Contemporary clinical trials最新文献

{"title":"Quantifying the role of communication in recruitment status outcomes for a clinical trial on genetic testing uptake","authors":"Arianna Morel ,&nbsp;Emerson Delacroix ,&nbsp;John D. Rice ,&nbsp;Sarah Austin ,&nbsp;Erika Koeppe ,&nbsp;Erika N. Hanson ,&nbsp;Jennifer J. Griggs ,&nbsp;Elena Martinez Stoffel ,&nbsp;Ken Resnicow","doi":"10.1016/j.cct.2026.108218","DOIUrl":"10.1016/j.cct.2026.108218","url":null,"abstract":"<div><h3>Background</h3><div>Participant recruitment remains a significant challenge in clinical trials, often resulting in delays, increased resource expenditures, and missed opportunities for advancing care. While previous research has largely focused on participants' perspectives regarding recruitment barriers, less is known about the influence of different outreach strategies (methods and frequency) from the viewpoint of research staff. This study evaluates the likelihood of reaching a definitive enrollment outcome to inform more effective and resource-efficient recruitment strategies.</div></div><div><h3>Methods</h3><div>Data were obtained from recruitment efforts for a two-phase clinical trial aimed at increasing hereditary cancer genetic testing uptake among eligible individuals. Participant recruitment utilized email invitations for patients in participating practices and multimedia campaigns for the public. Eligible participants received up to two email reminders and 5–8 recruitment calls, with a standardized call survey ensuring consistency.</div></div><div><h3>Results</h3><div>Of the invited, 2485 (82.8%) accessed the email link and completed the eligibility screening survey, of these 80.4% of invitees reached a definitive recruitment status outcome: ineligible (37.2%), refused (15.6%), consented (27.6%), while 19.5% were lost to enrollment. Analysis of call attempts revealed that call attempt one had the highest participant answer rate (∼45%), which declined with each additional attempt, reaching 13% at six or more attempts. Email outreach alone produced probability spikes in definitive outcomes following email reminders. Additional calls demonstrated sharply diminishing returns beyond the fourth to sixth attempts.</div></div><div><h3>Conclusion</h3><div>This study demonstrates that tracking and optimizing outreach frequency, timing, and mode can enhance clinical trial recruitment efficiency. Specifically, at least one email and one phone call significantly improve the likelihood of reaching a definitive recruitment outcome, while exceeding 4–6 call attempts yields minimal additional benefit. These findings provide a framework for recruitment strategies, enabling more effective allocation of resources and increasing the chances of meeting recruitment goals in future clinical trials.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108218"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145951532","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":"Evaluating missing outcome data methods for the analysis of the MEL-SELF trial of patient-led surveillance for early-stage melanoma: A simulation study","authors":"Ellie Medcalf ,&nbsp;Robin M. Turner ,&nbsp;David Espinoza ,&nbsp;Lin Zhu ,&nbsp;Katy J.L. Bell","doi":"10.1016/j.cct.2025.108186","DOIUrl":"10.1016/j.cct.2025.108186","url":null,"abstract":"<div><h3>Background</h3><div>Complete case analysis (CCA) is the most common method used to handle missing outcome data in trials but may often lead to biased estimates. Newer methods that address missing not at random data are infrequently used.</div></div><div><h3>Objective</h3><div>We evaluated six missing data methods in a simulation study based on a melanoma surveillance trial.</div></div><div><h3>Methods</h3><div>We used the MEL-SELF pilot of patient-led surveillance for patients with early-stage melanoma as the empirical basis of our simulated study. We evaluated three commonly used methods (CCA, mixed models for repeated measurements (MMRM), multiple imputation (MI)), and three recently developed methods (retrieved dropout (RD) imputation, jump to reference (J2R) imputation and trimmed means (TM)), under 48 scenarios where treatment effect size, missingness percentage and missingness assumptions were varied.