Contemporary clinical trials最新文献

{"title":"Prehabilitation and rehabilitation in peripheral arterial disease: Protocol and study design of the PREPARE-IT trial","authors":"Jonathan Myers ,&nbsp;Khin Chan ,&nbsp;Patricia Nguyen ,&nbsp;Charles Gronau ,&nbsp;Pallavi Gautam ,&nbsp;Shipra Arya ,&nbsp;Oliver Aalami","doi":"10.1016/j.cct.2025.107984","DOIUrl":"10.1016/j.cct.2025.107984","url":null,"abstract":"<div><h3>Background</h3><div>Both prehabilitation and rehabilitation programs have been shown to improve functional capabilities, surgical outcomes, and quality of life in patients with peripheral arterial disease (PAD). However, referral rates remain low, and the benefits of combined prehabilitation and rehabilitation for PAD have not been explored.</div></div><div><h3>Methods</h3><div>Three hundred patients with symptomatic claudication referred for femoral-popliteal endovascular stenting will be studied. In this randomized trial, the effectiveness of a 6-week pre-operative program of exercise therapy and risk management (prehabilitation) will be compared to: 1) a 6-week program of rehabilitation (post-operative); and 2) both prehabilitation and rehabilitation. Comparisons will be made of time to claudication symptoms, 6-min walk performance, peak VO₂, strength, endothelial function, biomarkers, and quality of life at baseline, 6-weeks (1 week prior to intervention), 14 weeks, and 22 weeks.</div></div><div><h3>Discussion</h3><div>The concept of prehabilitation is based on the principle that patients with higher functional capabilities will better tolerate a surgical intervention and therefore exhibit better outcomes following the intervention. Recent studies have consistently demonstrated better functional, psychosocial, and surgery-related morbidity outcomes among subjects participating in pre-surgical prehabilitation programs, but few such data are available in patients with PAD. The prehabilitation period also provides an ideal opportunity for cardiometabolic risk intervention. The primary aim of this trial is to explore the functional and psychosocial impact of prehabilitation, rehabilitation, and their combination in patients with PAD scheduled for a non-emergent endovascular intervention. We anticipate that the combination of prehabilitation and rehabilitation will result in better outcomes than either intervention alone.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107984"},"PeriodicalIF":2.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144306297","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":"Effects of one month of intermittent fasting on the blood microbiome in healthy volunteers (OMIF): A randomized controlled crossover study protocol","authors":"Junhong Su ,&nbsp;Bettina E. Hansen ,&nbsp;Zhongren Ma ,&nbsp;Maikel P. Peppelenbosch","doi":"10.1016/j.cct.2025.107986","DOIUrl":"10.1016/j.cct.2025.107986","url":null,"abstract":"<div><h3>Background</h3><div>It is hypothesized that the presence of microorganisms in the gut is reflected in circulating blood through small DNA fragments resulting from the degradation of these organisms. Cross-sectional studies have not yet provided a definitive answer regarding the validity of this hypothesis, and the potential presence of a so-called common blood-microbiome remains highly controversial. Both bioinformatical pipelines (which may produce false-positive results) and environmental contamination may obscure the less than 5 % microbial DNA that is postulated to be present within the total blood DNA.</div></div><div><h3>Method/design</h3><div>This study aims to validate the existence of the blood microbiome using one month of intermittent fasting (OMIF). Through a prospective, randomized, controlled cross-over trial, we will evaluate the effect of OMIF on the composition and function of the blood microbiome in healthy volunteers, with secondary outcomes on clarifying the relationship between the gut and blood microbiome. Healthy volunteers aged 18–65 will be enrolled. All volunteers will undergo OMIF, a washout period and an ad libitum diet for another month, with the order of the interventions assigned randomly. We will assess the dynamics in blood microbiome in response to OMIF versus those seen during an ad libitum diet, using shotgun sequencing. Physiological changes will be monitored A dietary recall interview will be conducted during the trial to evaluate energy intake, and movement data collected from Health App will be used to assess changes in physical activity.