Pub Date : 2024-10-15DOI: 10.1016/j.cct.2024.107717
Amber L. Kelly , Mary Elizabeth Baugh , Monica L. Ahrens , Abigail N. Valle , Rhianna M. Sullivan , Mary E. Oster , Mary E. Fowler , Bridget E. Carter , Brenda M. Davy , Alexandra L. Hanlon , Alexandra G. DiFeliceantonio
Overconsumption of ultra-processed foods (UPFs), which are linked with adverse health outcomes, is a growing public health concern. UPFs deliver highly bioavailable calories rapidly, which may contribute to their reinforcing potential and drive overconsumption. Our primary aim is to test the role of speed of nutrient availability on reward learning. We hypothesize that brain activity in reward related areas and behavioral preferences will be greater to a flavored drink predicting rapidly available calories (CS + Fast) compared with a flavored drink predicting more slowly available (CS + Slow) or no (CS-) calories. Participants (n = 64, aged 18–45 years, will consume 3 novel flavored, isosweet beverages containing 110 kcal of sucrose (CS + Fast), 110 kcal of maltodextrin (CS + Slow), or 0-kcal sucralose (CS-) 6 times in randomized, crossover order. Blood metabolites and indirect calorimetry measures, including metabolic rate and carbohydrate oxidation, will be assessed before and for 1 h after beverage consumption. Behavioral preference for beverages will be assessed in a pre- and post-test. Brain response to each flavor without calories will be assessed via functional magnetic resonance imaging in a post-test. Findings from this study will contribute to the understanding of basic mechanisms that may drive overconsumption of UPFs.
{"title":"Neural and metabolic factors in carbohydrate reward: Rationale, design, and methods for a flavor-nutrient learning paradigm in humans","authors":"Amber L. Kelly , Mary Elizabeth Baugh , Monica L. Ahrens , Abigail N. Valle , Rhianna M. Sullivan , Mary E. Oster , Mary E. Fowler , Bridget E. Carter , Brenda M. Davy , Alexandra L. Hanlon , Alexandra G. DiFeliceantonio","doi":"10.1016/j.cct.2024.107717","DOIUrl":"10.1016/j.cct.2024.107717","url":null,"abstract":"<div><div>Overconsumption of ultra-processed foods (UPFs), which are linked with adverse health outcomes, is a growing public health concern. UPFs deliver highly bioavailable calories rapidly, which may contribute to their reinforcing potential and drive overconsumption. Our primary aim is to test the role of speed of nutrient availability on reward learning. We hypothesize that brain activity in reward related areas and behavioral preferences will be greater to a flavored drink predicting rapidly available calories (CS + Fast) compared with a flavored drink predicting more slowly available (CS + Slow) or no (CS-) calories. Participants (<em>n</em> = 64, aged 18–45 years, will consume 3 novel flavored, isosweet beverages containing 110 kcal of sucrose (CS + Fast), 110 kcal of maltodextrin (CS + Slow), or 0-kcal sucralose (CS-) 6 times in randomized, crossover order. Blood metabolites and indirect calorimetry measures, including metabolic rate and carbohydrate oxidation, will be assessed before and for 1 h after beverage consumption. Behavioral preference for beverages will be assessed in a pre- and post-test. Brain response to each flavor without calories will be assessed via functional magnetic resonance imaging in a post-test. Findings from this study will contribute to the understanding of basic mechanisms that may drive overconsumption of UPFs.</div><div><strong>Trial registration:</strong> <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> registration #<span><span>NCT06053294</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107717"},"PeriodicalIF":2.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459892","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 : 2024-10-15DOI: 10.1016/j.cct.2024.107715
Cristina Palacios, Julia Leone, Priscilla Clayton, Jacqueline Hernandez, María Angélica Trak-Fellermeier, Alison Macchi, Daniela Ramirez-Roggio, Yivani Cobo, Shanelle Bautista, Jeneene Connelly, Malik Elington, Jorge Romero, Rodolfo Galvan
Background: Pediatric recruitment into clinical trials is very challenging. A recruitment plan was designed to recruit healthy children (9–14 years) in a trial testing the 1-year effect of corn soluble fiber supplementation on bone mass. We evaluated the effectiveness and costs of the recruitment strategies used in this trial. Methods: The recruitment plan included “Traditional” (mailings, flyers, posters, visits, snowball, etc.) or “Online” (email campaigns, social media, website, etc.) strategies. All strategies led to the pre-screening online form, which asked how they learned about the study. This analysis includes the number of pre-screenings and enrollment (consents signed), ineligibility, socio-demographics, and costs per strategy. Differences were analyzed using ANOVA or chi-square. Results: 649 individuals completed the pre-screening; 37.1 % came from “Traditional”, 46.7 % from “Online”, 2.6 % from “Other”, and 13.6 % from “Unknown” strategies. The most successful strategies were related to Florida International University (posting flyers around campus and email campaigns). The main reasons for ineligibility were obesity (38.9 %) or outside the age range (22.7 %). A total of 48.4 % of the children enrolled came from “Traditional”, 50.2 % from “Online”, and 1.4 % from “Other” strategies. The cost per screened participant was $1112 for “Traditional” and $512 for “Online” strategies, and the cost per enrolled participant was $2704 for “Traditional” and $1454 for “Online” strategies. The highest costs were staff salary. Conclusion: “Online” strategies were more effective and had a lower implementation cost than “Traditional” strategies, although these were also important in achieving the recruitment goal. Future pediatric trials should consider some of these strategies and their costs.
