Contemporary Clinical Trials Communications最新文献

{"title":"C.E.R.E.B.R.O.: A home-based physical activity study for older Latino adults","authors":"David X. Marquez ,&nbsp;Mariana Tellez ,&nbsp;Jocelyn Ocampo-Mota ,&nbsp;Michelle A. Jaldin ,&nbsp;Susan Hughes ,&nbsp;Olusola Ajilore ,&nbsp;Jinsong Chen ,&nbsp;Surrey Walton ,&nbsp;Naoko Muramatsu","doi":"10.1016/j.conctc.2025.101436","DOIUrl":"10.1016/j.conctc.2025.101436","url":null,"abstract":"<div><h3>Background</h3><div>The growing Latino population is 1.5 times more likely to develop Alzheimer's Disease (AD) and Related Dementias (ADRD) than non-Latino Whites. Interventions that can reduce the risk of ADRD are needed. Older Latinos face many barriers to the incorporation of physical activity (PA) into their daily lives given a lack social support, caregiving responsibilities, and lacking resources to maintain PA. Walking and dancing are the two most frequently reported forms of PA among older Latinos, and indoor PA programs conducted in a community location or at home can overcome barriers to participation.</div></div><div><h3>Methods</h3><div>C.E.R.E.B.R.O. (Cognitive Enhancement and Risk-reduction through Exercise for Brain-Related Outcomes; meaning “brain” in English) is testing two remote intervention programs, the BAILAMOS™ dance program and ¡En Forma y Fuerte! (Fit &amp; Strong!), a PA/behavior change program. Participants are randomly assigned to either study condition. The BAILAMOS™ dance program is a 6-month long dance program, in which participants learn different Latin dances including Merengue, Cha Cha Cha, Bachata, Salsa, Cumbia, and Kizomba. Trained CEREBRO staff also lead monthly discussions. Persons randomized to the 3-month long ¡En Forma y Fuerte! program participate in flexibility and aerobic exercise, strength training, and health education. All classes are held live via Zoom. Trained study staff assist participants with technology-related issues. Data are collected through remote testing at baseline, 12 weeks, and 24 weeks after the start of the interventions. Outcomes include PA, cognition, quality of life, social connectedness, and cost-effectiveness.</div></div><div><h3>Conclusion</h3><div>CEREBRO has the potential to provide evidence regarding the advantages of providing remote intervention programs to reduce PA barriers in the older Latino community.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101436"},"PeriodicalIF":1.4,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143101125","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":"Anti-viral action against type 1 diabetes autoimmunity: The GPPAD-AVAnT1A study protocol","authors":"Sandra Hummel ,&nbsp;Alexandra Käßl ,&nbsp;Stefanie Arnolds ,&nbsp;Peter Achenbach ,&nbsp;Reinhard Berner ,&nbsp;Kristina Casteels ,&nbsp;Heikki Hyöty ,&nbsp;Olga Kordonouri ,&nbsp;Helena Elding Larsson ,&nbsp;Markus Lundgren ,&nbsp;M. Loredana Marcovecchio ,&nbsp;Catherine Owen ,&nbsp;Markus Pfirrmann ,&nbsp;Steve Robson ,&nbsp;Agnieszka Szadkowska ,&nbsp;Agnieszka Szypowska ,&nbsp;Timothy Tree ,&nbsp;Andreas Weiss ,&nbsp;Anette-Gabriele Ziegler ,&nbsp;Ezio Bonifacio","doi":"10.1016/j.conctc.2025.101434","DOIUrl":"10.1016/j.conctc.2025.101434","url":null,"abstract":"<div><div>Viral infections in the first year of life are associated with islet autoimmunity and type 1 diabetes risk. The Anti-Viral Action against Type 1 Diabetes Autoimmunity (AVAnT1A)- study is a clinical phase IV investigator initiated, randomised, controlled, multicentre, primary prevention trial conducted to determine whether vaccination against COVID-19 from 6 months of age reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in children with elevated genetic risk. Additionally, it investigates the role of viral infections in the etiology of islet autoimmunity by intense surveillance within the first two years of life. Infants aged 3.00–4.00 months from Germany, Belgium, UK and Sweden are eligible if they have a &gt;10 % expected risk to develop islet autoantibodies by age 6 years as determined by HLA DR/DQ genotype, polygenic risk score and family history of type 1 diabetes. A total of 2252 eligible children are randomized 1:1 to COVID-19 vaccine (Comirnaty® 3 μg Omicron XBB.1.5 or future new variants) or placebo (0.9 % Sodium Chloride) administered three times. Children are followed until the minimum age of 2.5 years and maximum age of 6 years. The intervention is accompanied by analyses of immune and metabolic parameters to determine changes induced by viral infections and to investigate mechanisms by which viral infection may lead to islet autoimmunity. The Sponsor is the Klinikum rechts der Isar, Technical University Munich. The study was approved by Clinical Trials Information System (CTIS, EU Trial number: 2023-507348-35-00) and by Integrated Research Application System (IRAS, IRAS-ID: 1009668).