Contemporary Clinical Trials[JOURNAL]
Sun
200 papers
Prehabilitation in oncological patients undergoing major gastrointestinal surgery: rationale and design of the PROGRESS trial.
Oliva FM, Turi S, Veneziano M … +42 more , D'Amico F, Passuello N, Notarianni L, Fiorindi C, De Piccoli N, Ripamonti L, Fossati L, Gualtierotti M, Ghezzi M, Vecchiato M, Pontillo D, Priolo S, Marchetti C, Sandonà D, Cicero P, Nicastro V, Fumagalli A, Sarzo G, Kozhan P, Pecorelli N, Pieri M, Puccetti F, Foti S, Tettamanti A, Palumbo D, Basile G, Marmiere M, Fresilli S, Labanca R, Pruna A, Pasin L, Putzu A, Romero CS, Donadello K, Sardo S, Bove T, Nespoli L, Baldini G, Finco G, Vignali A, Beretta L, PROGRESS Study Group
Contemp Clin Trials · 2026 Mar · PMID 41621468 · Publisher ↗
BACKGROUND: Preliminary evidence suggests that multimodal prehabilitation may reduce postoperative complications in patients undergoing cancer surgery. However, its true effectiveness has yet to be fully demonstrated, an...
BACKGROUND: Preliminary evidence suggests that multimodal prehabilitation may reduce postoperative complications in patients undergoing cancer surgery. However, its true effectiveness has yet to be fully demonstrated, and there are still significant gaps in knowledge that need to be addressed. METHODS: This is a two-arm, multicenter, randomized controlled trial including 400 adult oncological patients undergoing major gastrointestinal surgery. Patients are randomized with a 1:1 allocation ratio either to receive a multimodal prehabilitation program in addition to standard care or standard care alone. The prehabilitation program consists of four weeks of intervention including exercise training, nutritional support, and psychological counseling. The standard of care is delivered in accordance with the Enhanced Recovery After Surgery (ERAS) pathways. RESULTS: The trial is ongoing and currently recruiting. The primary outcome is the rate of patients experiencing major postoperative complications within 30 days after surgery. We hypothesize that prehabilitation will reduce this rate from 40% to 25%. Secondary outcomes include the time of functional recovery, length of hospital stay, and complication severity. CONCLUSION: The PROGRESS trial will provide data to assess whether a prehabilitation program can reduce major postoperative complications and facilitate recovery in patients undergoing major oncological gastrointestinal surgery. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.gov with the trial identification NCT06404489.
A protocol for a randomized comparative effectiveness trial for treating PTSD symptoms for LGBTQIA+ people.
Price M, Sunder G, Cloitre M … +11 more , Kaysen D, Shumway M, Dilley JW, Lisha NE, Marko B, Hua W, Artime T, Hundertmark E, Huang E, Clifford A, Flentje A
Contemp Clin Trials · 2026 Mar · PMID 41620022 · Publisher ↗
BACKGROUND: LGBTQIA+ (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, and Asexual +) individuals face higher rates of posttraumatic stress disorder (PTSD) due to increased trauma exposure. Further, they may experie...
BACKGROUND: LGBTQIA+ (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, and Asexual +) individuals face higher rates of posttraumatic stress disorder (PTSD) due to increased trauma exposure. Further, they may experience factors that complicate treatment, like exposure to minority stress and increased substance use. No prior large-scale clinical trial has compared the effectiveness of PTSD treatments among LGBTQIA+ populations. STUDY OBJECTIVES: We are conducting a comparative effectiveness study that will compare two evidence-based psychotherapeutic interventions to reduce PTSD and depression symptoms and improve quality of life in LGBTQIA+ populations. Treatment dropout and satisfaction will be compared between the interventions. Minority stress and substance use will be examined as moderators for treatment effectiveness. We will also examine heterogeneity of treatment effects by gender subgroups, participant residence (urban versus suburban or rural), and race and ethnicity. METHODS: Participants will be recruited from community mental health settings, from the community, and through organizations throughout California. Eligibility will be based on PTSD symptom severity as determined by PTSD Checklist for DSM-5 (PCL-5) scores ≥33 during an initial phone screening. Each participant will be randomized to receive either Cognitive Processing Therapy (CPT) or STAIR Narrative Therapy (SNT). Study participants will complete survey assessments at baseline, 3 months, 6 months, and 12 months. DISCUSSION: This study will fill critical research gaps to inform effective PTSD treatments for LGBTQIA+ communities.
Handling missing data in longitudinal randomized clinical trials within the framework of targeted learning under MAR and MNAR.
Jin M
Contemp Clin Trials · 2026 Mar · PMID 41620021 · Publisher ↗
Missing data is a common issue in longitudinal randomized clinical trials (RCTs), where the effect of treatment is estimated by a pre-specified statistical model. The targeted learning approach, through targeted maximum...
Missing data is a common issue in longitudinal randomized clinical trials (RCTs), where the effect of treatment is estimated by a pre-specified statistical model. The targeted learning approach, through targeted maximum likelihood estimation (TMLE), has been suggested and evaluated in both clinical trials and observational studies to deal with missing data under the assumption of missing at random (MAR). In this research project, we propose methods for handling missing data in longitudinal RCTs Within the framework of targeted learning through longitudinal maximum likelihood estimation (LTMLE), with missing data mechanisms MAR and missing not at random (MNAR). The methods are applied to a real public RCT dataset.