{"title":"Effectiveness and costs of the recruitment strategies used in the MetA-Bone trial, a randomized clinical trial to test the effects of soluble corn fiber supplementation for 1 year in children","authors":"Cristina Palacios, Julia Leone, Priscilla Clayton, Jacqueline Hernandez, María Angélica Trak-Fellermeier, Alison Macchi, Daniela Ramirez-Roggio, Yivani Cobo, Shanelle Bautista, Jeneene Connelly, Malik Elington, Jorge Romero, Rodolfo Galvan","doi":"10.1016/j.cct.2024.107715","DOIUrl":"10.1016/j.cct.2024.107715","url":null,"abstract":"<div><div>Background: Pediatric recruitment into clinical trials is very challenging. A recruitment plan was designed to recruit healthy children (9–14 years) in a trial testing the 1-year effect of corn soluble fiber supplementation on bone mass. We evaluated the effectiveness and costs of the recruitment strategies used in this trial. Methods: The recruitment plan included “Traditional” (mailings, flyers, posters, visits, snowball, etc.) or “Online” (email campaigns, social media, website, etc.) strategies. All strategies led to the pre-screening online form, which asked how they learned about the study. This analysis includes the number of pre-screenings and enrollment (consents signed), ineligibility, socio-demographics, and costs per strategy. Differences were analyzed using ANOVA or chi-square. Results: 649 individuals completed the pre-screening; 37.1 % came from “Traditional”, 46.7 % from “Online”, 2.6 % from “Other”, and 13.6 % from “Unknown” strategies. The most successful strategies were related to Florida International University (posting flyers around campus and email campaigns). The main reasons for ineligibility were obesity (38.9 %) or outside the age range (22.7 %). A total of 48.4 % of the children enrolled came from “Traditional”, 50.2 % from “Online”, and 1.4 % from “Other” strategies. The cost per screened participant was $1112 for “Traditional” and $512 for “Online” strategies, and the cost per enrolled participant was $2704 for “Traditional” and $1454 for “Online” strategies. The highest costs were staff salary. Conclusion: “Online” strategies were more effective and had a lower implementation cost than “Traditional” strategies, although these were also important in achieving the recruitment goal. Future pediatric trials should consider some of these strategies and their costs.</div><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> registry number: <span><span>NCT02916862</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107715"},"PeriodicalIF":2.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142444903","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 : 2024-10-15DOI: 10.1016/j.cct.2024.107716
Jeanean B. Naqvi , Brittany Olesen , Emily Greenstadt , Jacob Carson , Bess Marcus , Job Godino , Michelle Zive , Dawn Meyer , Michael Higgins , Lilliana Osuna , Rubi Gomez , Shira Dunsiger , Britta Larsen
Background
Latina adolescents report low levels of physical activity (PA) and high lifetime risk of lifestyle-related diseases. They also have high rates of using technology, suggesting interventions delivered through mobile devices may be effective for this population. The current paper describes recruitment methods and baseline study characteristics for Chicas Fuertes, a fully powered randomized trial of a mobile technology PA intervention.
Methods
Underactive Latina adolescents (aged 13–18) were recruited using social media and presentations at local schools and community organizations in San Diego, California. Participants were randomly assigned 1:1 to either the intervention (Fitbit, tailored texting, social media, and website) or control group. Baseline measures included demographics, psychosocial variables, and PA measured by the 7-Day Physical Activity Recall (PAR), ActiGraph GT3X+ accelerometers, and Fitbits. Baseline data were collected from 2020 to 2023.
Results
Social media yielded the most contacts (465), but had the lowest chance of enrollment (14 %, vs. 52 % from school presentations). Participants (N = 160) were mostly second generation (68.8 %), and low income (61.8 %), but technology access was high (>99 %). Median self-reported moderate-to-vigorous PA (MVPA) using the 7-Day PAR was 120 min/week (range 0–720), and median daily steps were 5222 (IQR 359). Median MVPA measured by ActiGraphs, however, was 0 min per week. There was no correlation between the 7-day PAR and ActiGraphs (. However, ActiGraph MVPA was correlated with total steps recorded by the Fitbit ().
Conclusions
Both remote and in-person approaches were successful in recruiting a sample that was underactive and low income, but had high technology use.
