Pub Date : 2025-08-28DOI: 10.1016/j.conctc.2025.101543
Elena T. Remillard , Tracy L. Mitzner , Kara T. Mumma
Many people aging with mobility disabilities experience barriers engaging in exercise programs and social events in-person and could benefit from virtual programs that make participation more accessible. The Tele Tai Chi clinical trial is assessing the acceptability and effectiveness of an evidence-based in-person Tai Chi program for older adults, Tai Chi for Arthritis and Fall Prevention (seated version), when adapted to be an online group intervention (via videoconferencing) with moderated social time for individuals aging with mobility disabilities. Specifically, we are examining the intervention efficacy for the target population for increasing physical activity and social connectedness, which are the primary outcome measures. Secondary outcome measures include exercise self-efficacy, falls efficacy, depression, quality of life, and pain. The participant sample (N = 60) includes community-dwelling adults (60–77 years of age) with a self-identified mobility disability (i.e., using a mobility aid or having serious difficulty walking or climbing stairs) for at least 10 years. Follow-up assessments occurred at the end of the 8-week intervention and 1 month thereafter. This methods-focused paper highlights our novel, user-centered, technology-mediated approach to adapting an in-person intervention for individuals aging with mobility disabilities, which can be used as a roadmap for researchers and practitioners launching similar trials or programs.
{"title":"Tele Tai Chi for people aging with mobility disabilities: Novel methodology and structured adaptation approach","authors":"Elena T. Remillard , Tracy L. Mitzner , Kara T. Mumma","doi":"10.1016/j.conctc.2025.101543","DOIUrl":"10.1016/j.conctc.2025.101543","url":null,"abstract":"<div><div>Many people aging with mobility disabilities experience barriers engaging in exercise programs and social events in-person and could benefit from virtual programs that make participation more accessible. The Tele Tai Chi clinical trial is assessing the acceptability and effectiveness of an evidence-based in-person Tai Chi program for older adults, Tai Chi for Arthritis and Fall Prevention (seated version), when adapted to be an online group intervention (via videoconferencing) with moderated social time for individuals aging with mobility disabilities. Specifically, we are examining the intervention efficacy for the target population for increasing physical activity and social connectedness, which are the primary outcome measures. Secondary outcome measures include exercise self-efficacy, falls efficacy, depression, quality of life, and pain. The participant sample (N = 60) includes community-dwelling adults (60–77 years of age) with a self-identified mobility disability (i.e., using a mobility aid or having serious difficulty walking or climbing stairs) for at least 10 years. Follow-up assessments occurred at the end of the 8-week intervention and 1 month thereafter. This methods-focused paper highlights our novel, user-centered, technology-mediated approach to adapting an in-person intervention for individuals aging with mobility disabilities, which can be used as a roadmap for researchers and practitioners launching similar trials or programs.</div></div><div><h3>ClinicalTrials.gov no</h3><div>NCT04696887.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101543"},"PeriodicalIF":1.4,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144931927","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 : 2025-08-20DOI: 10.1016/j.conctc.2025.101542
Jaromme Kim, Prabhakar Chalise, Jianghua He
Introduction
Individual-level patient data (IPD) are helpful for designing clinical trials, conducting meta-analyses, or methodology research. However, such patient level data are not readily available. Multiple methods have been developed for reconstructing survival data using published Kaplan-Meier (KM) survival curves. There has been no practical guidance on an optimal approach or extensive evaluation of the performance of the approach.
Methods
We reviewed several methods of extracting the coordinates of KM survival curves and reconstructing individual-level survival data. Then, we reproduced data from 46 published KM curves. The accuracy of reconstructed data is quantified by comparing hazard ratios (HRs) and their confidence intervals (CIs) estimated from the reproduced data with those reported in the original papers.
Results
The comparison showed a high degree of similarity between the reproduced and original HRs and CIs. In most cases, the differences were less than 5 %. The mean and median absolute percentage differences of 58 reconstructed HRs were 2.85 % and 2.14 %, respectively. These results suggest the reconstruction method reliably reconstructs survival data from KM survival curves.
Conclusions
Based on an extensive number of reconstructions, we demonstrated that reconstructed data provided similar estimates overall to those from published papers. The quality of the reproduced data depends on the presence of noise in the published curves and whether the preprocessing step is properly done.
{"title":"Reconstructing patient level survival data from published Kaplan-Meier curves","authors":"Jaromme Kim, Prabhakar Chalise, Jianghua He","doi":"10.1016/j.conctc.2025.101542","DOIUrl":"10.1016/j.conctc.2025.101542","url":null,"abstract":"<div><h3>Introduction</h3><div>Individual-level patient data (IPD) are helpful for designing clinical trials, conducting meta-analyses, or methodology research. However, such patient level data are not readily available. Multiple methods have been developed for reconstructing survival data using published Kaplan-Meier (KM) survival curves. There has been no practical guidance on an optimal approach or extensive evaluation of the performance of the approach.</div></div><div><h3>Methods</h3><div>We reviewed several methods of extracting the coordinates of KM survival curves and reconstructing individual-level survival data. Then, we reproduced data from 46 published KM curves. The accuracy of reconstructed data is quantified by comparing hazard ratios (HRs) and their confidence intervals (CIs) estimated from the reproduced data with those reported in the original papers.</div></div><div><h3>Results</h3><div>The comparison showed a high degree of similarity between the reproduced and original HRs and CIs. In most cases, the differences were less than 5 %. The mean and median absolute percentage differences of 58 reconstructed HRs were 2.85 % and 2.14 %, respectively. These results suggest the reconstruction method reliably reconstructs survival data from KM survival curves.</div></div><div><h3>Conclusions</h3><div>Based on an extensive number of reconstructions, we demonstrated that reconstructed data provided similar estimates overall to those from published papers. The quality of the reproduced data depends on the presence of noise in the published curves and whether the preprocessing step is properly done.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101542"},"PeriodicalIF":1.4,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144904464","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 : 2025-08-19DOI: 10.1016/j.conctc.2025.101536
Marjorie Solomon , Jo A. Yon-Hernández , Steve Ruder , Susan R. McGurk , Daniel Tancredi , Yukari Takarae , Aubyn C. Stahmer
Relatively few autistic adults, including those with average intellectual abilities, are competitively employed, meaning that they hold jobs together with non-disabled workers and receive comparable wages and benefits. In California, for example, most autistic individuals served by the state are placed in programs where they participate in skill-building and socialization but not in actual competitive jobs. Failure to participate in the labor force can diminish autistic workers’ sense of purpose, well-being, and ability to earn a living wage.
