Pub Date : 2026-03-01Epub Date: 2026-01-21DOI: 10.1016/j.cct.2026.108240
Peter May , Samantha Smith , Mariama Jallow , Tracy Kalinjuna , Aline De Vlemnick , Orphé Matthys , Vincent Van Goethem , Mogens Groenvold , Suzanne Guerin , Elena Turola , Evi Bakker , Kevin Brazil , Richard Harding , Laurel Northouse , Peter Hudson , Joachim Cohen , Charles Normand , On behalf of the DIAdIC consortium
Background
Cancer is among the largest drivers of morbidity and mortality worldwide, causing physical, psychological and emotional strain for both patients and caregivers.
Aim
We estimated the cost-effectiveness of two dyadic psychoeducational interventions (FOCUS+ and iFOCUS) compared to usual care for people with advanced cancer and their primary family caregiver.
Methods
This was an economic evaluation within a clinical trial. Patient-caregiver dyads were recruited in Belgium, Denmark, Ireland, Italy, Netherlands and the UK from 2021 to 2023. We estimated costs by combining questionnaire responses with unit costs in euros (€) for 2022 and calculated outcomes as quality-adjusted life years (QALYs). Primary endpoint was 12 weeks, with secondary analysis at 24 weeks (trial exit).
Results
We recruited 431 dyads (140 FOCUS+, 148 iFOCUS, 143 usual care), of whom 281 (65%) participated to trial end. In primary analysis, estimated treatment effect of FOCUS+ versus usual care on total costs was +€253 (95% CI: −1440 to +3466), and estimated effect on QALYs was +0.010 (−0.02 to +0.04). For iFOCUS compared to usual care, the estimated effects were -€178 (−3047 to +2059) and − 0.001 (−0.04 to +0.04). Estimated incremental cost-effectiveness compared to usual care was highly uncertain in primary analysis, and in sensitivity analyses to timeframe and perspective.
Conclusion
Two dyadic, psychoeducational interventions for people with advanced cancer and their caregivers were not found to have a significant effect on costs, QALYs or cost-effectiveness compared to usual care. Multiple additional lessons for future trials in serious illness have been identified.
Trial registration
Registration on ClinicalTrials.gov on 12/11/2020, identifier NCT04626349.
{"title":"Assessing the cost-effectiveness of two psychoeducational interventions for people with cancer and their caregivers: An economic evaluation of the multi-country DIAdIC trial","authors":"Peter May , Samantha Smith , Mariama Jallow , Tracy Kalinjuna , Aline De Vlemnick , Orphé Matthys , Vincent Van Goethem , Mogens Groenvold , Suzanne Guerin , Elena Turola , Evi Bakker , Kevin Brazil , Richard Harding , Laurel Northouse , Peter Hudson , Joachim Cohen , Charles Normand , On behalf of the DIAdIC consortium","doi":"10.1016/j.cct.2026.108240","DOIUrl":"10.1016/j.cct.2026.108240","url":null,"abstract":"<div><h3>Background</h3><div>Cancer is among the largest drivers of morbidity and mortality worldwide, causing physical, psychological and emotional strain for both patients and caregivers.</div></div><div><h3>Aim</h3><div>We estimated the cost-effectiveness of two dyadic psychoeducational interventions (FOCUS+ and iFOCUS) compared to usual care for people with advanced cancer and their primary family caregiver.</div></div><div><h3>Methods</h3><div>This was an economic evaluation within a clinical trial. Patient-caregiver dyads were recruited in Belgium, Denmark, Ireland, Italy, Netherlands and the UK from 2021 to 2023. We estimated costs by combining questionnaire responses with unit costs in euros (€) for 2022 and calculated outcomes as quality-adjusted life years (QALYs). Primary endpoint was 12 weeks, with secondary analysis at 24 weeks (trial exit).</div></div><div><h3>Results</h3><div>We recruited 431 dyads (140 FOCUS+, 148 iFOCUS, 143 usual care), of whom 281 (65%) participated to trial end. In primary analysis, estimated treatment effect of FOCUS+ versus usual care on total costs was +€253 (95% CI: −1440 to +3466), and estimated effect on QALYs was +0.010 (−0.02 to +0.04). For iFOCUS compared to usual care, the estimated effects were -€178 (−3047 to +2059) and − 0.001 (−0.04 to +0.04). Estimated incremental cost-effectiveness compared to usual care was highly uncertain in primary analysis, and in sensitivity analyses to timeframe and perspective.</div></div><div><h3>Conclusion</h3><div>Two dyadic, psychoeducational interventions for people with advanced cancer and their caregivers were not found to have a significant effect on costs, QALYs or cost-effectiveness compared to usual care. Multiple additional lessons for future trials in serious illness have been identified.</div></div><div><h3>Trial registration</h3><div>Registration on <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> on 12/11/2020, identifier <span><span>NCT04626349</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108240"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146040632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Type 2 diabetes (T2D) is one of the most common non-communicable diseases worldwide. Current guidelines for prediabetes or T2D ((pre)diabetes) management include lifestyle modifications with or without medication. Recent evidence has indicated improvement in glycemia with gut-centric interventions (probiotics, prebiotics, or synbiotics) among (pre)diabetic patients. This study aims to explore the effect of a lifestyle intervention (exercise and dietary modification) with/without synbiotics on metabolic, physical, mental and gut health of (pre)diabetic Indian adults compared to standard of care (SOC).