{"title":"Randomized controlled trial of a multiple technology-based physical activity intervention for Latina adolescents: Recruitment strategies and baseline data from the Chicas Fuertes trial","authors":"Jeanean B. Naqvi , Brittany Olesen , Emily Greenstadt , Jacob Carson , Bess Marcus , Job Godino , Michelle Zive , Dawn Meyer , Michael Higgins , Lilliana Osuna , Rubi Gomez , Shira Dunsiger , Britta Larsen","doi":"10.1016/j.cct.2024.107716","DOIUrl":"10.1016/j.cct.2024.107716","url":null,"abstract":"<div><h3>Background</h3><div>Latina adolescents report low levels of physical activity (PA) and high lifetime risk of lifestyle-related diseases. They also have high rates of using technology, suggesting interventions delivered through mobile devices may be effective for this population. The current paper describes recruitment methods and baseline study characteristics for <em>Chicas Fuertes</em>, a fully powered randomized trial of a mobile technology PA intervention.</div></div><div><h3>Methods</h3><div>Underactive Latina adolescents (aged 13–18) were recruited using social media and presentations at local schools and community organizations in San Diego, California. Participants were randomly assigned 1:1 to either the intervention (Fitbit, tailored texting, social media, and website) or control group. Baseline measures included demographics, psychosocial variables, and PA measured by the 7-Day Physical Activity Recall (PAR), ActiGraph GT3X+ accelerometers, and Fitbits. Baseline data were collected from 2020 to 2023.</div></div><div><h3>Results</h3><div>Social media yielded the most contacts (465), but had the lowest chance of enrollment (14 %, vs. 52 % from school presentations). Participants (<em>N</em> = 160) were mostly second generation (68.8 %), and low income (61.8 %), but technology access was high (>99 %). Median self-reported moderate-to-vigorous PA (MVPA) using the 7-Day PAR was 120 min/week (range 0–720), and median daily steps were 5222 (IQR 359). Median MVPA measured by ActiGraphs, however, was 0 min per week<strong>.</strong> There was no correlation between the 7-day PAR and ActiGraphs (<span><math><mi>ρ</mi><mo>=</mo><mn>.13</mn><mo>,</mo><mi>p</mi><mo>=</mo><mn>.12</mn><mo>)</mo></math></span>. However, ActiGraph MVPA was correlated with total steps recorded by the Fitbit (<span><math><mi>ρ</mi><mo>=</mo><mn>.38</mn><mo>,</mo><mi>p</mi><mo><</mo><mn>.001</mn></math></span>).</div></div><div><h3>Conclusions</h3><div>Both remote and in-person approaches were successful in recruiting a sample that was underactive and low income, but had high technology use.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107716"},"PeriodicalIF":2.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459893","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 : 2024-10-11DOI: 10.1016/j.cct.2024.107711
Rebecca A. Krukowski , Kelsey R. Day , Wen You , Christine A. Pellegrini , Delia S. West
Background
Rural residents are more impacted by obesity and related comorbidities than their urban counterparts. Digital weight management interventions may produce meaningful weight loss among rural residents.
Objectives
The iREACH Rural Study aims to identify “high-touch” component(s) that contribute to meaningful weight loss (≥1.5 kg) at 6-months, over and above what the 24-week core online program produces. Three treatment components are assessed: group video sessions (yes/no); self-monitoring feedback (counselor-crafted/pre-scripted, modular); and individual coaching calls (yes/no).
Design
The iREACH Rural Study is a factorial experiment (n = 616).
Methods
Participants receive up to 3 “high-touch” components (weekly synchronous facilitated group video sessions, weekly counselor-crafted self-monitoring feedback, and individual coaching calls) to determine which contribute meaningfully to 6-month weight loss. Participants complete assessments at baseline, 2 months, 6 months, and 12 months. Weight loss at 6 months (primary outcome) and 12 months (secondary outcome) is measured by Bluetooth-enabled scales. The study seeks to identify the weight loss approach for underserved rural residents which optimizes weight change outcomes and also examines costs associated with delivering different treatment constellations.
Summary
The iREACH Rural Study is the first of its kind to isolate digital weight loss intervention components to determine which meaningfully contribute to long-term weight loss among rural residing individuals. The results may be used to refine digital weight loss programs by enhancing their effectiveness to allow broad dissemination.
{"title":"Addressing rural health disparities by optimizing “high-touch” intervention components in digital obesity treatment: The iREACH Rural study","authors":"Rebecca A. Krukowski , Kelsey R. Day , Wen You , Christine A. Pellegrini , Delia S. West","doi":"10.1016/j.cct.2024.107711","DOIUrl":"10.1016/j.cct.2024.107711","url":null,"abstract":"<div><h3>Background</h3><div>Rural residents are more impacted by obesity and related comorbidities than their urban counterparts. Digital weight management interventions may produce meaningful weight loss among rural residents.</div></div><div><h3>Objectives</h3><div>The iREACH Rural Study aims to identify “high-touch” component(s) that contribute to meaningful weight loss (≥1.5 kg) at 6-months, over and above what the 24-week core online program produces. Three treatment components are assessed: group video sessions (yes/no); self-monitoring feedback (counselor-crafted/pre-scripted, modular); and individual coaching calls (yes/no).</div></div><div><h3>Design</h3><div>The iREACH Rural Study is a factorial experiment (<em>n</em> = 616).</div></div><div><h3>Methods</h3><div>Participants receive up to 3 “high-touch” components (weekly synchronous facilitated group video sessions, weekly counselor-crafted self-monitoring feedback, and individual coaching calls) to determine which contribute meaningfully to 6-month weight loss. Participants complete assessments at baseline, 2 months, 6 months, and 12 months. Weight loss at 6 months (primary outcome) and 12 months (secondary outcome) is measured by Bluetooth-enabled scales. The study seeks to identify the weight loss approach for underserved rural residents which optimizes weight change outcomes and also examines costs associated with delivering different treatment constellations.</div></div><div><h3>Summary</h3><div>The iREACH Rural Study is the first of its kind to isolate digital weight loss intervention components to determine which meaningfully contribute to long-term weight loss among rural residing individuals. The results may be used to refine digital weight loss programs by enhancing their effectiveness to allow broad dissemination.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107711"},"PeriodicalIF":2.0,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459889","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 : 2024-10-10DOI: 10.1016/j.cct.2024.107713
Samantha A. Carreon , Charles G. Minard , Sarah K. Lyons , Wendy Levy , Stephanie Camey , Kishan Desai , Brenda Duran , Randi Streisand , Barbara J. Anderson , Siripoom V. McKay , Tricia S. Tang , Sridevi Devaraj , Ryan Ramphul , Marisa E. Hilliard
Background
Type 1 diabetes (T1D) management is challenging for young adults, who are expected to transfer from the pediatric to adult T1D healthcare system while also managing typical developmental demands (e.g., social, financial, work/school, residential). Many young adults have extended gaps in care before following up in adult care, increasing risk for poor health outcomes. There are few evidence-based programs to support young adults with T1D to promote a timelier transition during this period. This paper reports on the design of DiaBetter Together, a randomized controlled trial to evaluate a 12-month Peer Mentor-delivered intervention compared to usual care among young adults with T1D during the transfer from pediatric to adult care.