Available research suggests that supported employment that assists autistic adults in finding and keeping jobs, produces the highest sustained competitive employment rates. Thus, our team has been investigating the Individualized Placement and Support (IPS) model, which has an extensive evidence base for increasing competitive employment rates in individuals with chronic mental illnesses. In a California Department of Developmental Services Employment Grant investigating adults with autism and intellectual disabilities, we demonstrated a competitive employment placement rate of 52 % using IPS. Components of IPS were appropriate for this population, however there were implementation challenges related to IPS model fit with the vocational support agencies.
Based on focus groups and stakeholder input, we have adapted IPS to provide intensive agency training, leadership education, and record keeping support. Herein, we detail a protocol for a randomized controlled trial of the adapted model (IPS-AUT) to evaluate feasibility, acceptability, and work outcomes. We also investigate potential moderators and mediators of treatment effectiveness to provide a foundation for a larger more adequately powered randomized clinical trial.
This protocol is registered at ClinicalTrials.gov: NCT 06829264.
{"title":"A randomized controlled trial protocol for evaluating the feasibility, acceptability, and work outcomes of individualized placement and support adapted for autistic adults in the community","authors":"Marjorie Solomon , Jo A. Yon-Hernández , Steve Ruder , Susan R. McGurk , Daniel Tancredi , Yukari Takarae , Aubyn C. Stahmer","doi":"10.1016/j.conctc.2025.101536","DOIUrl":"10.1016/j.conctc.2025.101536","url":null,"abstract":"<div><div>Relatively few autistic adults, including those with average intellectual abilities, are competitively employed, meaning that they hold jobs together with non-disabled workers and receive comparable wages and benefits. In California, for example, most autistic individuals served by the state are placed in programs where they participate in skill-building and socialization but not in actual competitive jobs. Failure to participate in the labor force can diminish autistic workers’ sense of purpose, well-being, and ability to earn a living wage.</div><div>Available research suggests that supported employment that assists autistic adults in finding and keeping jobs, produces the highest sustained competitive employment rates. Thus, our team has been investigating the Individualized Placement and Support (IPS) model, which has an extensive evidence base for increasing competitive employment rates in individuals with chronic mental illnesses. In a California Department of Developmental Services Employment Grant investigating adults with autism and intellectual disabilities, we demonstrated a competitive employment placement rate of 52 % using IPS. Components of IPS were appropriate for this population, however there were implementation challenges related to IPS model fit with the vocational support agencies.</div><div>Based on focus groups and stakeholder input, we have adapted IPS to provide intensive agency training, leadership education, and record keeping support. Herein, we detail a protocol for a randomized controlled trial of the adapted model (IPS-AUT) to evaluate feasibility, acceptability, and work outcomes. We also investigate potential moderators and mediators of treatment effectiveness to provide a foundation for a larger more adequately powered randomized clinical trial.</div><div>This protocol is registered at ClinicalTrials.gov: NCT 06829264.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101536"},"PeriodicalIF":1.4,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144890874","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 : 2025-08-18DOI: 10.1016/j.conctc.2025.101537
Eric C. Meyer , Todd Farchione , Nathan A. Kimbrel , Oi-Man Kwok , Michelle L. Pennington , Jessica Rostockyj , Suzy B. Gulliver
Fire fighters (FFs) risk their lives, health, and well-being through trauma exposure and other occupational stressors. FFs report concerning rates of mental health challenges, alcohol use disorders, and suicide risk. These problems tend to co-occur, as each is linked with reliance on maladaptive emotion regulation strategies. As FFs advance in their careers, many tend to rely more heavily on these maladaptive emotion regulation strategies, thus exacerbating the problems. Many FFs leave fire service prematurely due to mental and physical health problems. FFs must be equipped with more effective emotion regulation skills to buffer against stressors they will face. FFs may benefit from training in transdiagnostic emotion regulation skills delivered by credible peers upon entry and socialization into the profession, potentially preventing substantial negative outcomes downstream while promoting resilience and wellness. This paper describes a cluster randomized controlled trial to compare peer-delivered emotion regulation training with peer-delivered psychoeducation regarding mental health, both delivered during the fire academy, for preventing symptoms of PTSD (primary outcome), depression, anxiety, alcohol use disorder, and functional impairment. Emotion regulation training is based on the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Participants will be a non-clinical population of FF trainees completing the fire academy at 10–12 cities nationwide (N = 312). Participants will be cluster randomized to training condition by recruit class. Subsequent recruit classes will then alternate between conditions within each city. Assessment measures will be administered at pre-training baseline, post-training, and at 6-, 12-, 18-, and 24 month follow-ups.
