Contemporary Clinical Trials Communications最新文献

{"title":"Novel approaches to recruiting clinical sites for embedded pragmatic clinical trials: Insights from the AIM-back trial","authors":"Tyler L. Cope ,&nbsp;Steven Z. George ,&nbsp;S. Nicole Hastings ,&nbsp;Courtni France ,&nbsp;Christa Tumminello ,&nbsp;Cynthia J. Coffman ,&nbsp;Ashley Choate ,&nbsp;Trevor A. Lentz","doi":"10.1016/j.conctc.2025.101483","DOIUrl":"10.1016/j.conctc.2025.101483","url":null,"abstract":"<div><h3>Background</h3><div>Embedded pragmatic clinical trials (ePCTs) assess interventions in real-world settings. Best practices for recruiting clinical sites for ePCTs are unknown, especially for sites that aren't known to the study team or familiar with clinical research. We describe the site recruitment process for AIM-Back, an ePCT of two nonpharmacologic pathways for low back pain within the Veterans Health Administration (VA).</div></div><div><h3>Methods</h3><div>During the planning phase of the AIM-Back trial, we aimed to recruit 18–20 sites. Eligible sites required provider capacity, administrative support, and geographic separation to avoid contamination. Our three-step approach involved: (1) lead (VA personnel) identification through existing VA contacts, data repositories of VA clinicians, and promotional outreach at events and listservs; (2) lead engagement via tailored communications emphasizing participation benefits; and (3) virtual meetings with administrators and clinicians.</div></div><div><h3>Results</h3><div>We identified 184 leads across 53 VA healthcare systems. Leads from 40 systems responded to outreach, and recruitment meetings were conducted with 23 systems involving primary care, physical therapy, research staff, and leadership. We met our recruitment goal, securing participation agreements from 19 sites, with a median timeline from outreach to participation agreement of 3.7 months. Common reasons for non-participation included infrastructure and resource constraints, resistance to new clinical programs, and competing programs.</div></div><div><h3>Conclusion</h3><div>AIM-Back's recruitment highlights ePCT site recruitment complexities for trials engaging new clinical research sites. Our innovative three-step recruitment approach provides an example for similarly designed trials. Future ePCTs should consider comprehensive recruitment strategies to ensure clinician buy-in, study feasibility, and broaden existing networks for completing ePCTs.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101483"},"PeriodicalIF":1.4,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143859283","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":"Combined chiropractic care and Tai Chi for chronic neck pain: A protocol for a pilot randomized trial","authors":"Peter M. Wayne ,&nbsp;Robert Vining ,&nbsp;Cynthia R. Long ,&nbsp;Wren M. Burton ,&nbsp;Daniel Litrownik ,&nbsp;Jacqueline Guzman ,&nbsp;Karen Kilgore ,&nbsp;Thomas J. Hagan ,&nbsp;Pamela M. Rist ,&nbsp;Matthew H. Kowalski","doi":"10.1016/j.conctc.2025.101482","DOIUrl":"10.1016/j.conctc.2025.101482","url":null,"abstract":"<div><h3>Background</h3><div>Neck pain presents a personal and socioeconomic burden globally. Despite increasing prevalence, research on chronic neck pain (CNP) is limited and management relies on generalized approaches. There is growing interest in non-pharmacological interventions, however their efficacy remains uncertain due to the multifactorial etiology of CNP. Two interventions, multimodal chiropractic care (MCC) and Tai Chi, have shown promise individually in managing CNP, and when combined may offer synergistic benefits. This pilot study aims to assess the feasibility of combining these interventions for CNP.</div><div>Methods/design: Forty-eight adults, aged 18-65y, with CNP defined as occurring ≥5 days a week for ≥3 consecutive months, severity of ≥3 on the numeric rating scale, and a score of ≥5 on the Neck Disability Index will be recruited. Participants will be randomized 1:1:1 to one of the three treatment groups (MCC plus Tai Chi and Enhanced Usual Care (EUC), MCC plus EUC, or EUC alone). The MCC was validated using a modified Delphi approach. Primary outcomes relate to feasibility (recruitment, retention, and adherence) and secondary outcomes include clinical measures of neck pain severity and disability, health-related quality-of-life, psychosocial well-being, and physical function. Outcomes will be assessed at baseline, 16-weeks (post-intervention), and 24-weeks. Qualitative interviews will be conducted.