Methods
One-hundred young adults (age 17–25) with T1D and 29 Peer Mentors enrolled in this randomized clinical trial. Peer Mentors are experienced, older young adults with T1D, trained by the study team to share transition experiences and strategies to successfully navigate the adult healthcare system, help young adults prepare for the first adult care visit, and use strengths-based support strategies to teach and model skills for managing T1D-related challenges.
Results
The primary outcome of the trial is HbA1c, and secondary outcomes include time to adult care, engagement in diabetes self-management behaviors, and psychosocial well-being.
Conclusion
The goal of this research is to evaluate a developmentally appropriate, supportive intervention that can improve T1D self-management and successful transfer of care during the difficult young adult years and promote optimal T1D health outcomes.
{"title":"DiaBetter Together: Clinical trial protocol for a strengths-based Peer Mentor intervention for young adults with type 1 diabetes transitioning to adult care","authors":"Samantha A. Carreon , Charles G. Minard , Sarah K. Lyons , Wendy Levy , Stephanie Camey , Kishan Desai , Brenda Duran , Randi Streisand , Barbara J. Anderson , Siripoom V. McKay , Tricia S. Tang , Sridevi Devaraj , Ryan Ramphul , Marisa E. Hilliard","doi":"10.1016/j.cct.2024.107713","DOIUrl":"10.1016/j.cct.2024.107713","url":null,"abstract":"<div><h3>Background</h3><div>Type 1 diabetes (T1D) management is challenging for young adults, who are expected to transfer from the pediatric to adult T1D healthcare system while also managing typical developmental demands (e.g., social, financial, work/school, residential). Many young adults have extended gaps in care before following up in adult care, increasing risk for poor health outcomes. There are few evidence-based programs to support young adults with T1D to promote a timelier transition during this period. This paper reports on the design of DiaBetter Together, a randomized controlled trial to evaluate a 12-month Peer Mentor-delivered intervention compared to usual care among young adults with T1D during the transfer from pediatric to adult care.</div></div><div><h3>Methods</h3><div>One-hundred young adults (age 17–25) with T1D and 29 Peer Mentors enrolled in this randomized clinical trial. Peer Mentors are experienced, older young adults with T1D, trained by the study team to share transition experiences and strategies to successfully navigate the adult healthcare system, help young adults prepare for the first adult care visit, and use strengths-based support strategies to teach and model skills for managing T1D-related challenges.</div></div><div><h3>Results</h3><div>The primary outcome of the trial is HbA1c, and secondary outcomes include time to adult care, engagement in diabetes self-management behaviors, and psychosocial well-being.</div></div><div><h3>Conclusion</h3><div>The goal of this research is to evaluate a developmentally appropriate, supportive intervention that can improve T1D self-management and successful transfer of care during the difficult young adult years and promote optimal T1D health outcomes.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107713"},"PeriodicalIF":2.0,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459891","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 : 2024-10-10DOI: 10.1016/j.cct.2024.107712
N.L. Henry , J.M. Unger , R. Vaidya , A.K. Darke , T.C. Skaar , M.J. Fisch , D.L. Hershman
Background
Premenopausal women with early stage, high risk hormone receptor positive breast cancer are at risk of early discontinuation of adjuvant endocrine therapy (ET), primarily because of toxicity, which can increase the risk of disease recurrence and death. We hypothesize that identification of bothersome symptoms between clinic visits, and automated notification of clinicians about symptoms, will result in improved persistence with ET.
