Contemporary Clinical Trials Communications最新文献

{"title":"Left ventromedial prefrontal cortex inhibitory rTMS as an anti-stress intervention in opioid use disorder: Trial design","authors":"Tabitha E. Moses ,&nbsp;Danielle Lenz ,&nbsp;Leslie H. Lundahl ,&nbsp;Nicholas A. Mischel ,&nbsp;Christine Rabinak ,&nbsp;Mark K. Greenwald","doi":"10.1016/j.conctc.2024.101414","DOIUrl":"10.1016/j.conctc.2024.101414","url":null,"abstract":"<div><h3>Background</h3><div>In people with substance use disorders (SUDs), stress-exposure can impair executive function, and increase craving and likelihood of drug-use recurrence. Research shows that acute stressors increase drug-seeking behavior; however, mechanisms underlying this effect are incompletely understood. The Competing Neurobehavioral Decisions System theory posits that persons with SUDs may have hyperactive limbic reward circuitry and hypoactive executive control circuitry.</div></div><div><h3>Objective</h3><div>To investigate how inhibitory repetitive transcranial magnetic stimulation (rTMS) targeting the left ventromedial prefrontal cortex (vmPFC) may alter stress-induced executive dysfunction, emotion dysregulation, and drug-seeking in people with opioid use disorder.</div></div><div><h3>Methods</h3><div>We will examine effects of a psychological stressor combined with inhibitory (1Hz) left vmPFC rTMS in participants (N = 24) receiving opioid agonist treatment. Participants undergo guided imagery of autobiographical stressors paired with 10 sessions of active vmPFC rTMS vs. sham (within-subject randomized crossover). Stress-induced dysfunction will be indexed with cognitive (e.g., executive function), affective (e.g., emotional arousal), and behavioral (e.g., opioid-seeking) measures pre- and post-rTMS. To confirm changes are associated with altered neural activity in targeted regions, we will measure event-related potentials during key tasks using EEG. We hypothesize that stressors will increase executive dysfunction, emotion dysregulation, and drug-seeking, and that left vmPFC inhibitory rTMS will decrease limbic activation, which could translate to reduced craving and drug-seeking.</div></div><div><h3>Conclusion</h3><div>Our findings should offer insights into how neural networks modulate drug-seeking and associated dysfunctions in people with SUDs. The results of this and similar studies can advance theory and neuromodulation interventions for people with SUDs.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101414"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11719330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to “Protocol for double-blind RCT of acupuncture for vulvodynia” [Contemp. Clin. Trials Commun. (2022) 1–8 101029]","authors":"Judith M. Schlaeger ,&nbsp;Marie L. Suarez ,&nbsp;Jennifer E. Glayzer ,&nbsp;William H. Kobak ,&nbsp;Monya Meinel ,&nbsp;Alana D. Steffen ,&nbsp;Larisa A. Burke ,&nbsp;Heather A. Pauls ,&nbsp;Yingwei Yao ,&nbsp;Miho Takayama ,&nbsp;Hiroyoshi Yajima ,&nbsp;Ted J. Kaptchuk ,&nbsp;Nobuari Takakura ,&nbsp;David Foster ,&nbsp;Diana J. Wilkie","doi":"10.1016/j.conctc.2024.101422","DOIUrl":"10.1016/j.conctc.2024.101422","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101422"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784261/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Utilization of an undergraduate emergency department research associate program for the screening and recruitment of research subjects with heart failure into a clinical study","authors":"Dillon J. Dzikowicz ,&nbsp;Brenda Hernandez-Romero ,&nbsp;Nancy Wood ,&nbsp;Beau W. Abar ,&nbsp;David H. Adler ,&nbsp;Linwei Wang ,&nbsp;Wojciech Zareba","doi":"10.1016/j.conctc.2024.101410","DOIUrl":"10.1016/j.conctc.2024.101410","url":null,"abstract":"<div><h3>Background</h3><div>Enrolling heart failure (HF) patients in clinical studies is challenging. Emergency department (ED) may use students as research associates programs, such as the University of Rochester Medical Center (URMC) ED Research Associate (EDRA) program, to screen and consent patients for clinical studies. This manuscript examines the effectiveness of the URMC EDRA program in consenting HF patients into a clinical study.</div></div><div><h3>Methods</h3><div>The URMC EDRA program recruited and consented HF patients presenting at URMC's ED. Research associates in the EDRA program identified potential patients based on age (&gt;18 years) and chief complaints indicative of HF. After identifying potential patients, a thorough chart review was conducted, and any uncertainties were discussed with the patient and treating provider before patients were consented into the study. Descriptive statistics were used to assess the program's effectiveness.