Contemporary Clinical Trials Communications最新文献

{"title":"Study protocol for Project SHINE (Sleep Health INitiative for Equity): A community-based pilot RCT to promote sleep and physical activity among Black/African American adults","authors":"Ivan HC. Wu ,&nbsp;Lorna McNeill ,&nbsp;Kristen Knutson ,&nbsp;Yisheng Li ,&nbsp;Diwakar Balachandran ,&nbsp;Rhonda Jones-Webb ,&nbsp;Pamela L. Lutsey ,&nbsp;Darin Erikson ,&nbsp;Shikha Bista ,&nbsp;Rachel Price ,&nbsp;Vanessa Anyanso ,&nbsp;Taylor Smith ,&nbsp;Rev Melvin Miller","doi":"10.1016/j.conctc.2025.101541","DOIUrl":"10.1016/j.conctc.2025.101541","url":null,"abstract":"<div><h3>Background</h3><div>Black/African American (AA) adults experience shorter sleep duration and poorer sleep quality compared to White counterparts, contributing to higher risks of chronic diseases. Project SHINE (Sleep Health INitiative for Equity) aims to address these sleep disparities by evaluating the feasibility, satisfaction, and plausibility (i.e., preliminary efficacy) of a culturally tailored sleep intervention designed to improve sleep duration and physical activity among AA adults with body mass index (BMI) ≥ 25 not meeting physical activity and sleep guideline recommendations.</div></div><div><h3>Methods</h3><div>This pilot community-based randomized controlled trial (RCT) includes two phases. Phase 1 involves qualitative interviews with AA adults to explore sleep-related sociocontextual factors to refine the intervention. Phase 2 is an RCT (n = 80) assigning participants to a four-week sleep extension intervention or a contact control. The sleep extension intervention aims to improve sleep duration and physical activity. Sessions occur via Zoom, with in-person baseline and follow-up visits. Primary outcomes include feasibility and satisfaction of the intervention. Secondary outcomes include self-reported and objective sleep and physical activity measures, plus exploratory biomarkers for cancer and cardiovascular risk. Additional self-reports assess sleep-related psychosocial factors and health behaviors.</div></div><div><h3>Discussion</h3><div>This study will assess the feasibility and implementation of a culturally tailored, virtual sleep intervention for AA adults. By integrating behavior change theories, cultural adaptation frameworks, and community-based participatory principles, <em>Project SHINE</em> aims to inform a larger-scale trial and support scalable behavioral interventions to improve sleep health and reduce disparities.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101541"},"PeriodicalIF":1.4,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145050424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Artificial Intelligence and the future of clinical trials","authors":"Consolato M. Sergi MD, PhD, MPH, FRCPC, FCAP Chief ,&nbsp;Howard D. Sesso","doi":"10.1016/j.conctc.2025.101545","DOIUrl":"10.1016/j.conctc.2025.101545","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101545"},"PeriodicalIF":1.4,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145095027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tele Tai Chi for people aging with mobility disabilities: Novel methodology and structured adaptation approach","authors":"Elena T. Remillard ,&nbsp;Tracy L. Mitzner ,&nbsp;Kara T. Mumma","doi":"10.1016/j.conctc.2025.101543","DOIUrl":"10.1016/j.conctc.2025.101543","url":null,"abstract":"<div><div>Many people aging with mobility disabilities experience barriers engaging in exercise programs and social events in-person and could benefit from virtual programs that make participation more accessible. The Tele Tai Chi clinical trial is assessing the acceptability and effectiveness of an evidence-based in-person Tai Chi program for older adults, Tai Chi for Arthritis and Fall Prevention (seated version), when adapted to be an online group intervention (via videoconferencing) with moderated social time for individuals aging with mobility disabilities. Specifically, we are examining the intervention efficacy for the target population for increasing physical activity and social connectedness, which are the primary outcome measures. Secondary outcome measures include exercise self-efficacy, falls efficacy, depression, quality of life, and pain. The participant sample (N = 60) includes community-dwelling adults (60–77 years of age) with a self-identified mobility disability (i.e., using a mobility aid or having serious difficulty walking or climbing stairs) for at least 10 years. Follow-up assessments occurred at the end of the 8-week intervention and 1 month thereafter. This methods-focused paper highlights our novel, user-centered, technology-mediated approach to adapting an in-person intervention for individuals aging with mobility disabilities, which can be used as a roadmap for researchers and practitioners launching similar trials or programs.