Methods
Pre- and perimenopausal women planning to receive adjuvant treatment with tamoxifen or an aromatase inhibitor plus ovarian function suppression or ablation for treatment of breast cancer are eligible. A total of 540 participants will be enrolled and randomized 1:1 to patient education with or without Active Symptom Monitoring (ASM). The ASM intervention includes 6 symptom questions (hot flashes, sadness, anxiety, insomnia, vaginal dryness, joint pain) that will be completed via text, email, or telephone weekly for 24 weeks, then every 4 weeks for 48 weeks. All participants will complete a battery of questionnaires every 12 weeks to examine symptoms, beliefs about medicine, self-efficacy, and ET adherence. Optional blood draws will be collected at baseline and after 12, 48, and 72 weeks of therapy to examine estradiol and ET concentrations. The primary endpoint is time to nonpersistence with initially prescribed ET within the first 72 weeks, evaluated using Kaplan-Meier plots and multivariable Cox regression.
Conclusion
We expect early identification and management of ET-related toxicities to improve persistence with breast cancer therapy, breast cancer outcomes, and quality of life for premenopausal women at high risk of breast cancer recurrence.
Clinicaltrials.govNCT05568472
背景患有早期、高风险激素受体阳性乳腺癌的绝经妇女面临着过早中断辅助内分泌治疗（ET）的风险，这主要是因为毒性会增加疾病复发和死亡的风险。我们假设，在就诊间隙发现令人烦恼的症状，并将症状自动通知临床医生，将提高 ET 的坚持率。方法 计划接受他莫昔芬或芳香化酶抑制剂加卵巢功能抑制或消融辅助治疗乳腺癌的绝经前和绝经期妇女均符合条件。共有 540 名参与者将被登记，并按 1:1 随机分配接受患者教育，同时接受或不接受主动症状监测 (ASM)。ASM 干预包括 6 个症状问题（潮热、悲伤、焦虑、失眠、阴道干涩、关节疼痛），这些问题将在 24 周内每周通过短信、电子邮件或电话完成，然后在 48 周内每 4 周完成一次。所有参与者将每 12 周完成一次问卷调查，以了解症状、对药物的看法、自我效能和坚持服药的情况。在基线期以及治疗 12、48 和 72 周后，将选择性地抽血检查雌二醇和 ET 浓度。主要终点是在最初开具的 72 周内不坚持使用 ET 的时间，使用 Kaplan-Meier 图和多变量 Cox 回归进行评估。结论：我们希望及早识别和处理 ET 相关毒性，以提高乳腺癌复发风险高的绝经前妇女的乳腺癌治疗坚持率、乳腺癌预后和生活质量。
{"title":"Active symptom monitoring for premenopausal women with breast cancer initiating adjuvant endocrine therapy: Protocol for the SWOG S2010 randomized controlled efficacy trial","authors":"N.L. Henry , J.M. Unger , R. Vaidya , A.K. Darke , T.C. Skaar , M.J. Fisch , D.L. Hershman","doi":"10.1016/j.cct.2024.107712","DOIUrl":"10.1016/j.cct.2024.107712","url":null,"abstract":"<div><h3>Background</h3><div>Premenopausal women with early stage, high risk hormone receptor positive breast cancer are at risk of early discontinuation of adjuvant endocrine therapy (ET), primarily because of toxicity, which can increase the risk of disease recurrence and death. We hypothesize that identification of bothersome symptoms between clinic visits, and automated notification of clinicians about symptoms, will result in improved persistence with ET.</div></div><div><h3>Methods</h3><div>Pre- and perimenopausal women planning to receive adjuvant treatment with tamoxifen or an aromatase inhibitor plus ovarian function suppression or ablation for treatment of breast cancer are eligible. A total of 540 participants will be enrolled and randomized 1:1 to patient education with or without Active Symptom Monitoring (ASM). The ASM intervention includes 6 symptom questions (hot flashes, sadness, anxiety, insomnia, vaginal dryness, joint pain) that will be completed via text, email, or telephone weekly for 24 weeks, then every 4 weeks for 48 weeks. All participants will complete a battery of questionnaires every 12 weeks to examine symptoms, beliefs about medicine, self-efficacy, and ET adherence. Optional blood draws will be collected at baseline and after 12, 48, and 72 weeks of therapy to examine estradiol and ET concentrations. The primary endpoint is time to nonpersistence with initially prescribed ET within the first 72 weeks, evaluated using Kaplan-Meier plots and multivariable Cox regression.</div></div><div><h3>Conclusion</h3><div>We expect early identification and management of ET-related toxicities to improve persistence with breast cancer therapy, breast cancer outcomes, and quality of life for premenopausal women at high risk of breast cancer recurrence.</div><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> <span><span>NCT05568472</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107712"},"PeriodicalIF":2.0,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142444902","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 : 2024-10-10DOI: 10.1016/j.cct.2024.107710
Anna Palatnik , Nadine Sunji , Zaira Peterson , Jennifer Ohlendorf , Amy Y. Pan , Jacquelyn Kulinski
Background
Hypertensive disorders of pregnancy (HDP) complicate about 10 % of pregnancies and lead to postpartum hospital readmissions and cardiovascular complications. Following HDP, vascular dysfunction could persist and accelerate the trajectory of cardiovascular disease risk. The benefits of intensive blood pressure (BP) control following HDP have not been adequately investigated. Therefore, no standard guidelines exist to guide the management of mild-to-moderate hypertension in the postpartum period, leading to a wide variation in clinical practice. The present study will investigate the effect of intensive BP control and healthy lifestyle education on maternal cardiovascular health (CVH) and vascular function following HDP.
