Contemporary clinical trials最新文献

{"title":"Sequenced treatment effectiveness for posttraumatic stress (STEPS) trial: A protocol for a pragmatic comparative effectiveness trial with baseline results","authors":"John C. Fortney ,&nbsp;Debra L. Kaysen ,&nbsp;Charles C. Engel ,&nbsp;Joseph M. Cerimele ,&nbsp;John P. Nolan Jr ,&nbsp;Erin Chase ,&nbsp;Brittany E. Blanchard ,&nbsp;Stephanie Hauge ,&nbsp;Jared Bechtel ,&nbsp;Danna L. Moore ,&nbsp;Ashley Taylor ,&nbsp;Ron Acierno ,&nbsp;Nancy Nagel ,&nbsp;Rebecca K. Sripada ,&nbsp;Jacob T. Painter ,&nbsp;Bryann B. DeBeer ,&nbsp;Ellen Bluett ,&nbsp;Alan R. Teo ,&nbsp;Leslie A. Morland ,&nbsp;Patrick J. Heagerty","doi":"10.1016/j.cct.2024.107606","DOIUrl":"10.1016/j.cct.2024.107606","url":null,"abstract":"<div><h3>Background</h3><p>There have only been two efficacy trials reporting a head-to-head comparison of medications and psychotherapy for PTSD, and neither was conducted in primary care. Therefore, this protocol paper describes a pragmatic trial that compares outcomes of primary care patients randomized to initially receive a brief trauma-focused psychotherapy or a choice of three antidepressants. In addition, because there are few trials examining the effectiveness of subsequent treatments for patients not responding to the initial treatment, this pragmatic trial also compares the outcomes of those switching or augmenting treatments.</p></div><div><h3>Method</h3><p>Patients screening positive for PTSD (<em>n</em> = 700) were recruited from the primary care clinics of 7 Federally Qualified Health Centers (FQHC) and 8 Department of Veterans Affairs (VA) Medical Centers and randomized in the ratio 1:1:2 to one of three treatment sequences: 1) selective serotonin reuptake inhibitor (SSRI) followed by augmentation with Written Exposure Therapy (WET), 2) SSRI followed by a switch to serotonin-norepinephrine reuptake inhibitor (SNRI), or 3) WET followed by a switch to SSRI. Participants complete surveys at baseline, 4 months, and 8 months. The primary outcome is PTSD symptom severity as measured by the PTSD Checklist (PCL-5).</p></div><div><h3>Results</h3><p>Average PCL-5 scores (M = 52.8, SD = 11.1) indicated considerable severity. The most common bothersome traumatic event for VA enrollees was combat (47.8%), and for FQHC enrollees was other (28.2%), followed by sexual assault (23.4%), and child abuse (19.8%). Only 22.4% were taking an antidepressant at baseline.</p></div><div><h3>Conclusion</h3><p>Results will help healthcare systems and clinicians make decisions about which treatments to offer to patients.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141310187","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":"Acute normovolemic hemodilution in cardiac surgery: rationale and design of a multicenter randomized trial","authors":"Fabrizio Monaco ,&nbsp;Fabio Guarracino ,&nbsp;Igor Vendramin ,&nbsp;Chong Lei ,&nbsp;Hui Zhang ,&nbsp;Vladimir Lomivorotov ,&nbsp;Roman Osinsky ,&nbsp;Sergey Efremov ,&nbsp;Mustafa Emre Gürcü ,&nbsp;Michael Mazzeffi ,&nbsp;Vadim Pasyuga ,&nbsp;Yuki Kotani ,&nbsp;Giuseppe Biondi-Zoccai ,&nbsp;Fabrizio D'Ascenzo ,&nbsp;Enrico Romagnoli ,&nbsp;Caetano Nigro Neto ,&nbsp;Vinicius Tadeu Nogueira Da Silva Do Nascimento ,&nbsp;Lian Kah Ti ,&nbsp;Suraphong Lorsomradee ,&nbsp;Ahmed Farag ,&nbsp;Alberto Zangrillo","doi":"10.1016/j.cct.2024.107605","DOIUrl":"10.1016/j.cct.2024.107605","url":null,"abstract":"<div><h3>Background</h3><p>Minimizing the use of blood component can reduce known and unknown blood transfusion risks, preserve blood bank resources, and decrease healthcare costs. Red Blood Cell (RBC) transfusion is common after cardiac surgery and associated with adverse perioperative outcomes, including mortality. Acute normovolemic hemodilution (ANH) may reduce bleeding and the need for blood product transfusion after cardiac surgery. However, its blood-saving effect and impact on major outcomes remain uncertain.