Contemporary Clinical Trials Communications最新文献

{"title":"Aroxybutynin and atomoxetine (AD109) for the treatment of obstructive sleep apnea: Rationale, design and baseline characteristics of the phase 3 clinical trials","authors":"Luigi Taranto-Montemurro ,&nbsp;Sanjay R. Patel ,&nbsp;Patrick J. Strollo Jr. ,&nbsp;John Cronin ,&nbsp;John Yee ,&nbsp;Huy Pho ,&nbsp;Andrea Werner ,&nbsp;Ron Farkas","doi":"10.1016/j.conctc.2025.101538","DOIUrl":"10.1016/j.conctc.2025.101538","url":null,"abstract":"<div><h3>Introduction</h3><div>Two key factors leading to obstructive sleep apnea (OSA) pathogenesis include relaxation of upper airway muscles at sleep onset and their insufficient reactivation during obstructive events. Medications that address this neuromuscular dysfunction by increasing upper airway tone during sleep represent a potential strategy for mitigating OSA.</div></div><div><h3>Methods</h3><div>AD109 is an investigational, once-daily oral agent taken at bedtime that combines an antimuscarinic, aroxybutynin (2.5 mg), with a selective norepinephrine reuptake inhibitor, atomoxetine (75 mg). LunAIRo (NCT05811247) and SynAIRgy (NCT05813275) are two ongoing, placebo-controlled 51-week and 26-week phase 3 clinical trials, respectively, investigating the efficacy and safety of AD109 to treat mild to severe OSA. Participants include adults with an apnea-hypopnea index with 4% desaturation (AHI₄) &gt;5 who either refuse or fail to tolerate positive airway pressure. Participants (LunAIRo: N = 660; SynAIRgy: N = 646) were randomized 1:1 to receive AD109 or placebo. We hypothesize that AD109 will significantly reduce AHI₄ and symptomatic fatigue compared to placebo in people with OSA. The primary outcome for both trials is the change from baseline to Week 26 in AHI₄ in the AD109 arm versus placebo. Key secondary outcomes include changes from baseline in oxygen desaturation index with 3% desaturation, hypoxic burden based on 4% desaturation, Patient Reported Outcome Measurement Information System (PROMIS)-Fatigue, and proportion of participants with ≥50% reduction in AHI₄ at Week 26.</div></div><div><h3>Discussion</h3><div>LunAIRo and SynAIRgy are fully enrolled, large Phase 3 clinical trials designed to confirm and extend our understanding of the safety and efficacy of AD109, a combination oral drug targeting the underlying neuromuscular dysfunction contributing to upper airway muscle collapse during sleep in adults with OSA.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101538"},"PeriodicalIF":1.4,"publicationDate":"2025-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144895000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study design and methods for the physical activity index (PAI) feasibility pilot trial for breast and colon cancer survivors in North Carolina","authors":"Shirley M. Bluethmann ,&nbsp;Janet Tooze ,&nbsp;Joni K. Evans ,&nbsp;Jeffrey Katula ,&nbsp;Kristy Wood ,&nbsp;Lesley Hitariansingh ,&nbsp;Charlotte Crotts ,&nbsp;Heidi D. Klepin ,&nbsp;Ravi Paluri ,&nbsp;Kunal Kadakia ,&nbsp;Katherine Ansley","doi":"10.1016/j.conctc.2025.101530","DOIUrl":"10.1016/j.conctc.2025.101530","url":null,"abstract":"<div><div>The majority of the 18 million US adults with cancer history (“survivors”) do not meet recommendations for obtaining regular physical activity (PA) or limiting sedentary behavior in their daily lives. Breast cancer survivors (BCS) and colon cancer survivors (CCS) are particularly at risk of insufficient PA and excessive sedentary behavior (i.e., sitting) that may increase physical impairments, worsen cancer treatment symptoms, limit optimal cancer recovery, and limit opportunities to potentially reduce cancer risk. Research has shown that completion of clinical cancer treatment may serve as a ‘teachable moment’ for patients as they transition to recovery at home. Many of these survivors are uncertain about building a healthier lifestyle without guidance from the medical team, but few validated clinical tools exist to assess and counsel survivors on their behavioral choices relative to PA and sedentary behavior.