Methods
The Intensive Postpartum Antihypertensive Treatment (IPAT) study is a randomized controlled, two-arm, single-site, pilot trial where 60 postpartum HDP patients will be randomized 1:1 to one of two groups: 1) Intensive postpartum BP control – nifedipine initiation at BP ≥140/90 mmHg to maintain BP <140/90 mmHg; or 2) Less intensive postpartum BP control – nifedipine initiation at BP ≥150/100 mmHg to maintain BP <150/100 mmHg. All participants will also undergo vascular function assessments and receive healthy lifestyle education. The study will primarily test feasibility of all study procedures. It will secondarily examine changes in BP and CVH scores from baseline to 12 months postpartum.
Conclusion
This pilot trial will study whether the BP threshold of 140/90 is superior to 150/100 for initiation of pharmacotherapy and evaluate feasibility to ultimately conduct a trial capable of generating robust evidence to standardize clinical practice and guidelines in postpartum HDP management.
{"title":"Intensive postpartum antihypertensive treatment (IPAT) and healthy lifestyle education: Study protocol for a pilot randomized controlled trial for patients with hypertensive disorders of pregnancy","authors":"Anna Palatnik , Nadine Sunji , Zaira Peterson , Jennifer Ohlendorf , Amy Y. Pan , Jacquelyn Kulinski","doi":"10.1016/j.cct.2024.107710","DOIUrl":"10.1016/j.cct.2024.107710","url":null,"abstract":"<div><h3>Background</h3><div>Hypertensive disorders of pregnancy (HDP) complicate about 10 % of pregnancies and lead to postpartum hospital readmissions and cardiovascular complications. Following HDP, vascular dysfunction could persist and accelerate the trajectory of cardiovascular disease risk. The benefits of intensive blood pressure (BP) control following HDP have not been adequately investigated. Therefore, no standard guidelines exist to guide the management of mild-to-moderate hypertension in the postpartum period, leading to a wide variation in clinical practice. The present study will investigate the effect of intensive BP control and healthy lifestyle education on maternal cardiovascular health (CVH) and vascular function following HDP.</div></div><div><h3>Methods</h3><div>The Intensive Postpartum Antihypertensive Treatment (IPAT) study is a randomized controlled, two-arm, single-site, pilot trial where 60 postpartum HDP patients will be randomized 1:1 to one of two groups: 1) Intensive postpartum BP control – nifedipine initiation at BP ≥140/90 mmHg to maintain BP <140/90 mmHg; or 2) Less intensive postpartum BP control – nifedipine initiation at BP ≥150/100 mmHg to maintain BP <150/100 mmHg. All participants will also undergo vascular function assessments and receive healthy lifestyle education. The study will primarily test feasibility of all study procedures. It will secondarily examine changes in BP and CVH scores from baseline to 12 months postpartum.</div></div><div><h3>Conclusion</h3><div>This pilot trial will study whether the BP threshold of 140/90 is superior to 150/100 for initiation of pharmacotherapy and evaluate feasibility to ultimately conduct a trial capable of generating robust evidence to standardize clinical practice and guidelines in postpartum HDP management.</div><div>Trial registration number: <span><span>NCT05687344</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107710"},"PeriodicalIF":2.0,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142441152","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 : 2024-10-09DOI: 10.1016/j.cct.2024.107708
Christina M. Charriez , Sandra Zhang , Claudia H.M.C. de Oliveira , Vrunda Patel , Young S. Oh , Ikuo Hirano , Alain Schoepfer , Evan S. Dellon
Background
Eosinophilic esophagitis (EoE) is a chronic, immune-mediated inflammatory condition that interferes with normal food ingestion, negatively impacting quality of life (QoL). Treatment options include proton pump inhibitors, corticosteroids, biologics, or dietary elimination; however, ∼1/3 of patients remain insufficiently controlled. The pathogenesis of EoE involves interleukin-13 (IL-13); therefore, targeted IL-13 inhibition may be beneficial. In a phase 2 study, cendakimab, a recombinant, humanized anti–IL-13 monoclonal antibody, significantly reduced mean esophageal eosinophil counts and improved other inflammatory parameters in patients with EoE. These findings prompted further investigation of the efficacy and safety of cendakimab in adults and adolescents with EoE in a phase 3 registrational study (NCT04753697), the design of which is presented here.
Methods
This multicenter, multinational, randomized, double-blind, placebo-controlled, 48-week, treat-through study plans to enroll 399 adults and adolescents. Randomized patients (1:1:1) will receive subcutaneous administration of 1) cendakimab 360 mg once weekly (QW) for 48 weeks, 2) cendakimab 360 mg QW for 24 weeks followed by cendakimab 360 mg every other week (with matching placebo on alternative weeks to maintain the blind) for 24 weeks, or 3) placebo QW for 48 weeks. Co-primary endpoints are mean change from baseline in dysphagia days and proportion of patients with eosinophil histologic response, defined as peak esophageal eosinophil count ≤6 per high-power field, at 24 weeks. Secondary and exploratory endpoints will address endoscopic and histologic features, QoL, safety, and pharmacokinetic assessments.