{"title":"Peer delivered, emotion regulation-focused mental health prevention training for fire fighter trainees: Design and methodology of a randomized controlled trial","authors":"Eric C. Meyer , Todd Farchione , Nathan A. Kimbrel , Oi-Man Kwok , Michelle L. Pennington , Jessica Rostockyj , Suzy B. Gulliver","doi":"10.1016/j.conctc.2025.101537","DOIUrl":"10.1016/j.conctc.2025.101537","url":null,"abstract":"<div><div>Fire fighters (FFs) risk their lives, health, and well-being through trauma exposure and other occupational stressors. FFs report concerning rates of mental health challenges, alcohol use disorders, and suicide risk. These problems tend to co-occur, as each is linked with reliance on maladaptive emotion regulation strategies. As FFs advance in their careers, many tend to rely more heavily on these maladaptive emotion regulation strategies, thus exacerbating the problems. Many FFs leave fire service prematurely due to mental and physical health problems. FFs must be equipped with more effective emotion regulation skills to buffer against stressors they will face. FFs may benefit from training in transdiagnostic emotion regulation skills delivered by credible peers upon entry and socialization into the profession, potentially preventing substantial negative outcomes downstream while promoting resilience and wellness. This paper describes a cluster randomized controlled trial to compare peer-delivered emotion regulation training with peer-delivered psychoeducation regarding mental health, both delivered during the fire academy, for preventing symptoms of PTSD (primary outcome), depression, anxiety, alcohol use disorder, and functional impairment. Emotion regulation training is based on the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Participants will be a non-clinical population of FF trainees completing the fire academy at 10–12 cities nationwide (<em>N</em> = 312). Participants will be cluster randomized to training condition by recruit class. Subsequent recruit classes will then alternate between conditions within each city. Assessment measures will be administered at pre-training baseline, post-training, and at 6-, 12-, 18-, and 24 month follow-ups.</div></div><div><h3>Clinical trial registration</h3><div>NCT06290778.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101537"},"PeriodicalIF":1.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144890873","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 : 2025-08-18DOI: 10.1016/j.conctc.2025.101540
Elisabeth C. Henley , Hannah A. Liphart , Keayra J. Morris , Iwalola Awoyinka , Michael R. Irwin , Erin S. Costanzo , Diana Winston , Anita D'Souza , Melinda Stolley , Binod Dhakal , Meera Mohan , Marcelo C. Pasquini , Steven W. Cole , Erin S. Doerwald , Peyton C. Bendis , Kelly E. Rentscher , Meredith E. Rumble , Aniko Szabo , Sridhar Rao , Jennifer M. Knight
Background
Sleep disturbance is common in patients receiving hematopoietic stem cell transplantation (HCT). Mindfulness-based interventions (MBIs) can improve sleep quality during and following cancer treatment by reducing treatment-related symptoms and enhancing immune function.
Methods
We conducted a randomized controlled pilot study investigating the feasibility of implementing Mindfulness Awareness Practices for Insomnia (MAP-I) in patients with multiple myeloma (MM) undergoing autologous HCT. Patients were randomized to receive either MAP-I or a Sleep Health Education (SHE) intervention, both consisting of six videos viewed pre-HCT and three virtual sessions in the two weeks post-HCT. Feasibility was assessed by meeting an enrollment rate of 35% and a retention rate of 85%.
Results
We screened 120 patients; 54 (45%) were deemed ineligible and 42 (35%) declined participation. Twenty-four of the 66 eligible patients approached were enrolled into the study (36.4% enrollment rate) and were randomized to either MAP-I or SHE. Seven patients completed the study (29.2% retention rate). Most participants who withdrew consent cited feeling overwhelmed or too sick to continue post-HCT. Amendments were iteratively implemented to increase enrollment and retention rates including addition of a study incentive, modifications to the video timeline, and earlier introduction of the mindfulness instructor.
Conclusion
Study results detail challenges and opportunities in retaining patients with MM in a virtual MBI sleep intervention during the peri-transplant period. While enrollment met feasibility criteria, most patients felt too overwhelmed or sick in the peri-transplant period to complete the intervention and associated study tasks. Future research should investigate MBIs at other time points throughout HCT.