</div></div><div><h3>ClinicalTrials.gov no</h3><div>NCT04696887.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101543"},"PeriodicalIF":1.4,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144931927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reconstructing patient level survival data from published Kaplan-Meier curves","authors":"Jaromme Kim,&nbsp;Prabhakar Chalise,&nbsp;Jianghua He","doi":"10.1016/j.conctc.2025.101542","DOIUrl":"10.1016/j.conctc.2025.101542","url":null,"abstract":"<div><h3>Introduction</h3><div>Individual-level patient data (IPD) are helpful for designing clinical trials, conducting meta-analyses, or methodology research. However, such patient level data are not readily available. Multiple methods have been developed for reconstructing survival data using published Kaplan-Meier (KM) survival curves. There has been no practical guidance on an optimal approach or extensive evaluation of the performance of the approach.</div></div><div><h3>Methods</h3><div>We reviewed several methods of extracting the coordinates of KM survival curves and reconstructing individual-level survival data. Then, we reproduced data from 46 published KM curves. The accuracy of reconstructed data is quantified by comparing hazard ratios (HRs) and their confidence intervals (CIs) estimated from the reproduced data with those reported in the original papers.</div></div><div><h3>Results</h3><div>The comparison showed a high degree of similarity between the reproduced and original HRs and CIs. In most cases, the differences were less than 5 %. The mean and median absolute percentage differences of 58 reconstructed HRs were 2.85 % and 2.14 %, respectively. These results suggest the reconstruction method reliably reconstructs survival data from KM survival curves.</div></div><div><h3>Conclusions</h3><div>Based on an extensive number of reconstructions, we demonstrated that reconstructed data provided similar estimates overall to those from published papers. The quality of the reproduced data depends on the presence of noise in the published curves and whether the preprocessing step is properly done.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101542"},"PeriodicalIF":1.4,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144904464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A randomized controlled trial protocol for evaluating the feasibility, acceptability, and work outcomes of individualized placement and support adapted for autistic adults in the community","authors":"Marjorie Solomon ,&nbsp;Jo A. Yon-Hernández ,&nbsp;Steve Ruder ,&nbsp;Susan R. McGurk ,&nbsp;Daniel Tancredi ,&nbsp;Yukari Takarae ,&nbsp;Aubyn C. Stahmer","doi":"10.1016/j.conctc.2025.101536","DOIUrl":"10.1016/j.conctc.2025.101536","url":null,"abstract":"<div><div>Relatively few autistic adults, including those with average intellectual abilities, are competitively employed, meaning that they hold jobs together with non-disabled workers and receive comparable wages and benefits. In California, for example, most autistic individuals served by the state are placed in programs where they participate in skill-building and socialization but not in actual competitive jobs. Failure to participate in the labor force can diminish autistic workers’ sense of purpose, well-being, and ability to earn a living wage.</div><div>Available research suggests that supported employment that assists autistic adults in finding and keeping jobs, produces the highest sustained competitive employment rates. Thus, our team has been investigating the Individualized Placement and Support (IPS) model, which has an extensive evidence base for increasing competitive employment rates in individuals with chronic mental illnesses. In a California Department of Developmental Services Employment Grant investigating adults with autism and intellectual disabilities, we demonstrated a competitive employment placement rate of 52 % using IPS. Components of IPS were appropriate for this population, however there were implementation challenges related to IPS model fit with the vocational support agencies.</div><div>Based on focus groups and stakeholder input, we have adapted IPS to provide intensive agency training, leadership education, and record keeping support. Herein, we detail a protocol for a randomized controlled trial of the adapted model (IPS-AUT) to evaluate feasibility, acceptability, and work outcomes. We also investigate potential moderators and mediators of treatment effectiveness to provide a foundation for a larger more adequately powered randomized clinical trial.