Estimating the probability of experiencing an improvement in randomized controlled trials based on anchor-based MIC studies - An alternative to responder analyses.
Vach W, Saxer F
Contemp Clin Trials · 2026 Mar · PMID 41617012 · Publisher ↗
BACKGROUND: When using a patient reported outcome as primary endpoint in a randomized contolled trial (RCT), responder analyses are widely used to describe the relevance of an observed effect attributable to the interven...
BACKGROUND: When using a patient reported outcome as primary endpoint in a randomized contolled trial (RCT), responder analyses are widely used to describe the relevance of an observed effect attributable to the intervention of interest. The choice of thresholds in responder analyses is often based on minimal important change (MIC) values. METHODS: As an alternative to simply computing MIC values, we suggest determining a translation function allowing to translate change scores values into the probability of experiencing an improvement. The application of such a translation function to the change scores observed in an RCT allows estimating arm-specific probabilities of experiencing an improvement. These values are conceptually similar to responder frequencies. The approach is illustrated using a pair of synthetic studies, both constructed mimicking existing studies. A simulation study investigates the gain in efficiency from avoiding the dichotomization. RESULTS: The illustrative application of the methodology demonstrates that the approach is feasible and allows drawing conclusions in a similar way as in a responder analysis, but with greater precision. The simulation study confirms that this gain in efficiency holds more generally. Considering all response levels of the anchor variable may allow gaining more nuanced insights. CONCLUSIONS: Estimating the probability of experiencing an improvement provides an alternative to responder analyses. This approach makes more efficient use of information comprised in the data from anchor-based MIC studies than the translation into MIC values to inform the choice of thresholds in a responder analysis.
Design of Heart Well: A randomized pilot study of a community health worker-delivered nutrition intervention for low-income adults with hypertension.
Gu KD, Cheng J, Bejarano O … +4 more , Gelsomin E, Malone A, Faulkner KC, Thorndike AN
Contemp Clin Trials · 2026 Mar · PMID 41610938 · Publisher ↗
BACKGROUND: Suboptimal diet and food insecurity contribute to hypertension disparities experienced by individuals with low-income. Clinic-based nutrition counseling is limited by time constraints and low access to dietit...
BACKGROUND: Suboptimal diet and food insecurity contribute to hypertension disparities experienced by individuals with low-income. Clinic-based nutrition counseling is limited by time constraints and low access to dietitians. Integrating community health workers (CHWs) with basic nutrition training into care teams may be an effective strategy to promote sustainable dietary modifications. OBJECTIVE: Describe the design of Heart Well, a study to determine whether adding nutrition counseling to a primary care-based CHW hypertension program is feasible and acceptable and improves diet and blood pressure (BP). METHODS: Heart Well is a 4-month randomized controlled study of low-income adults (N = 60) who have uncontrolled hypertension and are enrolled in a CHW hypertension coaching program. The control group receives usual care in the existing hypertension program. The intervention group additionally receives nutrition counseling on label reading, healthy eating on a budget, and simplified nutrition education (e.g., traffic light categories, green = healthy). Intervention CHWs are trained by a registered dietitian, who also provides ongoing CHW support. Primary outcomes are feasibility (i.e., proportion of participants enrolled, percent completion of nutrition modules) and acceptability (i.e., participant ratings of nutrition components). Secondary outcomes are changes over 4 months in Healthy Eating Index-2020 scores (calculated from dietary recalls) and in BP. CONCLUSIONS: Heart Well tests a novel strategy integrating nutrition counseling tailored to low-income adults into an existing CHW hypertension program. Results will inform a larger trial to evaluate the intervention's impact on cardiovascular health and may have implications for CHW interventions for other diet-sensitive chronic diseases. TRIAL REGISTRATION: ClinicalTrials.govNCT06358417.
Design and implementation of data collection and linkage of electronic health records in a large UK cluster-randomised trial of asthma management (ARRISA-UK).
Ashford PA, Musgrave S, Clark AB … +8 more , Stirling S, Pond M, Price D, Appiagyei F, Payerne E, Smith JR, Noble M, Wilson AM
Contemp Clin Trials · 2026 Mar · PMID 41577125 · Publisher ↗
Electronic health record data holds great potential for conducting large, efficient randomised controlled trials. Despite progress towards greater availability of linked NHS datasets, the use of routine clinical data rem...
Electronic health record data holds great potential for conducting large, efficient randomised controlled trials. Despite progress towards greater availability of linked NHS datasets, the use of routine clinical data remains challenging for trialists. In this paper we describe the design, adaptations and implementation of methods for data collection and linkage in ARRISA-UK: a cluster-randomised controlled trial of a complex asthma management intervention involving 275 primary care practices across England, Wales and Scotland. Our methods were designed to build a dataset of linked primary care and secondary care data for approximately 10,000 'at-risk' asthma patients to measure the trial's primary outcome (asthma crisis events comprising respiratory-related hospital admissions, emergency department attendances and/or death for 'at-risk' asthma patients) and secondary clinical outcomes including the impact of the intervention on ∼180,000 asthma patients at participating practices. A high level of practice attrition (33%) was observed due to data extraction delays and technical barriers, patient identification errors, and concerns about the processing of patient identifiable data for the purpose of record linkage. We highlight the technical achievements, barriers and lessons learned from ARRISA-UK and propose recommendations to facilitate future data-enabled trials, including greater resourcing in recognition of their complex nature, improved systems of support and training in primary care, and the need to maintain and improve clinician and public trust in research data use for long term sustainability.