</div></div><div><h3>Discussion</h3><div>Results of this study will provide preliminary evidence regarding the feasibility and clinical evaluation of pragmatically delivered MCC, alone or in combination with Tai Chi, for individuals with CNP. These data will be used to inform the design of a fully powered, factorial trial evaluating two promising non-pharmacological therapies for CNP.</div></div><div><h3>Trial registration</h3><div>This study is registered in <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (NCT05726331).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101482"},"PeriodicalIF":1.4,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143859297","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":"Training to Move an Evidence-based Dementia Caregiver Support Program into Practice: A pragmatic, randomized, non-inferiority trial protocol","authors":"Nancy A. Hodgson ,&nbsp;Miranda V. McPhillips ,&nbsp;Karen B. Hirschman ,&nbsp;Emily Summerhayes ,&nbsp;Catherine Verrier Piersol ,&nbsp;Laura N. Gitlin","doi":"10.1016/j.conctc.2025.101478","DOIUrl":"10.1016/j.conctc.2025.101478","url":null,"abstract":"<div><h3>Background</h3><div>Despite over 200 evidence-based dementia caregiver programs, we know little about the best approaches for optimally scaling these programs in daily service contexts, nor do we fully understand the most effective approaches of ensuring successful implementation. As a result, a small fraction of the many individuals living with dementia and their caregivers within in the US have access to evidence-based programs. A leading barrier to implementation of evidence-based dementia caregiver support programs into long-term care settings is the lack of streamlined, scalable, user-friendly, and tested training modalities.</div></div><div><h3>Objective</h3><div>To describe the protocol for a study evaluating the implementation of the Care of Persons in their Environment (COPE) in Programs of All-Inclusive Care for the Elderly (PACE) setting. The COPE in PACE study aims to determine if self-paced, online training in the evidence-based dementia care program COPE is non-inferior to the traditional, in-person, instructor-led training for improving clinician knowledge and competence, patient symptoms, function, caregiver confidence and burden, and therapeutic alliance between clinicians and caregivers.</div><div>Methods/Design: Pragmatic, multisite randomized controlled non-inferiority trial is being used to assess the implementation of COPE into PACE. The study utilizes a type III hybrid effectiveness design with a primary focus on measuring implementation factors and a secondary focus on measuring COPE effectiveness through caregiver and patient outcomes and therapeutic alliance. The ‘COPE in PACE’ study is an ongoing trial being conducted in 10 PACE settings throughout the US (NCT04165213).</div></div><div><h3>Discussion</h3><div>This study design has potential to guide future translational efforts by providing program adaptation, fidelity monitoring and implementation details to enhance scalability of evidence-based programs.</div></div><div><h3>Clinical trial registration</h3><div>NCT04165213.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101478"},"PeriodicalIF":1.4,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143791769","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 mixed-methods study on the recruitment of patients from ethnic minority groups to clinical trials in a central London teaching hospital","authors":"Cecilia Vindrola-Padros ,&nbsp;Katie Gilchrist ,&nbsp;Stuart Braverman ,&nbsp;Rumana Omar ,&nbsp;Edward Merivale ,&nbsp;Ambar Hussenbux ,&nbsp;Sanjay Khanna ,&nbsp;Patience Renias-Zuva ,&nbsp;Nick McNally ,&nbsp;Rosamund Yu","doi":"10.1016/j.conctc.2025.101475","DOIUrl":"10.1016/j.conctc.2025.101475","url":null,"abstract":"<div><h3>Background/aims</h3><div>Additional research is needed to fully understand barriers in recruitment to clinical trials and how these might affect different ethnic groups. The aim of this study was to explore the factors acting as barriers and facilitators in the process of recruiting patients to clinical trials in a UK (central London) teaching hospital, with a particular focus on patients from ethnic minority groups, and on areas where action could be taken.