Pub Date : 2026-02-01DOI: 10.1016/j.conctc.2026.101607
Janvi D. Nanavati , Daniel Mendoza Martinez , Grace W. Ryan , Melissa Goulding , Sonia Radu , Michelle Spano , Ted Kremer , Kali Pereira , John Almeida , Christine Frisard , Sybil Crawford , Milagros C. Rosal , Nancy Byatt , Stephenie C. Lemon , Lori Pbert , Michelle Trivedi
Introduction
Children and families from historically marginalized ethnic/racial backgrounds have low participation in clinical trials and pediatric practice staff perspectives on this topic are underexplored.
Methods
We conducted interviews (n = 20) with pediatric practice staff and used rapid template analysis to identify themes and sub-themes.
Results
We identified several primary themes related to strategies that both research staff and pediatric practice staff can use in order to support the recruitment of historically marginalized populations into research. For example, researchers can facilitate running reports within practices to identify potential trial participants with limited access to care and pediatric providers can offer research opportunities at well visits noting potential benefits of research and directly discuss mistrust in research.
Discussion
While the dynamics involved in the recruitment of historically marginalized children and families into trials are inherently complex, we identified several concrete strategies to support this work and increase diversity in pediatric clinical trials.
{"title":"Promoting the recruitment of historically underrepresented children and families in clinical trials: Perspectives of pediatric clinic staff","authors":"Janvi D. Nanavati , Daniel Mendoza Martinez , Grace W. Ryan , Melissa Goulding , Sonia Radu , Michelle Spano , Ted Kremer , Kali Pereira , John Almeida , Christine Frisard , Sybil Crawford , Milagros C. Rosal , Nancy Byatt , Stephenie C. Lemon , Lori Pbert , Michelle Trivedi","doi":"10.1016/j.conctc.2026.101607","DOIUrl":"10.1016/j.conctc.2026.101607","url":null,"abstract":"<div><h3>Introduction</h3><div>Children and families from historically marginalized ethnic/racial backgrounds have low participation in clinical trials and pediatric practice staff perspectives on this topic are underexplored.</div></div><div><h3>Methods</h3><div>We conducted interviews (n = 20) with pediatric practice staff and used rapid template analysis to identify themes and sub-themes.</div></div><div><h3>Results</h3><div>We identified several primary themes related to strategies that both research staff and pediatric practice staff can use in order to support the recruitment of historically marginalized populations into research. For example, researchers can facilitate running reports within practices to identify potential trial participants with limited access to care and pediatric providers can offer research opportunities at well visits noting potential benefits of research and directly discuss mistrust in research.</div></div><div><h3>Discussion</h3><div>While the dynamics involved in the recruitment of historically marginalized children and families into trials are inherently complex, we identified several concrete strategies to support this work and increase diversity in pediatric clinical trials.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101607"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146077864","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}
The approval of new disease-modifying treatments, diagnostic tools, and expansion of the drug pipeline has evolved the clinical trial landscape for spinal muscular atrophy (SMA) – a rare neuromuscular disease. Nonetheless, significant unmet needs for the SMA population remain and require continued evolution of the SMA clinical trial landscape. In 2023, Cure SMA developed a series of activities to assess the current SMA clinical trial landscape including the Cure SMA Capacity and Recruitment Survey. The purpose of the survey was to understand site capacity for SMA clinical trials in the US, identify factors that may limit site trial capacity and/or readiness, and identify opportunities to increase site capacity. Twenty-four (24) sites across the US with experience in conducting SMA clinical trials are represented in the results. Although existing clinical trial sites may have the capacity to take on additional SMA trials, many factors are inhibiting efficient trial management and study start-up. As recruitment needs for SMA clinical trials continue to evolve, action is needed to address the site needs – such as increased clinical staff support and bandwidth, streamlining training, and adequate funding to conduct trials – to further optimize trial site readiness and capacity. SMA clinical trial sites, sponsors, and contract research organizations will need to work together to optimize trial site readiness address challenges to capacity.