</div></div><div><h3>Results</h3><div>Over one fiscal year, the URMC EDRA program screened 1669 unique patients, of whom 118 (7.1 %) were consented. Consented patients tended to be younger (65 ± 12 years) than those who refused consent (70 ± 14 years) (p = 0.007). Of the 1551 patients not consented, 1021 (65.8 %) were deemed ineligible. Compared to a full time research associate, the URMC EDRA program was cheaper and more productive.</div></div><div><h3>Conclusion</h3><div>The URMC EDRA program was highly effective in screening and consenting HF patients, successfully consenting 118 patients (14 per month). This is a significant achievement, especially given the study's strict inclusion and exclusion criteria. Compared to other studies and a full time research associate, the URMC EDRA program demonstrated remarkable productivity.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101410"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11696846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A mind-body resilience intervention for emotional distress in cardiac arrest survivors and their informal caregivers – Recovering together after cardiac arrest: Protocol for an open pilot trial","authors":"Danielle La Camera ,&nbsp;Jonathan Elmer ,&nbsp;Sarah M. Perman ,&nbsp;Michael W. Donnino ,&nbsp;Ona Wu ,&nbsp;Robert A. Parker ,&nbsp;Ana-Maria Vranceanu ,&nbsp;Alexander M. Presciutti","doi":"10.1016/j.conctc.2024.101426","DOIUrl":"10.1016/j.conctc.2024.101426","url":null,"abstract":"<div><h3>Background</h3><div>Chronic emotional distress among cardiac arrest (CA) survivors and their caregivers is prevalent and worsens quality of life and recovery. Interventions to prevent chronic distress post-CA are needed. We developed <em>Recovering Together after Cardiac Arrest</em> (RT-CA), an intervention to increase resiliency in CA survivor-caregiver dyads (pairs).</div></div><div><h3>Method</h3><div>We will conduct an open pilot clinical trial of RT-CA to examine preliminary feasibility and refine the intervention based on participant feedback. We will enroll at least 7 CA survivor-caregiver dyads during their hospitalization at a single academic medical center. We will identify eligible survivors by screening admission reports and through referrals from medical staff. <em>Inclusion criteria</em>: Survivors - sufficient cognitive status to meaningfully participate (Short Form of the Mini Mental State Exam ≥5). Dyads - English-speakers; one member must have clinically significant distress (≥8 on either Hospital Anxiety and Depression Scale subscale). <em>Procedure:</em> dyads will participate in 6, 30–45 min sessions with a study clinician. Sessions will include mind-body coping skills training and provision of anticipatory guidance and resources to navigate CA-survivorship. Dyads will complete pre- and post-test measures of emotional distress and treatment targets. We will calculate frequencies and proportions of our primary outcomes (feasibility - recruitment, assessments, adherence, therapist fidelity and acceptability/credibility). After completing post-test assessments, dyads will provide feedback via exit interviews. We will integrate qualitative and quantitative data using explanatory-sequential mixed-methods.</div></div><div><h3>Discussion</h3><div>We will use our findings to refine RT-CA content and study procedures. If successful, RT-CA has potential to significantly improve quality of survivorship for CA survivors and their caregivers.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101426"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143047795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The METEMP protocol: Massed exposure therapy enhanced with MDMA for PTSD","authors":"Jessica L. Maples-Keller,&nbsp;Boadie W. Dunlop,&nbsp;Barbara O. Rothbaum","doi":"10.1016/j.conctc.2024.101400","DOIUrl":"10.1016/j.conctc.2024.101400","url":null,"abstract":"<div><div>This article describes the rationale and the specific methods for an open label pilot trial of 100 mg MDMA in combination with massed exposure therapy for PTSD, a treatment which involves daily exposure therapy sessions for two weeks which has found to be effective. We review the need for novel PTSD treatments and the existing research on MDMA-assisted therapy, and then describe the rationale for this novel treatment approach, including combining MDMA with a gold standard treatment, translational support for this treatment, strong dissemination potential, and strengths of providing massed exposure treatment. The specific methods of the open label pilot study are presented, followed by conclusions and future directions for this research. This study will enroll at least 15 adults with PTSD over the next 2 years in order to identify feasibility and lead to a manual describing how to combine MDMA with exposure therapy, tested in a randomized, placebo-controlled trial, with significant promise for dissemination and improving our ability to treat PTSD.