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101434"},"PeriodicalIF":1.4,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143101126","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 and rationale for a global novel non-invasive screening observational study using genetics and non-invasive methodologies to identify at-risk MASLD participants: The ALIGN study","authors":"Samuel J. Daniels ,&nbsp;Karin Nelander ,&nbsp;John Eriksson ,&nbsp;Lutz Jermutus ,&nbsp;Jelena Saillard ,&nbsp;Stephanie Oyesola ,&nbsp;Federica Tavaglione ,&nbsp;Marco Arrese ,&nbsp;Alma Laura Ladrón de Guevara ,&nbsp;Umberto Vespasiani-Gentilucci ,&nbsp;Naim Alkhouri ,&nbsp;Jenny E. Blau","doi":"10.1016/j.conctc.2025.101437","DOIUrl":"10.1016/j.conctc.2025.101437","url":null,"abstract":"<div><div>Metabolic dysfunction-associated steatotic liver disease (MASLD) is a common chronic liver disease that is heterogenous in nature with various drivers and modifiers such as metabolic dysfunction and genetic factors. MASLD and the progressive subtype, metabolic dysfunction-associated steatohepatitis (MASH) represent the most rapidly increasing cause of liver-related mortality. There are limited treatment options for patients living with MASLD and MASH, various treatments with an array of different targets are under investigation and one therapeutic has been approved since the initiation of this study. Clinical trials investigating treatments for MASLD and MASH are associated with a high screen failure rate, driven largely by the regulatory required histological inclusion criteria for clinical trial eligibility. Other available clinically utilized biomarkers, typically referred to as non-invasive tests (NITs), can assess both the presence of steatosis and the severity of liver fibrosis in patients with MASLD and MASH in the clinic but are not yet approved over histological changes as endpoints for pivotal trials. However, the use of NITs have been demonstrated to increase the likelihood of meeting clinical trial entry criteria. All-Liver Interventional Global Network (ALIGN) is the first described multi-centre global observational screening study aimed at identifying individuals with a high likelihood of MASLD/MASH interested in participating in therapeutic clinical trials using non-invasive methodologies and genetic testing. This study represents a valuable prototype for industry and academic groups looking to evaluate large populations for MASH eligibility and interest in clinical trial participation.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101437"},"PeriodicalIF":1.4,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143101124","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":"Evaluation of the efficacy of Capacitive Resistive Monopolar Radiofrequency at 448 kHz in the physiotherapeutic treatment of female dyspareunia","authors":"Anna Abelló Pla ,&nbsp;Anna Andreu-Povar ,&nbsp;Laura Fabbi ,&nbsp;Jordi Esquirol-Caussa ,&nbsp;Judith Lleberia-Juanós ,&nbsp;Antonio Gil-Moreno ,&nbsp;Mireia Coll Omaña","doi":"10.1016/j.conctc.2025.101433","DOIUrl":"10.1016/j.conctc.2025.101433","url":null,"abstract":"<div><h3>Background and purpose</h3><div>Dyspareunia is genital pain associated with sexual activity that affects the quality of life of many women. Physiotherapy is a promising, albeit sometimes uncomfortable, option. This study aims to integrate capacitive resistive monopolar radiofrequency (CRMRF) as a complementary therapy. This study aims to evaluate the benefits of combining CRMRF with vaginal manual physiotherapy in young women with dyspareunia.