Methods and analysis
The calculated sample-size is 108 participants (including 25% dropouts), both sexes, 25–75 years of age, body mass index (BMI)18.5–34.9 kg/m2 with either fasting, postprandial glucose or HbA1c above normal as per the American Diabetes Association (ADA, 2024). Participants will be randomized into one of 3 groups: SOC, lifestyle modification with synbiotics (LS + SYN), or lifestyle modification with placebo (LS + PLA). SOC group will follow routine practice, LS + SYN group will receive multimodal lifestyle-intervention (exercise, dietary modifications including a nutritional supplement) with synbiotic supplementation, while LS + PLA group will be enrolled for the same intervention with placebo supplementation for 12 weeks. Changes in metabolic, physical, mental and gut health will be compared between the 3 groups.
Discussion
This exploratory randomized trial will assess the effectiveness of a multimodal lifestyle intervention with a gut centric approach in the management of different domains of health among (pre)diabetic adults. Since both lifestyle and gut-centric interventions individually have provided promising results, it is important to understand their combined effect to optimize management of this disease.
{"title":"A multimodal lifestyle intervention program targeting the muscle and gut to improve metabolic health among Indian adults with (pre)diabetes: Design of the GUT-DM randomized trial","authors":"Shinjini Bhattacharya , Ardy van Helvoort , Annemie M.W.J. Schols , Sucharita Sambashivaiah","doi":"10.1016/j.cct.2026.108228","DOIUrl":"10.1016/j.cct.2026.108228","url":null,"abstract":"<div><h3>Introduction</h3><div>Type 2 diabetes (T2D) is one of the most common non-communicable diseases worldwide. Current guidelines for prediabetes or T2D ((pre)diabetes) management include lifestyle modifications with or without medication. Recent evidence has indicated improvement in glycemia with gut-centric interventions (probiotics, prebiotics, or synbiotics) among (pre)diabetic patients. This study aims to explore the effect of a lifestyle intervention (exercise and dietary modification) with/without synbiotics on metabolic, physical, mental and gut health of (pre)diabetic Indian adults compared to standard of care (SOC).</div></div><div><h3>Methods and analysis</h3><div>The calculated sample-size is 108 participants (including 25% dropouts), both sexes, 25–75 years of age, body mass index (BMI)18.5–34.9 kg/m<sup>2</sup> with either fasting, postprandial glucose or HbA1c above normal as per the American Diabetes Association (ADA, 2024). Participants will be randomized into one of 3 groups: SOC, lifestyle modification with synbiotics (LS + SYN), or lifestyle modification with placebo (LS + PLA). SOC group will follow routine practice, LS + SYN group will receive multimodal lifestyle-intervention (exercise, dietary modifications including a nutritional supplement) with synbiotic supplementation, while LS + PLA group will be enrolled for the same intervention with placebo supplementation for 12 weeks. Changes in metabolic, physical, mental and gut health will be compared between the 3 groups.</div></div><div><h3>Discussion</h3><div>This exploratory randomized trial will assess the effectiveness of a multimodal lifestyle intervention with a gut centric approach in the management of different domains of health among (pre)diabetic adults. Since both lifestyle and gut-centric interventions individually have provided promising results, it is important to understand their combined effect to optimize management of this disease.</div></div><div><h3>Trial registry</h3><div>Clinical trials registry-India (CTRI), registration number: CTRI/2022/08/045096.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108228"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146003126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-03-01Epub Date: 2026-01-30DOI: 10.1016/j.cct.2026.108247
Deborah Carey , Cheri Tolle , John Kim , Timothy Mullett , Aurora Occa , Anne E. Ray , Jerod L. Stapleton
Background
Community hospitals often lack research infrastructure, leading to fewer research opportunities for patients and low trial accrual rates. In practice, community hospitals can develop partnerships with academic facilities to refer patients for research opportunities but there is a dearth of research related to facilitating such referrals. We developed and implemented the Clinical Trial Referral Ambassadors (CTRA) training program to support trial referral efforts by nurses and clinic staff at community hospitals. This report describes CTRA and results from a formative evaluation.
Methods
CTRA was designed to create clinical research referral “Ambassadors” among nurses and research staff at community hospitals who can speak confidently to physicians and patients about the referral process and assist in facilitating referral activities. CTRA is grounded in best practices for community oncology training programs and includes didactic and interactive sessions, communication skills building, and self-assessment/discussions. The program evaluation included a post-training survey to assess acceptability and preliminary outcomes.
Results
Of the 25 individuals enrolled in CTRA, 13 (52%) attended all training sessions and 9 (36%) engaged in at least one session. Training acceptability ratings (evaluation survey n = 16) were favorable and participants reported high levels of confidence in their ability to refer patients, understanding of trials, and motivation to increase referrals after CTRA.