{"title":"An updated review of the SMA clinical trial landscape in the United States: Findings from analysis of recruitment targets on ClinicalTrials.gov and a survey of SMA clinical trial sites on factors affecting site capacity and readiness","authors":"Fatou Sarr , Ilse Peterson , Jacqueline Glascock , Mary Curry","doi":"10.1016/j.conctc.2026.101601","DOIUrl":"10.1016/j.conctc.2026.101601","url":null,"abstract":"<div><div>The approval of new disease-modifying treatments, diagnostic tools, and expansion of the drug pipeline has evolved the clinical trial landscape for spinal muscular atrophy (SMA) – a rare neuromuscular disease. Nonetheless, significant unmet needs for the SMA population remain and require continued evolution of the SMA clinical trial landscape. In 2023, Cure SMA developed a series of activities to assess the current SMA clinical trial landscape including the Cure SMA Capacity and Recruitment Survey. The purpose of the survey was to understand site capacity for SMA clinical trials in the US, identify factors that may limit site trial capacity and/or readiness, and identify opportunities to increase site capacity. Twenty-four (24) sites across the US with experience in conducting SMA clinical trials are represented in the results. Although existing clinical trial sites may have the capacity to take on additional SMA trials, many factors are inhibiting efficient trial management and study start-up. As recruitment needs for SMA clinical trials continue to evolve, action is needed to address the site needs – such as increased clinical staff support and bandwidth, streamlining training, and adequate funding to conduct trials – to further optimize trial site readiness and capacity. SMA clinical trial sites, sponsors, and contract research organizations will need to work together to optimize trial site readiness address challenges to capacity.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101601"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146077868","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}
Pub Date : 2026-02-01DOI: 10.1016/j.conctc.2026.101606
Thomas Gärtner , Fabian Stolp , Bert Arnrich , Stefan Konigorski
Background:
Focus and concentration are influenced by various environmental factors, such as listening to music. Recent research highlights the individualized nature of music’s effects on concentration, as responses vary significantly between individuals based on music genres and personal preference. Traditional population-based studies often obscure these between-person differences, while N-of-1 trials, which are individual crossover trials, can provide a personalized approach by allowing each participant to serve as their own control. This study design is particularly suited for examining how self-selected music genres might enhance or alter concentration in each individual. By leveraging an N-of-1 trial design, this study aims to contribute to the growing body of research investigating personalized cognitive interventions, providing insights into individual effects and variations in response to music.
Methods:
The study will include approximately 23 participants, who will be allocated to a block-randomized sequence with two cycles, each consisting of 3-min periods of listening to music (intervention, A) and 3 min of no music (control, B) in random order. Study participants will select one of fourteen predefined music genres, with or without lyrics, as their intervention. A playlist with preselected songs from this genre will be played and compared to not listening to music. To minimize the effects of carryover and concentration loss during the study, a 1-min break is planned between each period, resulting in a total duration of around 15 min. Concentration will be assessed by the number of correct classifications of a digital version of the Stroop test within each period. After each period, a short questionnaire will be administered to collect self-assessed concentration and stress scores. Additionally, physiological biomarkers will be assessed using wearables such as Electroencephalography, Heart Rate Variability, Electrodermal Activity, and eye- and pupil-movement data. In the statistical analysis, Bayesian generalized linear mixed models will be used to estimate the intervention effects of music on correct answers of the Stroop task on the individual level and population level.
Discussion:
This study will provide insights into the personalized effects of music on concentration, providing a blueprint for individuals on how they may test and improve their concentration.
{"title":"Study protocol for PIANo-1: Personalized Investigation of music’s effect on Attention in a series of N-of-1 trials","authors":"Thomas Gärtner , Fabian Stolp , Bert Arnrich , Stefan Konigorski","doi":"10.1016/j.conctc.2026.101606","DOIUrl":"10.1016/j.conctc.2026.101606","url":null,"abstract":"<div><h3>Background:</h3><div>Focus and concentration are influenced by various environmental factors, such as listening to music. Recent research highlights the individualized nature of music’s effects on concentration, as responses vary significantly between individuals based on music genres and personal preference. Traditional population-based studies often obscure these between-person differences, while N-of-1 trials, which are individual crossover trials, can provide a personalized approach by allowing each participant to serve as their own control. This study design is particularly suited for examining how self-selected music genres might enhance or alter concentration in each individual. By leveraging an N-of-1 trial design, this study aims to contribute to the growing body of research investigating personalized cognitive interventions, providing insights into individual effects and variations in response to music.