</div></div><div><h3>Results</h3><div>Under scenarios with small or small-moderate treatment effects and missing not at random outcome data, all methods produced some bias, with TM and CCA the most biased towards and away from the null, respectively. Both also had low precision and power. J2R performed best of methods that were biased towards the null (JR, TM), with small bias for small and small-moderate treatment effects, high precision and high coverage. RD performed best of methods that were biased away from the null (RD, CCA, MMRM, MI) with small bias, good precision and good coverage.</div></div><div><h3>Conclusion</h3><div>In this simulation of a melanoma surveillance trial with non-random missing outcomes, RD produced the least bias away from the null and J2R produced the least bias towards the null.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108186"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773939","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 cluster randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management intervention to support women with breast cancer to return to work: A study protocol","authors":"Nickola D. Pallin ,&nbsp;Naomi Algeo ,&nbsp;Mary Eileen O'Connor ,&nbsp;Hayley Connolly ,&nbsp;Michelle Lowry ,&nbsp;Kathleen Bennett ,&nbsp;Patrick Gillespie ,&nbsp;Anna Hobbins ,&nbsp;Pamela Gallagher ,&nbsp;Louise Mullen ,&nbsp;Kathleen D. Lyons ,&nbsp;Sheena M. McHugh ,&nbsp;Deirdre Connolly","doi":"10.1016/j.cct.2025.108185","DOIUrl":"10.1016/j.cct.2025.108185","url":null,"abstract":"<div><h3>Introduction</h3><div>Women living with and beyond breast cancer (LWBBC) often experience challenges in returning to work (RTW) because of disease and treatment-related side effects. Therefore, interventions to enhance RTW for those LWBBC are a recommended component of cancer survivorship care. CanWork is a six-week, self-management support programme designed to facilitate women LWBBC in developing knowledge and skills to manage cancer-related symptoms that interfere with RTW. This paper presents the protocol for a cluster randomised controlled trial that will test the effectiveness and cost effectiveness of CanWork in supporting women LWBBC in RTW following completion of cancer treatment.</div></div><div><h3>Methods</h3><div>A cluster-randomised controlled trial will be conducted through community cancer support centres in the Republic of Ireland. Centres will be assigned to the control or intervention arms by randomisation and the aim is to recruit 248 women. The two primary outcomes are changes in RTW (yes: returned to work; no: not returned to work) and self-efficacy to manage physical, psychological and emotional demands of work at 12 months follow up post-intervention. Secondary outcomes are readiness to return to work, self-efficacy for managing cancer-related symptoms that interfere with work, health related quality of life and absence from work for cancer-related reasons at 12 months follow up post-intervention. Cost effectiveness will also be measured. Follow-up will occur up to 12-months post-intervention using self-reported questionnaires.</div></div><div><h3>Discussion</h3><div>Findings will determine whether CanWork is an effective and cost-effective intervention in supporting women with breast cancer to return to work.</div><div><strong>Trial registration number:</strong> <span><span>NCT06723899</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108185"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773816","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":"Remotely-delivered exercise training program among older adults with multiple sclerosis: Feasibility results of a randomized controlled trial","authors":"Peixuan Zheng ,&nbsp;Sydney R. DeJonge ,&nbsp;Noah G. DuBose ,&nbsp;Ariel Kidwell-Chandler ,&nbsp;Trevor B. Martin ,&nbsp;Trinh L.T. Huynh ,&nbsp;Shane A. Phillips ,&nbsp;Jennifer Duffecy ,&nbsp;Robert W. Motl","doi":"10.1016/j.cct.2025.108190","DOIUrl":"10.1016/j.cct.2025.108190","url":null,"abstract":"<div><h3>Background</h3><div>Older adults with multiple sclerosis (MS) are often physically inactive and present with walking and cognitive impairments that may be remediated through rehabilitation approaches such as exercise training.</div></div><div><h3>Objectives</h3><div>We conducted a phase-Ib, randomized controlled trial (RCT) that examined the feasibility and initial efficacy of a 16-week remotely-delivered, home-based exercise training program in older adults with MS who had moderate mobility disability.