{"title":"Mindfulness vs. sleep education during autologous hematopoietic cell transplantation for multiple myeloma: Feasibility of a randomized controlled pilot study","authors":"Elisabeth C. Henley , Hannah A. Liphart , Keayra J. Morris , Iwalola Awoyinka , Michael R. Irwin , Erin S. Costanzo , Diana Winston , Anita D'Souza , Melinda Stolley , Binod Dhakal , Meera Mohan , Marcelo C. Pasquini , Steven W. Cole , Erin S. Doerwald , Peyton C. Bendis , Kelly E. Rentscher , Meredith E. Rumble , Aniko Szabo , Sridhar Rao , Jennifer M. Knight","doi":"10.1016/j.conctc.2025.101540","DOIUrl":"10.1016/j.conctc.2025.101540","url":null,"abstract":"<div><h3>Background</h3><div>Sleep disturbance is common in patients receiving hematopoietic stem cell transplantation (HCT). Mindfulness-based interventions (MBIs) can improve sleep quality during and following cancer treatment by reducing treatment-related symptoms and enhancing immune function.</div></div><div><h3>Methods</h3><div>We conducted a randomized controlled pilot study investigating the feasibility of implementing Mindfulness Awareness Practices for Insomnia (MAP-I) in patients with multiple myeloma (MM) undergoing autologous HCT. Patients were randomized to receive either MAP-I or a Sleep Health Education (SHE) intervention, both consisting of six videos viewed pre-HCT and three virtual sessions in the two weeks post-HCT. Feasibility was assessed by meeting an enrollment rate of 35% and a retention rate of 85%.</div></div><div><h3>Results</h3><div>We screened 120 patients; 54 (45%) were deemed ineligible and 42 (35%) declined participation. Twenty-four of the 66 eligible patients approached were enrolled into the study (36.4% enrollment rate) and were randomized to either MAP-I or SHE. Seven patients completed the study (29.2% retention rate). Most participants who withdrew consent cited feeling overwhelmed or too sick to continue post-HCT. Amendments were iteratively implemented to increase enrollment and retention rates including addition of a study incentive, modifications to the video timeline, and earlier introduction of the mindfulness instructor.</div></div><div><h3>Conclusion</h3><div>Study results detail challenges and opportunities in retaining patients with MM in a virtual MBI sleep intervention during the peri-transplant period. While enrollment met feasibility criteria, most patients felt too overwhelmed or sick in the peri-transplant period to complete the intervention and associated study tasks. Future research should investigate MBIs at other time points throughout HCT.</div></div><div><h3>Trial registration</h3><div>NCT04271930, 2/17/2020.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101540"},"PeriodicalIF":1.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144890872","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 : 2025-08-17DOI: 10.1016/j.conctc.2025.101539
Bushra Sabri , Jian Li , Subhash Aryal , Theresa Mata , Sarah M. Murray , Nancy Glass , Jacquelyn C. Campbell
Background
Intimate partner violence (IPV) disproportionately affects immigrant women, who often face barriers to accessing in-person services. Digital interventions offer a promising alternative by providing tailored, remote support.
Methods
In this SMART trial, 1265 foreign-born immigrant women across the U.S. were randomized to a personalized online (n = 660) or standard online safety information (n = 605) intervention. At 3 months, low responders (n = 366) were re-randomized to receive text-only (n = 183) or text + phone support (n = 183). Outcomes were assessed at 6 and 12 months.
Results
All groups showed reduced physical and sexual IPV over time, with no significant differences between first-stage conditions. Low responders in the text + phone group demonstrated significantly greater reductions in physical and sexual IPV (d = −0.25, p < 0.01), depression (d = −0.22, p < 0.01), and increased empowerment (d = 0.22, p < 0.01), from 3 to 12 months, compared to responders. These between-group effects were supported by significant within-group improvements, with the text + phone group narrowing or closing the gap with responders in most outcomes by 12 months. Among low responders initially assigned to the personalized online intervention, those re-randomized to text + phone support outperformed those receiving text-only support—showing significantly greater reductions in IPV (d = −0.32, p < 0.05), depression (d = −0.33, p < 0.05), and greater gains in empowerment (d = 0.27, p < 0.05). The text-only group also improved, particularly in depression and PTSD, with outcomes approaching those of responders by 12 months. Across conditions, low responders also showed substantial improvements in safety behaviors (d = 0.24–0.25; p < 0.05).
Conclusion
These findings highlight the value of stepped-care, adaptive approaches in addressing persistent IPV-related needs. Integrating personalized phone support into digital interventions can enhance outcomes for survivors who do not respond to brief, initial support alone.
