u>R</u>ecurrent Urinary Tract Infections (TAPER) trial is a randomized non-inferiority trial comparing the percentage of UTI-free participants after 6-months of vaginal estradiol via (1) intravaginal application of 1.0 g cream (standard) or (2) periurethral application of 0.5 g cream. Postmenopausal women with laboratory evidence of recurrent UTIs and without estrogen use in the prior 3 months were eligible. Secondary outcomes include urinary, sexual, and vulvovaginal symptoms, patient compliance, and translational measures, including change in vaginal pH, vaginal maturation index, and urinary and vaginal colonization by <em>Lactobacillus</em> and <em>Escherichia coli</em>.</div></div><div><h3>Results</h3><div>A total of 114 participants were randomized, and participants are currently in the follow-up phase.</div></div><div><h3>Conclusion</h3><div>This report highlights the study design and implementation challenges of the TAPER trial. Results from this trial will provide evidence regarding the effectiveness of intravaginal versus periurethral estradiol application for UTI prevention.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107893"},"PeriodicalIF":2.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143760018","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dose-finding designs for cell therapy cancer clinical trials evaluating drug-combinations","authors":"Evan M. Bagley ,&nbsp;Nolan A. Wages","doi":"10.1016/j.cct.2025.107894","DOIUrl":"10.1016/j.cct.2025.107894","url":null,"abstract":"<div><div>Cell therapies have taken hold as a promising modality of treatment for multiple types of cancer. Despite this, their efficacy as a monotherapy has been limited, driving interest in their possible role as part of a drug combination. This paper introduces a novel dose-finding design for phase I cancer trials assessing drug combinations where one of the drugs is a cell therapy. Our design adapts the partial order continual reassessment method (POCRM) to account for late-onset dose-limiting toxicities (DLT) and feasibility concerns due to complexities related to manufacturing the cell therapy product. We illustrate our design on a proposed trial to assess the combination of a Rituximab-based bispecific antibody activated T cell product and Nivolumab for the treatment of high-grade B-cell lymphoma. We also provide simulation results that demonstrate our design's ability to accurately identify the feasible maximum tolerated dose combination (FMTDC) while managing late-onset DLTs and feasibility concerns. Our methodology aims to improve the phase I drug combination landscape for cell therapy cancer clinical trials.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107894"},"PeriodicalIF":2.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763214","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"LIVING - protocol for a pragmatic randomized controlled trial investigating the effect of three different levels of diabetes self-management programs","authors":"Jonas Munk Jensen ,&nbsp;Karina Vejrum Sørensen ,&nbsp;Henrik Støvring ,&nbsp;Anette Andersen","doi":"10.1016/j.cct.2025.107891","DOIUrl":"10.1016/j.cct.2025.107891","url":null,"abstract":"<div><h3>Background</h3><div>In Denmark, Type 2 Diabetes (T2D) care includes diabetes self-management programs (DSMPs) delivered by municipalities. Following a successful pilot study, a DSMP was expanded to include a digital platform and flexible educational materials. While exercise therapy is recognized as essential in T2D management, high-quality studies on DSMPs incorporating exercise are limited. This trial assesses the (cost)effectiveness of three interventions with escalating intensity, hypothesizing that higher intensity enhances diabetes management competence and reduces complication risk.</div></div><div><h3>Methods/design</h3><div>A pragmatic randomized controlled trial will assess three different DSMP interventions in six Danish municipalities acting as trial sites. Each site will implement one of three versions of Lev Livet: a short version (SLL), a full version (FLL), or the full version with high intensity exercise (FLL + H). At each site, 48 participants will be randomly assigned (2:1) to intervention or control groups. Primary outcome is perceived competence in diabetes (questionnaire). Other outcomes measure physical activity level (accelerometer),HbA1c, disease progression, physical function, and self-reported metrics. The trial is approved by the Danish National Center for Ethics (case no 1–10–72-107-23) and registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06091501</span><svg><path></path></svg></span>).</div></div><div><h3>Discussion</h3><div>The LIVING trial has the potential to establish whether the Lev Livet program is effective and cost effective and how it can be implemented in municipalities. By analyzing dose-response relationships, the trial may refine intervention frequency and intensity, improve diabetes management, and inform both national and international guidelines for accessible, effective diabetes care.