</div></div><div><h3>Conclusion</h3><div>If successful, this trial provides a proof-of-concept study documenting the existence of a bona fide blood microbiome.</div><div>Clinical Trial Registration: <span><span>NCT06678516</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107986"},"PeriodicalIF":2.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144316053","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":"Virtual versus in-person ROSE program (La Luz) as universal prevention for perinatal depression: Protocol for a randomized controlled trial in a safety net hospital","authors":"Daphne Y. Liu ,&nbsp;Nicholas S. Perry ,&nbsp;Catherine H. Demers ,&nbsp;Jennifer S. Hyer ,&nbsp;Anely Alamo ,&nbsp;Paige Vuksanovich ,&nbsp;Nandi Dube ,&nbsp;Erin R. Flanagan ,&nbsp;Robert J. Gallop ,&nbsp;Galena K. Rhoades ,&nbsp;Elysia Poggi Davis","doi":"10.1016/j.cct.2025.107988","DOIUrl":"10.1016/j.cct.2025.107988","url":null,"abstract":"<div><div>Perinatal depression disproportionally affects underserved communities, who need effective and accessible prevention programs. Reach Out, Stay strong, Essentials for new mothers (ROSE) has demonstrated effectiveness in preventing postpartum depression in underserved populations when delivered in person. This ongoing randomized controlled trial (RCT) tests the novel virtual implementation of ROSE as universal prevention in a Federally Qualified Health Center setting. We adopted the name, La Luz, for ROSE to be culturally relevant to our population. Pregnant individuals &lt;30 gestational weeks (target <em>N</em> = 900) are randomized to either the virtual or in-person La Luz program, which consists of four 90-min group sessions. Groups are offered in English and Spanish, based on participants' preference. Participants complete surveys at seven timepoints: before program, 28 gestational weeks, 35 gestational weeks, and 6-weeks, 3-months, 6-months, and 12-months postpartum. Primary outcomes are postpartum depression severity measured by the 20-item Symptom Checklist (SCL-20) and 10-item Center of Epidemiologic Studies Depression Scale (CESD-10). We will perform intent-to-treat analysis to test whether virtual La Luz is non-inferior to in-person La Luz. This study also evaluates implementation process and outcomes of both modalities of La Luz to inform the development of an implementation toolkit. This RCT contributes to our knowledge of perinatal depression prevention and addresses access barriers for underserved populations. If effectiveness of virtual La Luz is demonstrated, the new evidence for a scalable low-cost prevention can be used to reduce perinatal depression and offer accessible treatment options for people who face significant barriers to care. <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> registration identifier: <span><span>NCT05766475</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107988"},"PeriodicalIF":2.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144316054","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":"Motivational Interviewing for Vaccine Uptake in Latinx Adults (MI Vacuna): Study protocol for a pragmatic multiple-period cluster-randomized crossover trial","authors":"Rachel M. Scrivano ,&nbsp;Brittney J. van de Water ,&nbsp;Nicolle Rueras ,&nbsp;Janin Alfonso ,&nbsp;Kimberly H. McManama O'Brien ,&nbsp;Ximena Soto ,&nbsp;Vannah Jiv S. Caumeran ,&nbsp;Barbara Mendez Campos ,&nbsp;Michael Mancusi ,&nbsp;Brian Diehl ,&nbsp;Elizabeth Southwick ,&nbsp;Elisabeth Moreno ,&nbsp;Celia Bora ,&nbsp;Stephanie Armbruster ,&nbsp;Nadia N. Abuelezam ,&nbsp;Rocío Calvo ,&nbsp;Sebastien Haneuse ,&nbsp;Kirsten K. Davison","doi":"10.1016/j.cct.2025.107987","DOIUrl":"10.1016/j.cct.2025.107987","url":null,"abstract":"<div><h3>Background</h3><div>While vaccines are safe and effective, vaccine hesitancy negatively impacts Latinx adults and adults with mental illness, resulting in low vaccination rates. Evidence suggests that Motivational interviewing (MI) may reduce vaccine hesitancy among underserved populations. This trial evaluates the effectiveness of MI integrated into behavioral health on vaccine hesitancy and COVID-19 and influenza vaccination among Latinx adults with mental illness.