最终伴侣暴力（IPV）对移民妇女的影响尤为严重，她们往往在获得面对面服务方面面临障碍。数字干预通过提供量身定制的远程支持，提供了一种有希望的替代方案。在这项SMART试验中，1265名美国外国出生的移民妇女被随机分为个性化在线（n = 660）和标准在线安全信息（n = 605）干预组。在3个月时，低应答者（n = 366）被重新随机分配到仅接受短信（n = 183）或短信+电话支持（n = 183）。在6个月和12个月时评估结果。结果随着时间的推移，所有组的身体和性IPV都有所下降，第一阶段的情况没有显著差异。与应答者相比，短信+电话组的低应答者在3至12个月内表现出更大的身体和性IPV (d = - 0.25, p < 0.01)，抑郁（d = - 0.22, p < 0.01）和赋权（d = 0.22, p < 0.01）的减少。这些组间效应得到了组内显著改善的支持，短信+电话组在12个月内缩小或消除了与应答者在大多数结果上的差距。在最初被分配到个性化在线干预的低应答者中，那些重新随机分配到文本+电话支持组的人比那些只接受文本支持组的人表现得更好——IPV （d = - 0.32, p < 0.05）、抑郁（d = - 0.33, p < 0.05）和赋权（d = 0.27, p < 0.05）的减少显著增加。短信组也有所改善，尤其是在抑郁症和创伤后应激障碍方面，结果接近应答组12个月。在各种情况下，低反应者的安全行为也有显著改善（d = 0.24-0.25; p < 0.05）。结论：这些发现突出了阶梯式护理和适应性方法在解决持久的ipvv相关需求方面的价值。将个性化的电话支持整合到数字干预措施中，可以提高那些不单单对简短的、最初的支持有反应的幸存者的结果。
{"title":"Evaluating digital intervention approaches for supporting immigrant women with intimate partner violence experiences: Findings from the It's weWomen plus sequential multiple assignment randomized trial (SMART)","authors":"Bushra Sabri , Jian Li , Subhash Aryal , Theresa Mata , Sarah M. Murray , Nancy Glass , Jacquelyn C. Campbell","doi":"10.1016/j.conctc.2025.101539","DOIUrl":"10.1016/j.conctc.2025.101539","url":null,"abstract":"<div><h3>Background</h3><div>Intimate partner violence (IPV) disproportionately affects immigrant women, who often face barriers to accessing in-person services. Digital interventions offer a promising alternative by providing tailored, remote support.</div></div><div><h3>Methods</h3><div>In this SMART trial, 1265 foreign-born immigrant women across the U.S. were randomized to a personalized online (<em>n</em> = 660) or standard online safety information (<em>n</em> = 605) intervention. At 3 months, low responders (<em>n</em> = 366) were re-randomized to receive text-only (<em>n</em> = 183) or text + phone support (<em>n</em> = 183). Outcomes were assessed at 6 and 12 months.</div></div><div><h3>Results</h3><div>All groups showed reduced physical and sexual IPV over time, with no significant differences between first-stage conditions. Low responders in the text + phone group demonstrated significantly greater reductions in physical and sexual IPV (<em>d</em> = −0.25, <em>p</em> < 0.01), depression (<em>d</em> = −0.22, <em>p</em> < 0.01), and increased empowerment (<em>d</em> = 0.22, <em>p</em> < 0.01), from 3 to 12 months, compared to responders. These between-group effects were supported by significant within-group improvements, with the text + phone group narrowing or closing the gap with responders in most outcomes by 12 months. Among low responders initially assigned to the personalized online intervention, those re-randomized to text + phone support outperformed those receiving text-only support—showing significantly greater reductions in IPV (<em>d</em> = −0.32, <em>p</em> < 0.05), depression (<em>d</em> = −0.33, <em>p</em> < 0.05), and greater gains in empowerment (<em>d</em> = 0.27, <em>p</em> < 0.05). The text-only group also improved, particularly in depression and PTSD, with outcomes approaching those of responders by 12 months. Across conditions, low responders also showed substantial improvements in safety behaviors (<em>d</em> = 0.24–0.25; <em>p</em> < 0.05).</div></div><div><h3>Conclusion</h3><div>These findings highlight the value of stepped-care, adaptive approaches in addressing persistent IPV-related needs. Integrating personalized phone support into digital interventions can enhance outcomes for survivors who do not respond to brief, initial support alone.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101539"},"PeriodicalIF":1.4,"publicationDate":"2025-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144863464","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 : 2025-08-17DOI: 10.1016/j.conctc.2025.101538
Luigi Taranto-Montemurro , Sanjay R. Patel , Patrick J. Strollo Jr. , John Cronin , John Yee , Huy Pho , Andrea Werner , Ron Farkas
Introduction
Two key factors leading to obstructive sleep apnea (OSA) pathogenesis include relaxation of upper airway muscles at sleep onset and their insufficient reactivation during obstructive events. Medications that address this neuromuscular dysfunction by increasing upper airway tone during sleep represent a potential strategy for mitigating OSA.
Methods
AD109 is an investigational, once-daily oral agent taken at bedtime that combines an antimuscarinic, aroxybutynin (2.5 mg), with a selective norepinephrine reuptake inhibitor, atomoxetine (75 mg). LunAIRo (NCT05811247) and SynAIRgy (NCT05813275) are two ongoing, placebo-controlled 51-week and 26-week phase 3 clinical trials, respectively, investigating the efficacy and safety of AD109 to treat mild to severe OSA. Participants include adults with an apnea-hypopnea index with 4% desaturation (AHI4) >5 who either refuse or fail to tolerate positive airway pressure. Participants (LunAIRo: N = 660; SynAIRgy: N = 646) were randomized 1:1 to receive AD109 or placebo. We hypothesize that AD109 will significantly reduce AHI4 and symptomatic fatigue compared to placebo in people with OSA. The primary outcome for both trials is the change from baseline to Week 26 in AHI4 in the AD109 arm versus placebo. Key secondary outcomes include changes from baseline in oxygen desaturation index with 3% desaturation, hypoxic burden based on 4% desaturation, Patient Reported Outcome Measurement Information System (PROMIS)-Fatigue, and proportion of participants with ≥50% reduction in AHI4 at Week 26.
Discussion
LunAIRo and SynAIRgy are fully enrolled, large Phase 3 clinical trials designed to confirm and extend our understanding of the safety and efficacy of AD109, a combination oral drug targeting the underlying neuromuscular dysfunction contributing to upper airway muscle collapse during sleep in adults with OSA.