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> identifier: NCT05746572.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101400"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784277/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"“Salud Mamaria”, an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trial","authors":"Reyna Jazmín Martínez-Arriaga ,&nbsp;Alejandro Dominguez-Rodriguez ,&nbsp;Sergio Osvaldo Meza-Chavolla ,&nbsp;Yineth Alejandra Muñoz-Anacona ,&nbsp;Adrián Antonio Cisneros-Hernández ,&nbsp;Joel Omar González-Cantero ,&nbsp;Leivy Patricia González-Ramírez ,&nbsp;Paulina Erika Herdoiza-Arroyo ,&nbsp;Norma Alicia Ruvalcaba-Romero ,&nbsp;Fabiola Macías-Espinoza ,&nbsp;Said Jiménez","doi":"10.1016/j.conctc.2024.101397","DOIUrl":"10.1016/j.conctc.2024.101397","url":null,"abstract":"<div><h3>Background</h3><div>Some of the key challenges during the breast cancer diagnosis process include a lack of information and negative psychological consequences, such as distress and anxiety about the process. Implementing a psychoeducational program during the diagnosis process may enhance the well-being of women. “<em>Salud Mamaria</em>” is an Internet-Based Psychoeducational Program (IBPP) that comprises three interventions: A (“Improving Your Health Habits and Self-Care”), B (“Waiting for the Result of Your Biopsy”), and C (“Supporting You After Your Breast Cancer Diagnosis”).</div></div><div><h3>Objective</h3><div>1) To evaluate changes in the study variables following each of the three interventions (A, B, and C), and 2) To assess the differences in study variables between the IBPP and an active control group.</div></div><div><h3>Methods</h3><div>This is a superiority trial employing an experimental design with two independent groups: an experimental group and an active control group. All participants will be randomized to one of the two conditions. Anxiety symptoms, negative screening of consequences, sense of coherence, satisfaction with the intervention, and system usability will be measured. Patients will be assigned to an intervention based on their clinical situation: without cancer suspicion (A), with cancer suspicion (B), or diagnosed with cancer (C). Questionnaires will be administered via the online platform before and after each intervention.</div></div><div><h3>Conclusions</h3><div>A psychoeducational program implemented during the breast cancer screening and diagnosis process may promote the health and well-being of women. It may also encourage adherence to medical screening recommendations, mitigating the lack of information and reducing associated distress.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov <span><span>NCT05830461</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101397"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11722602/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design of INSPIRE: Evaluation of the effectiveness of practice facilitation on implementation of screening, brief interventions, referral to treatment and medication for unhealthy alcohol use identification and treatment in primary care","authors":"Jennifer Bannon ,&nbsp;Justin D. Smith ,&nbsp;Mark J. Van Ryzin ,&nbsp;Megan McHugh ,&nbsp;Jennifer Heinrich ,&nbsp;Theresa L. Walunas ,&nbsp;Abel N. Kho","doi":"10.1016/j.conctc.2024.101413","DOIUrl":"10.1016/j.conctc.2024.101413","url":null,"abstract":"<div><h3>Background</h3><div>Unhealthy alcohol use is a leading cause of preventable mortality and a risk factor for an array of social and health problems. The Intervention in Small primary care Practices to Implement Reduction in unhealthy alcohol use (INSPIRE) study is part of a nationwide campaign to improve the identification and treatment of patients engaging in unhealthy alcohol use.</div></div><div><h3>Methods</h3><div>We conducted a single arm, pragmatic study consisting of seventeen primary care practices in the Chicago metropolitan area, Wisconsin, and California across two waves with a 6-month latent period, a 12-month intervention period, followed by a 6-month sustainability period. Enrolled practices were independent, Federally Qualified Health Centers, network-based, and academic health centers. INSPIRE utilized the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to examine implementation feasibility, fidelity, and performance of clinicians on practice adoption of screening, brief intervention, referral to treatment (SBIRT) and medication for unhealthy alcohol use (MAUD) activities in primary care clinics.</div></div><div><h3>Results</h3><div>Seventeen eligible primary care practices were enrolled over the course of 21 months beginning in March of 2020 through December of 2021. There was a pause in recruitment from March of 2020 through July of 2020 due to the Covid-19 pandemic. The majority of enrolled practices were small (&lt;6 clinicians) and were part of a network. 