</div></div><div><h3>Methods</h3><div>Implemented in partnership with NeighborHealth, a Federally Qualified Health Center (FQHC) in a predominantly-Latinx community, Motivational Interviewing for Vaccine Uptake in Latinx Adults (MI Vacuna) is a novel intervention, comprised of Motivational Interviewing (MI) and a warm handoff, implemented by behavioral health (BH) clinicians to address vaccine hesitancy in their patients. Utilizing a pragmatic multiple-period, cluster-randomized crossover trial design this study: 1) tests the effectiveness of MI Vacuna on COVID-19 and influenza vaccine uptake among Latinx adults with mental illness; 2) investigates moderators of intervention effects including patient-provider ethno-language concordance and country of origin; and 3) examines theory-based elements on the causal pathway between the intervention and vaccine uptake. Primary outcomes include patient COVID-19 and influenza vaccine uptake extracted from electronic health records. Secondary outcomes include vaccine hesitancy and provider trust, evaluated using patient surveys and interviews. Implementation outcomes are measured using multiple data sources.</div></div><div><h3>Discussion</h3><div>This novel study tests the effect of MI within the context of BH on COVID-19 and influenza vaccine hesitancy and uptake among Latinx adults. Results inform the sustainability and scale-up of MI Vacuna and BH-centered efforts to target patient vaccine hesitancy.</div><div><strong>Trial Registration:</strong> <span><span>clinicaltrials.gov</span><svg><path></path></svg></span>, <span><span>NCT06062056</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107987"},"PeriodicalIF":2.0,"publicationDate":"2025-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309669","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":"Baseline sample characteristics for the BackInAction pragmatic trial of acupuncture for chronic low back pain in older adults","authors":"Morgan Justice ,&nbsp;Annie Piccorelli ,&nbsp;Andrew L. Avins ,&nbsp;Andrea J. Cook ,&nbsp;Carolyn M. Eng ,&nbsp;Arya Nielsen ,&nbsp;Alice Pressman ,&nbsp;Katie L. Stone ,&nbsp;Raymond Y. Teets ,&nbsp;Robert Wellman ,&nbsp;Lynn L. DeBar","doi":"10.1016/j.cct.2025.107981","DOIUrl":"10.1016/j.cct.2025.107981","url":null,"abstract":"<div><h3>Background</h3><div>Chronic low back pain (cLBP) is a leading cause of disability, particularly among older adults. Despite this, effective nonpharmacologic treatments such as acupuncture have not been adequately studied in older adults. The “BackInAction” pragmatic clinical trial aims to address this gap by evaluating the effectiveness of acupuncture in reducing back pain-related disability among adults aged ≥65. The purpose of this manuscript is to compare sample characteristics across sites and across waves of COVID-19.</div></div><div><h3>Methods</h3><div>We describe participant baseline characteristics for the BackInAction trial, a three-arm randomized trial conducted across four U.S. healthcare systems: two integrated care delivery, a fee-for-service (FFS) system, and an urban federally qualified health center (FQHC). Participants (<em>N</em> = 800) with cLBP were randomized to receive standard acupuncture, standard acupuncture plus maintenance sessions, or usual medical care. Baseline data were collected through self-reported measures and electronic health records. Recruitment trends are evaluated during COVID waves.</div></div><div><h3>Results</h3><div>The sample was predominantly female (61.9 %) and non-Hispanic white (64.6 %), with an average age of 73.6 years. The FQHC enrolled a younger, more diverse and socioeconomically disadvantaged population with higher levels of back pain-related dysfunction. The FFS enrolled an older population but had similar rates of back pain-related dysfunction and pain intensity as in the integrated care delivery systems. There were no differences by site corresponding to the circulation of COVID-19 strains.