Background:Promoting at-home tests (e.g., for COVID-19) using chatbots may be a novel and scalable way to improve uptake across underserved populations. Objective:The objective of this study was to assess the navigational patterns (i.e., sequence of interactions) of underserved populations when using a chatbot designed to provide education on COVID-19 testing and free order access for at-home COVID-19 test kits. Methods:The study was a descriptive analysis of the original data of the chatbot intervention of the SCALE-UP II trial, which compared different digital health modalities (i.e., chatbots versus simple text messages) to deliver free at-home COVID-19 test kits to minority populations in Utah. SCALE-UP II (registration numbers NCT05533918 ; NCT05533359 ) was a multisite, pragmatic clinical trial with patients randomized in a 2×2×2 factorial design (smartphone study) to receive (1) chatbot or text messaging, (2) the option to request patient navigation, and (3) intervention frequency every 10 or 30 days. All other participants were randomized in a 2×2 factorial design (nonsmartphone study) to receive the option to request patient navigation and intervention frequency every 10 or 30 days. Eligible patients (1) had an appointment at one of the participating community health centers (CHC) in the last 3 years, (2) were 18 years and older, and (3) had a valid cellphone number recorded in the CHC electronic health record (EHR).The trial enrolled 2117 in the smartphone study and 31,439 in the nonsmartphone study. In the smartphone study, the proportion of participants who requested test kits in the Chatbot arm was lower than in SMS text messaging. In the nonsmartphone study, test kits was higher if they were messaged every 10 days.Sources of funding included the National Institute on Minority Health and Health Disparities (NIMHD) of the US National Institutes of Health (NIH) grant number 5U01MD017421 and by awards from the National Cancer Institute of the NIH (P30CA042014) and the Huntsman Cancer Foundation. Results:Of 1,051 patients randomized to the chatbot intervention, 309 (29%) launched the chatbot, 196 (63%) interacted with it, and 186 (60%) started the COVID-19 test kit ordering process. Among those who launched the chatbot, 170 (55%) completed a test kit order. One patient (0.3%) accessed the chatbot educational content. The median age was 51, with 66% female, 54% Latino/a, 55% uninsured, and 86% located in an urban area. Conclusion:Ordering of COVID-19 test kits among underserved patients who interacted with the chatbot was high. Thus, chatbots may represent a viable approach to reach underserved populations as a part of public health response in a pandemic. All patients except one placed orders without reviewing educational content. Chatbot design should identify and minimize the number of steps for patients to achieve a specific goal.

PURPOSE:To examine the use of hypofractionation among underserved populations, with a focus on implications for policy. METHODS AND MATERIALS:Using a 20% Medicare claims sample, we evaluated the receipt of hypofractionation, a short-course radiation therapy approach, among underserved versus nonunderserved populations. Hypofractionation was defined based on cancer/site-specific guidelines and expert review. Underserved groups included racially/ethnically minoritized, rural, and patients with low socioeconomic status. We included 4 cancer types that represent the majority of new cancer diagnoses and for which there is the highest level of support for hypofractionation. These included breast, colorectal, lung, and prostate cancer. Log-binomial regression models were used to assess the association between underserved status and hypofractionation use, adjusting for patient-level, practice-level, and area-level characteristics. RESULTS:We analyzed 6437 patients and found that 2200 were classified as underserved and 4237 as not underserved. Overall, 52.5% of patients received hypofractionation, and underserved populations were treated at similar rates to their nonunderserved counterparts. We noted a few exceptions. Rural patients with prostate cancer had a lower likelihood of receiving hypofractionation (relative risk, 0.59; P = .005), whereas rural patients with lung cancer had a higher likelihood of receiving hypofractionation (relative risk, 1.14; P = .039). CONCLUSIONS:Hypofractionation was received at similar rates among underserved and nonunderserved populations. Given existing disparities experienced by underserved patients with cancer, greater use of hypofractionation may contribute to more equitable outcomes. Implementation of policies that facilitate-rather than discourage-the use of hypofractionation, may reduce disparities experienced by underserved patients with cancer.