</div><div>Based on our recent findings, a simple screener that collects measures on PA, strength training, and sedentary behavior, the Physical Activity Index (PAI), may be effective for clinical use to monitor patient behaviors and provide specific, tailored recommendations on how to achieve and maintain behavioral goals. We propose a multicomponent, two-arm pilot 1:1 randomized controlled trial with waitlist control in which we will recruit (n = 20) BCS and CCS within three years of diagnosis to leverage the ‘teachable moment’ in early recovery. The PAI intervention will include standard survivorship follow-up care plus a PA assessment using the PAI screener that is supplied to the provider plus five remote coaching consultations with a certified exercise physiologist. All participants will also receive resistance bands to keep and an activity tracker to self-monitor their behaviors at home.</div><div>We will determine feasibility by examining recruitment, retention, acceptability, and PAI intervention adherence goals. Secondarily, we will measure changes/variability in achievement of behavioral outcomes for PA and sedentary behaviors to inform future trial planning.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101530"},"PeriodicalIF":1.4,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144841366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ASSIST in Pitjantjatjara: Protocol for a randomised crossover validation study among Aboriginal and Torres Strait Islander Australians","authors":"Matthew W.R. Stevens ,&nbsp;Sue Bertossa ,&nbsp;Dominic Barry ,&nbsp;Chris Holmwood ,&nbsp;KS Kylie Lee ,&nbsp;John Marsden ,&nbsp;Matt Pedler ,&nbsp;Mark Thompson ,&nbsp;Scott Wilson ,&nbsp;Robert L. Ali","doi":"10.1016/j.conctc.2025.101532","DOIUrl":"10.1016/j.conctc.2025.101532","url":null,"abstract":"<div><h3>Background</h3><div>Substance use significantly contributes to disease burden among Australians, with harms exacerbated among Aboriginal and Torres Strait Islander peoples by colonisation-related factors like stigma and trauma. Addressing this gap requires culturally acceptable, valid and reliable screening tools, available in a familiar language to the participant, to identify and provide support for those at-risk. This protocol describes a study aimed at validating a culturally-adapted screening tool — the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) — into Pitjantjatjara, to detect risk of substance-related harm.</div></div><div><h3>Methods</h3><div>Recruitment will occur at a variety of Aboriginal health and welfare settings across remote, rural and urban South Australia. Eligible participants (aged 18–65) will be briefed and, upon consent, randomly complete the ASSIST app on an iPad and a semi-structured, yarning-style diagnostic interview (see endnote 1) with a health professional and Pitjantjatjara interpreter. The interview will assess for a range of clinically-defined substance use disorders (based on DSM-5-TR and ICD-11 criteria). All participants will be asked to complete the app a second time (between 7 and 28 days) to assess reliability, while a subset of participants at highest-risk will also undergo specialist evaluation from an independent clinician, as a second check for validity.</div></div><div><h3>Discussion</h3><div>Valid and reliable assessment tools are essential for detecting risky and harmful substance use. If valid, this app has the potential to contribute to community-led efforts to bridge the health gap by addressing modifiable health risk factors.</div></div><div><h3>Trial registration</h3><div>ANZCTR: ACTRN12625000413426. Open Science Framework pre-registration: <span><span>https://doi.org/10.17605/OSF.IO/GNZAY</span><svg><path></path></svg></span>.</div></div><div><h3>Version control number</h3><div>Protocol version 1.1, June 23, 2025.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101532"},"PeriodicalIF":1.4,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144860648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"DISYNCRO: Perceived roles of clinical study coordinators and data managers: results from a web-based survey of professionals from contract research organizations","authors":"Susanna Yedro ,&nbsp;Elena Tinari ,&nbsp;Daniele Napolitano ,&nbsp;Giulia Wlderk ,&nbsp;Eleonora Ribaudi ,&nbsp;Luciana Giannone ,&nbsp;Gianluca Ianiro ,&nbsp;Mattia Bozzetti ,&nbsp;Antonio Gasbarrini ,&nbsp;Vincenzina Mora","doi":"10.1016/j.conctc.2025.101533","DOIUrl":"10.1016/j.conctc.2025.101533","url":null,"abstract":"<div><h3>Introduction</h3><div>The evolution of clinical trials has made it essential to introduce specific roles, such as Clinical Study Coordinator (CSC) and Data Manager (DM), into the research process. Their responsibilities sometimes overlap, creating operational challenges in the workplace. This study aims to determine how personnel at Contract Research Organizations (CROs) perceive the differences between the CSC and DM roles, assess their functional overlap, and identify areas where greater role clarity and training are needed to improve operational efficiency.