</div></div><div><h3>Methods:</h3><div>The study will include approximately 23 participants, who will be allocated to a block-randomized sequence with two cycles, each consisting of 3-min periods of listening to music (intervention, A) and 3 min of no music (control, B) in random order. Study participants will select one of fourteen predefined music genres, with or without lyrics, as their intervention. A playlist with preselected songs from this genre will be played and compared to not listening to music. To minimize the effects of carryover and concentration loss during the study, a 1-min break is planned between each period, resulting in a total duration of around 15 min. Concentration will be assessed by the number of correct classifications of a digital version of the Stroop test within each period. After each period, a short questionnaire will be administered to collect self-assessed concentration and stress scores. Additionally, physiological biomarkers will be assessed using wearables such as Electroencephalography, Heart Rate Variability, Electrodermal Activity, and eye- and pupil-movement data. In the statistical analysis, Bayesian generalized linear mixed models will be used to estimate the intervention effects of music on correct answers of the Stroop task on the individual level and population level.</div></div><div><h3>Discussion:</h3><div>This study will provide insights into the personalized effects of music on concentration, providing a blueprint for individuals on how they may test and improve their concentration.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101606"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146077867","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}
Pub Date : 2026-01-21DOI: 10.1016/j.conctc.2026.101605
Angela B. Combs , Janelle L. Wagner , Heather Huszti , Shari L. Wade , Matthew Schmidt , Stacy Buschhaus , Jake Scherra , Sara E. Wetter-Wren , David Ogundairo , Christopher Coffey , Dixie Ecklund , Emine Bayman , Sonal Bhatia , Tracy Glauser , Kristina K. Hardy , Avani C. Modi
Epilepsy is a common neurological condition that presents unique challenges for adolescents. Executive functioning (EF) deficits contribute to suboptimal academic, social, and quality of life outcomes, yet interventions addressing EF in pediatric epilepsy are lacking. One promising intervention is Epilepsy Journey (EJ), a comprehensive e-health, multi-component problem-solving intervention that incorporates self-guided learning modules and telehealth sessions facilitated by a therapist. This paper describes the methodology, advisory board feedback, changes to the original protocol/intervention, and current progress of a multi-site Phase 3 randomized control trial (RCT; EJ 2.0) to improve EF behaviors. Prior to the RCT, an advisory board comprised of six adolescents, two caregivers, two teachers, and two healthcare providers offered feedback on recruitment/retention, measurement selection, and intervention components. For the RCT, adolescents (age 13–17 years) who meet eligibility criteria for EJ 2.0 are randomized into four groups: EJ modules only, EJ telehealth only, EJ modules with telehealth, or a usual epilepsy care group. Participants in each of the three treatment arms learn about and problem-solve aims related to positive thinking, problem-solving, working memory, organization, inhibition, initiation, task/self-monitoring, emotion regulation, and sleep/stress. The goal is to randomize 232 participants across three sites. The EJ 2.0 study has been strengthened through advisory board feedback, and subsequent protocol changes were critical in the successful launch and execution of the trial to-date. Despite a brief funding gap, the study team has made significant progress in early recruitment.
{"title":"Epilepsy journey 2.0 study design and methods: A randomized trial of an executive functioning intervention for adolescents with epilepsy","authors":"Angela B. Combs , Janelle L. Wagner , Heather Huszti , Shari L. Wade , Matthew Schmidt , Stacy Buschhaus , Jake Scherra , Sara E. Wetter-Wren , David Ogundairo , Christopher Coffey , Dixie Ecklund , Emine Bayman , Sonal Bhatia , Tracy Glauser , Kristina K. Hardy , Avani C. Modi","doi":"10.1016/j.conctc.2026.101605","DOIUrl":"10.1016/j.conctc.2026.101605","url":null,"abstract":"<div><div>Epilepsy is a common neurological condition that presents unique challenges for adolescents. Executive functioning (EF) deficits contribute to suboptimal academic, social, and quality of life outcomes, yet interventions addressing EF in pediatric epilepsy are lacking. One promising intervention is Epilepsy Journey (EJ), a comprehensive e-health, multi-component problem-solving intervention that incorporates self-guided learning modules and telehealth sessions facilitated by a therapist. This paper describes the methodology, advisory board feedback, changes to the original protocol/intervention, and current progress of a multi-site Phase 3 randomized control trial (RCT; EJ 2.0) to improve EF behaviors. Prior to the RCT, an advisory board comprised of six adolescents, two caregivers, two teachers, and two healthcare providers offered feedback on recruitment/retention, measurement selection, and intervention components. For the RCT, adolescents (age 13–17 years) who meet eligibility criteria for EJ 2.0 are randomized into four groups: EJ modules only, EJ telehealth only, EJ modules with telehealth, or a usual epilepsy care group. Participants in each of the three treatment arms learn about and problem-solve aims related to positive thinking, problem-solving, working memory, organization, inhibition, initiation, task/self-monitoring, emotion regulation, and sleep/stress. The goal is to randomize 232 participants across three sites. The EJ 2.0 study has been strengthened through advisory board feedback, and subsequent protocol changes were critical in the successful launch and execution of the trial to-date. Despite a brief funding gap, the study team has made significant progress in early recruitment.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101605"},"PeriodicalIF":1.4,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146022842","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}
Pub Date : 2026-01-20DOI: 10.1016/j.conctc.2026.101604
Dawon Baik , Heather Coats , Blaine Reeder , Larry A. Allen , Catherine Jankowski
Background
Older adult family caregivers of persons with heart failure experience substantial burden due to the complex care needs of their care recipients. Targeted interventions for this population remain limited. To address this gap, we developed a digital health physical activity coaching intervention specifically designed for older family caregivers of persons with heart failure. In this paper, we describe the protocol for a pilot randomized controlled trial evaluating the preliminary feasibility and effects of the intervention in improving physical and mental health as well as caregiving self-efficacy and quality of life.