Background:The Comprehensive Oncology Rehabilitation and Exercise (CORE) pilot trial aimed to test the feasibility and acceptability of a clinical workflow algorithm that integrated exercise and rehabilitation services from breast cancer diagnosis throughout the first 24 weeks of care. Here, we investigated the preliminary effectiveness of the CORE algorithm compared with standard of care (SOC) on changes in physical function, health-related quality of life (HRQoL), and exercise engagement in women newly diagnosed with Stage I-III breast cancer with plans for surgery as first-line treatment. Methods:Seventy-two women were randomly assigned in a 2:1 ratio to CORE or SOC. All participants completed study assessments at three time points that aligned with routine breast surgical oncology clinic visits: surgical consultation (i.e., baseline), postoperative, and 24 weeks postoperative. The following outcomes and associated assessments were carried out in the clinic: physical function: PROMIS physical function survey (primary function assessment), five-time chair stand, 10-m walk, back scratch, and QuickDASH survey; HRQoL: FACT-B survey; and exercise engagement: modified Godin physical activity survey (primary engagement assessment) and accelerometer wear for 1 week following each clinic visit. Results:Fifty-nine participants had evaluable data, with the majority having Stage I disease (83%), being primarily White (75%) and non-Hispanic (90%), and having a median age and BMI of 58 years and 26.0 kg/m2, respectively. Mean difference in change in PROMIS physical function score from baseline to 24 weeks postoperative between CORE and SOC was not statistically significant (-1.86, 95% CI -6.02 to 2.3). A modest advantage in exercise engagement was observed in the CORE arm (Godin: 5.46, 95% CI -1.06 to 11.98; effect size: 0.36, 95% CI -0.07 to 0.78; accelerometry: median difference 12 min, bootstrapped 95% CI -37 to 40). Conclusion:The CORE clinical workflow algorithm demonstrates promise in improving exercise engagement. More work is needed in an adequately powered trial to confirm these findings and evaluate effectiveness on other outcomes. Trial Registration:ClinicalTrials.gov identifier: NCT04594473.

BACKGROUND:Children in rural and underserved communities face a higher risk of developing skin cancer later in life owing to social, behavioral, and environmental factors. The goal of the Rural Adult and Youth Sun Protection (RAYS) trial is to evaluate the efficacy of a multicomponent, multilevel sun-safety intervention in improving sun protection among children in these communities. METHODS:The RAYS cluster-randomized trial will test a sun safety intervention delivered through youth (ages 3-6) recreational sports settings in West Virginia and Utah and examine outcomes up to one year after enrollment. Enrolled sports leagues will be randomized to receive either RAYS, which targets sun safety-related adaptations at the individual, social, environmental, and policy levels, or an intervention that focuses on sports safety (no sun safety information). The primary outcome will be observed sun safety behaviors during sports practices and games; secondary outcomes will include parent-reported child sun protection and sunburn occurrence. Potential mediators (e.g., coach and parent knowledge and self-efficacy around skin cancer prevention) and factors related to trial outcomes, such as intervention fidelity and uptake and potential moderators (e.g., Area Deprivation Index), will also be examined. CONCLUSIONS:The RAYS trial will examine the efficacy of a sports safety-focused intervention targeting sun protection behaviors among children in rural and underserved communities. The project will lead to new scientific understanding of theoretical, interventional, and implementation components that influence study outcomes and sociodemographic moderators, which will inform future intervention implementation in similar settings and identify communities which could best be served by RAYS. CLINICAL TRIAL REGISTRATION:NCT06439979.

While platform trials have several benefits with their adaptive features, randomization challenges become of central relevance to the design and execution of a platform trial. This paper intends to address these challenges and explore some potential solutions. A platform type of clinical trial is a clinical trial design where multiple interventions are investigated simultaneously often against partly or fully shared controls, with new treatment arms added and completed treatment arms removed. Unequal allocation is often used in platform trials to improve statistical efficiency, deliver benefits to trial participants, and control the speed of enrollment in different treatment arms. Changes to the allocation ratio may be required after an interim analysis even when the number of treatment arms remains constant, for example, in a platform trial with response-adaptive randomization. To deliver the design efficiencies promised by the carefully optimized allocation ratio or simply to ensure a pre-determined allocation ratio, randomization methods that keep allocation proportions close to the target allocation ratio throughout randomization are helpful. Other situations commonly occurring in platform trials require special considerations for randomization methods and in some cases new classes of randomization methods. Such specific platform features include the requirement to accommodate differences in eligibility for different treatments, the need to ensure partial blinding with a 2-step randomization when mode of administration for different interventions is conspicuously different and full blinding is unfeasible, the objective to balance through dynamic randomization multiple prognostic factors or the need to accommodate limited drug supplies at the numerous trial centers, among others. The key to a successful execution of a complex randomization in the platform trial is the expert design of the Interactive Response Technology (IRT) system, where the system is built at the master protocol level and existing and potential randomization needs are incorporated from the outset. An additional, often overlooked, challenge when working with unequal allocation ratios and randomization methods to attain these, is the importance of preserving the unconditional allocation ratio at every allocation. Failure to do so might lead to a selection and evaluation bias even in double-blind trials, accidental bias, and reduced power of the re-randomization test.