Assessing the cost-effectiveness of two psychoeducational interventions for people with cancer and their caregivers: An economic evaluation of the multi-country DIAdIC trial.
May P, Smith S, Jallow M … +15 more , Kalinjuna T, De Vlemnick A, Matthys O, Van Goethem V, Groenvold M, Guerin S, Turola E, Bakker E, Brazil K, Harding R, Northouse L, Hudson P, Cohen J, Normand C, DIAdIC consortium
Contemp Clin Trials · 2026 Mar · PMID 41577124 · Publisher ↗
BACKGROUND: Cancer is among the largest drivers of morbidity and mortality worldwide, causing physical, psychological and emotional strain for both patients and caregivers. AIM: We estimated the cost-effectiveness of two...
BACKGROUND: Cancer is among the largest drivers of morbidity and mortality worldwide, causing physical, psychological and emotional strain for both patients and caregivers. AIM: We estimated the cost-effectiveness of two dyadic psychoeducational interventions (FOCUS+ and iFOCUS) compared to usual care for people with advanced cancer and their primary family caregiver. METHODS: This was an economic evaluation within a clinical trial. Patient-caregiver dyads were recruited in Belgium, Denmark, Ireland, Italy, Netherlands and the UK from 2021 to 2023. We estimated costs by combining questionnaire responses with unit costs in euros (€) for 2022 and calculated outcomes as quality-adjusted life years (QALYs). Primary endpoint was 12 weeks, with secondary analysis at 24 weeks (trial exit). RESULTS: We recruited 431 dyads (140 FOCUS+, 148 iFOCUS, 143 usual care), of whom 281 (65%) participated to trial end. In primary analysis, estimated treatment effect of FOCUS+ versus usual care on total costs was +€253 (95% CI: -1440 to +3466), and estimated effect on QALYs was +0.010 (-0.02 to +0.04). For iFOCUS compared to usual care, the estimated effects were -€178 (-3047 to +2059) and - 0.001 (-0.04 to +0.04). Estimated incremental cost-effectiveness compared to usual care was highly uncertain in primary analysis, and in sensitivity analyses to timeframe and perspective. CONCLUSION: Two dyadic, psychoeducational interventions for people with advanced cancer and their caregivers were not found to have a significant effect on costs, QALYs or cost-effectiveness compared to usual care. Multiple additional lessons for future trials in serious illness have been identified. TRIAL REGISTRATION: Registration on ClinicalTrials.gov on 12/11/2020, identifier NCT04626349.
Efficacy of a transdiagnostic guided internet-delivered intervention for anxiety, depression, trauma and stress-related symptoms: A randomized controlled trial.
de la Rosa Gómez A, Valencia PD, Díaz Sosa DM … +8 more , Plata LAF, Flores RG, Torija CST, Portillo AM, Leal AM, Elvira AIF, Esquivel-Santoveña EE, Ruiz EB
Contemp Clin Trials · 2026 Mar · PMID 41571230 · Publisher ↗
OBJECTIVE: There is strong evidence that online transdiagnostic interventions are effective in treating anxiety and depression, and contribute to improving patients' quality of life. This study aimed to evaluate the effi...
OBJECTIVE: There is strong evidence that online transdiagnostic interventions are effective in treating anxiety and depression, and contribute to improving patients' quality of life. This study aimed to evaluate the efficacy and acceptability of an internet-guided transdiagnostic intervention (guided UP) versus a self-guided internet-based transdiagnostic intervention (unguided UP) for the transdiagnostic treatment of emotional disorders targeting the Mexican community. METHODS: A randomized clinical trial was conducted to compare therapist-supported online transdiagnostic treatment with an unguided version and a waiting list control group. 247 individuals aged 18 to 70 years were assessed at four time points (before and after treatment, three and six months follow- up) to identify levels of anxiety, depression, trauma and stress-related symptoms. Participants who qualified and decided to participate were randomly assigned to one of three conditions. RESULTS: Higher levels of acceptability, satisfaction, and suitability were reported for the intervention with therapeutic support compared to the UP-unguided condition. After treatment, significant mean differences were found between the waitlist group and both the UP-guided and unguided groups in anxiety, depression, trauma and stress-related symptoms, and general distress, as well as in emotional dysregulation for the guided group only, all with large effect sizes. Direct comparisons between the UP-guided and unguided groups showed significant differences favoring the UP-guided treatment at post-test for depression and emotional dysregulation. However, at the 3- and 6-month follow-ups, the UP-unguided group continued to improve, whereas the UP-guided group tended to remain stable. As a result, by the end of the follow-up period, the UP-unguided group showed significantly lower levels of anxiety, PTSD symptoms, and emotional dysregulation. CONCLUSIONS: The study supports the preliminary evidence of the clinical utility of UP online interventions in a specific sample recruited for the treatment of anxiety, depression, trauma and stress-related symptoms with the advantage of reaching a larger number of people. Even though the UP-unguided intervention showed clinical utility, the support of a therapist in an online intervention could offer an advantage that improves treatment adherence and, in particular, resulted in a greater reduction in symptoms of depression and emotional dysregulation, making it the superior option from a clinical perspective.