Methods
The study aims to test a 12-week, two-arm pilot randomized controlled trial of older caregivers of persons with heart failure. Study enrollment began in June 2024. Participants are enrolled from inpatient units and outpatient clinics at a large medical center in the U.S. and randomized to the intervention or control arm. Participants in the intervention arm receive 24 exercise coaching sessions and motivational text messages over 12 weeks. Both groups are provided with Fitbit devices to monitor physical activity. Data are collected at baseline, during the intervention (1 and 2 months), on exit, and post-intervention (1 and 3 months following completion). Participants in the control arm receive a 1-page handout with general information on caregiver self-care. The primary outcome is daily step counts as measured by the Fitbit device.
Conclusion
Findings from this pilot trial will inform a subsequent efficacy study of the digital health physical activity coaching intervention in a larger, more diverse population of older family caregivers of adults with heart failure.
{"title":"Digital health physical activity coaching for older family caregivers of persons with heart failure – TPA4You: Protocol for a pilot randomized controlled trial","authors":"Dawon Baik , Heather Coats , Blaine Reeder , Larry A. Allen , Catherine Jankowski","doi":"10.1016/j.conctc.2026.101604","DOIUrl":"10.1016/j.conctc.2026.101604","url":null,"abstract":"<div><h3>Background</h3><div>Older adult family caregivers of persons with heart failure experience substantial burden due to the complex care needs of their care recipients. Targeted interventions for this population remain limited. To address this gap, we developed a digital health physical activity coaching intervention specifically designed for older family caregivers of persons with heart failure. In this paper, we describe the protocol for a pilot randomized controlled trial evaluating the preliminary feasibility and effects of the intervention in improving physical and mental health as well as caregiving self-efficacy and quality of life.</div></div><div><h3>Methods</h3><div>The study aims to test a 12-week, two-arm pilot randomized controlled trial of older caregivers of persons with heart failure. Study enrollment began in June 2024. Participants are enrolled from inpatient units and outpatient clinics at a large medical center in the U.S. and randomized to the intervention or control arm. Participants in the intervention arm receive 24 exercise coaching sessions and motivational text messages over 12 weeks. Both groups are provided with Fitbit devices to monitor physical activity. Data are collected at baseline, during the intervention (1 and 2 months), on exit, and post-intervention (1 and 3 months following completion). Participants in the control arm receive a 1-page handout with general information on caregiver self-care. The primary outcome is daily step counts as measured by the Fitbit device.</div></div><div><h3>Conclusion</h3><div>Findings from this pilot trial will inform a subsequent efficacy study of the digital health physical activity coaching intervention in a larger, more diverse population of older family caregivers of adults with heart failure.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov <span><span>NCT05852509</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101604"},"PeriodicalIF":1.4,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146022739","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}
Pub Date : 2026-01-17DOI: 10.1016/j.conctc.2026.101603
Laura N. Gitlin , Eric Jutkowitz , Catherine Piersol , Sokha Koeuth , Taylor Sivori , Melinda J. Webster , Rachel N. Barnett , David L. Roth
Objective
Few dementia caregivers have access to evidence-based support programs. Web applications (app) may address this gap. Plans4Care, a web app, provides caregivers with on-demand personalized solutions to address care challenges. We present results of a proof-of-concept study and describe a trial protocol to test efficacy.
Methods
To use Plans4Care, caregivers respond to brief onboarding questions, assess dementia patients’ cognitive function, identify care challenges, and generate “action plans” (personalized strategies). Telehealth sessions with dementia-trained care advisors are available. A proof-of-concept study evaluated a clickable prototype using standardized technology scales to determine if >75 % scored positively on four criteria (acceptability, feasibility, appropriateness, ease-of-use). The fully developed app will be tested in a prospective randomized trial (n = 160 caregivers). Caregivers will be assigned to an immediate treatment or 6-month delayed control group to evaluate short (3, 6-months) and long-term (12-month) outcomes on caregiver wellbeing and healthcare utilization of caregivers and people with dementia. App use patterns and care advisor interactions will be evaluated.
Findings/results
Proof-of-concept testing (N = 25 caregivers) resulted in high ratings (100 % achieved for acceptability and feasibility; 80 % for appropriateness; 96 % for usability), supporting full app development. The app contains >100 care challenges, >2700 nonpharmacological strategies, 60+ education-oriented guidance documents, brief how-to videos, novel assessment of cognitive function, an algorithm personalizing strategies to cognitive function and care context, and a care advisor portal. The trial will yield outcome data and utilization patterns to inform commercialization and scaling.
Conclusions
Plans4Care addresses a critical gap in dementia care with potential for commercialization and scalability.