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107891"},"PeriodicalIF":2.0,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strengthening older adults remembering (SOARing): Research protocol for a multi-site randomized clinical trial examining the efficacy of the Kessler Foundation modified story memory technique (KF-mSMT®) in mild cognitive impairment (MCI)","authors":"Nancy D. Chiaravalloti ,&nbsp;Erica Weber ,&nbsp;Ekaterina Dobryakova ,&nbsp;Jean Lengenfelder ,&nbsp;Tien T. Tong ,&nbsp;Kyler Mulhauser ,&nbsp;Nancy B. Moore ,&nbsp;Brionna Robinson ,&nbsp;Diana Maloku ,&nbsp;Amber Salter ,&nbsp;Nicholas M. Kanaan ,&nbsp;Silvana L. Costa ,&nbsp;Benjamin M. Hampstead","doi":"10.1016/j.cct.2025.107892","DOIUrl":"10.1016/j.cct.2025.107892","url":null,"abstract":"<div><h3>Background</h3><div>Long-term memory dysfunction is the hallmark feature of amnestic mild cognitive impairment (aMCI) resulting in substantial negative impact on everyday functioning and quality of life. The Kessler Foundation modified Story Memory Technique (KF-mSMT®) is a 10-session memory rehabilitation protocol in which participants are taught to utilize imagery and context to facilitate learning. This paper describes the protocol for a double blind, placebo controlled, randomized clinical trial (RCT) examining the efficacy of the KF-mSMT® in persons who meet criteria for aMCI.</div></div><div><h3>Methods</h3><div>Participants will undergo baseline assessments consisting of neuropsychological testing, neuroimaging, self-report questionnaires, and a blood draw for measuring plasma biomarkers. Participants will then be randomized to one of two conditions using concealed allocation: KF-mSMT® or an active placebo control condition consisting of memory exercises. Participants will be blinded to condition. Within 2 weeks of completing the intervention, participants will complete the same measures as at baseline administered by treatment-blinded assessors. The primary study outcome is new learning and memory measured by neuropsychological assessment (Open Trial Selective Reminding Test). Secondary outcomes include other measures of learning and memory (i.e. Repeatable Battery for the Assessment of Neuropsychological Status story), visuospatial memory (Brief Visuospatial Memory Test-Revised)) as well as everyday memory (Ecological Memory Simulations, Object Location Touchscreen Test), neuroimaging and plasma biomarkers.</div></div><div><h3>Conclusion</h3><div>If successful, this trial will provide Class I evidence supporting the application of the KF-mSMT® for treating MCI-related learning and memory decline in older adults.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107892"},"PeriodicalIF":2.0,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751363","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of out-of-pocket cost COMmunication and financial navigation (CostCOM) in cancer patients: Study protocol for ECOG-ACRIN EAQ222CD","authors":"Gelareh Sadigh ,&nbsp;Fenghai Duan ,&nbsp;Ilana F. Gareen ,&nbsp;Judy Hancock ,&nbsp;JoRean D. Sicks ,&nbsp;Sarah Hawley ,&nbsp;Veena Shankaran ,&nbsp;Mylin Torres ,&nbsp;Lynne I. Wagner ,&nbsp;Ruth C. Carlos","doi":"10.1016/j.cct.2025.107889","DOIUrl":"10.1016/j.cct.2025.107889","url":null,"abstract":"<div><h3>Background</h3><div>High out-of-pocket costs (OOPC) of cancer treatment and lost income result in financial hardship. There is compelling evidence that OOPC communication complemented by financial navigation and counseling will decrease financial hardship by enabling cancer patients to anticipate and accommodate treatment costs and proactively seek financial assistance.</div></div><div><h3>Methods</h3><div>This is a two-arm randomized controlled trial enrolling 720 patients with newly diagnosed solid tumors (stratified by non-metastatic vs. metastatic) who plan to receive anticancer systemic therapy at one of the participating NCI Community Oncology Research Practices (NCORP). Participants are randomized to receive four up to 1-h remote counseling sessions which include systemic therapy OOP cost communication, financial navigation and counseling (CostCOM intervention) vs. enhanced usual care with provision of an informational brochure for Patient Advocate Foundation (PAF), a national non-profit financial navigation organization (EUC). Patients will complete surveys at baseline, 3, 6, and 12 months after enrollment. Our goals are to compare the effectiveness of CostCOM vs. EUC at 12 months on (1) patient-reported cost-related cancer care nonadherence, defined as any self-reported incident of delay, forgo, stop or change in cancer care due to cost concerns and (2) patient-reported material financial hardship, financial worry, and quality of life; and to (3) conduct a process evaluation to examine practice providers' and CostCOM arm patients' satisfaction with the intervention and their perceptions of barriers and facilitators to CostCOM. A successful CostCOM is a scalable and financially sustainable program that can improve cancer care delivery, patients' experience, and health outcomes.