Conclusion
Preliminary evidence suggests the CTRA is acceptable and increased participants' knowledge, motivation, and skills for referring patients to clinical research. Future directions include identifying strategies to bolster CTRA participation and testing the impact of CTRA on trial referral rates.
{"title":"The Clinical Trial Referral Ambassadors program to promote clinical trial referrals within rural community hospitals: A formative program evaluation study","authors":"Deborah Carey , Cheri Tolle , John Kim , Timothy Mullett , Aurora Occa , Anne E. Ray , Jerod L. Stapleton","doi":"10.1016/j.cct.2026.108247","DOIUrl":"10.1016/j.cct.2026.108247","url":null,"abstract":"<div><h3>Background</h3><div>Community hospitals often lack research infrastructure, leading to fewer research opportunities for patients and low trial accrual rates. In practice, community hospitals can develop partnerships with academic facilities to refer patients for research opportunities but there is a dearth of research related to facilitating such referrals. We developed and implemented the Clinical Trial Referral Ambassadors (CTRA) training program to support trial referral efforts by nurses and clinic staff at community hospitals. This report describes CTRA and results from a formative evaluation.</div></div><div><h3>Methods</h3><div>CTRA was designed to create clinical research referral “Ambassadors” among nurses and research staff at community hospitals who can speak confidently to physicians and patients about the referral process and assist in facilitating referral activities. CTRA is grounded in best practices for community oncology training programs and includes didactic and interactive sessions, communication skills building, and self-assessment/discussions. The program evaluation included a post-training survey to assess acceptability and preliminary outcomes.</div></div><div><h3>Results</h3><div>Of the 25 individuals enrolled in CTRA, 13 (52%) attended all training sessions and 9 (36%) engaged in at least one session. Training acceptability ratings (evaluation survey <em>n</em> = 16) were favorable and participants reported high levels of confidence in their ability to refer patients, understanding of trials, and motivation to increase referrals after CTRA.</div></div><div><h3>Conclusion</h3><div>Preliminary evidence suggests the CTRA is acceptable and increased participants' knowledge, motivation, and skills for referring patients to clinical research. Future directions include identifying strategies to bolster CTRA participation and testing the impact of CTRA on trial referral rates.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108247"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146099560","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-03-01Epub Date: 2026-02-03DOI: 10.1016/j.cct.2026.108250
Elizabeth Campbell , Andrea Cassells , T.J. Lin , Jacqeline Cortez Lainez , Arlene Smaldone , Pooja Desai , Haomiao Jia , George Hripcsak , Jonathan Tobin , Lena Mamykina
Objective
Approaches to randomized clinical trial (RCT) implementation changed during the COVID-19 pandemic as clinical trials transitioned to largely virtual implementation which may continue in the future. Without careful consideration, virtual RCTs may exacerbate the historical under-representation of women, the elderly, and racial and ethnic minorities that has occurred in the past. The following study presents an approach to virtualizing an RCT for an mHealth intervention.
Materials and methods
Study participants were recruited from Federally Qualified Health Centers in medically underserved areas of the New York City metropolitan area. Recruitment began in January 2020 but was paused in March 2020 due to the COVID-19 pandemic's onset. The research team developed a virtual protocol for recruitment, onboarding, and study implementation.
Results
Study participants were predominantly from immigrant, low-income, and racial and ethnic minority groups. Our virtualization approach included an easier-to-understand consent form, expanded virtual training materials, and greater one-on-one attention during training. Despite the transition to virtual protocols, we did not detect statistically significant differences in key demographic characteristics, clinical factors, or mobile device proficiency between recruitment modalities, though the small in-person sample size (n = 21) limits definitive conclusions about selection bias.
Discussion
Our study represents an early investigation into how the change from in-person clinical trial recruitment and study implementation to virtual during the COVID-19 pandemic may impact recruitment of participants from medically underserved communities into RCTs.
Conclusion
This approach may be used in future trials testing mHealth and other technological interventions without exacerbating the under-representation of medically underserved populations.