</p></div><div><h3>Methods</h3><p>This is a single-blinded, multinational, pragmatic, randomized controlled trial with a 1:1 allocation ratio conducted in Tertiary and University hospitals. The study is designed to enroll patients scheduled for elective cardiac surgery with planned cardiopulmonary bypass (CPB). Patients are randomized to receive ANH before CPB or the best available treatment without ANH. We identified an ANH volume of at least 650 ml as the critical threshold for clinically relevant benefits. Larger ANH volumes, however, are allowed and tailored to the patient's characteristics and clinical conditions.</p></div><div><h3>Results</h3><p>The primary outcome is the percentage of patients receiving RBCs transfusion from randomization until hospital discharge, which we hypothesize will be reduced from 35% to 28% with ANH. Secondary outcomes are all-cause 30-day mortality, acute kidney injury, bleeding complications, and ischemic complications.</p></div><div><h3>Conclusion</h3><p>The trial is designed to determine whether ANH can safely reduce RBC transfusion after elective cardiac surgery with CPB.</p></div><div><h3>Study registration</h3><p>This trial was registered on <span>ClinicalTrials.gov</span><svg><path></path></svg> in April 2019 with the trial identification number <span>NCT03913481</span><svg><path></path></svg>.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141310185","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":"Addressing missing outcome data in randomised controlled trials: A methodological scoping review","authors":"Ellie Medcalf ,&nbsp;Robin M. Turner ,&nbsp;David Espinoza ,&nbsp;Vicky He ,&nbsp;Katy J.L. Bell","doi":"10.1016/j.cct.2024.107602","DOIUrl":"10.1016/j.cct.2024.107602","url":null,"abstract":"<div><h3>Background</h3><p>Missing outcome data is common in trials, and robust methods to address this are needed. Most trial reports currently use methods applicable under a missing completely at random assumption (MCAR), although this strong assumption can often be inappropriate.</p></div><div><h3>Objective</h3><p>To identify and summarise current literature on the analytical methods for handling missing outcome data in randomised controlled trials (RCTs), emphasising methods appropriate for data missing at random (MAR) or missing not at random (MNAR).</p></div><div><h3>Study design and setting</h3><p>We conducted a methodological scoping review and identified papers through searching four databases (MEDLINE, Embase, CENTRAL, and CINAHL) from January 2015 to March 2023. We also performed forward and backward citation searching. Eligible papers discussed methods or frameworks for handling missing outcome data in RCTs or simulation studies with an RCT design.</p></div><div><h3>Results</h3><p>From 1878 records screened, our search identified 101 eligible papers. 90 (89%) papers described specific methods for addressing missing outcome data and 11 (11%) described frameworks for overall methodological approach. Of the 90 methods papers, 30 (33%) described methods under the MAR assumption, 48 (53%) explored methods under the MNAR assumption and 11 (12%) discussed methods under a hybrid of MAR and MNAR assumptions. Control-based methods under the MNAR assumption were the most common method explored, followed by multiple imputation under the MAR assumption.</p></div><div><h3>Conclusion</h3><p>This review provides guidance on available analytic approaches for handling missing outcome data, particularly under the MNAR assumption. These findings may support trialists in using appropriate methods to address missing outcome data.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S155171442400185X/pdfft?md5=778068f8f07156e0db40c8d233959473&pid=1-s2.0-S155171442400185X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141300259","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":"Statistical analysis plan for the NU IMPACT stepped-wedge cluster randomized trial","authors":"Denise M. Scholtens ,&nbsp;Nicola Lancki ,&nbsp;Karla Hemming ,&nbsp;David Cella ,&nbsp;Justin D. Smith","doi":"10.1016/j.cct.2024.107603","DOIUrl":"10.1016/j.cct.2024.107603","url":null,"abstract":"<div><h3>Background</h3><p>As part of the IMPACT Consortium of three effectiveness-implementation trials, the NU IMPACT trial was designed to evaluate implementation and effectiveness outcomes for an electronic health record (EHR)-embedded symptom monitoring and management program for outpatient cancer care. NU IMPACT uses a unique stepped-wedge cluster randomized design, involving six clusters of 26 clinics, for evaluation of implementation outcomes with an embedded patient-level randomized trial to evaluate effectiveness outcomes. Collaborative, consortium-wide efforts to ensure use of the most robust and recent analytic methodologies for stepped-wedge trials motivated updates to the statistical analysis plan for implementation outcomes in the NU IMPACT trial.