</div><div>Trial registration: <span><span>NCT06295367</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107889"},"PeriodicalIF":2.0,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143725003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation of a seamless phase 2/3 study design in the setting of an emergent infectious disease pandemic: Lessons learned from the ACTIV-2 platform COVID-19 treatment trial","authors":"Mark J. Giganti ,&nbsp;Kara W. Chew ,&nbsp;Carlee Moser ,&nbsp;Joseph J. Eron ,&nbsp;Mauricio Pinilla ,&nbsp;Jonathan Z. Li ,&nbsp;Justin Ritz ,&nbsp;Arzhang Cyrus Javan ,&nbsp;David Alain Wohl ,&nbsp;Eric S. Daar ,&nbsp;Judith S. Currier ,&nbsp;Davey M. Smith ,&nbsp;Michael D. Hughes ,&nbsp;the ACTIV-2/A5401 Study Team","doi":"10.1016/j.cct.2025.107887","DOIUrl":"10.1016/j.cct.2025.107887","url":null,"abstract":"<div><div>Seamless phase 2/3 study designs provide a framework for a more efficient trial. During the COVID-19 pandemic, such study designs were considered particularly appealing as there was an urgent global need to rapidly identify effective therapeutics. However, limited in vivo safety and efficacy data was available early in the pandemic to inform decisions. As part of the ACTIV-2 study, we implemented a phase 2/3 platform trial to evaluate multiple candidate treatments for non-hospitalized adults with COVID-19. In addition to an adequate safety profile, the decision to graduate an agent from phase 2 to phase 3 was based on showing treatment effects on clinical or laboratory markers. Decision criteria evolved over time as more data became available during the global pandemic. A seamless transition and approximately 20 % reduction in total sample size was achieved for one agent, amubarvimab plus romlusevimab. Using both simulation studies and actual results from graduation assessments of five ACTIV-2 candidate therapeutics, we provide a discussion of lessons learned from our implementation and recommendations for future seamless trials of interventions for emergent infections.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107887"},"PeriodicalIF":2.0,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a multisite, parallel-group, randomized clinical trial comparing a brief tele-cognitive behavioral therapy intervention (BRIGHT) with attention control for the reduction of body image-related distress among head and neck cancer survivors","authors":"Evan M. Graboyes ,&nbsp;Stacey N. Maurer ,&nbsp;Emily Kistner-Griffin ,&nbsp;Kent Armeson ,&nbsp;Ella Starr ,&nbsp;Taylor McLeod ,&nbsp;Wendy E. Balliet ,&nbsp;Jacquelyn Doenges ,&nbsp;Olga Slavin-Spenny ,&nbsp;Jessica R. Vanderlan ,&nbsp;Andrew Day ,&nbsp;Patrik Pipkorn ,&nbsp;Sidharth V. Puram ,&nbsp;Samantha H. Tam ,&nbsp;Kenneth J. Ruggiero ,&nbsp;Katherine R. Sterba","doi":"10.1016/j.cct.2025.107888","DOIUrl":"10.1016/j.cct.2025.107888","url":null,"abstract":"<div><div>One in four head and neck cancer (HNC) survivors experience clinically significant body image distress (BID), a devastating psychosocial morbidity that adversely affects quality of life. To date, effective interventions for these patients are lacking. BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment), a brief cognitive behavioral treatment (CBT), has shown potential efficacy as a novel treatment paradigm for HNC survivors with BID. The primary objective of this randomized clinical trial (RCT) is to test the hypothesis that BRIGHT improves BID among HNC survivors relative to an Attention Control (AC) intervention. In this multisite RCT, <em>N</em> = 180 HNC survivors with BID will be randomized 1:1 to six weeks of BRIGHT or AC of dose and delivery-matched survivorship education. Outcomes are assessed at baseline and 2, 3, 6, and 9-months post-randomization. The primary endpoint is the IMAGE-HN (Inventory to Measure and Assess imaGe disturbancE–Head and Neck) score, a validated patient-reported outcome of HNC-related BID. Secondary endpoints include the HN Shame and Stigma Scale, the PROMIS SF v1.0-Depression 8a, Anxiety 8a, and Ability to Participate in Social Activities 8a, the Beck Scale for Suicidal Ideation, and the EORTC QLQ-HN35 Trouble with Social Eating and Trouble with Social Contact subscales. The trial will also evaluate whether the effect of BRIGHT on BID is mediated through improvements in automatic thinking and body image coping strategies. Findings from this multisite RCT will provide a rigorous test of the efficacy of BRIGHT as the first evidence-based strategy to manage BID among HNC survivors.</div></div><div><h3>Trial registration ID</h3><div><span><span>NCT05442957</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107888"},"PeriodicalIF":2.0,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143725097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}