{"title":"Impact of clinical trial virtualization on recruitment in underserved communities for a type 2 diabetes mHealth intervention","authors":"Elizabeth Campbell , Andrea Cassells , T.J. Lin , Jacqeline Cortez Lainez , Arlene Smaldone , Pooja Desai , Haomiao Jia , George Hripcsak , Jonathan Tobin , Lena Mamykina","doi":"10.1016/j.cct.2026.108250","DOIUrl":"10.1016/j.cct.2026.108250","url":null,"abstract":"<div><h3>Objective</h3><div>Approaches to randomized clinical trial (RCT) implementation changed during the COVID-19 pandemic as clinical trials transitioned to largely virtual implementation which may continue in the future. Without careful consideration, virtual RCTs may exacerbate the historical under-representation of women, the elderly, and racial and ethnic minorities that has occurred in the past. The following study presents an approach to virtualizing an RCT for an mHealth intervention.</div></div><div><h3>Materials and methods</h3><div>Study participants were recruited from Federally Qualified Health Centers in medically underserved areas of the New York City metropolitan area. Recruitment began in January 2020 but was paused in March 2020 due to the COVID-19 pandemic's onset. The research team developed a virtual protocol for recruitment, onboarding, and study implementation.</div></div><div><h3>Results</h3><div>Study participants were predominantly from immigrant, low-income, and racial and ethnic minority groups. Our virtualization approach included an easier-to-understand consent form, expanded virtual training materials, and greater one-on-one attention during training. Despite the transition to virtual protocols, we did not detect statistically significant differences in key demographic characteristics, clinical factors, or mobile device proficiency between recruitment modalities, though the small in-person sample size (<em>n</em> = 21) limits definitive conclusions about selection bias.</div></div><div><h3>Discussion</h3><div>Our study represents an early investigation into how the change from in-person clinical trial recruitment and study implementation to virtual during the COVID-19 pandemic may impact recruitment of participants from medically underserved communities into RCTs.</div></div><div><h3>Conclusion</h3><div>This approach may be used in future trials testing mHealth and other technological interventions without exacerbating the under-representation of medically underserved populations.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108250"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146124141","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-03-01Epub Date: 2026-01-07DOI: 10.1016/j.cct.2025.108213
Diana Anena , Elizabeth Chappell , Rashidah Nazzinda , Cecilia Kiilu , Moses Chitsamatanga , Tiyara Arumugam , Alexandra Green , Cissy Kityo Mutuluuza , Mutsa Bwakura-Dangarembizi , Abraham Siika , Moherndran Archary , Lungile Jafta , Stella Namukwaya , Janet Seeley , George Akabwai , Henry Mugerwa , Lisanne Bevers , David Burger , Simon Walker , Alasdair Bamford , Sarah L. Pett
Background
Alternatives to daily oral antiretroviral therapy (ART) are important for adolescents with HIV (AHIV) to improve adherence and outcomes. Long-Acting-injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) has demonstrated excellent efficacy and safety and strong patient preference in adults.
Methods
LATA is an ongoing randomised, open-label, 96-week, non-inferiority trial evaluating the efficacy, safety and acceptability of LAI CAB/RPV vs. daily oral therapy with tenofovir (disoproxil fumarate or alafenamide)/lamivudine/dolutegravir (TLD). Participants are virologically suppressed AHIV aged 12- < 20 years in Kenya/South Africa/Uganda/Zimbabwe. Randomisation was 1:1 to LAI CAB/RPV given once every 8 weeks (after optional oral lead-in) or daily oral TLD. The primary outcome is viral rebound (two consecutive viral loads ≥50 copies/mL by 96-weeks). Viral loads are measured every 24 weeks. The trial employs the Smooth Away From the Expected (SAFE) non-inferiority frontier, where the non-inferiority margin depends on the observed event rate in the control arm. Secondary outcomes include confirmed viral load ≥200 copies/mL by 96-weeks, HIV resistance, safety, patient-reported outcomes and cost-effectiveness. LAI participants return to oral ART at confirmed viral load ≥200 copies/mL; LAI participants who become pregnant are given the choice to continue on LAI or to switch back to daily oral ART, with optional pharmacokinetic sampling during pregnancy and post-partum in both groups. Enrolment of 476 AHIV completed in April 2024. Results will be reported in 2026.
Conclusion
LATA is the first trial comparing the efficacy, safety and acceptability of LAI CAB/RPV to oral ART in AHIV, enrolled in Sub-Saharan Africa, using a programmatic approach to viral load testing.
Trial registration: This trial has been registered with ClinicalTrials.gov (NCT05154747).
{"title":"Trial design and enrolment characteristics of LATA (Long-Acting Treatment in Adolescents): A randomised, open-label, non-inferiority, 96-week trial evaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen cabotegravir/ rilpivirine compared to daily oral therapy in virologically suppressed adolescents with HIV-1 infection, aged 12 to <20 years, in Sub-Saharan Africa","authors":"Diana Anena , Elizabeth Chappell , Rashidah Nazzinda , Cecilia Kiilu , Moses Chitsamatanga , Tiyara Arumugam , Alexandra Green , Cissy Kityo Mutuluuza , Mutsa Bwakura-Dangarembizi , Abraham Siika , Moherndran Archary , Lungile Jafta , Stella Namukwaya , Janet Seeley , George Akabwai , Henry Mugerwa , Lisanne Bevers , David Burger , Simon Walker , Alasdair Bamford , Sarah L. Pett","doi":"10.1016/j.cct.2025.108213","DOIUrl":"10.1016/j.cct.2025.108213","url":null,"abstract":"<div><h3>Background</h3><div>Alternatives to daily oral antiretroviral therapy (ART) are important for adolescents with HIV (AHIV) to improve adherence and outcomes. Long-Acting-injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) has demonstrated excellent efficacy and safety and strong patient preference in adults.</div></div><div><h3>Methods</h3><div>LATA is an ongoing randomised, open-label, 96-week, non-inferiority trial evaluating the efficacy, safety and acceptability of LAI CAB/RPV vs. daily oral therapy with tenofovir (disoproxil fumarate or alafenamide)/lamivudine/dolutegravir (TLD). Participants are virologically suppressed AHIV aged 12- < 20 years in Kenya/South Africa/Uganda/Zimbabwe. Randomisation was 1:1 to LAI CAB/RPV given once every 8 weeks (after optional oral lead-in) or daily oral TLD. The primary outcome is viral rebound (two consecutive viral loads ≥50 copies/mL by 96-weeks). Viral loads are measured every 24 weeks. The trial employs the Smooth Away From the Expected (SAFE) non-inferiority frontier, where the non-inferiority margin depends on the observed event rate in the control arm. Secondary outcomes include confirmed viral load ≥200 copies/mL by 96-weeks, HIV resistance, safety, patient-reported outcomes and cost-effectiveness. LAI participants return to oral ART at confirmed viral load ≥200 copies/mL; LAI participants who become pregnant are given the choice to continue on LAI or to switch back to daily oral ART, with optional pharmacokinetic sampling during pregnancy and post-partum in both groups. Enrolment of 476 AHIV completed in April 2024. Results will be reported in 2026.