</p></div><div><h3>Methods</h3><p>In the updated statistical analysis plan for NU IMPACT, the primary implementation outcome patient adoption, as measured by clinic-level monthly proportions of patient engagement with the EHR-based cancer symptom monitoring system, will be analyzed using generalized least squares linear regression with auto-regressive errors and adjustment for cluster and time effects (underlying secular trends). A similar strategy will be used for secondary patient and provider implementation outcomes.</p></div><div><h3>Discussion</h3><p>The analytic updates described here resulted from highly iterative, collaborative efforts among statisticians, implementation scientists, and trial leads in the IMPACT Consortium. This updated statistical analysis plan will serve as the a priori specified approach for analyzing implementation outcomes for the NU IMPACT trial.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424001861/pdfft?md5=9f73a7eaf9dd7888db53ffb0c81d32ae&pid=1-s2.0-S1551714424001861-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141295717","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":"Rationale and design of the KP ENRICH trial: A food is medicine intervention in low-income high-risk adults with diabetes within Kaiser Permanente","authors":"Rishi V. Parikh ,&nbsp;Claudia L. Nau ,&nbsp;Thida C. Tan ,&nbsp;Emma Tucher ,&nbsp;Jessica D. Vallejo ,&nbsp;Jennifer J. Jimenez ,&nbsp;Kate M. Horiuchi ,&nbsp;Amanda R. Allen ,&nbsp;Peter Stehr ,&nbsp;Stacey E. Alexeeff ,&nbsp;Bing Han ,&nbsp;Joan C. Lo ,&nbsp;Dariush Mozaffarian ,&nbsp;Alan S. Go ,&nbsp;Richard W. Grant ,&nbsp;for the KP ENRICH study team","doi":"10.1016/j.cct.2024.107601","DOIUrl":"10.1016/j.cct.2024.107601","url":null,"abstract":"<div><h3>Background</h3><p>Food insecurity is associated with poor glycemic control and increased risk for diabetes-related complications. The clinical benefit of addressing these challenges through a medically supportive grocery prescription (GRx) program in patients with type 2 diabetes mellitus (T2D) remains unclear. We report the aims and design of a randomized clinical trial to evaluate the effectiveness of a 6-month GRx intervention on hemoglobin A1c (HbA1c) levels among low-income adults with T2D.</p></div><div><h3>Methods</h3><p>The Kaiser Permanente <u>E</u>valuating <u>N</u>utritional Inte<u>r</u>ventions in Food-<u>I</u>nse<u>c</u>ure <u>H</u>igh-Risk Adults (KP ENRICH) Study is a pragmatic randomized trial enrolling 1100 participants within Kaiser Permanente Northern California and Southern California, two integrated health care delivery systems serving &gt;9 million members. Medicaid-insured adults with T2D and baseline HbA1c ≥7.5% will be randomized at a 1:1 ratio to either GRx, delivered as $100 per month for select items from among a curated list of healthful food groups in an online grocery ordering and home-delivery platform along with biweekly digital nutrition educational materials, or control, consisting of free membership and deliveries from the online grocery platform but without curated food groups or purchasing dollars. The primary outcome is 6-month change in HbA1c. Secondary outcomes include 12-month change in HbA1c, and 6- and 12-month change in medical resource utilization, food security, nutrition security, dietary habits, diabetes-related quality of life, and dietary self-efficacy.</p></div><div><h3>Conclusions</h3><p>The results of this large randomized clinical trial of GRx will help inform future policy and health system-based initiatives to improve food and nutrition security, disease management, and health equity among patients with T2D.