BACKGROUND:Immune-checkpoint Inhibitors (ICIs) are increasingly used in advanced cancers and can be associated with immune-related adverse events (irAEs). AIMS:This study examined the association between anxiety and depression, irAEs, and overall survival in a national cohort of ICI-treated cancer survivors. METHODS:This retrospective cohort study used data from 8671 2-year survivors following ICI treatment with advanced melanoma, lung, colorectal, head and neck, and bladder cancers from a nationwide de-identified electronic health record-derived database. Bivariate tests, Kaplan-Meier curves, and multivariable logistic regressions were conducted using R. RESULTS:The majority (79%, N = 6820) did not have irAEs, anxiety, or depression. The landmark analysis observed that accounting for covariates, irAEs were associated with anxiety or depression (aOR: 1.70, 95% CI: 1.41, 2.06, p < 0.001) in the first 2 years after ICIs. Female sex (aOR: 1.46, 95% CI: 1.24, 1.73, p < 0.001), poorer functional status (ECOG = 2: 1.47, 95% CI: 1.06, 2.04, p = 0.022), Medicaid coverage (aOR: 1.54, 95% CI: 1.08, 2.18, p = 0.016), and being seen in an academic practice setting (aOR: 3.62, 95% CI: 3.02, 4.35, p < 0.001) were associated with greater odds of anxiety/depression diagnoses compared with male sex, ECOG = 0, Medicare, and community practice settings. Non-white survivors who experienced an irAE had lower odds of experiencing anxiety/depression (aOR: 0.58, 95% CI: 0.45, 0.46, p < 0.001) compared with White survivors. CONCLUSIONS:Few studies have examined the relationship between anxiety and depression and irAEs in a national sample. Findings have implications for survivorship quality of life and integrated mental health care delivery.

Background:Digital health interventions could be a scalable approach to delivering at-home COVID-19 testing. Objective:SCALE-UP II aimed to investigate the effectiveness of 3 digital health interventions on the delivery of mailed at-home COVID-19 testing: SMS text messaging, automated chatbot, and patient navigation upon request. Methods:The study was a pragmatic randomized controlled trial. Participants who self-reported that they had a smartphone were randomized in a 2×2×2 factorial design (smartphone study) to receive (1) chatbot or text messaging, (2) the option to request patient navigation, and (3) intervention frequency every 10 or 30 days. All other participants were randomized in a 2×2 factorial design (nonsmartphone study) to receive the option to request patient navigation and intervention frequency every 10 or 30 days. Study settings were safety net community health centers located across the state of Utah, United States. Eligible patients were >18 years old, with a primary care visit in the last 3 years, and a valid cellphone in the community health centers electronic health record. The primary outcome was the proportion of participants requesting at-home COVID-19 tests. Results:The trial enrolled 2117 in the smartphone study and 31,439 in the nonsmartphone study. In the smartphone study, the proportion of participants who requested test kits in the Chatbot arm was lower than in SMS text messaging (174/1051, 16.6% vs 555/1066, 52.1%; adjusted risk ratio (aRR) 0.317, 98.33% CI 0.27-0.38; P<.001). In the nonsmartphone study, the proportion of participants who requested test kits was higher if they were messaged every 10 days rather than every 30 days (860/15,717, 5.5% vs 752/15,722, 4.8%; aRR 1.144, 97.5% CI 1.03-1.28; P=.005). However, participants in the 10-day versus 30-day condition were more likely to opt out of receiving study interventions (1977/15,717, 12.6% vs 1147/15,722, 7.3%; aRR 1.72, 97.5% CI 1.59-1.86; P<.001). In the nonsmartphone study, the proportion of participants who requested test kits was lower for those in the patient navigation condition compared with no patient navigation (680/15,718, 4.3% vs 932/15,721, 5.9%; aRR 0.729, 97.5% CI 0.65-0.81; P<.001). Conclusions:Simple bidirectional text messaging was more effective than an interactive web-based chatbot on the delivery of COVID-19 testing. Although messaging every 10 days was more effective than every 30 days, it also led to a larger opt-out rate. Digital health interventions based on automated bidirectional SMS text messaging are a simple, scalable, and low-cost strategy to offer access to at-home COVID-19 testing. Similar approaches may be used to support public health response and other forms of at-home testing.