</div></div><div><h3>Conclusion</h3><div>LATA is the first trial comparing the efficacy, safety and acceptability of LAI CAB/RPV to oral ART in AHIV, enrolled in Sub-Saharan Africa, using a programmatic approach to viral load testing.</div><div><strong>Trial registration:</strong> This trial has been registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT05154747</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108213"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145942790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-03-01Epub Date: 2026-01-13DOI: 10.1016/j.cct.2026.108222
D. Brad Rindal, Stephen Asche, Elyse Kharbanda, Bryan Michalowicz, Don Worley, Meghan Jaka, Kay Kromrey, Linda Fletcher, Amanda Gillesby, Sarah Basile, Patricia L. Mabry
Background
Human papillomavirus is a prevalent DNA virus and the leading cause of both oropharyngeal and cervical cancer. Despite the availability of an effective vaccine (HPV-V), uptake is below national targets. A behavioral intervention, Increasing HPV Vaccine Uptake – Delivered in Dental Settings (HPV-V Uptake-DDS), was developed to support dental providers in promoting HPV-V to their patients to help close this gap.
Objectives
This protocol for an efficacy trial of HPV-V Uptake-DDS is designed to increase HPV-V promotion by dental practitioners, and subsequent vaccine uptake among adolescent and young adult patients.
Methods
The trial will be conducted in dental clinics in a single midwestern health system utilizing a prospective, two-arm, parallel, cluster-randomized controlled design. Eighteen clinics will be randomly assigned to either the intervention or usual care. The intervention includes didactic training, clinical decision support tool embedded in the electronic dental record, tip sheet, patient education handout, and practitioner performance reports. The primary outcome is change in HPV-V promotion by practitioners. Secondary outcomes include change in HPV-V uptake by patients and changes in three behavioral mechanisms: practitioner knowledge, self-efficacy, and fear of negative consequences related to HPV-V promotion. Outcomes will be captured from the electronic health record, practitioner surveys, patient or guardian surveys, and state vaccination registries.
Conclusions
The protocol for a clinical trial will test the efficacy of the intervention and the measurement of behavioral mechanisms of action will inform which components of the intervention of needed to address barriers in different practice settings.
{"title":"Increasing HPV vaccine promotion by dental providers: A clinical trial protocol","authors":"D. Brad Rindal, Stephen Asche, Elyse Kharbanda, Bryan Michalowicz, Don Worley, Meghan Jaka, Kay Kromrey, Linda Fletcher, Amanda Gillesby, Sarah Basile, Patricia L. Mabry","doi":"10.1016/j.cct.2026.108222","DOIUrl":"10.1016/j.cct.2026.108222","url":null,"abstract":"<div><h3>Background</h3><div>Human papillomavirus is a prevalent DNA virus and the leading cause of both oropharyngeal and cervical cancer. Despite the availability of an effective vaccine (HPV-V), uptake is below national targets. A behavioral intervention, Increasing HPV Vaccine Uptake – Delivered in Dental Settings (HPV-V Uptake-DDS), was developed to support dental providers in promoting HPV-V to their patients to help close this gap.</div></div><div><h3>Objectives</h3><div>This protocol for an efficacy trial of HPV-V Uptake-DDS is designed to increase HPV-V promotion by dental practitioners, and subsequent vaccine uptake among adolescent and young adult patients.</div></div><div><h3>Methods</h3><div>The trial will be conducted in dental clinics in a single midwestern health system utilizing a prospective, two-arm, parallel, cluster-randomized controlled design. Eighteen clinics will be randomly assigned to either the intervention or usual care. The intervention includes didactic training, clinical decision support tool embedded in the electronic dental record, tip sheet, patient education handout, and practitioner performance reports. The primary outcome is change in HPV-V promotion by practitioners. Secondary outcomes include change in HPV-V uptake by patients and changes in three behavioral mechanisms: practitioner knowledge, self-efficacy, and fear of negative consequences related to HPV-V promotion. Outcomes will be captured from the electronic health record, practitioner surveys, patient or guardian surveys, and state vaccination registries.</div></div><div><h3>Conclusions</h3><div>The protocol for a clinical trial will test the efficacy of the intervention and the measurement of behavioral mechanisms of action will inform which components of the intervention of needed to address barriers in different practice settings.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108222"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145976431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-03-01Epub Date: 2026-01-17DOI: 10.1016/j.cct.2026.108217
Jinghua An , Maisha Huq , Erin Speiser , Sherry Grumet , Beth N. Peshkin , Emily Heidt , Lucile Adams-Campbell , Christopher Grisham , Samuel Tundealao , Rose Yesha , Deborah Toppmeyer , Claudine Isaacs , Lia Sorgen , Naomi Tan , Anupama Hooda-Nehra , Melanie A. Nix , Dorothy J. Reed , Jimmie Staton , Marc D. Schwartz , Anita Y. Kinney
Background
Despite national guidelines recommending germline genetic testing (GT) for cancer survivors at high risk for hereditary cancers, GT remains underutilized, particularly among underserved populations who experience significant population health differences and higher cancer mortality. Barriers at the individual, interpersonal, and system levels contribute to this underutilization. Proactive clinical outreach and technology-based tools such as chatbots may help address these barriers and streamline cancer genetic service delivery, but culturally tailored chatbot interventions have rarely been tested for efficacy in Black cancer survivors. This paper describes the formative research and protocol for a multisite, randomized controlled trial testing a streamlined care delivery model addressing multilevel barriers to GT uptake.