{"title":"Plans4Care, a web application providing caregivers personalized solutions to manage dementia-related care challenges: Proof of concept and efficacy trial","authors":"Laura N. Gitlin , Eric Jutkowitz , Catherine Piersol , Sokha Koeuth , Taylor Sivori , Melinda J. Webster , Rachel N. Barnett , David L. Roth","doi":"10.1016/j.conctc.2026.101603","DOIUrl":"10.1016/j.conctc.2026.101603","url":null,"abstract":"<div><h3>Objective</h3><div>Few dementia caregivers have access to evidence-based support programs. Web applications (app) may address this gap. Plans4Care, a web app, provides caregivers with on-demand personalized solutions to address care challenges. We present results of a proof-of-concept study and describe a trial protocol to test efficacy.</div></div><div><h3>Methods</h3><div>To use Plans4Care, caregivers respond to brief onboarding questions, assess dementia patients’ cognitive function, identify care challenges, and generate “action plans” (personalized strategies). Telehealth sessions with dementia-trained care advisors are available. A proof-of-concept study evaluated a clickable prototype using standardized technology scales to determine if >75 % scored positively on four criteria (acceptability, feasibility, appropriateness, ease-of-use). The fully developed app will be tested in a prospective randomized trial (n = 160 caregivers). Caregivers will be assigned to an immediate treatment or 6-month delayed control group to evaluate short (3, 6-months) and long-term (12-month) outcomes on caregiver wellbeing and healthcare utilization of caregivers and people with dementia. App use patterns and care advisor interactions will be evaluated.</div></div><div><h3>Findings/results</h3><div>Proof-of-concept testing (N = 25 caregivers) resulted in high ratings (100 % achieved for acceptability and feasibility; 80 % for appropriateness; 96 % for usability), supporting full app development. The app contains >100 care challenges, >2700 nonpharmacological strategies, 60+ education-oriented guidance documents, brief how-to videos, novel assessment of cognitive function, an algorithm personalizing strategies to cognitive function and care context, and a care advisor portal. The trial will yield outcome data and utilization patterns to inform commercialization and scaling.</div></div><div><h3>Conclusions</h3><div>Plans4Care addresses a critical gap in dementia care with potential for commercialization and scalability.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101603"},"PeriodicalIF":1.4,"publicationDate":"2026-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146022746","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}
Pub Date : 2026-01-14DOI: 10.1016/j.conctc.2026.101600
Ting Lu , Zhixuan Shi , Shuna Huang , Lan Lv , Xinyuan Chen , Ke Ma , Xu Li , Fancai Lai , Jun Ni
<div><h3>Aims</h3><div>Surgery provides the best chance of survival for early-stage non-small cell lung cancer patients, resulting in a large number of patients requiring surgical resection each year. Preoperative inspiratory muscle training (IMT) is recognized as an important component of the preoperative management of lung cancer, although there is limited evidence for the delivery of a home-based IMT combined with preoperative education. We developed a programme combining short-term home-based IMT and preoperative physiotherapy education ("the programme") for lung patients with lung cancer. This study aims to evaluate the effectiveness of the programme in reducing postoperative pulmonary complications (PPCs) after video-assisted thoracoscopic surgery (VATs) compared to standard care.</div></div><div><h3>Methods</h3><div>This randomized controlled clinical trial (RCT) called for 114 participants at a tertiary hospital to be randomized 1:1 to the control group (CG) and the intervention group (IG). All subjects in both groups received routine perioperative rehabilitation intervention and health education manual. Participants in the IG received a detailed education course plus at least seven-day inspiratory muscle training programme before VATs. Outcome assessments were obtained in person at baseline (T0), the day before surgery (T1) and hospital discharge (T2). Primary outcome measure was PPCs using the Melbourne Group Score (MGS) obtained at discharge. Secondary outcomes were health-related quality of life, maximal inspiratory pressure (MIP), Forced expiratory volume in the first second (FEV1), 6-min walk distance (6MWD), length of hospital stay (LOS), anxiety and depression levels, and hospital costs. SPSS 26.0 statistical analysis software was used for analysis, and bilateral tests were used according to statistical tests. When P < 0.05, the difference was considered statistically significant.</div></div><div><h3>Results</h3><div>In accordance with the protocol, we performed interim unblinding after 50 % of the patients had been enrolled. At the interim analysis, the conditional power was calculated as 0.035 (futility index: 0.965; Supplementary 1), indicating this study should be stopped because there is little chance of achieving statistical significance. No safety concerns were identified. A total of 56 cases (27 cases in the IG and 29 cases in the CG) were finally included from March 2023 to March 2024. The incidence of PPCs between the two groups was not statistically significant (CG = 2/29, IG = 3/27, adjust RR was1.90 (0.29–12.82). One-week preoperative training programme increased MIP, but the results were not sufficient to make a significant difference (P = 0.208). Other secondary outcome measures were also assessed, but no significant between-group differences were found.</div></div><div><h3>Conclusion</h3><div>Preoperative education combined with one-week IMT has no significant clinical significance in reducing the incidence of p