Conclusion
This phase 3 pivotal study will determine whether cendakimab provides an effective, safe, targeted treatment for patients with EoE.
{"title":"Design of a phase 3, randomized, double-blind, placebo-controlled, 48-week study to evaluate the efficacy and safety of cendakimab in adult and adolescent patients with eosinophilic esophagitis","authors":"Christina M. Charriez , Sandra Zhang , Claudia H.M.C. de Oliveira , Vrunda Patel , Young S. Oh , Ikuo Hirano , Alain Schoepfer , Evan S. Dellon","doi":"10.1016/j.cct.2024.107708","DOIUrl":"10.1016/j.cct.2024.107708","url":null,"abstract":"<div><h3>Background</h3><div>Eosinophilic esophagitis (EoE) is a chronic, immune-mediated inflammatory condition that interferes with normal food ingestion, negatively impacting quality of life (QoL). Treatment options include proton pump inhibitors, corticosteroids, biologics, or dietary elimination; however, ∼1/3 of patients remain insufficiently controlled. The pathogenesis of EoE involves interleukin-13 (IL-13); therefore, targeted IL-13 inhibition may be beneficial. In a phase 2 study, cendakimab, a recombinant, humanized anti–IL-13 monoclonal antibody, significantly reduced mean esophageal eosinophil counts and improved other inflammatory parameters in patients with EoE. These findings prompted further investigation of the efficacy and safety of cendakimab in adults and adolescents with EoE in a phase 3 registrational study (<span><span>NCT04753697</span><svg><path></path></svg></span>), the design of which is presented here.</div></div><div><h3>Methods</h3><div>This multicenter, multinational, randomized, double-blind, placebo-controlled, 48-week, treat-through study plans to enroll 399 adults and adolescents. Randomized patients (1:1:1) will receive subcutaneous administration of 1) cendakimab 360 mg once weekly (QW) for 48 weeks, 2) cendakimab 360 mg QW for 24 weeks followed by cendakimab 360 mg every other week (with matching placebo on alternative weeks to maintain the blind) for 24 weeks, or 3) placebo QW for 48 weeks. Co-primary endpoints are mean change from baseline in dysphagia days and proportion of patients with eosinophil histologic response, defined as peak esophageal eosinophil count ≤6 per high-power field, at 24 weeks. Secondary and exploratory endpoints will address endoscopic and histologic features, QoL, safety, and pharmacokinetic assessments.</div></div><div><h3>Conclusion</h3><div>This phase 3 pivotal study will determine whether cendakimab provides an effective, safe, targeted treatment for patients with EoE.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107708"},"PeriodicalIF":2.0,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388710","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 : 2024-10-09DOI: 10.1016/j.cct.2024.107707
Kathryn M. Ross , Meena N. Shankar , Peihua Qiu , Zibo Tian , Taylor N. Swanson , Armaan Shetty , Jaime Ruiz , Lisa Anthony , Michael G. Perri
Background
Without provision of additional intervention, most individuals regain weight after the end of weight-loss programs. Extended-care programs have been demonstrated to improve long-term weight-loss maintenance, but effects are modest.
Methods
We proposed to evaluate whether delivering extended-care telephone sessions on an ADAPTIVE (provided when individuals are deemed to be at high-risk for weight regain) versus STATIC (the once-per-month schedule typically used in extended-care programs) schedule improves weight regain after initial weight loss. Adults with obesity were initially recruited for a 16-week lifestyle weight-loss program, and those who lost ≥5 % of their initial weight were eligible for enrollment in the Project STAR maintenance trial.
Results
A total of 449 individuals (mean ± SD age = 49.5 ± 11.4 years, BMI = 35.7 ± 4.0 kg/m2, 83.5 % female, 23.4 % Black or African American, 9.8 % Hispanic) were recruited for the initial weight-loss program and lost an average of 6.4 ± 4.9 % of their initial body weight; 255 were randomized to the maintenance trial. There were no significant differences between participants randomized to the trial versus those who were not in terms of baseline weight, gender, race/ethnicity, education, or marital status, all ps > 0.05; however, participants who were randomized to the trial were older, p = .014, and reported higher incomes, p < .001.
Conclusion
Results from Project STAR will demonstrate whether providing extended-care intervention on an individually adaptable schedule improves long-term weight-loss maintenance. Moreover, the rich longitudinal dataset collected during the trial will serve as a foundation for building future predictive algorithms of weight regain and novel weight-maintenance interventions.