Methods
Using electronic health records from two health systems, we will proactively identify and enroll 428 Black patients who have a prior diagnosis of breast, ovarian, uterine, colorectal, prostate, or pancreatic cancer and meet national guideline criteria for genetic testing. Participants are randomized to either the Genetic Education Decision Assistant (GEDA), a chatbot-based intervention, or Enhanced Usual Care (EUC, a clinical letter recommending genetic counseling and testing). The primary outcome is genetic testing completion. Secondary outcomes include genetic counseling uptake, knowledge, psychological distress, and decision regret, satisfaction, and conflict.
Discussion
This ongoing trial addresses an important translational gap by developing and implementing an alternative care delivery model that includes a chatbot to provide streamlined cancer genetic services. If effective, this intervention has the potential to reduce population differences in cancer genetics care and guide cancer risk reduction, surveillance, and cascade testing.
Trial registration number: The trial is registered on clinicaltrials.gov (NCT06073626).
{"title":"Expanding access to cancer genetic care for cancer survivors: Rationale and design for a randomized controlled trial of a chatbot-based genetic education and testing","authors":"Jinghua An , Maisha Huq , Erin Speiser , Sherry Grumet , Beth N. Peshkin , Emily Heidt , Lucile Adams-Campbell , Christopher Grisham , Samuel Tundealao , Rose Yesha , Deborah Toppmeyer , Claudine Isaacs , Lia Sorgen , Naomi Tan , Anupama Hooda-Nehra , Melanie A. Nix , Dorothy J. Reed , Jimmie Staton , Marc D. Schwartz , Anita Y. Kinney","doi":"10.1016/j.cct.2026.108217","DOIUrl":"10.1016/j.cct.2026.108217","url":null,"abstract":"<div><h3>Background</h3><div>Despite national guidelines recommending germline genetic testing (GT) for cancer survivors at high risk for hereditary cancers, GT remains underutilized, particularly among underserved populations who experience significant population health differences and higher cancer mortality. Barriers at the individual, interpersonal, and system levels contribute to this underutilization. Proactive clinical outreach and technology-based tools such as chatbots may help address these barriers and streamline cancer genetic service delivery, but culturally tailored chatbot interventions have rarely been tested for efficacy in Black cancer survivors. This paper describes the formative research and protocol for a multisite, randomized controlled trial testing a streamlined care delivery model addressing multilevel barriers to GT uptake.</div></div><div><h3>Methods</h3><div>Using electronic health records from two health systems, we will proactively identify and enroll 428 Black patients who have a prior diagnosis of breast, ovarian, uterine, colorectal, prostate, or pancreatic cancer and meet national guideline criteria for genetic testing. Participants are randomized to either the Genetic Education Decision Assistant (GEDA), a chatbot-based intervention, or Enhanced Usual Care (EUC, a clinical letter recommending genetic counseling and testing). The primary outcome is genetic testing completion. Secondary outcomes include genetic counseling uptake, knowledge, psychological distress, and decision regret, satisfaction, and conflict.</div></div><div><h3>Discussion</h3><div>This ongoing trial addresses an important translational gap by developing and implementing an alternative care delivery model that includes a chatbot to provide streamlined cancer genetic services. If effective, this intervention has the potential to reduce population differences in cancer genetics care and guide cancer risk reduction, surveillance, and cascade testing.</div><div>Trial registration number: The trial is registered on <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06073626</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108217"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146003198","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-03-01Epub Date: 2026-01-18DOI: 10.1016/j.cct.2026.108231
Jennifer Erdrich , Melissa M. Carton , Adriena Hernandez , Dominique Nosie-Romo , Amanda Huber , Trevor Chapman , Colter Sanchez , William R. Montfort , Jennifer W. Bea , Angela Yung , Cynthia A. Thomson
Prehabilitation (prehab) utilizes preoperative strategies in nutrition, exercise, substance cessation, and stress reduction to optimize patients' health before surgery. Some oncology prehab studies have demonstrated an anti-inflammatory effect on the tumor microenvironment, and thereby raised the possibility of altering carcinogenesis. By increasing physical activity, prehab may be a relevant intervention for addressing obesity-related inflammation and its link to cancer. American Indian/Alaska Native populations have longstanding inequities in obesity, cancer mortality, and clinical research participation. In response, the Adaptive Prehab Approaches in Cancer Healing and Education (A.P.A.C.H.E.) Program developed collaboratively between the San Carlos Apache Healthcare Corporation and the University of Arizona. The A.P.A.C.H.E. Program is a multimodal, window of opportunity, anti-inflammatory prehab clinical trial piloted for 30 patients. The intervention entails daily walking, consumption of walnuts, supervised fitness sessions, and supportive services for 3 weeks before oncologic surgery. Feasibility is the primary outcome assessed by patient acceptability and measures of functional capacity, lifestyle behaviors, and qualitative indices. Inflammatory biomarkers from blood and tumor biospecimens are measured pre and post intervention as secondary outcomes to test responsiveness to the program. This trial has foundational components that keep it rooted in the broader field of prehab, which allows comparisons to other programs and contributes to this area of science, while being adapted to the San Carlos Apache community to improve uptake and adherence. The A.P.A.C.H.E. Program is the first prehab for American Indian/Alaska Native surgical patients and one of the earliest registered clinical trials conducted on a reservation.