</div><div>This protocol is registered at ClinicalTrials.gov: NCT 06829264.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101536"},"PeriodicalIF":1.4,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144890874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peer delivered, emotion regulation-focused mental health prevention training for fire fighter trainees: Design and methodology of a randomized controlled trial","authors":"Eric C. Meyer ,&nbsp;Todd Farchione ,&nbsp;Nathan A. Kimbrel ,&nbsp;Oi-Man Kwok ,&nbsp;Michelle L. Pennington ,&nbsp;Jessica Rostockyj ,&nbsp;Suzy B. Gulliver","doi":"10.1016/j.conctc.2025.101537","DOIUrl":"10.1016/j.conctc.2025.101537","url":null,"abstract":"<div><div>Fire fighters (FFs) risk their lives, health, and well-being through trauma exposure and other occupational stressors. FFs report concerning rates of mental health challenges, alcohol use disorders, and suicide risk. These problems tend to co-occur, as each is linked with reliance on maladaptive emotion regulation strategies. As FFs advance in their careers, many tend to rely more heavily on these maladaptive emotion regulation strategies, thus exacerbating the problems. Many FFs leave fire service prematurely due to mental and physical health problems. FFs must be equipped with more effective emotion regulation skills to buffer against stressors they will face. FFs may benefit from training in transdiagnostic emotion regulation skills delivered by credible peers upon entry and socialization into the profession, potentially preventing substantial negative outcomes downstream while promoting resilience and wellness. This paper describes a cluster randomized controlled trial to compare peer-delivered emotion regulation training with peer-delivered psychoeducation regarding mental health, both delivered during the fire academy, for preventing symptoms of PTSD (primary outcome), depression, anxiety, alcohol use disorder, and functional impairment. Emotion regulation training is based on the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Participants will be a non-clinical population of FF trainees completing the fire academy at 10–12 cities nationwide (<em>N</em> = 312). Participants will be cluster randomized to training condition by recruit class. Subsequent recruit classes will then alternate between conditions within each city. Assessment measures will be administered at pre-training baseline, post-training, and at 6-, 12-, 18-, and 24 month follow-ups.</div></div><div><h3>Clinical trial registration</h3><div>NCT06290778.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101537"},"PeriodicalIF":1.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144890873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mindfulness vs. sleep education during autologous hematopoietic cell transplantation for multiple myeloma: Feasibility of a randomized controlled pilot study","authors":"Elisabeth C. Henley ,&nbsp;Hannah A. Liphart ,&nbsp;Keayra J. Morris ,&nbsp;Iwalola Awoyinka ,&nbsp;Michael R. Irwin ,&nbsp;Erin S. Costanzo ,&nbsp;Diana Winston ,&nbsp;Anita D'Souza ,&nbsp;Melinda Stolley ,&nbsp;Binod Dhakal ,&nbsp;Meera Mohan ,&nbsp;Marcelo C. Pasquini ,&nbsp;Steven W. Cole ,&nbsp;Erin S. Doerwald ,&nbsp;Peyton C. Bendis ,&nbsp;Kelly E. Rentscher ,&nbsp;Meredith E. Rumble ,&nbsp;Aniko Szabo ,&nbsp;Sridhar Rao ,&nbsp;Jennifer M. Knight","doi":"10.1016/j.conctc.2025.101540","DOIUrl":"10.1016/j.conctc.2025.101540","url":null,"abstract":"<div><h3>Background</h3><div>Sleep disturbance is common in patients receiving hematopoietic stem cell transplantation (HCT). Mindfulness-based interventions (MBIs) can improve sleep quality during and following cancer treatment by reducing treatment-related symptoms and enhancing immune function.</div></div><div><h3>Methods</h3><div>We conducted a randomized controlled pilot study investigating the feasibility of implementing Mindfulness Awareness Practices for Insomnia (MAP-I) in patients with multiple myeloma (MM) undergoing autologous HCT. Patients were randomized to receive either MAP-I or a Sleep Health Education (SHE) intervention, both consisting of six videos viewed pre-HCT and three virtual sessions in the two weeks post-HCT. Feasibility was assessed by meeting an enrollment rate of 35% and a retention rate of 85%.</div></div><div><h3>Results</h3><div>We screened 120 patients; 54 (45%) were deemed ineligible and 42 (35%) declined participation. Twenty-four of the 66 eligible patients approached were enrolled into the study (36.4% enrollment rate) and were randomized to either MAP-I or SHE. Seven patients completed the study (29.2% retention rate). Most participants who withdrew consent cited feeling overwhelmed or too sick to continue post-HCT. Amendments were iteratively implemented to increase enrollment and retention rates including addition of a study incentive, modifications to the video timeline, and earlier introduction of the mindfulness instructor.