The impact of a potassium-enriched salt substitute on blood pressure control in patients with resistant arterial hypertension: A randomized pilot trial.
Dos Santos ECB, de Souza Lima Bitar Y, Dos Anjos JLM … +10 more , de Macedo CRB, Brito AMN, Ferreira MP, Carvalho TM, Assis GE, Pereira JPB, Ceron ABC, Rodrigues VB, Roever L, Durães AR
Contemp Clin Trials · 2026 Mar · PMID 41571229 · Publisher ↗
BACKGROUND: Dietary sodium reduction and potassium enrichment are recommended non-pharmacological strategies for blood pressure (BP) control; however, randomized evidence evaluating potassium-enriched salt substitutes sp...
BACKGROUND: Dietary sodium reduction and potassium enrichment are recommended non-pharmacological strategies for blood pressure (BP) control; however, randomized evidence evaluating potassium-enriched salt substitutes specifically in patients with resistant arterial hypertension (RAH) remains limited. METHODS: We conducted a randomized, double-blind, controlled pilot trial including adults with RAH. Participants were assigned to receive either a potassium-enriched salt substitute (approximately 50% sodium chloride and 50% potassium chloride) or regular salt for 24 weeks. The primary outcome was the between-group difference in change in 24-h systolic BP assessed by ambulatory blood pressure monitoring (ABPM). The primary analyses used an available-case approach (completers) to prioritize analytical rigor, with intention-to-treat and sensitivity analyses assessing robustness. Between-group comparisons were utilized to control for regression to the mean and white-coat variability. RESULTS: Among 60 randomized participants, 49 completed valid baseline and follow-up ABPM assessments (23 intervention, 26 control). At 24 weeks, patients assigned to potassium-enriched salt exhibited a directionally greater reduction in 24-h systolic blood pressure compared with the control group, resulting in a between-group difference of -2.47 mmHg (95% CI -4.93 to 0.00; P = 0.05). A similar directional pattern was observed for diastolic blood pressure. Office blood pressure measurements showed greater variability and less consistent between-group differences over time. Urinary potassium excretion increased in the intervention group, whereas changes in urinary sodium excretion were modest. No cases of clinically relevant hyperkalemia or serious adverse events were observed. CONCLUSIONS: In this randomized pilot trial, the use of a potassium-enriched salt substitute was safe and associated with modest, directionally greater reductions in ambulatory BP compared with regular salt in patients with RAH. These findings support the feasibility and safety of potassium-enriched salt substitution as a pragmatic adjunctive strategy for blood pressure management in patients with resistant hypertension.
Study protocol for a patient-centered hybrid type 1 effectiveness-implementation randomized controlled trial evaluating caregiver involvement in primary care-based brief interventions for adolescents with mild alcohol use disorder.
Adams ZW, Marriott BR, Burns A … +5 more , Agley J, Wu W, Aalsma MC, Hulvershorn LA, Zapolski TC
Contemp Clin Trials · 2026 Mar · PMID 41571228 · Publisher ↗
INTRODUCTION: Primary care is a useful setting for identifying and delivering brief interventions to adolescents with mild alcohol use disorders (AUD). High-quality evidence suggests brief interventions that incorporate...
INTRODUCTION: Primary care is a useful setting for identifying and delivering brief interventions to adolescents with mild alcohol use disorders (AUD). High-quality evidence suggests brief interventions that incorporate motivational interviewing (MI) and basic cognitive behavioral therapy (CBT) skills help adolescents reduce substance use. Caregiver involvement in interventions for mild AUD may improve outcomes. However, when and how to involve caregivers in primary care-based interventions for adolescents with mild AUD remains unclear. METHODS: In this patient-centered hybrid type 1 effectiveness-implementation randomized controlled trial, adolescents with mild AUD receiving an individual skill-building intervention (Teen Intervene, TI) in primary care will be randomized to one of three conditions: 1) no caregiver involvement; 2) a single, live caregiver session; and 3) an online, self-paced caregiver program. The primary aim is to compare the effectiveness of TI conditions (i.e., no caregiver involvement vs. caregiver session vs. online caregiver component) in reducing alcohol use in adolescents. The second study aim is to identify youth and family factors associated with intervention response vs. non-response in each treatment condition, such as baseline substance use intensity, youth and caregiver perceptions of alcohol/substance use risk, youth personality factors, and caregiving practices. CONCLUSION: Findings from this study will help support decisions and eventual cost-benefit analyses about which programs to offer to different patients. When interventions are matched appropriately to patient needs at scale, possible long-term benefits include improved outcomes among the approximately 750,000 U.S. adolescents with mild AUD.
A multilevel clinic- and community-based intervention to increase COVID-19 vaccination among Latinos in San Diego County: Protocol description of the vaccine promotion program.