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141293252","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":"Increasing pre-exposure prophylaxis (PrEP) in primary care: A study protocol for a multi-level intervention using the multiphase optimization strategy (MOST) framework","authors":"Elizabeth Lockhart ,&nbsp;DeAnne Turner ,&nbsp;Kate Guastaferro ,&nbsp;Laura A. Szalacha ,&nbsp;Herica Torres Alzate ,&nbsp;Stephanie Marhefka ,&nbsp;Bianca Pittiglio ,&nbsp;Megan Dekker ,&nbsp;Hsueh-Han Yeh ,&nbsp;Logan Zelenak ,&nbsp;Jeremy Toney ,&nbsp;Sean Manogue ,&nbsp;Brian K. Ahmedani","doi":"10.1016/j.cct.2024.107599","DOIUrl":"10.1016/j.cct.2024.107599","url":null,"abstract":"<div><h3>Background</h3><p>In the United States, over 1.2 million people are living with HIV. This disease disproportionately affects men who have sex with men (MSM), people of color, youth and young adults, and transgender individuals. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention method. Barriers exist for both primary care providers (PCPs) to prescribe PrEP and prevent patients from initiating PrEP.</p></div><div><h3>Methods</h3><p>This study, MOST: PrEP, follows the multiphase optimization strategy (MOST) framework. The purpose is to identify a multi-level intervention among patients and PCPs to increase PrEP prescriptions in primary care. First, feedback will be obtained from providers and patients via focus groups, then, suggestions related to the context-specific (provider and individual level) factors of intervention component delivery will be incorporated. Subsequently, a rigorous experiment will be conducted using a 2⁴ factorial design focusing on priority populations for PrEP initiation. Provider components include computer-based simulation training and a best practice alert. Patient components include a tailored PrEP educational video and HIV risk assessment. Finally, the facilitators and barriers to implementing the intervention components will be qualitatively examined.</p></div><div><h3>Conclusion</h3><p>In this protocol paper, we describe the one of the first known multilevel MOST optimization trial in healthcare. Intervention components are to be delivered to patients and providers in a large healthcare system, based in an HIV Ending the Epidemic priority jurisdiction. If effective, this multi-level approach could be disseminated to providers and patients in other large healthcare systems to make a significant impact on HIV prevention.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141287860","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":"Rationale, design, and participant characteristics of the FAITH! Heart Health+ study: An exploration of the influence of the social determinants of health, stress, and structural racism on African American cardiovascular health","authors":"Mathias Lalika ,&nbsp;Carrie R. McCoy ,&nbsp;Clarence Jones ,&nbsp;Irina Bancos ,&nbsp;Lisa A. Cooper ,&nbsp;Sharonne N. Hayes ,&nbsp;Matthew P. Johnson ,&nbsp;Iftikhar J. Kullo ,&nbsp;Ashok Kumbamu ,&nbsp;Peter A. Noseworthy ,&nbsp;Christi A. Patten ,&nbsp;Ravinder Singh ,&nbsp;Chung-Il Wi ,&nbsp;LaPrincess C. Brewer","doi":"10.1016/j.cct.2024.107600","DOIUrl":"10.1016/j.cct.2024.107600","url":null,"abstract":"<div><h3>Background</h3><p>African Americans (AAs) face cardiovascular health (CVH) disparities linked to systemic racism. The 2020 police killing of Mr. George Floyd in Minneapolis, Minnesota, alongside the COVID-19 pandemic, exacerbated adverse psychosocial factors affecting CVH outcomes among AAs. This manuscript describes the study protocol and participant characteristics in an ancillary study exploring the relationship between biopsychosocial factors and CVH among AAs.</p></div><div><h3>Methods</h3><p>Using a community-based participatory approach, a mixed-methods ancillary study of 58 AA participants from an overarching randomized control trial (RCT) was conducted. Baseline RCT health assessments (November 2020) provided sociodemographic, medical, and clinical data. Subsequent health assessments (February–December 2022) measured sleep quality, psychosocial factors (e.g., high-effort coping), biomarkers (e.g., cortisol), and cardiovascular diagnostics (e.g., cardio-ankle vascular index). CVH was assessed using the American Heart Association Life's Simple 7 (LS7) (range 0 to 14, poor to ideal) and Life's Essential 8 (LE8) scores (range 0 to 100, low to high). Correlations between these scores will be examined. Focus group discussions via videoconferencing (March to April 2022) assessed psychosocial and structural barriers, along with the impact of COVID-19 and George Floyd's killing on daily life.