{"title":"Effect of preoperative inspiratory muscle training combined with education course on postoperative pulmonary complications in high-risk patients with lung cancer after video-assisted thoracoscopic surgery: a randomized controlled trial","authors":"Ting Lu , Zhixuan Shi , Shuna Huang , Lan Lv , Xinyuan Chen , Ke Ma , Xu Li , Fancai Lai , Jun Ni","doi":"10.1016/j.conctc.2026.101600","DOIUrl":"10.1016/j.conctc.2026.101600","url":null,"abstract":"<div><h3>Aims</h3><div>Surgery provides the best chance of survival for early-stage non-small cell lung cancer patients, resulting in a large number of patients requiring surgical resection each year. Preoperative inspiratory muscle training (IMT) is recognized as an important component of the preoperative management of lung cancer, although there is limited evidence for the delivery of a home-based IMT combined with preoperative education. We developed a programme combining short-term home-based IMT and preoperative physiotherapy education (\"the programme\") for lung patients with lung cancer. This study aims to evaluate the effectiveness of the programme in reducing postoperative pulmonary complications (PPCs) after video-assisted thoracoscopic surgery (VATs) compared to standard care.</div></div><div><h3>Methods</h3><div>This randomized controlled clinical trial (RCT) called for 114 participants at a tertiary hospital to be randomized 1:1 to the control group (CG) and the intervention group (IG). All subjects in both groups received routine perioperative rehabilitation intervention and health education manual. Participants in the IG received a detailed education course plus at least seven-day inspiratory muscle training programme before VATs. Outcome assessments were obtained in person at baseline (T0), the day before surgery (T1) and hospital discharge (T2). Primary outcome measure was PPCs using the Melbourne Group Score (MGS) obtained at discharge. Secondary outcomes were health-related quality of life, maximal inspiratory pressure (MIP), Forced expiratory volume in the first second (FEV1), 6-min walk distance (6MWD), length of hospital stay (LOS), anxiety and depression levels, and hospital costs. SPSS 26.0 statistical analysis software was used for analysis, and bilateral tests were used according to statistical tests. When P < 0.05, the difference was considered statistically significant.</div></div><div><h3>Results</h3><div>In accordance with the protocol, we performed interim unblinding after 50 % of the patients had been enrolled. At the interim analysis, the conditional power was calculated as 0.035 (futility index: 0.965; Supplementary 1), indicating this study should be stopped because there is little chance of achieving statistical significance. No safety concerns were identified. A total of 56 cases (27 cases in the IG and 29 cases in the CG) were finally included from March 2023 to March 2024. The incidence of PPCs between the two groups was not statistically significant (CG = 2/29, IG = 3/27, adjust RR was1.90 (0.29–12.82). One-week preoperative training programme increased MIP, but the results were not sufficient to make a significant difference (P = 0.208). Other secondary outcome measures were also assessed, but no significant between-group differences were found.</div></div><div><h3>Conclusion</h3><div>Preoperative education combined with one-week IMT has no significant clinical significance in reducing the incidence of p","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101600"},"PeriodicalIF":1.4,"publicationDate":"2026-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977690","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}
Pub Date : 2026-01-13DOI: 10.1016/j.conctc.2026.101598
Carmen P. McLean , Meghan M. Bell , Christopher K. Haddock , Stefanie T. LoSavio , Jeffrey Mann , Shannon McCaslin , Nazia Rahman , Lauren Rodden , Timothy Rogers , Craig S. Rosen , Craig Woodworth , Jeffrey Cook
Posttraumatic stress disorder (PTSD) affects up to 13–17 % of active duty military personnel who deployed after 9/11 and significantly impacts military readiness. However, behavioral health providers in the Military Health System (MHS) face significant challenges in implementing evidence-based psychotherapies (EBPs) such as Written Exposure Therapy (WET). One of the main obstacles is the limited capacity to schedule and conduct weekly therapy sessions due to large patient panels and heavy workloads. This study uses a Hybrid Type 1 implementation-effectiveness design to increase access to WET by task sharing delivery with behavioral health technicians (BHTs). We will compare BHT-delivered WET plus treatment as usual (TAU) to TAU alone in a Phase II randomized clinical trial with 150 active-duty participants. The primary aims are to evaluate the clinical effectiveness of BHT-delivered WET, patient acceptability, and BHT treatment fidelity. Secondary aims include identifying barriers and facilitators to WET implementation. Participants will be randomly assigned to BHT-delivered WET or TAU alone, with WET delivered weekly over five sessions either in-person or via telehealth. Quality control will be maintained through rigorous BHT training, supervision, and fidelity assessments. Community-Based Participatory Research methods will ensure stakeholder engagement and feedback throughout the study. Data analysis involves linear mixed-effects models and rapid qualitative analysis to assess outcomes. The results will demonstrate the effectiveness of WET in routine care settings and the feasibility of BHT-delivered WET as an implementation strategy. The findings have the potential to enhance PTSD treatment accessibility and inform best practices within the MHS and similar settings.