Crespo NC, Elder J, Oren E … +9 more , Arredondo E, Lin CJ, Godino J, Madanat H, Cervantes G, Patron A, Fraga K, Vargas-Tequida B, Ramers CB
Contemp Clin Trials · 2026 Mar · PMID 41565103 · Publisher ↗
BACKGROUND: COVID-19 has disproportionately affected minority groups, including Latinos. Since the development of COVID-19 vaccines, effective implementation faced challenges due to multiple factors, necessitating multi-...
BACKGROUND: COVID-19 has disproportionately affected minority groups, including Latinos. Since the development of COVID-19 vaccines, effective implementation faced challenges due to multiple factors, necessitating multi-level and multi-sector approaches. This study describes the Vaccine Promotion Program (VPP), a multi-level intervention to increase COVID-19 vaccine uptake among Latinos in clinical and community settings. METHODS: VPP is a double-blind, pragmatic, 12-month cluster-randomized trial in collaboration with a large Federally Qualified Health Center (FQHC) in San Diego, CA. Ten clinics will be randomized to a Multilevel Intervention involving activities at the interpersonal, clinic, and community levels (VPP) or Standard Clinical Practice (SCP) (n = 5 clinics, respectively). Patients in VPP clinics will receive tailored clinic-originated messages about COVID-19 vaccination and motivational interviews (MI) (15-30-min telephone/telehealth encounters) from Health Educators (HE) to encourage COVID-19 vaccination. HEs will send emails and/or text message-based information to encourage vaccination. The community-level intervention involves targeted and tailored activities to promote COVID-19 vaccine uptake in neighborhoods surrounding the five VPP clinics. A cohort of 200 patients will be enrolled to participate in comprehensive surveys and follow-up for 24 months to assess longer-term outcomes. The primary outcome (COVID-19 aggregated vaccination rates) will be compared at baseline, 6, and 12 months between VPP and SCP clinics and neighborhoods, respectively. DISCUSSION: VPP directly addresses the most prominent COVID-19 vaccination barriers, including health literacy, community trust, and vaccine access, through a multi-level approach in collaboration with an FQHC. This approach has the potential to be an effective and scalable public health approach to vaccination among underserved communities.
A reservation-based clinical trial on inflammatory biomarkers in American Indian/Alaska Native cancer patients: Rationale and design of the Adaptive Prehab Approaches in Cancer Healing and Education (APACHE) Program.
Erdrich J, Carton MM, Hernandez A … +8 more , Nosie-Romo D, Huber A, Chapman T, Sanchez C, Montfort WR, Bea JW, Yung A, Thomson CA
Contemp Clin Trials · 2026 Mar · PMID 41558611 · Full text
Prehabilitation (prehab) utilizes preoperative strategies in nutrition, exercise, substance cessation, and stress reduction to optimize patients' health before surgery. Some oncology prehab studies have demonstrated an a...
Prehabilitation (prehab) utilizes preoperative strategies in nutrition, exercise, substance cessation, and stress reduction to optimize patients' health before surgery. Some oncology prehab studies have demonstrated an anti-inflammatory effect on the tumor microenvironment, and thereby raised the possibility of altering carcinogenesis. By increasing physical activity, prehab may be a relevant intervention for addressing obesity-related inflammation and its link to cancer. American Indian/Alaska Native populations have longstanding inequities in obesity, cancer mortality, and clinical research participation. In response, the Adaptive Prehab Approaches in Cancer Healing and Education (A.P.A.C.H.E.) Program developed collaboratively between the San Carlos Apache Healthcare Corporation and the University of Arizona. The A.P.A.C.H.E. Program is a multimodal, window of opportunity, anti-inflammatory prehab clinical trial piloted for 30 patients. The intervention entails daily walking, consumption of walnuts, supervised fitness sessions, and supportive services for 3 weeks before oncologic surgery. Feasibility is the primary outcome assessed by patient acceptability and measures of functional capacity, lifestyle behaviors, and qualitative indices. Inflammatory biomarkers from blood and tumor biospecimens are measured pre and post intervention as secondary outcomes to test responsiveness to the program. This trial has foundational components that keep it rooted in the broader field of prehab, which allows comparisons to other programs and contributes to this area of science, while being adapted to the San Carlos Apache community to improve uptake and adherence. The A.P.A.C.H.E. Program is the first prehab for American Indian/Alaska Native surgical patients and one of the earliest registered clinical trials conducted on a reservation.
The impact of prescribed versus achieved resistance training intensity on strength, body composition, and psychological health in women survivors of breast cancer: Protocol for the EFICAN 2.0 randomized trial.
Esteban-Simón A, Díez-Fernández DM, Baena-Raya A … +6 more , Pérez-Castilla A, Rodriguez-Solana A, Ramos-Teodoro M, Pérez-Romero A, Rodríguez-Pérez MA, Soriano-Maldonado A
Contemp Clin Trials · 2026 Mar · PMID 41554334 · Publisher ↗
BACKGROUND: Strength training (ST) is recommended for survivors of breast cancer due to its health-related benefits. However, the optimal method for prescribing ST intensity in this population remains unexplored. OBJECTI...