导致阻塞性睡眠呼吸暂停（OSA）发病的两个关键因素包括睡眠时上呼吸道肌肉的松弛和阻塞性事件时上呼吸道肌肉的再激活不足。通过增加睡眠时上呼吸道张力来解决这种神经肌肉功能障碍的药物是缓解OSA的潜在策略。方法sad109是一种研究性药物，每日一次，睡前口服，由抗蛇毒碱阿洛布宁（2.5 mg）和选择性去甲肾上腺素再摄取抑制剂托莫西汀（75 mg）组成。LunAIRo （NCT05811247）和SynAIRgy （NCT05813275）是两项正在进行的安慰剂对照临床试验，分别为51周和26周，研究AD109治疗轻至重度OSA的有效性和安全性。参与者包括呼吸暂停低通气指数为4%去饱和（AHI4） >；5的成年人，他们拒绝或无法忍受气道正压。参与者（LunAIRo: N = 660; SynAIRgy: N = 646）以1:1的比例随机分为AD109组或安慰剂组。我们假设与安慰剂相比，AD109可以显著降低OSA患者的AHI4和症状性疲劳。两项试验的主要结局是AD109组与安慰剂组的AHI4从基线到第26周的变化。关键的次要结局包括血氧去饱和指数从基线到3%的变化，基于4%去饱和的缺氧负担，患者报告的结果测量信息系统(PROMIS)-疲劳，以及26周时AHI4降低≥50%的参与者比例。lunairo和SynAIRgy是完全入组的大型3期临床试验，旨在证实和扩展我们对AD109的安全性和有效性的理解，AD109是一种联合口服药物，针对成人OSA患者睡眠期间潜在的神经肌肉功能障碍，导致上呼吸道肌肉塌陷。
{"title":"Aroxybutynin and atomoxetine (AD109) for the treatment of obstructive sleep apnea: Rationale, design and baseline characteristics of the phase 3 clinical trials","authors":"Luigi Taranto-Montemurro , Sanjay R. Patel , Patrick J. Strollo Jr. , John Cronin , John Yee , Huy Pho , Andrea Werner , Ron Farkas","doi":"10.1016/j.conctc.2025.101538","DOIUrl":"10.1016/j.conctc.2025.101538","url":null,"abstract":"<div><h3>Introduction</h3><div>Two key factors leading to obstructive sleep apnea (OSA) pathogenesis include relaxation of upper airway muscles at sleep onset and their insufficient reactivation during obstructive events. Medications that address this neuromuscular dysfunction by increasing upper airway tone during sleep represent a potential strategy for mitigating OSA.</div></div><div><h3>Methods</h3><div>AD109 is an investigational, once-daily oral agent taken at bedtime that combines an antimuscarinic, aroxybutynin (2.5 mg), with a selective norepinephrine reuptake inhibitor, atomoxetine (75 mg). LunAIRo (NCT05811247) and SynAIRgy (NCT05813275) are two ongoing, placebo-controlled 51-week and 26-week phase 3 clinical trials, respectively, investigating the efficacy and safety of AD109 to treat mild to severe OSA. Participants include adults with an apnea-hypopnea index with 4% desaturation (AHI<sub>4</sub>) >5 who either refuse or fail to tolerate positive airway pressure. Participants (LunAIRo: N = 660; SynAIRgy: N = 646) were randomized 1:1 to receive AD109 or placebo. We hypothesize that AD109 will significantly reduce AHI<sub>4</sub> and symptomatic fatigue compared to placebo in people with OSA. The primary outcome for both trials is the change from baseline to Week 26 in AHI<sub>4</sub> in the AD109 arm versus placebo. Key secondary outcomes include changes from baseline in oxygen desaturation index with 3% desaturation, hypoxic burden based on 4% desaturation, Patient Reported Outcome Measurement Information System (PROMIS)-Fatigue, and proportion of participants with ≥50% reduction in AHI<sub>4</sub> at Week 26.</div></div><div><h3>Discussion</h3><div>LunAIRo and SynAIRgy are fully enrolled, large Phase 3 clinical trials designed to confirm and extend our understanding of the safety and efficacy of AD109, a combination oral drug targeting the underlying neuromuscular dysfunction contributing to upper airway muscle collapse during sleep in adults with OSA.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101538"},"PeriodicalIF":1.4,"publicationDate":"2025-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144895000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-08-07DOI: 10.1016/j.conctc.2025.101530
Shirley M. Bluethmann , Janet Tooze , Joni K. Evans , Jeffrey Katula , Kristy Wood , Lesley Hitariansingh , Charlotte Crotts , Heidi D. Klepin , Ravi Paluri , Kunal Kadakia , Katherine Ansley
The majority of the 18 million US adults with cancer history (“survivors”) do not meet recommendations for obtaining regular physical activity (PA) or limiting sedentary behavior in their daily lives. Breast cancer survivors (BCS) and colon cancer survivors (CCS) are particularly at risk of insufficient PA and excessive sedentary behavior (i.e., sitting) that may increase physical impairments, worsen cancer treatment symptoms, limit optimal cancer recovery, and limit opportunities to potentially reduce cancer risk. Research has shown that completion of clinical cancer treatment may serve as a ‘teachable moment’ for patients as they transition to recovery at home. Many of these survivors are uncertain about building a healthier lifestyle without guidance from the medical team, but few validated clinical tools exist to assess and counsel survivors on their behavioral choices relative to PA and sedentary behavior.
Based on our recent findings, a simple screener that collects measures on PA, strength training, and sedentary behavior, the Physical Activity Index (PAI), may be effective for clinical use to monitor patient behaviors and provide specific, tailored recommendations on how to achieve and maintain behavioral goals. We propose a multicomponent, two-arm pilot 1:1 randomized controlled trial with waitlist control in which we will recruit (n = 20) BCS and CCS within three years of diagnosis to leverage the ‘teachable moment’ in early recovery. The PAI intervention will include standard survivorship follow-up care plus a PA assessment using the PAI screener that is supplied to the provider plus five remote coaching consultations with a certified exercise physiologist. All participants will also receive resistance bands to keep and an activity tracker to self-monitor their behaviors at home.