</div></div><div><h3>Methods</h3><div>This study utilized a parallel-group RCT design. Participants (<em>n</em> = 51; mean age = 60.5 years, 78 % females) were randomized into exercise training (aerobic and resistance) or active control (stretching) conditions. Both conditions were undertaken within a participant's home/community and remotely supported by a behavioral coach. Participants received training manuals and equipment, one-on-one behavioral coaching, action-planning calendars, self-monitoring logs, and social cognitive theory-based newsletters. Feasibility was assessed across process, resource, management, and scientific domains. Scientific outcomes focused on physical function, cognition, and physical activity, with data collected by treatment-blinded assessors.</div></div><div><h3>Results</h3><div>The intervention was cost-effective, accessible, well-received, and safe based on formative evaluation. Forty-one (80.4 %) participants completed the conditions, with adherence and compliance rates across conditions exceeding 80 %. There were moderate-to-large improvements in walking speed, functional mobility, lower-extremity function, and verbal learning and memory (<em>p</em> &lt; 0.05, <em>|d|</em> = 0.58–0.80) in the exercise condition, but not in control (<em>p</em> &gt; 0.05).</div></div><div><h3>Conclusions</h3><div>This study established the feasibility and initial efficacy of a theory-based, remotely-delivered exercise training intervention for older adults with MS. The promising results support the design and implementation of a subsequent, phase-II RCT for improving physical and cognitive functions in the older MS population.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108190"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145789180","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":"Basic needs navigation intervention to address multidimensional adversity in African Americans with diabetic kidney disease: A pilot randomized clinical trial protocol","authors":"Mukoso N. Ozieh ,&nbsp;Charity G. Patterson ,&nbsp;Joni S. Williams ,&nbsp;Rebekah J. Walker ,&nbsp;Leonard E. Egede","doi":"10.1016/j.cct.2025.108183","DOIUrl":"10.1016/j.cct.2025.108183","url":null,"abstract":"<div><h3>Background</h3><div>Diabetic kidney disease (DKD) is the leading cause of end stage kidney disease (ESKD) in the United States. African Americans have a risk of developing chronic kidney disease and are almost four times more likely to progress to ESKD compared to non-Hispanic whites. The presence of social adversities impacts the complex self-management of DKD and negatively impacts health outcomes. Patient navigation interventions offer a promising strategy to improve health outcomes in individuals with chronic disease. However, it is not known whether a basic needs navigation intervention that addresses social adversities in combination with patient education and lifestyle coaching leads to improved clinical and patient-centered outcomes.</div></div><div><h3>Methods and analysis</h3><div>This ongoing 3-year two-arm pilot randomized clinical trial will test the feasibility of a basic needs navigation intervention in African American adults with DKD experiencing multidimensional adversity (having one or more social adversity). Fifty African American adults with DKD experiencing one or more social adversity and who have uncontrolled diabetes (HbA1c 8 % or more) will be randomized into one of two arms: 1) basic needs navigation intervention arm or 2) enhanced usual care arm. The primary clinical outcome is feasibility of the basic needs navigation intervention as measured by recruitment, session attendance and retention.</div></div><div><h3>Discussion</h3><div>The results of this study will serve as a first step in addressing current gaps in knowledge and will provide feasibility data for a large-scale appropriately powered, randomized clinical trial focused on addressing social adversity in African American adults with DKD.</div></div><div><h3>Ethics and dissemination</h3><div>This trial was approved by Medical College of Wisconsin IRB Protocol # PRO00041675.