BACKGROUND: Strength training (ST) is recommended for survivors of breast cancer due to its health-related benefits. However, the optimal method for prescribing ST intensity in this population remains unexplored. OBJECTIVE: To compare the effects of three intensity prescription methods on muscular strength, body composition, physical function and psychological health in survivors of breast cancer; and to examine how the training intensity progresses over time according to each method. METHODS: A three-arm randomized trial will be conducted with 60 women survivors of breast cancer randomly allocated to: (1) daily estimated one-repetition maximum (1RM) using individual load-velocity relationship; (2) initial 1RM estimation via load-velocity relationship, without daily updates; or (3) initial 1RM estimation via a 10RM test, without daily updates. The intervention includes a 2-week familiarization phase and an 8-week intervention phase. Training intensity will be prescribed between 60 and 75% 1RM, following the American College of Sports Medicine guidelines. Primary outcomes include muscle strength, physical function, cardiorespiratory fitness, fatigue, pain, quality of life, anxiety, and depressive symptoms. The secondary outcome is the difference between prescribed and achieved training intensity, which will be continuously monitored in all groups using a linear velocity transducer, and analyzed over time. Adherence, adverse events, and deviations from the protocol will be recorded. CONCLUSION: This trial will provide novel insights into the effects of different ST intensity prescription methods on physical and psychological outcomes in survivors of breast cancer. It will also determine whether traditional approaches achieve intended training intensities, thereby advancing knowledge on exercise prescription in oncology.
Expanding access to cancer genetic care for cancer survivors: Rationale and design for a randomized controlled trial of a chatbot-based genetic education and testing.
An J, Huq M, Speiser E … +17 more , Grumet S, Peshkin BN, Heidt E, Adams-Campbell L, Grisham C, Tundealao S, Yesha R, Toppmeyer D, Isaacs C, Sorgen L, Tan N, Hooda-Nehra A, Nix MA, Reed DJ, Staton J, Schwartz MD, Kinney AY
Contemp Clin Trials · 2026 Mar · PMID 41554333 · Full text
BACKGROUND: Despite national guidelines recommending germline genetic testing (GT) for cancer survivors at high risk for hereditary cancers, GT remains underutilized, particularly among underserved populations who experi...
BACKGROUND: Despite national guidelines recommending germline genetic testing (GT) for cancer survivors at high risk for hereditary cancers, GT remains underutilized, particularly among underserved populations who experience significant population health differences and higher cancer mortality. Barriers at the individual, interpersonal, and system levels contribute to this underutilization. Proactive clinical outreach and technology-based tools such as chatbots may help address these barriers and streamline cancer genetic service delivery, but culturally tailored chatbot interventions have rarely been tested for efficacy in Black cancer survivors. This paper describes the formative research and protocol for a multisite, randomized controlled trial testing a streamlined care delivery model addressing multilevel barriers to GT uptake. METHODS: Using electronic health records from two health systems, we will proactively identify and enroll 428 Black patients who have a prior diagnosis of breast, ovarian, uterine, colorectal, prostate, or pancreatic cancer and meet national guideline criteria for genetic testing. Participants are randomized to either the Genetic Education Decision Assistant (GEDA), a chatbot-based intervention, or Enhanced Usual Care (EUC, a clinical letter recommending genetic counseling and testing). The primary outcome is genetic testing completion. Secondary outcomes include genetic counseling uptake, knowledge, psychological distress, and decision regret, satisfaction, and conflict. DISCUSSION: This ongoing trial addresses an important translational gap by developing and implementing an alternative care delivery model that includes a chatbot to provide streamlined cancer genetic services. If effective, this intervention has the potential to reduce population differences in cancer genetics care and guide cancer risk reduction, surveillance, and cascade testing. TRIAL REGISTRATION NUMBER: The trial is registered on clinicaltrials.gov (NCT06073626).
Increasing COVID-19 vaccine uptake through motivational interviewing-informed tailored digital intervention: Study protocol.
Ku CP, Christian A, Delacroix E … +6 more , Trzeciak K, Resnicow K, Bailey S, Israel B, Valbuena F, Williamson S
Contemp Clin Trials · 2026 Mar · PMID 41554332 · Publisher ↗
BACKGROUND: Marginalized communities have been disproportionately impacted by COVID-19. In Michigan as of 2024, while 59% of Hispanic people, 46% of African American people, and 56% of White people received at least one...
BACKGROUND: Marginalized communities have been disproportionately impacted by COVID-19. In Michigan as of 2024, while 59% of Hispanic people, 46% of African American people, and 56% of White people received at least one dose of vaccine, only 8% of African American and 8% of Hispanic residents report being up-to-date, per CDC definition, compared to 13% of White residents. The goals of the project were to increase vaccine uptake through the implementation and evaluation of a tailored behavioral intervention. METHODS: This group-tailored digital intervention investigates the effect of an SMS-based health education program on vaccine intent in African American and Latino/Hispanic individuals. Recruited in-person and digitally throughout Michigan, 1327 participants were randomized into two arms, and then stratified into four audience segment groups based on vaccine readiness. The primary aim of the study is to increase uptake of the COVID-19 vaccine following receipt of the tailored text messages. Participants were evaluated pre- and post-intervention for intent to vaccinate, perceptions of barriers to vaccination, attitudes towards the vaccine, and knowledge of common vaccine misinformation. DISCUSSION: This study will inform future literature in addressing vaccine hesitancy for racial and ethnic populations, the use of motivational interviewing-based interventions, and digital health interventions in general.