</div></div><div><h3>Methods</h3><div>An online survey instrument was used to gather data from CRO professionals through an internet-based questionnaire. The survey gathered sociodemographic data and included a knowledge assessment of 18 items and a 9-item role responsibilities section. Participants were stratified into three ability groups using Item Response Theory (IRT) analysis based on a Rasch model. McNemar's tests and non-parametric tests analyzed knowledge discrepancies and perceptual contradictions.</div></div><div><h3>Results</h3><div>A total of 122 participants completed the survey. Most partecipants (98.4 %) identified the CSC as the primary figure within a research center, and 77.9 % considered the CSC essential for clinical trial execution. Regarding functional overlap, 57.4 % of respondents believed that the CSC could perform the duties of a DM, whereas only 42.6 % thought the DM could assume the CSC's responsibilities. Participants with lower levels of knowledge demonstrated a higher rate of contradictory responses, indicating greater difficulty distinguishing between the two roles.</div></div><div><h3>Conclusion</h3><div>Study findings demonstrate an overwhelming preference for CSCs, who play a key versatile role in managing clinical trials. The insufficient theoretical understanding of the different duties of CSCs and DMs hampers operational efficiency. Establishing standard training programs combined with harmonization is essential to defining roles, enhancing teamwork, and providing quality clinical research practices.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101533"},"PeriodicalIF":1.4,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144810179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the impact of the ‘Blow, Breathe, Cough’ health promotion intervention in resolving otitis media with effusion in children: An adaptive randomized-controlled trial protocol","authors":"Jaimee R. Rich ,&nbsp;Michael Dymock ,&nbsp;Elke J. Seppanen ,&nbsp;Elena Montgomery ,&nbsp;Tanisha Cayley ,&nbsp;Tamara Veselinović ,&nbsp;Greta Bernabei ,&nbsp;Anri Lester ,&nbsp;Amy Hannigan ,&nbsp;Nicole Irvine ,&nbsp;Kerryn Gidgup ,&nbsp;Edna Ninyette ,&nbsp;Steph Bray ,&nbsp;Tu Trang Tran ,&nbsp;Valerie M. Swift ,&nbsp;Melinda Edmunds ,&nbsp;Natalie Strobel ,&nbsp;Daniel McAullay ,&nbsp;Julie Marsh ,&nbsp;Evelyn Tay ,&nbsp;Christopher G. Brennan-Jones","doi":"10.1016/j.conctc.2025.101531","DOIUrl":"10.1016/j.conctc.2025.101531","url":null,"abstract":"<div><h3>Introduction</h3><div>Otitis media with effusion (OME) affects hearing, speech development, and quality of life (QoL) in children. The ‘Blow, Breathe, Cough’ (BBC) intervention promotes nasal, respiratory, and middle ear clearance through nose blowing, deep breathing, coughing, and hand hygiene. It shows promise in resolving OME but lacks randomized-controlled trial (RCT) evaluation. This paper presents a RCT protocol evaluating BBC's effect on OME resolution, hearing, speech, and QoL in children aged two to seven years.</div></div><div><h3>Methods</h3><div>This parallel-group, 1:1, outcome assessor-blinded, individual adaptive RCT investigates whether completing the BBC intervention plus hand hygiene twice-daily at home increases OME resolution after 4-to-6 weeks in children with OME, compared to hand hygiene alone. Families (n = 250) perform their individually randomized program (BBC plus hand hygiene, or hand hygiene only) at home. The primary outcome is the difference in OME resolution rates between trial arms, assessed using tympanometry (type B to A or C₁ transition) and otoscopy. Secondary outcomes include natural OME resolution, discharges from tertiary care, family satisfaction, hearing thresholds, QoL, bacterial load in the nasopharynx and on hands, cost comparison within the RCT versus standard care, and adverse events. All outcomes are measured by blinded researchers. An intention-to-treat analysis will be performed on all randomized participants. Guided by an Aboriginal Community Advisory Group, the RCT ensures culturally appropriate research whilst addressing community priorities in managing childhood ear disease.</div></div><div><h3>Discussion</h3><div>If efficacious, BBC could reform OME treatment, reduce costs, and improve long-term hearing, speech, and QoL outcomes in some children. Its accessibility offers a globally scalable solution.