</div></div><div><h3>Methods</h3><div>The study was designed as a mixed-methods study comprised of: 1) a quantitative workstream which explored variations in the ethnic and gender breakdown of people admitted to hospital relative to the demographic characteristics of patients enrolled into research studies at the hospital, and 2) a qualitative workstream which explored staff experiences of recruiting patients to clinical trials and patients’ experiences of being approached to take part in a clinical trial. The quantitative workstream provided the necessary context for the design of the qualitative workstream.</div></div><div><h3>Results</h3><div>We found that the chances of being involved in research at the hospital were lower in all ethnic minority groups and lower amongst female patients. Some of the factors acting as barriers in trial participation included patients’ perceptions of clinical research as a form of experimental medicine that might have high risks, the role of family members in decision-making processes, and language barriers (where patients might not be fluent in English and the study information is not communicated in other languages). Potential strategies to address underrepresentation included the development of accessible information about research and how patient data are used, development of study materials in multiple languages and use of interpreters during the recruitment process, support for staff in involving family members in decision-making and a greater ethnic diversity within study teams.</div></div><div><h3>Conclusions</h3><div>The under-representation of people from minority ethnic populations in clinical research remains a major challenge, impacting on the rigour and applicability of findings as well as implying some populations are missing out on the benefits of research. Study design needs to place greater emphasis on patient need and convenience and therefore to take greater account of the deterrent effect of financial and time burdens on trial participants. Recruiting sites and sponsors need to review the provision of interpreting and translation support for trials, including availability and cost to individual studies and staff confidence in reliability.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101475"},"PeriodicalIF":1.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143767592","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":"Addressing challenges and barriers to rural Veteran participation in clinical research within the Veterans Affairs healthcare system","authors":"Marcus R. Johnson ,&nbsp;Aliya Asghar ,&nbsp;Danielle J. Beck ,&nbsp;Tassos Kyriakides ,&nbsp;Matthew P. Vincenti ,&nbsp;Grant D. Huang","doi":"10.1016/j.conctc.2025.101466","DOIUrl":"10.1016/j.conctc.2025.101466","url":null,"abstract":"<div><div>The execution of clinical research in medical facilities that serve rural populations and/or that have lower care complexity levels has been proven to be challenging, as compared to larger healthcare institutions with higher complexity levels. Issues such as isolation, lack of organizational support and resources, difficulty with enrollment of study participants in rural settings, and challenges with identifying and retaining experienced clinical research staff serve as barriers to developing and establishing the necessary infrastructure to conduct clinical research at rural and/or smaller medical facilities. The United States (U.S.) Department of Veterans Affairs’ (VA) has the largest integrated health care system in the country and provides care to over 9 million Veterans. These considerations, combined with feedback collected from a subset of these types of (VA) Medical Centers (VAMCs) on this topic, demonstrate the need for a comprehensive enterprise-level strategy to address these challenges within the VA healthcare system. The VA Cooperative Studies Program (CSP) is a clinical research infrastructure that has vast expertise in the conduct of multi-site clinical research within the VA and is well poised to lead this effort.