Promoting at-home tests (e.g., for COVID-19) using chatbots may be a novel and scalable way to improve uptake across diverse populations. The objective of this study was to assess patients’ navigational patterns (i.e., sequence of interactions) when using a chatbot designed to provide education on COVID-19 testing and to order free at-home COVID-19 test kits. The study was a secondary analysis of the SCALE-UP II trial, which compared different digital health strategies (i.e., chatbots versus simple text messages) to deliver free at-home COVID-19 test kits to minority populations in Utah. We analyzed chatbot usage logs to understand user behavior. Of 1,051 patients randomized to the chatbot intervention, 309 (29%) launched the chatbot and 196 (63%) interacted with it. Among those who interacted, 170 (87%) completed a test kit order. One patient (0.3%) accessed the chatbot educational content. Ordering of COVID-19 test kits among patients who interacted with the chatbot was high. Patients placed orders without reviewing educational content. Chatbot design should minimize the number of steps for patients to achieve a goal.

Background:Caregiving to lung cancer patients is distressing, isolating, and associated with a high burden of anxiety and depression. However, few population-based studies in the U.S. have examined the risk of mental health conditions (MHCs) among spouses of lung cancer patients after the death of their partner. Guided by Anderson's Behavioral Health Utilization model, we examined the role of sex, pre-bereavement MHC, and decedents' healthcare utilization on the risk of having a diagnosed MHC after the death of a lung cancer patient. Methods:This retrospective cohort study linked state-wide health facility records of 1,224 dyads-deceased lung cancer patients and their bereaved spouses (824 female, 400 male)-in Utah between 2013 and 2021. Bereavement-related mood/stress-related conditions were identified for spouses using diagnostic codes (starting from day 1 following the patients' deaths). The Kaplan-Meier curves and Cox proportional hazard models were used to estimate the risk for a composite outcome of MHC/death and the risk of MHC, after adjusting for censorship due to death and controlling for covariates. Results:The majority of spouses were aged 65+ (female: 67%; male: 33%), white/non-Hispanic (female: 89%; male: 90%), and urban-dwelling (female: 69%; male: 71%). Spouses experienced 374 events (MHCs/death) across the follow-up period. Adjusting for census-tract level income, cancer stage, insurance, censoring due to death, and the interaction between sex and MHC, spouses with preexisting MHCs had 4.09 times higher risk of developing MHCs during bereavement (95% CI: 2.70, 6.19) compared to spouses without pre-existing MHCs. Spouses of decedents with some college education (aHR: 0.68, 95% CI = 0.48-0.97) and longer survival (aHR: 0.85, 95% CI = 0.74-0.99) had a lower risk of MHCs compared to those of decedents with high school education and shorter survival. Discussion:This population-based study supports evidence for multi-level risk factors associated with having MHC after the death of a spouse with lung cancer. Findings suggest the need for targeted bereavement support for subgroups of spouses at greater risk of MHCs.