</div></div><div><h3>Method</h3><div>ology: A randomized, prospective, single-blind clinical trial was conducted. Women aged 18 to 30 with superficial dyspareunia were divided into two groups: an intervention group (GI) receiving CRMRF and manual therapy, and a control group (GC) receiving only manual therapy. Four sessions were conducted, assessing sexual function using the Female Sexual Function Index (FSFI) and the Female Sexual Function Questionnaire (FSM). Data were collected before and after treatment, with a follow-up at three months.</div></div><div><h3>Results</h3><div>Both groups showed significant improvements in sexual function at the end of treatment. In the GI, improvements were observed in desire, arousal, lubrication, satisfaction, and pain reduction. The GC also showed improvements in these domains. No significant improvements were observed in either group at three months, suggesting that treatment benefits were maintained without additional long-term improvements.</div></div><div><h3>Conclusion</h3><div>Manual therapy alone and in combination with CRMRF improved sexual function immediately after treatment. No additional improvements were observed at three months, indicating the sustained benefits and emphasizing the need to evaluate maintenance strategies and consider psychological factors.</div></div><div><h3>Clinical trials registration</h3><div>#NCT5844189.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101433"},"PeriodicalIF":1.4,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11780710/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068429","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":"Demographic clinical trial diversity assessment methods: Use of real-world data","authors":"Hua Chen ,&nbsp;Nnadozie Emechebe ,&nbsp;Sudeep Karve ,&nbsp;Leon Raskin ,&nbsp;Jailene Leal ,&nbsp;Ning Cheng ,&nbsp;Wendy Sebby ,&nbsp;Kim Ribeiro ,&nbsp;Samuel Crawford","doi":"10.1016/j.conctc.2025.101432","DOIUrl":"10.1016/j.conctc.2025.101432","url":null,"abstract":"<div><div>Diversity in clinical trials is defined by the inclusion of clinical trial participants from various demographic groups that are representative of the broader population impacted by a disease state. Diversity in clinical trials is critical in identifying potential differences in safety and efficacy of treatments across races, ethnicities, ages, sexes, or other variables. In the United States, clinical trial diversity is often benchmarked against US Census data, which may limit the representativeness of patient demographics in clinical trials. Disease-specific, demographic estimates from real-world data (RWD) can facilitate benchmarking of clinical trials, support trial enrollment and the development of trial diversity plans. Notably, development and dissemination of these estimates from RWD can be challenging without a standardized process. To address this issue, we developed a new evaluation framework to assess patient demographics and characteristics within specific disease populations using RWD and disease population estimates.</div><div>Suitable databases were identified using predefined criteria such as accessibility to patient-level data, availability of all demographic variables of interest, sufficient sample size of the disease population, and availability of population weights to enhance generalizability. Concurrent data were gathered via targeted literature reviews for each disease condition. Together, this data was used to create disease-specific, demographic estimate profiles to inform diverse enrollment goals for prospective clinical trials. We present two examples of application of this framework to illustrate the results in the case of two disease states, rheumatoid arthritis and stroke.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101432"},"PeriodicalIF":1.4,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143100582","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":"Transmural collaborative care model for cardiovascular risk management and medication review in patients using antipsychotics in primary care (TACTIC): A study protocol of an incomplete stepped wedge cluster randomized trial","authors":"Kirsti M. Jakobs ,&nbsp;Karlijn J. van den Brule-Barnhoorn ,&nbsp;Jan van Lieshout ,&nbsp;Joost G.E. Janzing ,&nbsp;Wiepke Cahn ,&nbsp;Wietske Kievit ,&nbsp;Steven Teerenstra ,&nbsp;Maria van den Muijsenbergh ,&nbsp;Marion C.J. Biermans ,&nbsp;Erik