</div></div><div><h3>Conclusion</h3><div>Findings suggest that FQHC populations have higher-than-average social and clinical risks, illustrating the complexity of delivering treatment for cLBP and the urgency to ensure such clinical environments are included in trials.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT04982315</span><svg><path></path></svg></span>. Clinical trial registration date: July 29, 2021.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107981"},"PeriodicalIF":2.0,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144240310","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":"Prostate Assessment using Comparative Interventions – Fast MRI and Image-fusion for Cancer (IP7-PACIFIC): A prospective, multi-centre, dual sequential randomised controlled trial","authors":"Nikhil Mayor ,&nbsp;Alexander Light ,&nbsp;Francesca Rawlins ,&nbsp;Emma Cullen ,&nbsp;Natalia Klimowska-Nassar ,&nbsp;Thiagarajah Sasikaran ,&nbsp;Puja Jadav ,&nbsp;Heminder Sokhi ,&nbsp;Andrew Smith ,&nbsp;Darren Walls ,&nbsp;Robert Oldroyd ,&nbsp;Derek Price ,&nbsp;Clare Robinson ,&nbsp;Emily Lane ,&nbsp;Andrea Rockall ,&nbsp;Rakesh Heer ,&nbsp;Luke Vale ,&nbsp;Anwar R. Padhani ,&nbsp;Mathias Winkler ,&nbsp;Taimur T. Shah ,&nbsp;Hashim U. Ahmed","doi":"10.1016/j.cct.2025.107983","DOIUrl":"10.1016/j.cct.2025.107983","url":null,"abstract":"<div><h3>Background</h3><div>Multiparametric MRI (mpMRI) with contrast medium is recommended in the prostate cancer diagnostic pathway. It is unclear if MRI without contrast medium (biparametric [bp]) can be used instead whilst remaining sensitive to detection of clinically significant cancers. For those with a positive MRI, is image-fusion targeting better than visual-registration (cognitive) targeting in detecting clinically significant prostate cancer? And does bpMRI represent better value for money than mpMRI? A randomised controlled trial testing clinical utility and cost-effectiveness of these approaches is vital before changes in practice.</div></div><div><h3>Methods</h3><div>IP7-PACIFIC is a prospective, multicentre, co-enrolment trial with two randomisations and embedded economic evaluation. The first randomisation will evaluate non-inferiority of bpMRI compared to mpMRI in those with clinical suspicion of prostate cancer. Men with a suspicious MRI will undergo a second randomisation to evaluate if image-fusion targeting is superior to standard visual-registration targeted biopsy. Ethics committee approval has been granted by the London Bromley Research Ethics Committee.</div></div><div><h3>Results</h3><div>The primary objective for Randomisation 1 is to determine non-inferiority of bpMRI to detect Gleason score ≥ 7 [ISUP Grade Group ≥2] cancer compared to mpMRI. The objective for Randomisation 2 is to determine if image-fusion targeted biopsy is superior to visual-registration targeted biopsy. An internal pilot phase will enrol 700 patients; the overall recruitment target is 3600.</div></div><div><h3>Discussion</h3><div>IP7-PACIFIC aims to provide randomised comparative evidence for the clinical utility and cost-effectiveness of using bpMRI and image-fusion biopsy. The findings will inform guidelines. The sequential randomised co-enrolment design allows simultaneous evaluation of two research questions and avoids heterogeneity of trial populations. By contrast to previous paired-cohort studies, the randomised design will reduce reporter bias, providing the highest level of diagnostic evidence.