{"title":"Behavioral health technician delivered written exposure therapy for posttraumatic stress disorder in the military: Design of a hybrid implementation effectiveness trial","authors":"Carmen P. McLean , Meghan M. Bell , Christopher K. Haddock , Stefanie T. LoSavio , Jeffrey Mann , Shannon McCaslin , Nazia Rahman , Lauren Rodden , Timothy Rogers , Craig S. Rosen , Craig Woodworth , Jeffrey Cook","doi":"10.1016/j.conctc.2026.101598","DOIUrl":"10.1016/j.conctc.2026.101598","url":null,"abstract":"<div><div>Posttraumatic stress disorder (PTSD) affects up to 13–17 % of active duty military personnel who deployed after 9/11 and significantly impacts military readiness. However, behavioral health providers in the Military Health System (MHS) face significant challenges in implementing evidence-based psychotherapies (EBPs) such as Written Exposure Therapy (WET). One of the main obstacles is the limited capacity to schedule and conduct weekly therapy sessions due to large patient panels and heavy workloads. This study uses a Hybrid Type 1 implementation-effectiveness design to increase access to WET by task sharing delivery with behavioral health technicians (BHTs). We will compare BHT-delivered WET plus treatment as usual (TAU) to TAU alone in a Phase II randomized clinical trial with 150 active-duty participants. The primary aims are to evaluate the clinical effectiveness of BHT-delivered WET, patient acceptability, and BHT treatment fidelity. Secondary aims include identifying barriers and facilitators to WET implementation. Participants will be randomly assigned to BHT-delivered WET or TAU alone, with WET delivered weekly over five sessions either in-person or via telehealth. Quality control will be maintained through rigorous BHT training, supervision, and fidelity assessments. Community-Based Participatory Research methods will ensure stakeholder engagement and feedback throughout the study. Data analysis involves linear mixed-effects models and rapid qualitative analysis to assess outcomes. The results will demonstrate the effectiveness of WET in routine care settings and the feasibility of BHT-delivered WET as an implementation strategy. The findings have the potential to enhance PTSD treatment accessibility and inform best practices within the MHS and similar settings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101598"},"PeriodicalIF":1.4,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977689","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}
Pub Date : 2026-01-13DOI: 10.1016/j.conctc.2026.101597
Alexandria M. Boykins , Asos Mahmood , Mona N. Wicks , Satya Surbhi , Santos A. Martinez , Frankie B. Stentz , James E. Bailey
Background
Intensive lifestyle programs promoting weight loss have been shown to induce long-term remission of early Type 2 diabetes (T2D). Further, multicomponent weight loss interventions are recommended for all patients with obesity, but these programs are largely unavailable for people living in low-income and medically underserved areas in the United States (US) and little is known about the benefits, feasibility, and costs of such interventions in community settings.
Objective
To assess the feasibility, preliminary effectiveness, and costs of a multicomponent intensive healthy eating and weight-loss program designed to support diabetes remission.
Study design
The US-based Healthy Eating and Active Living to reverse diabetes (HEAL Diabetes-USA) is a pragmatic randomized controlled pilot study conducted in Memphis, Tennessee (data collection: August 2023–August 2025), independent of and not affiliated with the UK-based HEAL-D program. Adults (≥18 years) with early T2D (<6 years), HbA1c ≥ 6.5%, and overweight/obesity (n = 60) are randomized to either Enhanced Care (EC) or Intensive Care (IC). EC includes printed materials and standard health coaching. IC is the multi-component intervention arm which includes grocery delivery, nutrition education, biweekly group sessions, and ongoing health coaching. Primary outcomes include changes in body weight and HbA1c, and proportion of patients who achieved diabetes remission at 6 and 12 months. Secondary outcomes include changes in random blood glucose, self-efficacy, diabetes self-care activities and program cost analyses.
Conclusions
This protocol describes the design of HEAL Diabetes-USA, a community-based intensive lifestyle intervention for early T2D. Findings will inform the feasibility and cost-effectiveness of delivering multicomponent diabetes-remission programs in medically underserved US settings.