{"title":"A reservation-based clinical trial on inflammatory biomarkers in American Indian/Alaska Native cancer patients: Rationale and design of the adaptive prehab approaches in cancer healing and education (APACHE) program","authors":"Jennifer Erdrich , Melissa M. Carton , Adriena Hernandez , Dominique Nosie-Romo , Amanda Huber , Trevor Chapman , Colter Sanchez , William R. Montfort , Jennifer W. Bea , Angela Yung , Cynthia A. Thomson","doi":"10.1016/j.cct.2026.108231","DOIUrl":"10.1016/j.cct.2026.108231","url":null,"abstract":"<div><div>Prehabilitation (prehab) utilizes preoperative strategies in nutrition, exercise, substance cessation, and stress reduction to optimize patients' health before surgery. Some oncology prehab studies have demonstrated an anti-inflammatory effect on the tumor microenvironment, and thereby raised the possibility of altering carcinogenesis. By increasing physical activity, prehab may be a relevant intervention for addressing obesity-related inflammation and its link to cancer. American Indian/Alaska Native populations have longstanding inequities in obesity, cancer mortality, and clinical research participation. In response, the Adaptive Prehab Approaches in Cancer Healing and Education (A.P.A.C.H.E.) Program developed collaboratively between the San Carlos Apache Healthcare Corporation and the University of Arizona. The A.P.A.C.H.E. Program is a multimodal, window of opportunity, anti-inflammatory prehab clinical trial piloted for 30 patients. The intervention entails daily walking, consumption of walnuts, supervised fitness sessions, and supportive services for 3 weeks before oncologic surgery. Feasibility is the primary outcome assessed by patient acceptability and measures of functional capacity, lifestyle behaviors, and qualitative indices. Inflammatory biomarkers from blood and tumor biospecimens are measured pre and post intervention as secondary outcomes to test responsiveness to the program. This trial has foundational components that keep it rooted in the broader field of prehab, which allows comparisons to other programs and contributes to this area of science, while being adapted to the San Carlos Apache community to improve uptake and adherence. The A.P.A.C.H.E. Program is the first prehab for American Indian/Alaska Native surgical patients and one of the earliest registered clinical trials conducted on a reservation.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108231"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146008681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-03-01Epub Date: 2026-01-13DOI: 10.1016/j.cct.2026.108224
Hannah E. Reese , W. Alan Brown , Yaerin H. Wallenberger , Kesley A. Ramsey , Lauren E. Browning , Joshua Rooks , Neda F. Gould , Jeannie-Marie Leoutsakos , Tamar Mendelson , Alexandria H. Chang , Joseph F. McGuire
Tourette Syndrome and persistent tic disorders (collectively, TS) are characterized by involuntary motor and/or vocal tics that onset in childhood. Existing evidence-based treatments—including behavior therapy and pharmacotherapy—are often only partially effective, associated with burdensome side effects, and/or inaccessible. The current paper describes a randomized controlled trial designed to compare a novel, remotely delivered mindfulness-based group intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) in 150 adults with TS. All interventions and assessments will be delivered remotely using secure telehealth platforms and online electronic data capture systems. An independent evaluator masked to treatment condition will administer all tic assessments. The primary aims of the study are to: 1) examine the efficacy of MBIT relative to PRST for tic severity and 2) investigate the mechanism by which MBIT reduces tic severity. Additional aims include: 1) examination of secondary outcomes (e.g., comorbid conditions, quality of life), and 2) exploration of the durability of any observed improvements over a 6-month follow-up. Findings have the potential to meaningfully expand the range of evidence-based treatment options available to adults with TS.