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101531"},"PeriodicalIF":1.4,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144827306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the effect of acupuncture on weight loss in postpartum obese women: a study protocol for a randomized controlled trial","authors":"Han Zhang ,&nbsp;Xinyu Zhang ,&nbsp;Yuejiao Wang ,&nbsp;Ran Yang ,&nbsp;Yanan Zhen ,&nbsp;Yang Zhang ,&nbsp;Qi Zhao ,&nbsp;Yinping Xu ,&nbsp;Zhishun Liu ,&nbsp;Shulan Wang","doi":"10.1016/j.conctc.2025.101528","DOIUrl":"10.1016/j.conctc.2025.101528","url":null,"abstract":"<div><h3>Background</h3><div>Pregnant women gain an average weight of 16.6 ± 4.8 kg during pregnancy, with weight retention of 4 kg at 6 months, 4 kg at 12 months, and 2.9 kg at 18 months postpartum. At 3, 6, 9 and 12 months after delivery, 61.92 %, 68.73 %, 78.18 % and 84.24 % of women whose BMI returned to the normal range, respectively. Obesity has negative effects on postpartum women's physical and mental health. Prior research has suggested that acupuncture may be beneficial for weight loss. This study investigates the effectiveness of manual acupuncture (MA) for treating postpartum obesity (PO), compared to sham acupuncture (SA).</div></div><div><h3>Methods</h3><div>This is a multicenter, randomized, single-blind controlled trial. A total of 82 eligible PO participants will be randomly assigned to either MA (n = 41) or SA (n = 41) group using a 1:1 ratio. The MA group received acupuncture treatment and the control group received sham acupuncture treatment. Both groups received diet and exercise instructions and were treated for 30 min each session, three times a week, for a total of 8 weeks. The primary outcome measure was the change in body mass index (BMI) after 8 weeks of treatment, compared to baseline. Secondary outcome measures include changes in BMI from baseline to 4 weeks of treatment, changes in waist circumference, waist-to-hip ratio (WHR), blood glucose, lipid levels, thyroid function and other serological measures from baseline to 8 weeks of treatment. Secondary measures also included dietary and exercise guidance compliance scales, as well as assessments of depression and anxiety status. The safety of acupuncture was continuously evaluated throughout the study. Follow-up was performed at 14 and 20 weeks after treatment.</div></div><div><h3>Discussion</h3><div>This prospective randomized trial will help evaluate the efficacy and safety of acupuncture in treating PO. The results of this study will provide evidence of the therapeutic effectiveness of acupuncture on PO.</div></div><div><h3>Trial registration</h3><div>chictr.org.cn: ChiCTR2300067658, registered on January 17, 2023.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101528"},"PeriodicalIF":1.4,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144703293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pilot feasibility of a financial and health-related social needs navigation intervention (AYA-NAV) for adolescents and young adults with Cancer: Study protocol for a prospective, single-arm study","authors":"Rhea K. Khurana ,&nbsp;Kathryn Valera ,&nbsp;Rohit Raghunathan ,&nbsp;Kathleen D. Gallagher ,&nbsp;Rebekah SM. Angove ,&nbsp;Erin Bradshaw ,&nbsp;Janet Patton ,&nbsp;Sabrina Alvarado ,&nbsp;Stephen Crespo ,&nbsp;Kimberly Judon ,&nbsp;Katie DiCola ,&nbsp;Dara M. Steinberg ,&nbsp;Shikun Wang ,&nbsp;Dawn L. Hershman ,&nbsp;Melissa P. Beauchemin","doi":"10.1016/j.conctc.2025.101523","DOIUrl":"10.1016/j.conctc.2025.101523","url":null,"abstract":"<div><h3>Background</h3><div>Adolescent and young adult (AYA: 15–39 years) cancer survivors face high financial toxicity risk. Addressing unmet health-related social needs (HRSN: financial strain, food, housing, transportation, or utility difficulties) may reduce health and financial disparities. This pilot study examines the feasibility and preliminary impact of a needs navigation intervention (AYA-NAV) for AYAs with cancer who screen positive for financial toxicity or unmet HRSN.</div></div><div><h3>Methods</h3><div>This single-arm study involves 30 AYAs receiving cancer treatment at a large, diverse academic institution. After a baseline assessment to determine eligibility, those screening positive for financial toxicity or unmet HRSN will receive AYA-NAV, including resource provision and hybrid needs navigation via a referral to the Patient Advocate Foundation (PAF) and a digital platform, <span><span>findhelp.org</span><svg><path></path></svg></span>. Data will be collected at baseline (preintervention), monthly check-ins (months 2–5), and 6-month follow-up (postintervention) through surveys using validated scales to measure financial toxicity, HRSN, quality of life, and implementation outcomes. Feasibility will be evaluated with predetermined acceptability measures.