</div></div><div><h3>Trial registration number</h3><div>Registration for this trial can be found under ID: <span><span>NCT05357742</span><svg><path></path></svg></span> and online (<span><span>https://clinicaltrials.gov/ct2/show/NCT05357742?id=NCT05357742&amp;draw=2&amp;rank=1</span><svg><path></path></svg></span>) on the NIH U.S. National Library of Medicine Clinical Trials Database.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108183"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145793408","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":"Geographic location and clinical trial knowledge, invitation, and participation among adults in the United States","authors":"Henry K. Onyeaka ,&nbsp;Manfred N. Mate-Kole ,&nbsp;Irene A. Acheampong ,&nbsp;Abigail Arthur ,&nbsp;M. Tim Song ,&nbsp;Ted O. Akhiwu ,&nbsp;Diana Mensah ,&nbsp;Chioma Ozoalor ,&nbsp;Onyema G. Chido-Amajuoyi ,&nbsp;Hermioni L. Amonoo","doi":"10.1016/j.cct.2025.108193","DOIUrl":"10.1016/j.cct.2025.108193","url":null,"abstract":"<div><h3>Background/Aims</h3><div>Clinical trials are essential to evaluating novel treatments and improving disease-related outcomes through innovative therapies. Despite underrepresentation of rural communities in clinical trial outreach and participation, geographic disparities in clinical trials have been minimally explored. We examined clinical trial knowledge, invitation, and participation among participants in urban and rural geographic locations in the United States.</div></div><div><h3>Methods</h3><div>We conducted cross-sectional data analysis on self-reported data from Health Information National Trends Survey (HINTS) 5 Cycle 4. Population-level estimates were obtained using jack-knife replicate weights.</div></div><div><h3>Results</h3><div>Geographic location was not associated with clinical trial knowledge, invitation, and participation. However, the relatively low absolute invitation rates across urban and rural populations may suggest that substantial gaps in recruitment persist universally, regardless of geographic location in the United States.</div></div><div><h3>Conclusions</h3><div>In this nationally representative study, we found no statistically significant differences in clinical trial knowledge, invitation or participation by geographical location in the United States. Our findings suggest that geographic residence may not be a primary barrier to clinical trial engagement once sociodemographic differences are accounted for. Targeted efforts to improve awareness and reduce structural barriers, along with continued investment in equitable recruitment strategies, will be important to ensuring that clinical trials reflect the diversity of the populations they aim to serve.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108193"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145800107","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 auricular vagus nerve stimulation and aerobic training in individuals with hypertension – Protocol for a controlled, randomized, and blind clinical trial","authors":"Paulo Henrique Leite Souza ,&nbsp;Fernanda Marciano Consolim-Colombo ,&nbsp;Bruno Paulino Venancio ,&nbsp;Katia de Angelis ,&nbsp;João Carlos Ferrari Corrêa ,&nbsp;Márcio Gonçalves de Sousa ,&nbsp;Raphael Mendes Ritti Dias ,&nbsp;Fernanda Ishida Corrêa","doi":"10.1016/j.cct.2025.108182","DOIUrl":"10.1016/j.cct.2025.108182","url":null,"abstract":"<div><h3>Introduction</h3><div>Hypertensive individuals experience chronic inflammation, higher sympathetic nervous system activity, and decreased functional capacity. While Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and aerobic training have shown benefits for hypertension, their combined effects have not been explored.</div></div><div><h3>Objective</h3><div>To evaluate the effects of taVNS combined with aerobic training on blood pressure, cardiac autonomic modulation, inflammation, oxidative stress, and functional capacity in individuals with hypertension.</div></div><div><h3>Methods</h3><div>This protocol outlines a randomized, controlled, single-blind clinical trial involving hypertensive adults. Participants will be randomly assigned to one of three groups: aerobic training with taVNS, aerobic training alone, or taVNS alone. Aerobic training will consist of 50 min of stationary cycling, while taVNS will be applied using a neuromuscular stimulator with an electrode placed on the left ear for 30 min. The intervention will be administered three times per week for 8 weeks, totaling 24 sessions. The primary outcome is blood pressure measurement, while secondary outcomes include heart rate variability, functional capacity, serum inflammatory mediators, and biomarkers of systemic oxidative stress. Assessments will be conducted before the intervention, after 24 sessions, and 30 days of post-treatment.