W.M.A. Bischoff","doi":"10.1016/j.conctc.2024.101418","DOIUrl":"10.1016/j.conctc.2024.101418","url":null,"abstract":"<div><h3>Background</h3><div>It is well established that patients with severe mental illness and those treated with atypical antipsychotics (AAPs) are at an increased risk of cardiovascular disease. However, primary care currently lacks adequate monitoring of AAP usage, its effects, and the associated cardiovascular risk. We have developed TACTIC, a transmural collaborative care model for patients using AAPs prescribed by the general practitioner (GP) to address the issues of potential overtreatment with AAPs and undertreatment for cardiovascular risk. TACTIC comprises three steps: an informative video for patients, a multidisciplinary meeting, and a shared decision-making consultation with the GP.</div></div><div><h3>Objectives</h3><div>To evaluate TACTIC's effectiveness on cardiovascular risk and mental health and its cost-effectiveness.</div></div><div><h3>Methods</h3><div>We will conduct an incomplete stepped wedge cluster randomized trial in the Netherlands.</div><div>40 GP-nurse clusters are randomized into four waves. Each cluster recruits adult patients (25–85 years), without prior diagnoses of dementia, delirium, or cardiovascular disease, for whom the GP prescribes AAPs. Every five months, a new wave starts with TACTIC. Measurements are taken before the intervention starts and every 5 months until the study concludes. Primary outcomes are cardiovascular risk and mental health as measured with the QRISK3 score and MHI5, respectively. The economic evaluation consists of two cost-utility analyses, one on the data collected alongside the trial and one based on a model extrapolating the trial data to a 10-year horizon. We will also evaluate the process of delivering TACTIC.</div></div><div><h3>Conclusion</h3><div>This study will assess TACTIC's (cost)effectiveness and provide insights for successful delivery in general practice.</div></div><div><h3>Clinical trials registration</h3><div>clinicaltrials.gov NCT05647980.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101418"},"PeriodicalIF":1.4,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11787019/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080768","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":"Strategies for recruitment and retention of diverse and underserved cancer survivor and caregiver dyads in clinical trials","authors":"Mary Hadeed ,&nbsp;Terry A. Badger ,&nbsp;Chris Segrin ,&nbsp;Rogelio Robles-Morales ,&nbsp;Samantha J. Werts-Pelter","doi":"10.1016/j.conctc.2024.101425","DOIUrl":"10.1016/j.conctc.2024.101425","url":null,"abstract":"<div><h3>Background</h3><div>Cancer survivor-caregiver dyads from underrepresented racial and ethnic groups and those with lower socioeconomic status are less likely to participate in clinical research. Sociocultural and socioeconomic barriers perpetuate health inequity and increase disparities in cancer care.</div></div><div><h3>Purpose</h3><div>We describe our systematic approach to recruiting and retaining diverse survivor-caregiver dyads in supportive cancer care studies.</div></div><div><h3>Methods</h3><div>Matsuda's research recruitment guidelines of evaluate, engage, reflect, and carefully match (“EERC”) were adapted and applied through a framework of six guiding principles.</div></div><div><h3>Results</h3><div>A systematic approach to recruitment of underrepresented dyads in cancer support research includes 1) Developing a bilingual, bicultural study team with shared language and culture of the study population, 2) Ensuring team members share a passion for cancer health equity and are trained with a community-centric approach, 3) Designing accessible interventions, study materials, and shared data collection tools across similar studies with community and stakeholder input, 4) Engaging local and regional stakeholders with expertise of health disparities among the catchment area, 5) Partnering with Community Health Workers (CHWs) and gatekeepers to enhance community presence, and 6) Ensuring careful application of matching study team members and participants beyond race and ethnicity to prioritize the cultural values and social factors that impact cancer survivors and caregivers.