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107983"},"PeriodicalIF":2.0,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246855","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":"Corrigendum to “DiaBetter Together: Clinical trial protocol for a strengths-based Peer Mentor intervention for young adults with type 1 diabetes transitioning to adult care” [Contemporary Clinical Trials Volume 147, December 2024, 107713].","authors":"Samantha A. Carreon ,&nbsp;Charles G. Minard ,&nbsp;Sarah K. Lyons ,&nbsp;Wendy Levy ,&nbsp;Stephanie Camey ,&nbsp;Kishan Desai ,&nbsp;Brenda Duran ,&nbsp;Randi Streisand ,&nbsp;Barbara J. Anderson ,&nbsp;Siripoom V. McKay ,&nbsp;Tricia S. Tang ,&nbsp;Sridevi Devaraj ,&nbsp;Ryan Ramphul ,&nbsp;Marisa E. Hilliard","doi":"10.1016/j.cct.2025.107977","DOIUrl":"10.1016/j.cct.2025.107977","url":null,"abstract":"","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107977"},"PeriodicalIF":2.0,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144223213","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":"A multi-site randomized clinical trial of socially assistive robots on engaging older adults with cognitive impairment residing in long-term care settings: A protocol paper","authors":"Judith A. Tate ,&nbsp;Lorraine C. Mion ,&nbsp;Miroslava Migovich ,&nbsp;Ritam Ghosh ,&nbsp;Nibraas Khan ,&nbsp;Abigail Kilpatrick ,&nbsp;Douglas W. Scharre ,&nbsp;Paul A. Newhouse ,&nbsp;Cathy A. Maxwell ,&nbsp;Alai Tan ,&nbsp;Nilanjan Sarkar","doi":"10.1016/j.cct.2025.107980","DOIUrl":"10.1016/j.cct.2025.107980","url":null,"abstract":"<div><div>Apathy is common in persons with dementias, especially those in long-term care facilities (LTCs). Few pharmacologic options exist; a major strategy is to foster engagement in social, physical, and cognitive activities, but requires extensive personnel time. Non-immersive virtual environments (VE) combined with socially assistive robots (VE-SARs) can support LTC staff.</div><div>We are conducting a randomized multi-site clinical trial to compare the effect of usual care (UC) to VE-SAR + UC on reducing apathy (primary outcome) among 188 older adults with cognitive impairment and enhancing executive cognitive function (secondary outcome). Eligibility of state-licensed LTCs include an hour's drive from the principal investigators' offices, activity personnel willing to interact with research staff, certified by the U.S. Centers for Medicare and Medicaid, and physical space for equipment storage and robot set-up. Eligibility for older adults include age ≥ 60 years, LTC residance &gt;3 months, evidence of mild cognitive impairment or dementia, and symptoms of apathy. Older adults randomized to VE-SAR + UC are paired and participate in twice-weekly sessions for 8 weeks. Staff are interviewed using the Apathy Evaluation Scale-Clinician for apathy ratings. Older adults are interviewed on executive cognitive function using the Trail Making Tests A and B and Animal Naming Test. Data are collected at baseline, Week 4, and Week 8. Field notes are taken throughout and sessions are videorecorded. We will use mixed-effects linear modeling for repeated measures to model apathy as a function of fixed-effects of intervention (VE-SAR + UC vs. UC), time, and intervention by time interaction, adjusting for covariates (e.g., baseline cognitive function).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107980"},"PeriodicalIF":2.0,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246853","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":"Choice architecture in cascade genetic testing (CHARGE study) for hereditary cancer: Design of a hybrid type I randomized feasibility trial","authors":"Sukh Makhnoon ,&nbsp;Grace Getchell ,&nbsp;Yanete Rodriguez ,&nbsp;Luis Pena ,&nbsp;Jennifer Rodriguez ,&nbsp;Tiwatope Ibidapo ,&nbsp;Nora B. Henrikson ,&nbsp;MinJae Lee ,&nbsp;Shelly Wu ,&nbsp;Sara Pirzadeh-Miller","doi":"10.1016/j.cct.2025.107979","DOIUrl":"10.1016/j.cct.2025.107979","url":null,"abstract":"<div><h3>Background</h3><div>Although cascade testing affords disease-free relatives the opportunity for genetically targeted primary disease prevention and is endorsed by multiple guidelines, utilization studies reveal that rates remain low. Lack of family communication and high testing costs are two of the most commonly documented barriers to testing. We leverage two well-known choice-architecture tools from psychology and behavioral science – default effect and zero price effect – to address these barriers and improve cascade testing rates in hereditary cancer. By altering the underlying choice architecture, individual decision-making can be influenced with minimal effort to support behavioral changes.