</p></div><div><h3>Results</h3><p>Participants were predominantly female (67%), with a mean age of 54.6 [11.9] years, high cardiometabolic risk (93% had overweight/obesity and 70% hypertension), and moderate LE8 scores (mean 57.4, SD 11.5).</p></div><div><h3>Conclusion</h3><p>This study will enhance understanding of the associations between biopsychosocial factors and CVH among AAs in Minnesota. Findings may inform risk estimation, patient care, and healthcare policies to address CVD disparities in marginalized populations.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141293253","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":"Planning for the forgotten fourth trimester of pregnancy: A parallel group randomized control trial to test a postpartum planning intervention vs. standard prenatal care","authors":"Kaitlyn K. Stanhope ,&nbsp;Taé Stallworth ,&nbsp;Alexandra D. Forest ,&nbsp;Danielle Vuncannon ,&nbsp;Gabriela Juarez ,&nbsp;Sheree L. Boulet ,&nbsp;Franklyn Geary ,&nbsp;Anne L. Dunlop ,&nbsp;Sarah C. Blake ,&nbsp;Victoria L. Green ,&nbsp;Denise J. Jamieson","doi":"10.1016/j.cct.2024.107586","DOIUrl":"10.1016/j.cct.2024.107586","url":null,"abstract":"<div><h3>Background</h3><p>Black and brown birthing people experience persistent disparities in adverse maternal health outcomes, partially due to inadequate perinatal care. The goal of this study is to design and evaluate a patient-centered intervention for obstetric patients with one or more cardiometabolic risk factors for severe maternal morbidity [gestational diabetes, diabetes mellitus, hypertensive disorders of pregnancy (chronic hypertension, preeclampsia, eclampsia, or gestational hypertension), or preconception obesity (BMI &gt; 30)] to promote postpartum visit attendance.</p></div><div><h3>Methods</h3><p>To address identified unmet needs for postpartum support and barriers to postpartum care, we developed 20 thematic postpartum planning modules, each with corresponding patient educational materials, community resources, care coordination protocols, and clinician support tools (decision aids, electronic medical record prompts and fields). During prenatal care encounters, a research coordinator delivers the educational content (in English or Spanish), facilitates the participant's planning and shared decision-making, provides the participant with resources, and documents decisions in the electronic medical record. We will randomize 320 eligible patients with a 1:1 ratio to the intervention or standard prenatal care and evaluate the impact on postpartum visit attendance at 4–12 weeks and secondary outcomes (postpartum mental health, perceived future maternal and cardiometabolic risk, contraceptive use, primary care use, readmission, and patient satisfaction with care).</p></div><div><h3>Discussion</h3><p>Through engagement with patients and community stakeholders, we developed a guideline-based, locally tailored intervention to address drivers of engagement with postpartum care for high-risk obstetric patients. If demonstrated to be effective, the educational materials and electronic medical record based-tool can be adapted to other settings.</p></div><div><h3>Trial registration</h3><p>This trial was registered on <span>ClinicalTrials.gov</span><svg><path></path></svg> (<span>NCT05430815</span><svg><path></path></svg>) on June 23, 2022.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141261495","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":"Effect of a multimodal intervention in breast Cancer patients undergoing neoadjuvant therapy: A study protocol of the multimodal project","authors":"Amelia Muñoz-Lerma ,&nbsp;Rocío Sánchez-Sánchez ,&nbsp;Julia Ruiz-Vozmediano ,&nbsp;Tábatha Yebras Cano ,&nbsp;Antonio González-Jiménez ,&nbsp;Lucas Jurado-Fasoli","doi":"10.1016/j.cct.2024.107598","DOIUrl":"10.1016/j.cct.2024.107598","url":null,"abstract":"<div><h3>Background and aims</h3><p>To determine the effect of a multimodal intervention (nutritional behavior change and physical exercise) on quality of life, chemotherapy response rate and tolerance, histopathological level of the tumor, body composition, and biochemical parameters, in patients diagnosed with breast cancer during neoadjuvant chemotherapy treatment, and to compare them with the control group.