Rationale and design of a three-arm randomized clinical trial to improve drug use and retention in care of people with opioid use disorder on buprenorphine: OVERCOME II study.
Pericot-Valverde I, Heo M, Byrne KA … +8 more , Karasz A, Perez A, Lopes S, Groome M, Voss S, King A, Barnick K, Litwin AH
Contemp Clin Trials · 2026 Mar · PMID 41554331 · Publisher ↗
Medications for opioid use disorder (MOUD) are effective in reducing opioid use, but retention to buprenorphine remains suboptimal among OUD patients. Integration of computer-based cognitive behavioral therapy (CBT4CBT)...
Medications for opioid use disorder (MOUD) are effective in reducing opioid use, but retention to buprenorphine remains suboptimal among OUD patients. Integration of computer-based cognitive behavioral therapy (CBT4CBT) and utilization of recovery coaches (RCs), called RC + CBT4CBT-Buprenorphine, into OUD care could improve drug use and retention in care among patients taking buprenorphine. The OVERCOME II (OUD Intervention Recovery Coach CBT and OUD Medications II) study is a three-arm 1:1:1 randomized clinical trial designed to test the remotely delivered RC + CBT4CBT-Buprenorphineintervention as an adjunct to buprenorphine treatment for patients with OUD, and to compare it with both CBT4CBT-Buprenorphine alone and the treatment as usual (TAU). Patients (n = 90) who have newly initiated buprenorphine in the past 90 days are planned to be recruited. Comprehensive measures on demographics, various conditions/constructs, and outcomes will be collected from medical charts and survey instruments. Additionally, neurophysiological outcomes and neurocognitive inhibitory controls will be measured using the NEXUS-10-MKII physiological system with BioTrace+ software and computerized Drug Go/NoGo Task, respectively. Qualitative analysis of interviews with N = 2 RCs and N = 15 participants will also be conducted. The study will be the first to examine the effectiveness of the remotely delivered RC + CBT4CBT-Buprenorphine intervention on drug use (during the first 8 weeks and follow-up) and retention in care, as well as on various neurophysiological and cognitive performances in comparison to CBT4CBT-Buprenorphine alone and TAU. Clinical Trial Registration: This study was registered at ClinicalTrials.gov (NCT06102200, www.clinicaltrials.gov/) on August 31, 2023, with a title, An Integrated Intervention Involving Recovery Coaching and Cognitive Behavioral Therapy for Opioid Use Disorder (OVERCOME 2).
Time-restricted eating in patients with metabolic syndrome: A protocol paper for a feasibility clinical trial.
Piñeiro B, Kue J, Costa J … +6 more , Santiago A, Msaddi J, Nuss K, Yadav H, Szalacha L, Menon U
Contemp Clin Trials · 2026 Mar · PMID 41554330 · Publisher ↗
Recent studies have evaluated Time-Restricted Eating (TRE) as a promising dietary behavioral intervention for weight loss and cardiometabolic risk factor improvement. Yet the results are mixed. We describe a TRE protocol...
Recent studies have evaluated Time-Restricted Eating (TRE) as a promising dietary behavioral intervention for weight loss and cardiometabolic risk factor improvement. Yet the results are mixed. We describe a TRE protocol, a behavioral dietary intervention where all calorie intake is limited to 10-h eating window followed by a 14-h fasting period, without altering diet quality and quantity. This study aims to determine the feasibility and acceptability of a 12-week TRE intervention among patients with metabolic syndrome. Dietary lifestyle changes can decrease risk in metabolic syndrome, but such changes are difficult to implement and sustain. This is a pilot feasibility study with a single-arm group. A total of 40 adult patients with metabolic syndrome are being enrolled. Participants document their daily eating patterns through MyCap app. The primary outcome is to assess the feasibility and acceptability of the intervention, including recruitment, program delivery, adherence and patient satisfaction. Secondary outcome measures include changes in weight, blood pressure, sleep, quality of life, and biological measures including gut microbiome, HbA1c, lipids, and thyroid function. Findings of this pilot study will provide novel insights into improving information health markers in individuals with metabolic syndrome, as well as inform the feasibility and sustainability of this dietary intervention.
A multimodal lifestyle intervention program targeting the muscle and gut to improve metabolic health among Indian adults with (pre)diabetes: Design of the GUT-DM randomized trial.
Bhattacharya S, van Helvoort A, Schols AMWJ … +1 more , Sambashivaiah S
Contemp Clin Trials · 2026 Mar · PMID 41554329 · Publisher ↗
INTRODUCTION: Type 2 diabetes (T2D) is one of the most common non-communicable diseases worldwide. Current guidelines for prediabetes or T2D ((pre)diabetes) management include lifestyle modifications with or without medi...