</div></div><div><h3>Conclusion</h3><div>Study results detail challenges and opportunities in retaining patients with MM in a virtual MBI sleep intervention during the peri-transplant period. While enrollment met feasibility criteria, most patients felt too overwhelmed or sick in the peri-transplant period to complete the intervention and associated study tasks. Future research should investigate MBIs at other time points throughout HCT.</div></div><div><h3>Trial registration</h3><div>NCT04271930, 2/17/2020.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101540"},"PeriodicalIF":1.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144890872","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating digital intervention approaches for supporting immigrant women with intimate partner violence experiences: Findings from the It's weWomen plus sequential multiple assignment randomized trial (SMART)","authors":"Bushra Sabri ,&nbsp;Jian Li ,&nbsp;Subhash Aryal ,&nbsp;Theresa Mata ,&nbsp;Sarah M. Murray ,&nbsp;Nancy Glass ,&nbsp;Jacquelyn C. Campbell","doi":"10.1016/j.conctc.2025.101539","DOIUrl":"10.1016/j.conctc.2025.101539","url":null,"abstract":"<div><h3>Background</h3><div>Intimate partner violence (IPV) disproportionately affects immigrant women, who often face barriers to accessing in-person services. Digital interventions offer a promising alternative by providing tailored, remote support.</div></div><div><h3>Methods</h3><div>In this SMART trial, 1265 foreign-born immigrant women across the U.S. were randomized to a personalized online (<em>n</em> = 660) or standard online safety information (<em>n</em> = 605) intervention. At 3 months, low responders (<em>n</em> = 366) were re-randomized to receive text-only (<em>n</em> = 183) or text + phone support (<em>n</em> = 183). Outcomes were assessed at 6 and 12 months.</div></div><div><h3>Results</h3><div>All groups showed reduced physical and sexual IPV over time, with no significant differences between first-stage conditions. Low responders in the text + phone group demonstrated significantly greater reductions in physical and sexual IPV (<em>d</em> = −0.25, <em>p</em> &lt; 0.01), depression (<em>d</em> = −0.22, <em>p</em> &lt; 0.01), and increased empowerment (<em>d</em> = 0.22, <em>p</em> &lt; 0.01), from 3 to 12 months, compared to responders. These between-group effects were supported by significant within-group improvements, with the text + phone group narrowing or closing the gap with responders in most outcomes by 12 months. Among low responders initially assigned to the personalized online intervention, those re-randomized to text + phone support outperformed those receiving text-only support—showing significantly greater reductions in IPV (<em>d</em> = −0.32, <em>p</em> &lt; 0.05), depression (<em>d</em> = −0.33, <em>p</em> &lt; 0.05), and greater gains in empowerment (<em>d</em> = 0.27, <em>p</em> &lt; 0.05). The text-only group also improved, particularly in depression and PTSD, with outcomes approaching those of responders by 12 months. Across conditions, low responders also showed substantial improvements in safety behaviors (<em>d</em> = 0.24–0.25; <em>p</em> &lt; 0.05).</div></div><div><h3>Conclusion</h3><div>These findings highlight the value of stepped-care, adaptive approaches in addressing persistent IPV-related needs. Integrating personalized phone support into digital interventions can enhance outcomes for survivors who do not respond to brief, initial support alone.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101539"},"PeriodicalIF":1.4,"publicationDate":"2025-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144863464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aroxybutynin and atomoxetine (AD109) for the treatment of obstructive sleep apnea: Rationale, design and baseline characteristics of the phase 3 clinical trials","authors":"Luigi Taranto-Montemurro ,&nbsp;Sanjay R. Patel ,&nbsp;Patrick J. Strollo Jr. ,&nbsp;John Cronin ,&nbsp;John Yee ,&nbsp;Huy Pho ,&nbsp;Andrea Werner ,&nbsp;Ron Farkas","doi":"10.1016/j.conctc.2025.101538","DOIUrl":"10.1016/j.conctc.2025.101538","url":null,"abstract":"<div><h3>Introduction</h3><div>Two key factors leading to obstructive sleep apnea (OSA) pathogenesis include relaxation of upper airway muscles at sleep onset and their insufficient reactivation during obstructive events. Medications that address this neuromuscular dysfunction by increasing upper airway tone during sleep represent a potential strategy for mitigating OSA.