57 % of clinicians completed the educational modules in part or in full.</div><div>This paper will outline the INSPIRE protocol and design. Additionally, we will present practice demographic data, recruitment data and results related to on-line learning module completion.</div></div><div><h3>Conclusion</h3><div>The INSPIRE study will evaluate the ability of primary care clinicians in small practices to participate in practice education programs and implement standard screening and treatment protocols, adapted for documentation in the electronic health record (EHR). The study will also identify the factors that facilitated or hindered improvement and sustainability using quantitative and qualitative analysis methods.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101413"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11718291/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tools to improve discharge equity: Protocol for the pilot TIDE trial","authors":"Kirsten Austad ,&nbsp;Cecilia Thai ,&nbsp;Alegna Zavatti ,&nbsp;Nhi Nguyen ,&nbsp;Diana Bautista-Hurtado ,&nbsp;Patrick Kenney ,&nbsp;Noelia Lugo ,&nbsp;Joo H. Lee ,&nbsp;Howard Lanney ,&nbsp;Ziming Xuan ,&nbsp;Erika G. Cordova-Ramos ,&nbsp;Mari-Lynn Drainoni ,&nbsp;Brian Jack","doi":"10.1016/j.conctc.2024.101419","DOIUrl":"10.1016/j.conctc.2024.101419","url":null,"abstract":"<div><h3>Background</h3><div>Written discharge instructions after hospitalization promote patient understanding and positive clinical outcomes. Despite the rising prevalence of patients with non-English language preference (NELP) in the U.S., most hospitals do not routinely provide discharge instructions in their preferred language, thereby placing them at higher risk for medical errors and hospital readmission. Innovative solutions to close this implementation gap at hospital discharge for patients with NELP are needed. The Tools to Improve Discharge Equity (TIDE) intervention leverages communication practices proven effective in addressing communication barriers to create language concordant discharge tools from hospital discharge paperwork.</div></div><div><h3>Methods</h3><div>We present the protocol for a type I hybrid implementation-effectiveness pilot randomized trial. The TIDE intervention includes a translated medication calendar, pictographs, and an audio recording of the discharge instructions in the patient's preferred language. We will recruit an estimated 50 patient participants from the hospital's top four non-English language groups—Spanish, Haitian Creole, Cape Verdean Creole, and Vietnamese—as well as the nurse and in-person interpreter caring for them. Outcomes include patient recall of primary diagnosis and overall understanding of discharge instructions using a newly developed 24-point score, patient experience, implementation measures (acceptability, feasibility, and appropriateness), and clinical effectiveness (including hospital reutilization). A mixed methods evaluation will identify determinants of intervention uptake to guide selection of multi-level implementation strategies to test in a future hybrid type III trial.</div></div><div><h3>Discussion</h3><div>The TIDE intervention is the first hospital discharge intervention designed for patients with NELP. Result will inform future efforts to improve the safety and equity of the hospital discharge process.</div></div><div><h3>Trial registration</h3><div>clinicaltrials.gov <span><span>NCT05988229</span><svg><path></path></svg></span> (August 14, 2023) <span><span>https://classic.clinicaltrials.gov/ct2/show/NCT05988229</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101419"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11731754/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142984105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility trial of STRONG: A digital intervention to improve nutritional management for individuals with esophageal and gastroesophageal junction cancer","authors":"Yu Chen Lin ,&nbsp;Jose M. Pimiento ,&nbsp;Jeanine Milano ,&nbsp;Diane Riccardi ,&nbsp;Nakesha Mckinnie ,&nbsp;Emma Hume ,&nbsp;Olivia Sprow ,&nbsp;Sophia Diaz-Carraway ,&nbsp;Mara Budnetz ,&nbsp;Ryan Hagen ,&nbsp;Mohammed Al-Jumayli ,&nbsp;Allan Lima Pereira ,&nbsp;Andrew J. Sinnamon ,&nbsp;Ashwin Somasundaram ,&nbsp;Jennifer B. Permuth ,&nbsp;Amir Alishahi Tabriz ,&nbsp;Kea Turner","doi":"10.1016/j.conctc.2024.101421","DOIUrl":"10.1016/j.conctc.2024.101421","url":null,"abstract":"<div><h3>Introduction</h3><div>Individuals with esophageal and gastroesophageal junction (GEJ) cancers are at especially high risk of malnutrition. However, most patients with malnutrition do not receive adequate nutritional support. We conducted a single-arm trial to test the implementation of Support Through Remote Observation and Nutrition Guidance (STRONG), a multilevel digital intervention to improve nutritional outcomes for patients with locally advanced esophageal and gastroesophageal junction cancer.