</div><div>This manuscript describes the CSP “Advancing Capacity for Clinical Research through Engagement with Strategic Sites (ACCESS)” initiative. It focuses specifically on the successes, challenges, and lessons learned from the CSP ACCESS Workgroup (AW) during the development and implementation of a comprehensive pilot plan for engaging rural/lower complexity VAMCs (strategic sites) to participate in CSP clinical research.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101466"},"PeriodicalIF":1.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143777437","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":"Predicting clinical trial duration via statistical and machine learning models","authors":"Joonhyuk Cho ,&nbsp;Qingyang Xu ,&nbsp;Chi Heem Wong ,&nbsp;Andrew W. Lo","doi":"10.1016/j.conctc.2025.101473","DOIUrl":"10.1016/j.conctc.2025.101473","url":null,"abstract":"<div><div>We apply survival analysis as well as machine learning models to predict the duration of clinical trials using the largest dataset so far constructed in this domain. Neural network-based DeepSurv yields the most accurate predictions and we identify key factors that are most predictive of trial duration. This methodology may help clinical researchers optimize trial designs for expedited testing, and can also reduce the financial risk of drug development, which in turn will lower the cost of funding and increase the amount of capital allocated to this sector.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101473"},"PeriodicalIF":1.4,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143791768","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":"Standardization of laparoscopic intraperitoneal onlay mesh repair for incisional hernia: Impact on clinical outcome and quality-of-life (LIPOM trial, NCT 02089958)","authors":"A. Hellinger ,&nbsp;F. Wotzlaw ,&nbsp;V. Fackeldey ,&nbsp;G. Pistorius ,&nbsp;M. Zdichavsky ,&nbsp;O. Stern ,&nbsp;R. Jünemann ,&nbsp;A. Buia ,&nbsp;LIPOM trial Study Group","doi":"10.1016/j.conctc.2025.101481","DOIUrl":"10.1016/j.conctc.2025.101481","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Purpose&lt;/h3&gt;&lt;div&gt;Current available outcome data following laparoscopic intraperitoneal onlay mesh repair (IPOM) for incisional hernia (IH) are comparable to a limited extent only because of a huge number of variability particulary in surgical technique and use of medical devices. In this prospective observational multicenter cohort study we evaluate the impact of a consensus driven standard protocol for IPOM, that is mesh fixation with absorbable tacks in double crown technique enforced by additional non-absorbable transfascial sutures at the edges of the mesh along with the use of Physiomesh™, on clinical and patient reported outcome measures.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;A total of 102 consecutive patients were screened for eligibility between September 2013 and October 2014. 85 patients (IH: EHS W1: n = 39, W2: n = 46) were included into the study. Clinical examination and PROM for pain and quality of life measure (Carolina Comfort Scale, CCS) were performed at baseline, during hospital stay and at 6 weeks, 6 months and 1 year follow-up.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The follow-up rate was 87,1 % for the primary endpoint. The Kaplan-Meier estimate for freedom-of-recurrence at 1 year was 95.9 % (95 %-CI: 87.9–98.7 %), the cumulative recurrence rate at 1 year was 4.1 % (95 %-CI: 0.9–11.7 %). There was no intraoperative complication. One seroma (type I; 1/84 (1,2 %), 95 %-CI: 0–7.1 %) was diagnosed during hospital stay. 12 seroma (n = 12/74 (16,2 %), 95 %-CI: 9.4–26.4 %; n = 10 type II and n = 2 type IV) were diagnosed during follow-up requiring surgical intervention in 1 patient (1,4 %, Clavien Dindo grade IIIb). Subcutaneous hematoma were found during follow-up in 8 patients (8/75 (10.7 %); 95 %-CI: 5.3–19.9) with need for surgical intervention in 2 patients (2,7 %, Clavien Dindo grade IIIb). There were 3 superficial surgical site infections (3/74 (4,1 %); 95 %-CI: 0.9–11.7 %, Clavien-Dindo grade I) without need for reoperation. Patient reported pain as measured by numeric rating scale at baseline was 1.36 ± 1.53 and 0.35 ± 1.04 at 1 year follow-up. CCS total scores indicated a good outcome with a decrease to 2.80 ± 6.47 (Min: 0, Q1: 0, Median: 0; Q3: 3.0; Max: 38.0) at 1 year follow-up. Subscore sensation of mesh decreased from 4.01 ± 6.76 (min: 0, Q1: 0, Median: 0; Q3: 5.0; Max: 28.0) at 6 weeks to 1.67 ± 3.99 (Min: 0, Q1: 0, Median: 0; Q3: 1.0; Max: 21.0) after 6 months and 0.90 ± 2.69 (Min: 0, Q1: 0, Median: 0; Q3: 0; Max: 14.0) after 1 year follow-up. Subscores pain and movement limitation both decreased during follow-up and were significantly reduced at 1 year compared to preoperative assessment (p &lt; 0.001).