</div></div><div><h3>Results</h3><div>The groups will be compared to the outcome measures to determine the taVNS benefits combined with aerobic training for hypertensive individuals.</div></div><div><h3>Conclusion</h3><div>This is the first clinical trial to assess the taVNS effects combined with physical exercise in hypertensive individuals. The study will provide data on this approach's efficacy for improving blood pressure, cardiac autonomic modulation, oxidative stress, and functional capacity in hypertensive people.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108182"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773894","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":"50k4Life: A SMART study protocol to improve walking engagement in public school employees on the US-Mexico border","authors":"Jennifer J. Salinas ,&nbsp;Susan W. Buchholz ,&nbsp;Zenong Yin ,&nbsp;Jennifer L. Gay ,&nbsp;Jing Wang ,&nbsp;Janani Rajbhandari-Thapa ,&nbsp;Mark G. Wilson ,&nbsp;Erin Finley ,&nbsp;Zuber Mulla ,&nbsp;Elizabeth Ramirez ,&nbsp;Deborah Parra Medina","doi":"10.1016/j.cct.2025.108211","DOIUrl":"10.1016/j.cct.2025.108211","url":null,"abstract":"<div><h3>Introduction</h3><div>Mexican Americans living in the U.S.-Mexico border region suffer disproportionately from preventable cardiometabolic and cancer diseases. Workplace health promotion programs that include physical activity promotion are promising strategies to address this public health problem to improve physical activity engagement. Workplace-based programs can increase moderate to vigorous physical activity (MVPA) engagement while addressing barriers associated with inactivity.</div></div><div><h3>Methods</h3><div>We plan to conduct a clustered Sequential Multiple Assignment Randomized Trial (SMART) to determine the effectiveness of a workplace walking challenge intervention – 50,000 for Life (50K4Life) – in improving brisk walking engagement (at least 7000 steps/day, representing approximately 50,000 steps/week) for public school employees. The two-phase trial will include 30 public schools in two cohorts (15 per cohort) with predominantly Mexican American employees from El Paso County area schools in Texas on the U.S.-Mexico border. In Phase 1, the schools will be randomly assigned to 50K4Life or 50K4Life plus app-based push notifications. In Phase 2, schools with 50 % or more participants accumulating 50,000 steps/week will continue receiving the same intervention. The remaining schools will be randomly assigned to receive individual or school-level intervention. As part of our intervention evaluation, we will conduct a process and cost-effectiveness evaluation to provide insight into cost and scalability.</div></div><div><h3>Discussion</h3><div>This study will provide evidence to support the implementation of walking challenge-based interventions that improve engagement among Mexican Americans living in the U.S.-Mexico border region.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108211"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145899306","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":"Kinesiologist-delivered mobilization to mitigate inpatient frailty: A study protocol for a randomized controlled trial","authors":"Madeline E. Shivgulam ,&nbsp;Mathieu Dumont ,&nbsp;Shirko Ahmadi ,&nbsp;Molly Courish ,&nbsp;Luc Barrieau ,&nbsp;Luc Cormier ,&nbsp;Olga Theou ,&nbsp;Saïd Mekari ,&nbsp;Myles W. O'Brien","doi":"10.1016/j.cct.2025.108204","DOIUrl":"10.1016/j.cct.2025.108204","url":null,"abstract":"<div><h3>Background</h3><div>Hospitalized older adults spend excessive amounts of time in sedentary postures (sitting/lying while awake). Mobilizing patients may prevent physical deconditioning, exacerbated frailty levels, and worsened hospital outcomes. The purpose of this study will be to test the hypothesis that compared to usual care, patients who receive multiple kinesiologist visits each day will, 1) increase their step counts and upright time, 2) decrease their frailty levels from admission to discharge, and 3) have shorter lengths of stays and decreased readmission rates.