We will determine feasibility by examining recruitment, retention, acceptability, and PAI intervention adherence goals. Secondarily, we will measure changes/variability in achievement of behavioral outcomes for PA and sedentary behaviors to inform future trial planning.
{"title":"Study design and methods for the physical activity index (PAI) feasibility pilot trial for breast and colon cancer survivors in North Carolina","authors":"Shirley M. Bluethmann , Janet Tooze , Joni K. Evans , Jeffrey Katula , Kristy Wood , Lesley Hitariansingh , Charlotte Crotts , Heidi D. Klepin , Ravi Paluri , Kunal Kadakia , Katherine Ansley","doi":"10.1016/j.conctc.2025.101530","DOIUrl":"10.1016/j.conctc.2025.101530","url":null,"abstract":"<div><div>The majority of the 18 million US adults with cancer history (“survivors”) do not meet recommendations for obtaining regular physical activity (PA) or limiting sedentary behavior in their daily lives. Breast cancer survivors (BCS) and colon cancer survivors (CCS) are particularly at risk of insufficient PA and excessive sedentary behavior (i.e., sitting) that may increase physical impairments, worsen cancer treatment symptoms, limit optimal cancer recovery, and limit opportunities to potentially reduce cancer risk. Research has shown that completion of clinical cancer treatment may serve as a ‘teachable moment’ for patients as they transition to recovery at home. Many of these survivors are uncertain about building a healthier lifestyle without guidance from the medical team, but few validated clinical tools exist to assess and counsel survivors on their behavioral choices relative to PA and sedentary behavior.</div><div>Based on our recent findings, a simple screener that collects measures on PA, strength training, and sedentary behavior, the Physical Activity Index (PAI), may be effective for clinical use to monitor patient behaviors and provide specific, tailored recommendations on how to achieve and maintain behavioral goals. We propose a multicomponent, two-arm pilot 1:1 randomized controlled trial with waitlist control in which we will recruit (n = 20) BCS and CCS within three years of diagnosis to leverage the ‘teachable moment’ in early recovery. The PAI intervention will include standard survivorship follow-up care plus a PA assessment using the PAI screener that is supplied to the provider plus five remote coaching consultations with a certified exercise physiologist. All participants will also receive resistance bands to keep and an activity tracker to self-monitor their behaviors at home.</div><div>We will determine feasibility by examining recruitment, retention, acceptability, and PAI intervention adherence goals. Secondarily, we will measure changes/variability in achievement of behavioral outcomes for PA and sedentary behaviors to inform future trial planning.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101530"},"PeriodicalIF":1.4,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144841366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-08-07DOI: 10.1016/j.conctc.2025.101532
Matthew W.R. Stevens , Sue Bertossa , Dominic Barry , Chris Holmwood , KS Kylie Lee , John Marsden , Matt Pedler , Mark Thompson , Scott Wilson , Robert L. Ali
Background
Substance use significantly contributes to disease burden among Australians, with harms exacerbated among Aboriginal and Torres Strait Islander peoples by colonisation-related factors like stigma and trauma. Addressing this gap requires culturally acceptable, valid and reliable screening tools, available in a familiar language to the participant, to identify and provide support for those at-risk. This protocol describes a study aimed at validating a culturally-adapted screening tool — the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) — into Pitjantjatjara, to detect risk of substance-related harm.
Methods
Recruitment will occur at a variety of Aboriginal health and welfare settings across remote, rural and urban South Australia. Eligible participants (aged 18–65) will be briefed and, upon consent, randomly complete the ASSIST app on an iPad and a semi-structured, yarning-style diagnostic interview (see endnote 1) with a health professional and Pitjantjatjara interpreter. The interview will assess for a range of clinically-defined substance use disorders (based on DSM-5-TR and ICD-11 criteria). All participants will be asked to complete the app a second time (between 7 and 28 days) to assess reliability, while a subset of participants at highest-risk will also undergo specialist evaluation from an independent clinician, as a second check for validity.
Discussion
Valid and reliable assessment tools are essential for detecting risky and harmful substance use. If valid, this app has the potential to contribute to community-led efforts to bridge the health gap by addressing modifiable health risk factors.
Trial registration
ANZCTR: ACTRN12625000413426. Open Science Framework pre-registration: https://doi.org/10.17605/OSF.IO/GNZAY.