</div></div><div><h3>Conclusion</h3><div>Applying a systematic approach to recruiting and retaining underrepresented dyads in cancer research can potentially reduce sociocultural and socioeconomic barriers to cancer health equity.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101425"},"PeriodicalIF":1.4,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773091/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068433","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":"Comparative main effects, mediators, and moderators of cognitive behavioral therapy, acceptance and commitment therapy, and emotional awareness and expression therapy for chronic spinal pain: Randomized controlled trial rationale and protocol","authors":"John W. Burns ,&nbsp;Mark A. Lumley ,&nbsp;Kevin E. Vowles ,&nbsp;Mark P. Jensen ,&nbsp;Melissa A. Day ,&nbsp;Howard Schubiner ,&nbsp;Emma Jaszczak ,&nbsp;Britney Abro ,&nbsp;Sarah H. Addicks ,&nbsp;Michael J. Bordieri ,&nbsp;Michael M. Dow ,&nbsp;Shoshana Krohner ,&nbsp;Zyanya Mendoza ,&nbsp;Eric C. Meyer ,&nbsp;Danielle Z. Miro ,&nbsp;Hallie Tankha ,&nbsp;David S. Tubman ,&nbsp;Jolin B. Yamin ,&nbsp;Dokyoung S. You","doi":"10.1016/j.conctc.2025.101428","DOIUrl":"10.1016/j.conctc.2025.101428","url":null,"abstract":"<div><h3>Background</h3><div>Chronic spinal (back/neck) pain is common and costly. Psychosocial treatments are available but have modest effects. Knowledge of treatment mechanisms (mediators and moderators) can be used to enhance efficacy. Trials that directly compare different treatments are needed to determine which mechanisms are treatment-specific, which are shared across treatments, and which contribute the most to outcomes.</div></div><div><h3>Methods</h3><div>We will conduct a 4-arm randomized, controlled clinical trial to compare the main effects, mediators, and moderators of three pain therapies: Cognitive-Behavioral Therapy, Acceptance and Commitment Therapy, and Emotional Awareness and Expression Therapy in adults with chronic spinal pain. Following baseline assessment of outcomes variables (two primary outcomes: pain intensity and pain interference) and potential mediators and moderators, we will randomize participants (up to 460) to one of the treatments or usual care control. Treatments will be conducted individually each week for 8 weeks via telehealth. We will conduct weekly assessments of both potential mediators and outcomes, as well as post-treatment and 6-month follow-up assessments. We will test whether any of the therapies is superior to the others (Aim 1); identify mediators that are specific to treatments and those that are shared across treatments (Aim 2); and identify baseline moderators that are specific to treatments or shared across treatments, and moderated mediators of treatments (Aim 3).</div></div><div><h3>Discussion</h3><div>The findings from this project can be used to improve the effects of psychosocial chronic pain treatments by identifying the most powerful specific and shared mechanisms and revealing for whom the mediator-outcome pathways are strongest.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101428"},"PeriodicalIF":1.4,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773268/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068272","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":"Effect of foot reflexology on pain, anxiety, and physiological indices in leukemia patients undergoing bone marrow aspiration: A randomized clinical trial study","authors":"Marjan Mehri ,&nbsp;Mohamad Golitaleb ,&nbsp;Ali Safdari ,&nbsp;Sabah Madadi ,&nbsp;Fatemeh Rafiei ,&nbsp;Hossein Shahbazi ,&nbsp;Razieh Mokhtari ,&nbsp;Nazi Nejat","doi":"10.1016/j.conctc.2025.101427","DOIUrl":"10.1016/j.conctc.2025.101427","url":null,"abstract":"<div><h3>Introduction</h3><div>Patients with leukemia undergoing bone marrow aspiration (BMA) frequently experience considerable pain and anxiety, which may negatively impact physiological outcomes. Reflexology, a complementary therapeutic approach, has demonstrated effectiveness in reducing pain and anxiety across various medical procedures. This randomized clinical trial aimed to evaluate the impact of foot reflexology on pain, anxiety, and physiological indices in leukemia patients undergoing BMA.