</div></div><div><h3>Methods</h3><div>Sixty middle-aged-to-older adult patients (≥50 years) from a general/internal medicine unit will be randomized into a usual care control (visit from the kinesiologist once/day) or intervention group (multiple visits from the kinesiologist/day). Kinesiologist visits will include individualized patient mobilization. All participants will be equipped with three waterproofed activPAL inclinometers positioned on their thigh, torso, and shin for 24-h/day throughout hospitalization to measure physical activity (step counts, physical activity intensity), upright postures, and detailed sedentary postures (bent-legged sitting, straight-legged sitting, lying). Frailty will be assessed via a validated 65-item index and the Clinical Frailty Scale two weeks before admission (retrospectively), at admission, and at discharge. Secondary measures will include length of stay and hospital re-admissions. Mixed models for repeated measures will determine whether daily activity differed between groups, changed throughout hospital stay, and effected frailty levels.</div></div><div><h3>Discussion</h3><div>This randomized controlled trial will aim to refine mobilization strategies and individualize interventions for the prevention of decline in mobility and worsening frailty among hospitalized patients.</div><div>Trial Registration: The protocol has been registered at <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (identifier: <span><span>NCT06802289</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108204"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843541","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":"Sequential choice vs colonoscopy outreach for colorectal cancer screening: Design and rationale of a pragmatic randomized clinical trial","authors":"Shivan J. Mehta ,&nbsp;Pamela A. Shaw ,&nbsp;Catherine Reitz ,&nbsp;Caitlin Brophy ,&nbsp;Evelyn Okorie ,&nbsp;Keyirah Williams ,&nbsp;Abraham Segura ,&nbsp;Jinming Tao ,&nbsp;Christopher K. Snider ,&nbsp;Colin Wollack ,&nbsp;Sadie Friday ,&nbsp;Katharine A. Rendle ,&nbsp;Tamar Klaiman ,&nbsp;Karen Glanz ,&nbsp;Corinne Rhodes ,&nbsp;David A. Asch","doi":"10.1016/j.cct.2025.108188","DOIUrl":"10.1016/j.cct.2025.108188","url":null,"abstract":"<div><h3>Background</h3><div>Colorectal cancer (CRC) screening rates remain limited, and effective methods for offering the choice of colonoscopy or stool testing through outreach have not been identified. We evaluate the effect of sequential choice compared to colonoscopy outreach on screening completion, and further evaluate behavioral nudges in the electronic health record (EHR).</div></div><div><h3>Methods</h3><div>In this pragmatic randomized clinical trial, patients were randomly allocated in a 1:2:2 ratio to 1) usual care (no outreach), 2) colonoscopy only, or 3) sequential choice of colonoscopy, then fecal immunochemical testing (FIT). Patients in arms 2 and 3 were additionally randomized to receive either (a) usual care, or (b) a visit-based, clinician-directed nudge facilitated by the EHR with follow-up texting to the patient. The primary outcome is CRC screening completion within 3 years by either colonoscopy, 2 negative fecal immunochemical tests (FIT), or 1 positive FIT followed by colonoscopy within one year.</div></div><div><h3>Analysis</h3><div>For the patient-directed analysis, the primary outcome will be evaluated by comparing CRC screening completion among patients randomized to either outreach arm (2 or 3) to the no outreach arm (1). We will also compare completion between the colonoscopy only arm (1) and the sequential choice arm (2). For the visit-based analysis, we will compare CRC screening completion among patients between the usual care arms (2a and 3a) and the nudge arms (2b and 3b).</div></div><div><h3>Conclusion</h3><div>This trial is unique in evaluating the long-term effectiveness of offering sequential choice to colonoscopy alone through a multi-level, centralized outreach and visit-based design.</div><div><em>Clinical Trials Identifier:</em> <span><span>NCT05693649</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108188"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145780538","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}