{"title":"Design of Project STAR: A randomized controlled trial evaluating the impact of an adaptive intervention on long-term weight-loss maintenance","authors":"Kathryn M. Ross , Meena N. Shankar , Peihua Qiu , Zibo Tian , Taylor N. Swanson , Armaan Shetty , Jaime Ruiz , Lisa Anthony , Michael G. Perri","doi":"10.1016/j.cct.2024.107707","DOIUrl":"10.1016/j.cct.2024.107707","url":null,"abstract":"<div><h3>Background</h3><div>Without provision of additional intervention, most individuals regain weight after the end of weight-loss programs. Extended-care programs have been demonstrated to improve long-term weight-loss maintenance, but effects are modest.</div></div><div><h3>Methods</h3><div>We proposed to evaluate whether delivering extended-care telephone sessions on an <em>ADAPTIVE</em> (provided when individuals are deemed to be at high-risk for weight regain) versus <em>STATIC</em> (the once-per-month schedule typically used in extended-care programs) schedule improves weight regain after initial weight loss. Adults with obesity were initially recruited for a 16-week lifestyle weight-loss program, and those who lost ≥5 % of their initial weight were eligible for enrollment in the Project STAR maintenance trial.</div></div><div><h3>Results</h3><div>A total of 449 individuals (<em>mean</em> ± <em>SD</em> age = 49.5 ± 11.4 years, BMI = 35.7 ± 4.0 kg/m<sup>2</sup>, 83.5 % female, 23.4 % Black or African American, 9.8 % Hispanic) were recruited for the initial weight-loss program and lost an average of 6.4 ± 4.9 % of their initial body weight; 255 were randomized to the maintenance trial. There were no significant differences between participants randomized to the trial versus those who were not in terms of baseline weight, gender, race/ethnicity, education, or marital status, all <em>p</em>s > 0.05; however, participants who were randomized to the trial were older, <em>p</em> = .014, and reported higher incomes, <em>p</em> < .001.</div></div><div><h3>Conclusion</h3><div>Results from Project STAR will demonstrate whether providing extended-care intervention on an individually adaptable schedule improves long-term weight-loss maintenance. Moreover, the rich longitudinal dataset collected during the trial will serve as a foundation for building future predictive algorithms of weight regain and novel weight-maintenance interventions.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107707"},"PeriodicalIF":2.0,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388711","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 : 2024-10-09DOI: 10.1016/j.cct.2024.107709
Christopher N. Sciamanna , Jordan D. Kurth , William Luzier , David E. Conroy , Willam A. Calo , Kathryn Schmitz , Matthew L. Silvis , Noel H. Ballentine , Shouhao Zhou , Margaret Danilovich , Liza S. Rovniak , Matthew Moeller , Natalia Pierwola-Gawin , Jennifer L. Kraschnewski , Jennifer Poger , Cheyenne Herrell
One in four older adults report difficulty walking, greatly increasing the risk of future disability and death. Though exercise improves mobility, too few older adults do it. While studies show that brief exercise sessions provide most of the benefit of longer sessions and that older adults note that “time” is a critical barrier to being active, what remains unknown is whether briefer RT sessions can improve mobility as well as, or better than, longer traditional sessions, possibly due to greater adherence. We present the design of a 12-month randomized controlled trial of 700 older adults with self-reported walking difficulty. Participants will be randomly assigned, in a 2 × 2 factorial design, to one of two home-based exercise programs: 1) Standard of Care: 45-min, three-times weekly sessions or 2) Experimental: 5-min daily sessions and to one of two doses of behavior change techniques (Standard or Enhanced) as part of their exercise program. The primary outcome measure is self-reported physical function. Secondary outcome measures include objectively measured lower extremity physical performance, walking endurance, balance, walking speed, strength and physical activity as well as self-reported falls, pain, fatigue and balance. This is one of the first studies to examine the clinical outcomes of brief exercise sessions, which may lead to a new generation of exercise programs that are optimized not only for impact, but for adherence as well.
{"title":"Testing Interventions for Mobility through Exercise (TIME): Study protocol for a randomized trial comparing a novel, brief home-based exercise program and a standard home-based group exercise for older adults with mobility disability","authors":"Christopher N. Sciamanna , Jordan D. Kurth , William Luzier , David E. Conroy , Willam A. Calo , Kathryn Schmitz , Matthew L. Silvis , Noel H. Ballentine , Shouhao Zhou , Margaret Danilovich , Liza S. Rovniak , Matthew Moeller , Natalia Pierwola-Gawin , Jennifer L. Kraschnewski , Jennifer Poger , Cheyenne Herrell","doi":"10.1016/j.cct.2024.107709","DOIUrl":"10.1016/j.cct.2024.107709","url":null,"abstract":"<div><div>One in four older adults report difficulty walking, greatly increasing the risk of future disability and death. Though exercise improves mobility, too few older adults do it. While studies show that brief exercise sessions provide most of the benefit of longer sessions and that older adults note that “time” is a critical barrier to being active, what remains unknown is whether briefer RT sessions can improve mobility as well as, or better than, longer traditional sessions, possibly due to greater adherence. We present the design of a 12-month randomized controlled trial of 700 older adults with self-reported walking difficulty. Participants will be randomly assigned, in a 2 × 2 factorial design, to one of two home-based exercise programs: 1) Standard of Care: 45-min, three-times weekly sessions or 2) Experimental: 5-min daily sessions and to one of two doses of behavior change techniques (Standard or Enhanced) as part of their exercise program. The primary outcome measure is self-reported physical function. Secondary outcome measures include objectively measured lower extremity physical performance, walking endurance, balance, walking speed, strength and physical activity as well as self-reported falls, pain, fatigue and balance. This is one of the first studies to examine the clinical outcomes of brief exercise sessions, which may lead to a new generation of exercise programs that are optimized not only for impact, but for adherence as well.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107709"},"PeriodicalIF":2.0,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388712","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}
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