{"title":"ASSIST in Pitjantjatjara: Protocol for a randomised crossover validation study among Aboriginal and Torres Strait Islander Australians","authors":"Matthew W.R. Stevens , Sue Bertossa , Dominic Barry , Chris Holmwood , KS Kylie Lee , John Marsden , Matt Pedler , Mark Thompson , Scott Wilson , Robert L. Ali","doi":"10.1016/j.conctc.2025.101532","DOIUrl":"10.1016/j.conctc.2025.101532","url":null,"abstract":"<div><h3>Background</h3><div>Substance use significantly contributes to disease burden among Australians, with harms exacerbated among Aboriginal and Torres Strait Islander peoples by colonisation-related factors like stigma and trauma. Addressing this gap requires culturally acceptable, valid and reliable screening tools, available in a familiar language to the participant, to identify and provide support for those at-risk. This protocol describes a study aimed at validating a culturally-adapted screening tool — the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) — into Pitjantjatjara, to detect risk of substance-related harm.</div></div><div><h3>Methods</h3><div>Recruitment will occur at a variety of Aboriginal health and welfare settings across remote, rural and urban South Australia. Eligible participants (aged 18–65) will be briefed and, upon consent, randomly complete the ASSIST app on an iPad and a semi-structured, yarning-style diagnostic interview (see endnote 1) with a health professional and Pitjantjatjara interpreter. The interview will assess for a range of clinically-defined substance use disorders (based on DSM-5-TR and ICD-11 criteria). All participants will be asked to complete the app a second time (between 7 and 28 days) to assess reliability, while a subset of participants at highest-risk will also undergo specialist evaluation from an independent clinician, as a second check for validity.</div></div><div><h3>Discussion</h3><div>Valid and reliable assessment tools are essential for detecting risky and harmful substance use. If valid, this app has the potential to contribute to community-led efforts to bridge the health gap by addressing modifiable health risk factors.</div></div><div><h3>Trial registration</h3><div>ANZCTR: ACTRN12625000413426. Open Science Framework pre-registration: <span><span>https://doi.org/10.17605/OSF.IO/GNZAY</span><svg><path></path></svg></span>.</div></div><div><h3>Version control number</h3><div>Protocol version 1.1, June 23, 2025.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101532"},"PeriodicalIF":1.4,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144860648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-08-07DOI: 10.1016/j.conctc.2025.101533
Susanna Yedro , Elena Tinari , Daniele Napolitano , Giulia Wlderk , Eleonora Ribaudi , Luciana Giannone , Gianluca Ianiro , Mattia Bozzetti , Antonio Gasbarrini , Vincenzina Mora
Introduction
The evolution of clinical trials has made it essential to introduce specific roles, such as Clinical Study Coordinator (CSC) and Data Manager (DM), into the research process. Their responsibilities sometimes overlap, creating operational challenges in the workplace. This study aims to determine how personnel at Contract Research Organizations (CROs) perceive the differences between the CSC and DM roles, assess their functional overlap, and identify areas where greater role clarity and training are needed to improve operational efficiency.
Methods
An online survey instrument was used to gather data from CRO professionals through an internet-based questionnaire. The survey gathered sociodemographic data and included a knowledge assessment of 18 items and a 9-item role responsibilities section. Participants were stratified into three ability groups using Item Response Theory (IRT) analysis based on a Rasch model. McNemar's tests and non-parametric tests analyzed knowledge discrepancies and perceptual contradictions.
Results
A total of 122 participants completed the survey. Most partecipants (98.4 %) identified the CSC as the primary figure within a research center, and 77.9 % considered the CSC essential for clinical trial execution. Regarding functional overlap, 57.4 % of respondents believed that the CSC could perform the duties of a DM, whereas only 42.6 % thought the DM could assume the CSC's responsibilities. Participants with lower levels of knowledge demonstrated a higher rate of contradictory responses, indicating greater difficulty distinguishing between the two roles.
Conclusion
Study findings demonstrate an overwhelming preference for CSCs, who play a key versatile role in managing clinical trials. The insufficient theoretical understanding of the different duties of CSCs and DMs hampers operational efficiency. Establishing standard training programs combined with harmonization is essential to defining roles, enhancing teamwork, and providing quality clinical research practices.
{"title":"DISYNCRO: Perceived roles of clinical study coordinators and data managers: results from a web-based survey of professionals from contract research organizations","authors":"Susanna Yedro , Elena Tinari , Daniele Napolitano , Giulia Wlderk , Eleonora Ribaudi , Luciana Giannone , Gianluca Ianiro , Mattia Bozzetti , Antonio Gasbarrini , Vincenzina Mora","doi":"10.1016/j.conctc.2025.101533","DOIUrl":"10.1016/j.conctc.2025.101533","url":null,"abstract":"<div><h3>Introduction</h3><div>The evolution of clinical trials has made it essential to introduce specific roles, such as Clinical Study Coordinator (CSC) and Data Manager (DM), into the research process. Their responsibilities sometimes overlap, creating operational challenges in the workplace. This study aims to determine how personnel at Contract Research Organizations (CROs) perceive the differences between the CSC and DM roles, assess their functional overlap, and identify areas where greater role clarity and training are needed to improve operational efficiency.</div></div><div><h3>Methods</h3><div>An online survey instrument was used to gather data from CRO professionals through an internet-based questionnaire. The survey gathered sociodemographic data and included a knowledge assessment of 18 items and a 9-item role responsibilities section. Participants were stratified into three ability groups using Item Response Theory (IRT) analysis based on a Rasch model. McNemar's tests and non-parametric tests analyzed knowledge discrepancies and perceptual contradictions.</div></div><div><h3>Results</h3><div>A total of 122 participants completed the survey. Most partecipants (98.4 %) identified the CSC as the primary figure within a research center, and 77.9 % considered the CSC essential for clinical trial execution. Regarding functional overlap, 57.4 % of respondents believed that the CSC could perform the duties of a DM, whereas only 42.6 % thought the DM could assume the CSC's responsibilities. Participants with lower levels of knowledge demonstrated a higher rate of contradictory responses, indicating greater difficulty distinguishing between the two roles.</div></div><div><h3>Conclusion</h3><div>Study findings demonstrate an overwhelming preference for CSCs, who play a key versatile role in managing clinical trials. The insufficient theoretical understanding of the different duties of CSCs and DMs hampers operational efficiency. Establishing standard training programs combined with harmonization is essential to defining roles, enhancing teamwork, and providing quality clinical research practices.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101533"},"PeriodicalIF":1.4,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144810179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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