INTRODUCTION: Type 2 diabetes (T2D) is one of the most common non-communicable diseases worldwide. Current guidelines for prediabetes or T2D ((pre)diabetes) management include lifestyle modifications with or without medication. Recent evidence has indicated improvement in glycemia with gut-centric interventions (probiotics, prebiotics, or synbiotics) among (pre)diabetic patients. This study aims to explore the effect of a lifestyle intervention (exercise and dietary modification) with/without synbiotics on metabolic, physical, mental and gut health of (pre)diabetic Indian adults compared to standard of care (SOC). METHODS AND ANALYSIS: The calculated sample-size is 108 participants (including 25% dropouts), both sexes, 25-75 years of age, body mass index (BMI)18.5-34.9 kg/m with either fasting, postprandial glucose or HbA1c above normal as per the American Diabetes Association (ADA, 2024). Participants will be randomized into one of 3 groups: SOC, lifestyle modification with synbiotics (LS + SYN), or lifestyle modification with placebo (LS + PLA). SOC group will follow routine practice, LS + SYN group will receive multimodal lifestyle-intervention (exercise, dietary modifications including a nutritional supplement) with synbiotic supplementation, while LS + PLA group will be enrolled for the same intervention with placebo supplementation for 12 weeks. Changes in metabolic, physical, mental and gut health will be compared between the 3 groups. DISCUSSION: This exploratory randomized trial will assess the effectiveness of a multimodal lifestyle intervention with a gut centric approach in the management of different domains of health among (pre)diabetic adults. Since both lifestyle and gut-centric interventions individually have provided promising results, it is important to understand their combined effect to optimize management of this disease. TRIAL REGISTRY: Clinical trials registry-India (CTRI), registration number: CTRI/2022/08/045096.
Increasing HPV vaccine promotion by dental providers: A clinical trial protocol.
Rindal DB, Asche S, Kharbanda E … +8 more , Michalowicz B, Worley D, Jaka M, Kromrey K, Fletcher L, Gillesby A, Basile S, Mabry PL
Contemp Clin Trials · 2026 Mar · PMID 41539537 · Full text
BACKGROUND: Human papillomavirus is a prevalent DNA virus and the leading cause of both oropharyngeal and cervical cancer. Despite the availability of an effective vaccine (HPV-V), uptake is below national targets. A beh...
BACKGROUND: Human papillomavirus is a prevalent DNA virus and the leading cause of both oropharyngeal and cervical cancer. Despite the availability of an effective vaccine (HPV-V), uptake is below national targets. A behavioral intervention, Increasing HPV Vaccine Uptake - Delivered in Dental Settings (HPV-V Uptake-DDS), was developed to support dental providers in promoting HPV-V to their patients to help close this gap. OBJECTIVES: This protocol for an efficacy trial of HPV-V Uptake-DDS is designed to increase HPV-V promotion by dental practitioners, and subsequent vaccine uptake among adolescent and young adult patients. METHODS: The trial will be conducted in dental clinics in a single midwestern health system utilizing a prospective, two-arm, parallel, cluster-randomized controlled design. Eighteen clinics will be randomly assigned to either the intervention or usual care. The intervention includes didactic training, clinical decision support tool embedded in the electronic dental record, tip sheet, patient education handout, and practitioner performance reports. The primary outcome is change in HPV-V promotion by practitioners. Secondary outcomes include change in HPV-V uptake by patients and changes in three behavioral mechanisms: practitioner knowledge, self-efficacy, and fear of negative consequences related to HPV-V promotion. Outcomes will be captured from the electronic health record, practitioner surveys, patient or guardian surveys, and state vaccination registries. CONCLUSIONS: The protocol for a clinical trial will test the efficacy of the intervention and the measurement of behavioral mechanisms of action will inform which components of the intervention of needed to address barriers in different practice settings.
Remote delivery of a mindfulness-based intervention for adults with tics: Protocol of a randomized controlled trial.
Reese HE, Brown WA, Wallenberger YH … +8 more , Ramsey KA, Browning LE, Rooks J, Gould NF, Leoutsakos JM, Mendelson T, Chang AH, McGuire JF
Contemp Clin Trials · 2026 Mar · PMID 41539536 · Full text
Tourette Syndrome and persistent tic disorders (collectively, TS) are characterized by involuntary motor and/or vocal tics that onset in childhood. Existing evidence-based treatments-including behavior therapy and pharma...
Tourette Syndrome and persistent tic disorders (collectively, TS) are characterized by involuntary motor and/or vocal tics that onset in childhood. Existing evidence-based treatments-including behavior therapy and pharmacotherapy-are often only partially effective, associated with burdensome side effects, and/or inaccessible. The current paper describes a randomized controlled trial designed to compare a novel, remotely delivered mindfulness-based group intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) in 150 adults with TS. All interventions and assessments will be delivered remotely using secure telehealth platforms and online electronic data capture systems. An independent evaluator masked to treatment condition will administer all tic assessments. The primary aims of the study are to: 1) examine the efficacy of MBIT relative to PRST for tic severity and 2) investigate the mechanism by which MBIT reduces tic severity. Additional aims include: 1) examination of secondary outcomes (e.g., comorbid conditions, quality of life), and 2) exploration of the durability of any observed improvements over a 6-month follow-up. Findings have the potential to meaningfully expand the range of evidence-based treatment options available to adults with TS.
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