</div></div><div><h3>Methods/Design</h3><div>This two-arm, single site, hybrid type I effectiveness-implementation randomized trial compares the effectiveness of a choice-architecture based cascade testing intervention versus usual care control among English-speaking patients with a pathogenic variant in a cancer susceptibility gene receiving care at a tertiary cancer center. The intervention includes proband-mediated recruitment of at-risk relatives, provision of genetic counseling, educational information about cascade genetic testing and free testing window, and return of results. The usual care arm follows standard of care for cascade genetic testing. The primary study outcome is cascade genetic testing rate measured by proband self-report. The study evaluates implementation process via survey, administrative, and interview data including acceptability, feasibility, and process outcomes.</div></div><div><h3>Discussion</h3><div>This trial will generate findings about the effectiveness of a cascade testing intervention targeting patients with a pathogenic variant in a cancer susceptibility gene and identify barriers and facilitators that influence implementing this intervention in clinical cancer genetic settings (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT06284330</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107979"},"PeriodicalIF":2.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246854","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":"Expedition for new symptom-specific TMS targets: Protocol for the first randomized causal circuit mapping trial","authors":"Emily Aquadro ,&nbsp;Leanna Bomer ,&nbsp;Ryan Webler ,&nbsp;Andrew Pines ,&nbsp;Danielle D. DeSouza ,&nbsp;David Carreon ,&nbsp;Nicole Chiulli ,&nbsp;Summer Frandsen ,&nbsp;Joseph J. Taylor ,&nbsp;Shan H. Siddiqi","doi":"10.1016/j.cct.2025.107978","DOIUrl":"10.1016/j.cct.2025.107978","url":null,"abstract":"<div><h3>Background</h3><div>Functional neuroimaging has been used to map brain organization, but only identifies correlates of brain functions rather than causes. Causal brain mapping can be conducted by randomly applying transcranial magnetic stimulation (TMS) to different targets, as randomization controls for all confounders, and comparing clinical outcomes across different targeted circuits. Random targets can be systematically compared by mapping their functional connectivity to specific circuits. This study will build a multidimensional atlas of circuits that are causally involved in human brain function. We aim to identify TMS targets for a wide range of transdiagnostic constructs relevant to psychopathology from broad spectra (e.g., internalizing) to specific symptoms (e.g., worry) and processes (e.g. emotional regulation).</div></div><div><h3>Methods/design</h3><div>90 participants with major depression, obsessive-compulsive disorder, generalized anxiety disorder, or schizophrenia will receive 40 total sessions of accelerated intermittent theta burst stimulation (aiTBS). The first 20 sessions will be applied over two days to a random target in the left prefrontal cortex (PFC). A deep circuit-based phenotyping battery pre- and post-aiTBS will be conducted. Six weeks later, participants will receive 20 sessions of aiTBS to a different random target in the left PFC. Patients with schizophrenia will be offered an open-label extension with aiTBS to the rostromedial prefrontal cortex (rmPFC), a previously proposed, novel target for schizophrenia.</div></div><div><h3>Discussion</h3><div>We aim to map circuitry connected to TMS sites that causally modify transdiagnostic and diagnosis-specific behaviors. This will complement prior retrospective studies using incidental lesions and stimulation sites and aim to define optimal TMS target circuits across diagnoses.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107978"},"PeriodicalIF":2.0,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144233429","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}