</p></div><div><h3>Methods</h3><p>Anticipated 80 patients diagnosed with breast cancer aged 18–70 years will be recruited for this randomized, unblinded clinical trial based on a nutritional behavior change and physical exercise in patients during the approximately 6 months in which the patient receives neoadjuvant treatment. Participants will be randomly allocated (1:1) to one of two groups (intervention or control). Primary and secondary outcomes will be assessed before the beginning and after the neoadjuvant treatment (before surgery). The primary outcome is quality of life, whereas secondary outcomes include chemotherapy response rate and tolerance, histopathological level of the tumor and body composition (i.e., visceral adipose tissue activity, bone, lean and fat masses). We will analyze blood parameters (i.e., biochemical, inflammatory, and tumor markers) as exploratory outcomes.</p></div><div><h3>Conclusion</h3><p>This study will address the influence of a practical and viable multimodal intervention (i.e., nutritional behavior change and physical exercise) on breast cancer patients undergoing neoadjuvant chemotherapy. Given the practical viability of the intervention in real-world settings, our study holds promise for significant scientific and clinical implications.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141261493","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":"Selecting trial centers using a standardized, automated site assessment survey instrument (SASI)","authors":"Karen Lane ,&nbsp;Shannon Hillery ,&nbsp;Ryan Majkowski ,&nbsp;Bradley J. Barney ,&nbsp;Daniel Amirault ,&nbsp;Sarah J. Nelson ,&nbsp;Mary Bailey ,&nbsp;Eun Hea Unsicker ,&nbsp;Mary Stroud ,&nbsp;Lindsay M. Eyzaguirre ,&nbsp;Amy Gawad ,&nbsp;Angeline Nanni ,&nbsp;Gwendolyn Mirzoyan ,&nbsp;Theodora Cohen ,&nbsp;Salina P. Waddy ,&nbsp;Ken Wiley ,&nbsp;Paul A. Harris ,&nbsp;Daniel E. Ford ,&nbsp;Daniel Hanley ,&nbsp;For the Trial Innovation Network","doi":"10.1016/j.cct.2024.107583","DOIUrl":"10.1016/j.cct.2024.107583","url":null,"abstract":"<div><h3>Background</h3><p>To improve the site selection process for clinical trials, we expanded a site survey to include standardized assessments of site commitment time, team experience, feasibility of tight timelines, and local medical community equipoise as factors that might better predict performance. We also collected contact information about institutional research services ahead of site onboarding.</p></div><div><h3>Aim</h3><p>As a first step, we wanted to confirm that an expanded survey could be feasible and generalizable—that asking site teams for more details upfront was acceptable and that the survey could be completed in a reasonable amount of time, despite the assessment length.</p></div><div><h3>Methods</h3><p>A standardized, two-part Site Assessment Survey Instrument (SASI), examining qualitative components and with multiple contact list sections, was developed using a publicly accessible dashboard and later transferred to a REDCap platform. After multiple rounds of internal testing, the SASI was deployed 11 times for multicenter trials. Follow-up questionnaires were sent to site teams to confirm that an expanded survey instrument is acceptable to the research community and could be completed during a brief work shift.</p></div><div><h3>Results</h3><p>Respondents thought the SASI collected useful and relevant information about their sites (100%). Sites were “comfortable” (90%) supplying detailed information early in the site selection process and 57% completed the SASI in one to two hours.</p></div><div><h3>Conclusions</h3><p>Coordinating centers and sites found the SASI tool to be acceptable and helpful when collecting data in consideration of multicenter trial site selection.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141183964","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}