</div></div><div><h3>Methods</h3><div>Participants received five nutritional counseling sessions with a dietitian, logged daily food intake through the Fitbit app, and completed five study assessments related to patient malnutrition, nutrition-related symptoms, and quality-of-life outcomes. We assessed the feasibility, acceptability, and usability of STRONG against a priori benchmarks.</div></div><div><h3>Results</h3><div>Participants (N = 17) had a median age of 68 years, and 71 % were male. Feasibility benchmarks were met for participants completing the baseline assessment (94 %), completing four out of five assessments (82 %), and participant retention (85 %). Among participants who only received an oral diet during the study period, adherence to dietetic appointments (89 %) and food intake tracking (78 %) were high. Participant recruitment rate (47 %) was slightly below the benchmark (50 %). All participants found the intervention to be acceptable. Usability of the intervention was high, with 69 % and 92 % of participants reporting high satisfaction with tracking food intake through the Fitbit and the dietitian-led nutrition counseling sessions, respectively.</div></div><div><h3>Conclusion</h3><div>Our study demonstrated that STRONG could be implemented with high feasibility, acceptability, and usability for esophageal and GEJ cancer patients. Findings from this study can guide a future efficacy study to assess the impact of STRONG on patient outcomes.</div></div><div><h3>Clinical trial registration</h3><div>The Support Through Remote Observation and Nutrition Guidance Program for Gastroesophageal Cancer Patients (STRONG-GEC) study was registered on clinicaltrials.gov (NCT05438940) in June 2022 prior to participant enrollment.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101421"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11732474/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142985094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The hypotension prediction index in major abdominal surgery – A prospective randomised clinical trial protocol","authors":"Jakub Szrama,&nbsp;Agata Gradys,&nbsp;Zuzanna Nowak,&nbsp;Ashish Lohani,&nbsp;Krzysztof Zwoliński,&nbsp;Tomasz Bartkowiak,&nbsp;Amadeusz Woźniak,&nbsp;Tomasz Koszel,&nbsp;Krzysztof Kusza","doi":"10.1016/j.conctc.2024.101417","DOIUrl":"10.1016/j.conctc.2024.101417","url":null,"abstract":"<div><h3>Background</h3><div>Patients undergoing major abdominal surgery are at increased risk of developing perioperative hypotension, which is associated with increased mortality and morbidity. Despite using advanced technologies such as evaluating arterial pressure derived cardiac output, anaesthetic management to maintain hemodynamic stability is still reactive when the clinical decision is made after hypotension has developed. Previous perioperative goal-directed studies have not proven the benefits of this approach with high certainty. A new, approved technology called the Hypotension Prediction Index (HPI) aims to prevent hypotension occurrence by allowing the precise hemodynamic monitoring of patients under general anaesthesia, significantly reducing intraoperative hypotension events. This prospective randomised clinical trial aims to compare the rate of perioperative hypotension in patients undergoing major abdominal surgery according to their type of hemodynamic monitoring.</div></div><div><h3>Methods</h3><div><em>and Analysis</em>: Patients meeting the inclusion criteria will be randomly assigned to receive hemodynamic assessment with arterial pressure cardiac output (APCO) monitoring (group A) or hemodynamic monitoring with the HPI software (group B). The primary outcome is a time-weighted average (TWA) mean arterial pressure (MAP) of &lt;65 mmHg: TWA MAP = (depth of hypotension [in mmHg] below a MAP of 65 mmHg × time [in minutes] spent below a MAP of 65 mmHg)/total duration of the operation (in minutes). Its secondary outcomes include perioperative hemodynamic management and the rate of postoperative complications.</div></div><div><h3>Ethics and dissemination</h3><div>This trial was approved by the Ethics Committee of the Poznan University of Medical Sciences (KB–559/220; date: 01/07/2022). Its results will be submitted for publication in a peer-reviewed journal.</div></div><div><h3>Trial registration number</h3><div>NCT06247384.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101417"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784284/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}