</div></div><div><h3>Methods</h3><div>This randomized clinical trial was conducted at Ayatollah Khansari Hospital in Arak between August 2021 and January 2023. Patients were randomly assigned to either a reflexology intervention group or a control group receiving routine care. The intervention group underwent a 30-min foot reflexology session. Pain was assessed using the Numeric Rating Scale (NRS), and anxiety levels were measured via the Spielberger State-Trait Anxiety Inventory (STAI). Physiological indices, including systolic and diastolic blood pressure, heart rate, and arterial oxygen saturation, were measured before and after the intervention.</div></div><div><h3>Results</h3><div>Of the 72 patients, 68 completed the study (intervention: n = 35, control: n = 33). Post-intervention, the intervention group showed a significant reduction in systolic (p = 0.017) and diastolic blood pressure (p = 0.028), while the control group experienced no significant changes. Heart rate significantly increased in the control group (p = 0.030), but no significant change was observed in the intervention group (p = 0.977). Anxiety levels significantly decreased in the intervention group (p &lt; 0.001), with a notable between-group difference (p = 0.006). Pain intensity was also significantly lower in the intervention group compared to the control group (p = 0.034).</div></div><div><h3>Conclusion</h3><div>Foot reflexology is an effective intervention for reducing pain and anxiety in leukemia patients undergoing BMA. Reflexology may be considered a valuable, non-invasive supportive therapy for managing procedural pain and anxiety in oncology settings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101427"},"PeriodicalIF":1.4,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773030/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068412","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 a structured research site mentorship model to facilitate site performance in a clinical research network","authors":"Marcus R. Johnson ,&nbsp;Danielle Beck ,&nbsp;Melyssa Sueiro ,&nbsp;Makaila Decker ,&nbsp;Jeff Newcomb ,&nbsp;Margaret Tiktin ,&nbsp;Amelia Kiliveros ,&nbsp;Aliya Asghar","doi":"10.1016/j.conctc.2024.101423","DOIUrl":"10.1016/j.conctc.2024.101423","url":null,"abstract":"<div><h3>Background</h3><div>Research site mentorship has a positive impact on study enrollment. The VA Cooperative Studies Program's (CSP) Network of Dedicated Enrollment Sites (NODES) utilized an existing site mentorship model to onboard 13 new expansion sites. We describe the successes, challenges, and lessons learned during the development and implementation of this model in this paper.</div></div><div><h3>Methods</h3><div>NODES established a “Site Mentorship/Expansion Workgroup (SWG)” in October 2020 to plan and guide the consortium on providing mentorship and services to other clinical research networks, non-Node CSP study sites, and NODES expansion sites. In 2021, the SWG developed a 12-month implementation plan to onboard 13 new sites by pairing original Node (mentor) sites with expansion Node (mentee) sites. Mentors offered prompt guidance and solutions to mentees on site-level challenges by working with them closely. Implementation of the plan occurred from February 2022 through September 2023.</div></div><div><h3>Results</h3><div>Data from the implementation of this mentorship plan demonstrated a 32.7 % increase (from 54.8 % in 2022 to 87.5 % in 2023) in the expansion sites’ achievement of their Objectives &amp; Key Results (OKRs). From October 2020–September 2021, prior to mentorship assignments, the original sites (mentors) achieved an average of 88 % of their OKRs and attained an average of 86.7 % and 80.9 % of those OKRs in October–September of 2022 and 2023 respectively during the mentorship implementation phase.</div></div><div><h3>Conclusions</h3><div>The results demonstrate that developing and implementing a research site mentorship model to facilitate onboarding and performance of research sites into an established network was feasible and contributed to the success of those sites.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101423"},"PeriodicalIF":1.4,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11782873/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080805","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}