{"title":"Remote delivery of a mindfulness-based intervention for adults with tics: Protocol of a randomized controlled trial","authors":"Hannah E. Reese , W. Alan Brown , Yaerin H. Wallenberger , Kesley A. Ramsey , Lauren E. Browning , Joshua Rooks , Neda F. Gould , Jeannie-Marie Leoutsakos , Tamar Mendelson , Alexandria H. Chang , Joseph F. McGuire","doi":"10.1016/j.cct.2026.108224","DOIUrl":"10.1016/j.cct.2026.108224","url":null,"abstract":"<div><div>Tourette Syndrome and persistent tic disorders (collectively, TS) are characterized by involuntary motor and/or vocal tics that onset in childhood. Existing evidence-based treatments—including behavior therapy and pharmacotherapy—are often only partially effective, associated with burdensome side effects, and/or inaccessible. The current paper describes a randomized controlled trial designed to compare a novel, remotely delivered mindfulness-based group intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) in 150 adults with TS. All interventions and assessments will be delivered remotely using secure telehealth platforms and online electronic data capture systems. An independent evaluator masked to treatment condition will administer all tic assessments. The primary aims of the study are to: 1) examine the efficacy of MBIT relative to PRST for tic severity and 2) investigate the mechanism by which MBIT reduces tic severity. Additional aims include: 1) examination of secondary outcomes (e.g., comorbid conditions, quality of life), and 2) exploration of the durability of any observed improvements over a 6-month follow-up. Findings have the potential to meaningfully expand the range of evidence-based treatment options available to adults with TS.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108224"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145988542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-12-24DOI: 10.1016/j.cct.2025.108207
Amy Gawad , Jessica Mendoza , Megan Singleton , Ryan Majkowski , Erica Hopkins , Jordyn Carll , Cindy MacInnis , Daniel Amirault , Bahiyyah Jackson , Nichol McBee , Andrew Mould , Lindsay M. Eyzaguirre , Cecilia Pessoa-Gingerich , Shmuel Shoham , David Sullivan , Karen Lane
We implemented two outpatient randomized controlled trials of COVID-19 convalescent plasma during the COVID-19 public health crisis. Unique challenges included how to maneuver all the moving parts to precipitously mobilize and guide clinical teams and facilities through multiple review groups, to reach multiple target populations, and to share trial results. We describe how a flexible clinical trial coordinating center team approached and robustly coordinated multiple regulatory agencies and protocol changes to keep up with rapidly changing pandemic conditions and knowledge. Four agencies oversaw ethical and regulatory reviews for 26 participating sites, two protocols, and two master informed consent forms, in English and Spanish, through a two-month start-up cycle and 68 protocol and consent form changes, culminating in a national conversation of positive trial results presented in a public forum by the site investigators to trial participants. Ethical and regulatory reviews were at a faster than usual pace, sites were ready to activate in 12–15 days, and about 2 % of those transfused used Spanish language materials. Although these extraordinary practices cannot become standard, they can provide lessons for normal and emergency trial conduct. From a clinical trial coordinating center viewpoint, we recommend developing emergency interagency standard operating procedures (SOPs) for coordinating protocol reviews and emergency ceding guidelines among agencies when multiple regulatory reviews are required. English and non-English Informed Consent Forms (ICFs) developed centrally and in parallel and including a return of trial results to participants as a contact option should help trials improve participant-centered outreach.
{"title":"Clinical trial coordination of multifaceted ethical and regulatory oversight entities during the COVID-19 public health emergency","authors":"Amy Gawad , Jessica Mendoza , Megan Singleton , Ryan Majkowski , Erica Hopkins , Jordyn Carll , Cindy MacInnis , Daniel Amirault , Bahiyyah Jackson , Nichol McBee , Andrew Mould , Lindsay M. Eyzaguirre , Cecilia Pessoa-Gingerich , Shmuel Shoham , David Sullivan , Karen Lane","doi":"10.1016/j.cct.2025.108207","DOIUrl":"10.1016/j.cct.2025.108207","url":null,"abstract":"<div><div>We implemented two outpatient randomized controlled trials of COVID-19 convalescent plasma during the COVID-19 public health crisis. Unique challenges included how to maneuver all the moving parts to precipitously mobilize and guide clinical teams and facilities through multiple review groups, to reach multiple target populations, and to share trial results. We describe how a flexible clinical trial coordinating center team approached and robustly coordinated multiple regulatory agencies and protocol changes to keep up with rapidly changing pandemic conditions and knowledge. Four agencies oversaw ethical and regulatory reviews for 26 participating sites, two protocols, and two master informed consent forms, in English and Spanish, through a two-month start-up cycle and 68 protocol and consent form changes, culminating in a national conversation of positive trial results presented in a public forum by the site investigators to trial participants. Ethical and regulatory reviews were at a faster than usual pace, sites were ready to activate in 12–15 days, and about 2 % of those transfused used Spanish language materials. Although these extraordinary practices cannot become standard, they can provide lessons for normal and emergency trial conduct. From a clinical trial coordinating center viewpoint, we recommend developing emergency interagency standard operating procedures (SOPs) for coordinating protocol reviews and emergency ceding guidelines among agencies when multiple regulatory reviews are required. English and non-English Informed Consent Forms (ICFs) developed centrally and in parallel and including a return of trial results to participants as a contact option should help trials improve participant-centered outreach.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108207"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145838279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
扫码关注我们
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号