</div></div><div><h3>Discussion</h3><div>This protocol assesses the feasibility of AYA-NAV, a hybrid needs navigation intervention for AYAs with cancer. Findings will inform future randomized studies on efficacy and impact. Additionally, this study may guide sustainable community-partnered navigation research to improve cancer care delivery and patient outcomes.</div></div><div><h3>Trial registration</h3><div>Clinicaltrials.gov registry: NCT06072833. The study was registered on October 3, 2023.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101523"},"PeriodicalIF":1.4,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144656014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient-centered medical tools for sustained motivation in cardiac rehabilitation of patients with heart failure: protocol of a multicenter randomized controlled trial (EXERCISE-HF trial)","authors":"Koki Yamaoka ,&nbsp;Yoshinori Katsumata ,&nbsp;Shun Kohsaka ,&nbsp;Yasuyuki Shiraishi ,&nbsp;Masahiro Kondo ,&nbsp;Kengo Nagashima ,&nbsp;Takeshi Onoue ,&nbsp;Masaharu Kataoka ,&nbsp;Takatomo Watanabe ,&nbsp;Daisuke Nakashima ,&nbsp;Yuki Muramoto ,&nbsp;Yasunori Sato ,&nbsp;Kazuki Sato ,&nbsp;Masaya Nakamura ,&nbsp;Masaki Ieda","doi":"10.1016/j.conctc.2025.101522","DOIUrl":"10.1016/j.conctc.2025.101522","url":null,"abstract":"<div><h3>Introduction</h3><div>Heart failure substantially affects the quality of life of patients and imposes notable social and economic burdens. Despite the beneficial effects of cardiac rehabilitation, global participation rates remain low. Recent advances in wearable biometric technologies may improve patient adherence through real-time monitoring and personalized feedback. This study aimed to develop and evaluate an exercise-support program that integrates wearable devices to enhance rehabilitation outcomes in patients with heart failure.</div></div><div><h3>Methods</h3><div>An innovative and practical cardiac rehabilitation program combined with a wearable device was developed based on patients and physicians’ feedback. A multicenter randomized controlled clinical trial was designed to evaluate the safety and effectiveness of the application in patients with heart failure in Japan from October 2022 to January 2025. Compared with traditional exercise-monitoring applications, the developed application offers an array of features that are designed to foster patient engagement and promote long-term adherence. These features include (1) individualized goal setting, (2) direct communication with healthcare providers, (3) education on heart failure through instructional videos, (4) automated motivational feedback, and (5) a curated library of research summaries on cardiac rehabilitation and self-care. Patients who meet the inclusion criteria (including those aged ≥18 years with a clinical diagnosis of heart failure) will be randomly assigned to one of two groups as follows: the integrated exercise-support app group or the standard care group, in which only a wearable device was implemented. The change in peak VO₂ at 12 weeks, adjusted for baseline and allocation factors, will be analyzed as the primary endpoint. The secondary outcomes include quality-of-life measures and re-hospitalization rates. Data analysis will follow the intention-to-treat principle, with results reported as two-tailed 95 % confidence intervals and corresponding <em>p</em>-values.</div><div>This study was approved by the relevant institutional ethics committee (approval number: DB23-001; iRCT: 2032230388). Informed consent will be obtained from all participants before study participation. The results of the study will be disseminated through peer-reviewed publications and presented at relevant scientific meetings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101522"},"PeriodicalIF":1.4,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144656015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The feasibility of the Community health worker Outreach and Navigation Network for Enhancing representation in Clinical Trials (CONNECT) model: A community-physician engagement approach for increasing representation in clinical trials","authors":"Mindy