</div></div><div><h3>Methods</h3><div>AD109 is an investigational, once-daily oral agent taken at bedtime that combines an antimuscarinic, aroxybutynin (2.5 mg), with a selective norepinephrine reuptake inhibitor, atomoxetine (75 mg). LunAIRo (NCT05811247) and SynAIRgy (NCT05813275) are two ongoing, placebo-controlled 51-week and 26-week phase 3 clinical trials, respectively, investigating the efficacy and safety of AD109 to treat mild to severe OSA. Participants include adults with an apnea-hypopnea index with 4% desaturation (AHI₄) &gt;5 who either refuse or fail to tolerate positive airway pressure. Participants (LunAIRo: N = 660; SynAIRgy: N = 646) were randomized 1:1 to receive AD109 or placebo. We hypothesize that AD109 will significantly reduce AHI₄ and symptomatic fatigue compared to placebo in people with OSA. The primary outcome for both trials is the change from baseline to Week 26 in AHI₄ in the AD109 arm versus placebo. Key secondary outcomes include changes from baseline in oxygen desaturation index with 3% desaturation, hypoxic burden based on 4% desaturation, Patient Reported Outcome Measurement Information System (PROMIS)-Fatigue, and proportion of participants with ≥50% reduction in AHI₄ at Week 26.</div></div><div><h3>Discussion</h3><div>LunAIRo and SynAIRgy are fully enrolled, large Phase 3 clinical trials designed to confirm and extend our understanding of the safety and efficacy of AD109, a combination oral drug targeting the underlying neuromuscular dysfunction contributing to upper airway muscle collapse during sleep in adults with OSA.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101538"},"PeriodicalIF":1.4,"publicationDate":"2025-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144895000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study design and methods for the physical activity index (PAI) feasibility pilot trial for breast and colon cancer survivors in North Carolina","authors":"Shirley M. Bluethmann ,&nbsp;Janet Tooze ,&nbsp;Joni K. Evans ,&nbsp;Jeffrey Katula ,&nbsp;Kristy Wood ,&nbsp;Lesley Hitariansingh ,&nbsp;Charlotte Crotts ,&nbsp;Heidi D. Klepin ,&nbsp;Ravi Paluri ,&nbsp;Kunal Kadakia ,&nbsp;Katherine Ansley","doi":"10.1016/j.conctc.2025.101530","DOIUrl":"10.1016/j.conctc.2025.101530","url":null,"abstract":"<div><div>The majority of the 18 million US adults with cancer history (“survivors”) do not meet recommendations for obtaining regular physical activity (PA) or limiting sedentary behavior in their daily lives. Breast cancer survivors (BCS) and colon cancer survivors (CCS) are particularly at risk of insufficient PA and excessive sedentary behavior (i.e., sitting) that may increase physical impairments, worsen cancer treatment symptoms, limit optimal cancer recovery, and limit opportunities to potentially reduce cancer risk. Research has shown that completion of clinical cancer treatment may serve as a ‘teachable moment’ for patients as they transition to recovery at home. Many of these survivors are uncertain about building a healthier lifestyle without guidance from the medical team, but few validated clinical tools exist to assess and counsel survivors on their behavioral choices relative to PA and sedentary behavior.</div><div>Based on our recent findings, a simple screener that collects measures on PA, strength training, and sedentary behavior, the Physical Activity Index (PAI), may be effective for clinical use to monitor patient behaviors and provide specific, tailored recommendations on how to achieve and maintain behavioral goals. We propose a multicomponent, two-arm pilot 1:1 randomized controlled trial with waitlist control in which we will recruit (n = 20) BCS and CCS within three years of diagnosis to leverage the ‘teachable moment’ in early recovery. The PAI intervention will include standard survivorship follow-up care plus a PA assessment using the PAI screener that is supplied to the provider plus five remote coaching consultations with a certified exercise physiologist. All participants will also receive resistance bands to keep and an activity tracker to self-monitor their behaviors at home.</div><div>We will determine feasibility by examining recruitment, retention, acceptability, and PAI intervention adherence goals. Secondarily, we will measure changes/variability in achievement of behavioral outcomes for PA and sedentary behaviors to inform future trial planning.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101530"},"PeriodicalIF":1.4,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144841366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}