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;This study showed favourable clinical and patient reported outcomes and a low rate of recurrences at 1 year follow-up after IPOM for elective IH applying a standardized surgical technique including the use of Physiomesh™. In view of the data leading to the market with","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101481"},"PeriodicalIF":1.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143767593","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 three-arm randomized controlled trial protocol: Effects of telephone-based, layperson-delivered wisdom-enhancement narrative therapy and empathy-focused interventions on loneliness, social, and mental health in older adults","authors":"Vivien Foong Yee Tang ,&nbsp;Da Jiang ,&nbsp;Maninder Kahlon ,&nbsp;Esther Oi-wah Chow ,&nbsp;Dannii Yuen-lan Yeung ,&nbsp;Rhonda Aubrey ,&nbsp;Kee-Lee Chou","doi":"10.1016/j.conctc.2025.101479","DOIUrl":"10.1016/j.conctc.2025.101479","url":null,"abstract":"<div><h3>Background</h3><div>Loneliness is an increasingly widespread issue among older adults globally, with significant implications on physical, social, and mental health. While various interventions exist to address this challenge, their long-term effects remain unclear. Using a 3-arm randomized controlled trial, this study aims to evaluate the efficacy of a telephone-based and layperson-delivered wisdom-enhancement narrative therapy (Tele-NT) and empathy-focused program (Tele-EP) against an active control group (ACG) in reducing loneliness.</div></div><div><h3>Methods</h3><div>282 community-dwelling lonely older adults will be recruited and randomly allocated into 1 of the 3 interventions. Older adults will receive two 30-min intervention per week, over the course of 4 weeks, delivered over the phone by a layperson. Assessments will be conducted in-person at baseline (T0), 1-month (T1), 6-month (T2), and 12-month (T3) post-intervention. The primary outcome will be assessed using the Chinese validated 6-item De Jong Gierveld Loneliness Scale and the Revised UCLA Loneliness Scale. The secondary outcomes will include sleep quality, perceived social support, and depressive symptoms. Potential mediators and moderators will also be explored. The data will be analysed using linear mixed models on an intention-to-treat basis.</div></div><div><h3>Discussion</h3><div>This RCT is effective, Tele-NT and/or Tele-EP could serve as a model for broader implementation in the community, offering practical solutions to mitigate loneliness and its associated health burdens in the aging populations.</div></div><div><h3>Trial registration</h3><div>This trial is registered with the Chinese Clinical Trial Registry; ChiCTR2300070179 on April 4, 2024.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101479"},"PeriodicalIF":1.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143746322","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":"Pharmacokinetic boosting of olaparib: Study protocol of a multicentre, open-label, randomised, non-inferiority trial (PROACTIVE-B)","authors":"Joanneke K. Overbeek ,&nbsp;Niels A.D. Guchelaar ,&nbsp;Ma Ida Mohmaed Ali ,&nbsp;Muriëlle Sark ,&nbsp;Carolien Hovenier ,&nbsp;Wietske Kievit ,&nbsp;Marjolijn J.L. Ligtenberg ,&nbsp;Petronella B. Ottevanger ,&nbsp;Haiko J. Bloemendal ,&nbsp;Stijn L.W. Koolen ,&nbsp;Ron H.J. Mathijssen ,&nbsp;Ingrid A. Boere ,&nbsp;Alwin D.R. Huitema ,&nbsp;Gabe S. Sonke ,&nbsp;Frans L. Opdam ,&nbsp;Rob ter Heine ,&nbsp;Nielka P. van Erp","doi":"10.1016/j.conctc.2025.101477","DOIUrl":"10.1016/j.conctc.2025.101477","url":null,"abstract":"<div><h3>Background</h3><div>Pharmacokinetic (PK) boosting is the intentional use of a drug-drug interaction to enhance systemic drug exposure. PK boosting of the anticancer drug olaparib, a CYP3A-substrate, has the potential to reduce PK variability, side effects and financial burden associated with this drug. After establishing adequate pharmacokinetic exposure with boosting in the PROACTIVE-A study, the PROACTIVE-B study is designed to evaluate non-inferiority for both efficacy and toxicity of the boosted therapy compared to the standard monotherapy of olaparib.