Feldman Hecht ,&nbsp;Mara Minguez ,&nbsp;Alejandra Aguirre ,&nbsp;Melissa Fajardo ,&nbsp;Olajide Williams","doi":"10.1016/j.conctc.2025.101521","DOIUrl":"10.1016/j.conctc.2025.101521","url":null,"abstract":"<div><h3>Background</h3><div>Despite efforts to increase racial and ethnic representation in clinical trials (CT), inclusion of minoritized participants remains inadequate. To address the barriers of ineffective outreach and reduced opportunities, we developed a program called <u>C</u>ommunity health worker <u>O</u>utreach and <u>N</u>avigation <u>N</u>etwork for <u>E</u>nhancing representation in <u>C</u>linical <u>T</u>rials (CONNECT). This article describes CONNECT and its feasibility of implementation over a 3-month period.</div></div><div><h3>Methods</h3><div>At the core of CONNECT is a dedicated culturally and language concordant CT-trained Community Health Worker (CHW) and local community physician. The CHW was embedded in a local community physician's practice, where they educated patients about CTs during one-on-one encounters. The CHW then followed up with patients to assist with referral to a CT that fit patients' interests. Our primary outcome was patient openness and fit for CTs as demonstrated by a CHW referral to a CT.</div></div><div><h3>Results</h3><div>The CHW met with 74 of ∼150 patients (49 %) one-on-one and referred 62 of the 74 participants (84 %) to CTs that fit their preferences.</div></div><div><h3>Conclusion</h3><div>Our study demonstrates the feasibility of the CONNECT model for increasing openness and fit to CT referrals for underrepresented populations. Strengthening relationships with community physicians serving wide-ranging patient populations and embedding a CHW in their practice to educate patients about CTs may be an important pathway for increasing openness to and support for CT participation. We found that CHWs can bridge the research trust gaps, facilitate openness to CT participation and create accessible opportunities to participate in CTs that fit participant preferences.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101521"},"PeriodicalIF":1.4,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144633391","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response variability to exercise (REVISE): Study rationale, design and methods","authors":"Robert Ross ,&nbsp;Andrew G. Day ,&nbsp;Paula J. Stotz ,&nbsp;Samantha Wade ,&nbsp;Robert Cooke ,&nbsp;Erin Miller ,&nbsp;Nick Liberatore ,&nbsp;Benoit Lamarche","doi":"10.1016/j.conctc.2025.101519","DOIUrl":"10.1016/j.conctc.2025.101519","url":null,"abstract":"<div><div>Physical inactivity and low levels of cardiorespiratory fitness (CRF, VO₂peak) are major threats to public health<strong>.</strong> In response, leading health authorities worldwide recommend that all adults accumulate 150 min/wk of moderate to-vigorous physical activity. However, we and others have demonstrated an extraordinary inter-individual variability in CRF response to standardized exercise wherein a substantial number of adults may not improve CRF beyond day-to-day variability. Whether CRF response to first line therapy is a permanent feature of the individual or can be altered by increasing exercise dose is unknown. We will perform a single-centre, two-phased, randomized controlled trial. In Phase I we will randomly assign previously inactive, adult men and women between 25 and 65 years in a 1:9 ratio to a no-exercise wait-list control, or a low amount, low intensity (∼150 min/wk) group for 16 weeks. In Phase II (16 weeks), participants randomized to exercise in phase I will be re-randomized to 1 of 3 exercise groups: 1) the same low amount, low intensity; 2) low amount, high intensity, or 3) high amount, high intensity. The primary outcome is CRF. Our primary question is, after 16 weeks of ∼150 min/wk of moderate intensity exercise, does increasing exercise intensity or exercise amount for an additional 16 weeks improve CRF differently depending on the response to exercise during the first 16 weeks? The findings will provide first evidence and immense opportunity for development of a more personalized approach to exercise that recognizes individual response variability.</div></div><div><h3>Trial registration</h3><div>clinicaltrials. gov identifier: NCT05496751.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101519"},"PeriodicalIF":1.4,"publicationDate":"2025-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144588543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}