{"title":"Healthy eating and active living to reverse diabetes (HEAL Diabetes-USA): a randomized controlled pilot study protocol to assess the feasibility of a weight loss intervention for diabetes remission","authors":"Alexandria M. Boykins , Asos Mahmood , Mona N. Wicks , Satya Surbhi , Santos A. Martinez , Frankie B. Stentz , James E. Bailey","doi":"10.1016/j.conctc.2026.101597","DOIUrl":"10.1016/j.conctc.2026.101597","url":null,"abstract":"<div><h3>Background</h3><div>Intensive lifestyle programs promoting weight loss have been shown to induce long-term remission of early Type 2 diabetes (T2D). Further, multicomponent weight loss interventions are recommended for all patients with obesity, but these programs are largely unavailable for people living in low-income and medically underserved areas in the United States (US) and little is known about the benefits, feasibility, and costs of such interventions in community settings.</div></div><div><h3>Objective</h3><div>To assess the feasibility, preliminary effectiveness, and costs of a multicomponent intensive healthy eating and weight-loss program designed to support diabetes remission.</div></div><div><h3>Study design</h3><div>The US-based Healthy Eating and Active Living to reverse diabetes (HEAL Diabetes-USA) is a pragmatic randomized controlled pilot study conducted in Memphis, Tennessee (data collection: August 2023–August 2025), independent of and not affiliated with the UK-based HEAL-D program. Adults (≥18 years) with early T2D (<6 years), HbA1c ≥ 6.5%, and overweight/obesity (n = 60) are randomized to either Enhanced Care (EC) or Intensive Care (IC). EC includes printed materials and standard health coaching. IC is the multi-component intervention arm which includes grocery delivery, nutrition education, biweekly group sessions, and ongoing health coaching. Primary outcomes include changes in body weight and HbA1c, and proportion of patients who achieved diabetes remission at 6 and 12 months. Secondary outcomes include changes in random blood glucose, self-efficacy, diabetes self-care activities and program cost analyses.</div></div><div><h3>Conclusions</h3><div>This protocol describes the design of HEAL Diabetes-USA, a community-based intensive lifestyle intervention for early T2D. Findings will inform the feasibility and cost-effectiveness of delivering multicomponent diabetes-remission programs in medically underserved US settings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101597"},"PeriodicalIF":1.4,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977558","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}
Pub Date : 2026-01-12DOI: 10.1016/j.conctc.2026.101596
Charlie Olvera , Vanessa Ramirez-Zohfeld , Alaine Murawski , Angela Fidler Pfammatter , Lee A. Lindquist
Traditional clinical trial designs such as the isolated two-arm randomized controlled trial (RCT) do not offer robust solutions for evaluating and optimizing delivery of complex, multi-component behavioral interventions. A recent alternative design, the Multiphase Optimization Strategy (MOST), addresses many shortcomings of the isolated two-arm RCT. The MOST framework for trial design provides researchers opportunities to perform independent evaluations of intervention content, dosage levels, delivery formats, and potential intra-intervention interactions. Results from factorial trials which implement MOST frameworks are used to optimize ongoing interventions.
Herein, we describe the protocol for a MOST RCT which evaluates NegotiAge, an artificial intelligence-based negotiation and dispute resolution training program for family caregivers of older adults. Many family caregivers experience conflicts as they support older adult care recipients. Teaching negotiation skills to family caregivers has potential to improve communication and resolve conflicts more efficiently. The trial evaluation of NegotiAge eschews traditional two-arm RCT design and instead employs the MOST framework. Our MOST trial tests eight treatment combination packages against one another and evaluates associations between specific treatment combinations and user-centered outcomes.
This research is the first to apply the MOST framework in geriatrics and family caregiving. Our use of the MOST framework to evaluate and optimize NegotiAge enables us to identify which components are most effective for family caregivers and isolate the interactional effects of each component. The protocol and eventual results of our MOST trial will demonstrate how to optimize an intervention to be efficient and potent for busy family caregivers of older adults.
{"title":"Evaluating a negotiation training program for family caregivers of older people using a Multiphase Optimization Strategy (MOST) design and protocol","authors":"Charlie Olvera , Vanessa Ramirez-Zohfeld , Alaine Murawski , Angela Fidler Pfammatter , Lee A. Lindquist","doi":"10.1016/j.conctc.2026.101596","DOIUrl":"10.1016/j.conctc.2026.101596","url":null,"abstract":"<div><div>Traditional clinical trial designs such as the isolated two-arm randomized controlled trial (RCT) do not offer robust solutions for evaluating and optimizing delivery of complex, multi-component behavioral interventions. A recent alternative design, the Multiphase Optimization Strategy (MOST), addresses many shortcomings of the isolated two-arm RCT. The MOST framework for trial design provides researchers opportunities to perform independent evaluations of intervention content, dosage levels, delivery formats, and potential intra-intervention interactions. Results from factorial trials which implement MOST frameworks are used to optimize ongoing interventions.</div><div>Herein, we describe the protocol for a MOST RCT which evaluates NegotiAge, an artificial intelligence-based negotiation and dispute resolution training program for family caregivers of older adults. Many family caregivers experience conflicts as they support older adult care recipients. Teaching negotiation skills to family caregivers has potential to improve communication and resolve conflicts more efficiently. The trial evaluation of NegotiAge eschews traditional two-arm RCT design and instead employs the MOST framework. Our MOST trial tests eight treatment combination packages against one another and evaluates associations between specific treatment combinations and user-centered outcomes.</div><div>This research is the first to apply the MOST framework in geriatrics and family caregiving. Our use of the MOST framework to evaluate and optimize NegotiAge enables us to identify which components are most effective for family caregivers and isolate the interactional effects of each component. The protocol and eventual results of our MOST trial will demonstrate how to optimize an intervention to be efficient and potent for busy family caregivers of older adults.</div></div><div><h3>Trial registration ID</h3><div>NCT04837937.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101596"},"PeriodicalIF":1.4,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977559","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}
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