</div></div><div><h3>Methods</h3><div>The PROACTIVE-B study is a nationwide, multicentre, prospective, randomized, non-inferiority trial. A total of 142 patients (128 patients with BRCA+, high-grade, FIGO III/IV ovarian cancer who receive olaparib as maintenance therapy; 14 patients with other approved indications for olaparib) who start olaparib treatment in line with the drug label will be randomized between the standard monotherapy of olaparib 300 mg twice daily (BID) and the boosted therapy of olaparib 100 mg BID with cobicistat 150 mg BID. The co-primary objectives are tolerability (dose reductions due to toxicity), and efficacy (progression-free survival at 12 months) in the ovarian cancer population. Secondary objectives include health status (EQ-5D-5L), patient satisfaction (Cancer Therapy Satisfaction Questionnaire (CTSQ)), and cost effectiveness using the institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) and iMTA Medical Consumption Questionnaire (iMCQ).</div></div><div><h3>Discussion</h3><div>PK boosting of olaparib is a potentially valuable strategy to reduce the olaparib dose and the variability in olaparib exposure with fewer side effects. Moreover, the lower costs related to the boosted therapy contribute to a durable and accessible anticancer treatment for all patients.</div></div><div><h3>Trial registration</h3><div>The PROACTIVE study has been published at ClinicalTrials.gov under NCT05078671 on October 14, 2021 and at EudraCT under 2021-004032-28 on August 24, 2021.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101477"},"PeriodicalIF":1.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143791770","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":"Effectiveness of electrical stimulation with conservative treatment for lower urinary tract symptoms in Parkinson's disease: A three-armed randomized controlled trial protocol","authors":"Dorien Bennink ,&nbsp;Rob A. de Bie ,&nbsp;Henk W. Elzevier ,&nbsp;Dagmar H. Hepp ,&nbsp;Gommert A. van Koeveringe ,&nbsp;Anton A. van der Plas ,&nbsp;Hein Putter ,&nbsp;Maxime T.M. Kummeling ,&nbsp;Heidi F.A. Moossdorff-Steinhauser","doi":"10.1016/j.conctc.2025.101480","DOIUrl":"10.1016/j.conctc.2025.101480","url":null,"abstract":"<div><h3>Background</h3><div>Despite the high prevalence of lower urinary tract symptoms (LUTS) in patients with Parkinson's disease (PD)—ranging from 27 % to 85 % including symptoms such as urinary urgency,- incontinence, frequency, and nocturia—evidence-based treatment options remain limited. Conservative treatments, such as bladder training, pelvic floor muscle exercises (PFME) with biofeedback and electrical stimulation, have been shown safe and effective in the general population, with minimal side effects. However, their efficacy specifically in PD patients remains unclear. Therefore this study aims to evaluate the effect of electrical stimulation with conservative treatment for LUTS in PD patients.</div></div><div><h3>Methods and analysis</h3><div>This randomized controlled trial includes three study arms. All three groups will receive conservative treatment in combination with different electrical stimulation parameters, small- and broad pulse duration and sham electrical stimulation. In total 150 PD patients with self-reported LUTS who are able to attend a pelvic physical therapy practice independently and complete online questionnaires will be enrolled. The primary outcome is the difference in international prostate symptom score (IPSS), with a range of 0–35.</div><div>A minimal important difference of 4.2 between baseline and 12 weeks of treatment will be statistical significant (p˂0.05). Secondary outcome include questionnaires evaluating bladder dysfunction, burden, and quality of life and will be collected at baseline, 12 weeks and 24 weeks and at one year. Additionally pelvic floor muscle function will be assed at baseline and after 12 weeks.</div><div>All participants receive eight sessions along with their assigned electrical stimulation treatment and conservative treatment.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101480"},"PeriodicalIF":1.4,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143777438","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}