Excessive sodium intake exacerbates rates of hypertension. African American adults have higher rates of hypertension in part due to a higher-sodium diet. The multi-level Communication for Behavioral Impact for Sodium Reduction (COMBI-SR) community-based intervention effectively reduces sodium intake in international settings, but it has not yet been implemented and tested in the U.S. This study explored the contextual factors (barriers/facilitators) and implementation strategies for COMBI-SR in Chicago’s South Side neighborhood–an area with high rates of hypertension. Between May and November 2023, we conducted qualitative interviews with potential intervention recipients (n = 8), Research Ministry Ambassadors (n = 5) and healthcare professionals (n = 2), 1 focus group with potential intervention recipients (n = 9) and 3 focus groups with healthcare professionals (n = 10). The Consolidated Framework for Implementation Research (CFIR) 2.0 guided the development of semi-structured interview guides. Thematic analysis was performed using CFIR 2.0 constructs to identify barriers and facilitators to implementation, and the Expert Recommendations for Implementing Change (ERIC) compilation to identify implementation strategies. Key barriers included a lack of awareness of sodium content in foods, socioeconomic disparities limiting access to healthy options, and cultural dietary traditions. Facilitators included strong community partnerships, engaged faith-based organizations, and openness to integrating technology, such as a mobile app, to help monitor and reduce sodium intake. Specific strategies to support sodium reduction involved simplifying public health messages, offering low sodium cooking demonstrations, promoting healthier food options through community outreach, and providing personalized education on reading nutrition labels and managing sodium intake. Successful implementation of COMBI-SR in Chicago’s South Side requires addressing financial, educational, and cultural barriers while leveraging trusted community structures to promote sustainable sodium reduction. These findings will guide future efforts to implement COMBI-SR in the U.S., emphasizing culturally tailored messaging and ongoing community engagement to improve cardiovascular health.

Performance status (PS) is the foundation for clinical trial eligibility and the basis for treatment decisions in thoracic oncology, but it is limited by subjectivity and potential miscommunication between patient, physician, and family. Activity trackers offer a collection of a broad range of patient-generated data that can be used to supplement PS in clinical trials and practice while minimizing subjectivity. Introduction/Background: Prognostication by performance status (PS) assessment is a fundamental element of treatment decisions and clinical trial design in oncology, but it is limited by subjectivity and potential miscommunication between patient, physician, and family. Activity tracker offers the potential to collect a broad range of patient-generated data to supplement the assessment of PS. Patients and Methods: Patients with metastatic NSCLC (mNSCLC) participated in a single institute, prospective, observational feasibility study conducted at Huntsman Cancer Institute. Patients were given a Fitbit (R) activity tracker, which collects their steps taken, distance moved, heart rate, and activity intensity. At baseline, PS was assessed by physicians and patients, and demographics and clinical data were collected. We defined novel indices of health: Heart rate Activity zone Mismatch (HAM) and excessive Sedentary Heart Rate (eSHR). We used multivariable Cox proportional hazards models adjusted for age, sex, and treatment line to estimate and test the prognostic ability of clinical and fitness metrics on overall survival (OS). Each prognostic model was evaluated using Harrell's concordance index (C-index). Results: Fifty-five patients with mNSCLC were enrolled. The median OS was 10.4 months (95% CI: 7.2, 15.2). PS-physician (HR = 2.0; P < .001) and Fitbit metrics were associated with OS, including daily total steps (1,000-steps) (HR = 0.8; P = .004), HAM (HR = 2; P = .02), eSHR (HR = 0.3; P = .001). The prognostic model that includes PS-physician was associated with the best concordance (C-index = 0.75), followed by daily total distance (C-index = 0.74) and steps (C-index = 0.73) Conclusions: Tracker-based measures were prognostic of survival in mNSCLC and may be useful as a supplement or alternative to PS in practice and clinical trials.

BACKGROUND:This pilot, mixed-methods, randomized controlled trial determined the feasibility and acceptability of the Comprehensive Oncology Rehabilitation and Exercise (CORE) clinical workflow algorithm. CORE was designed to connect patients with newly diagnosed breast cancer to exercise and rehabilitation services from the time of diagnosis throughout cancer care. METHODS:In total, 72 patients with newly diagnosed, stage I-III breast cancer who required surgery as first-line treatment were randomized 2:1 to CORE or standard of care. CORE included a triaging tool of two questionnaires regarding self-reported exercise (the Godin Leisure Time physical activity questionnaire) and functional status (the Patient-Reported Outcomes Measurement Information System physical function questionnaire), which were administered at the check-in desk for routine breast surgical oncology clinic visits at the initial surgical consultation, postoperatively, and 24 weeks after surgery. Responses to questionnaires in the triaging tool triaged participants to one of three pathways within the algorithm: exercise service, rehabilitation service, or exercise self-management (not a service). Service pathways required referral by clinic staff. Feasibility was determined based on completing the triaging tool (≥66%) and referral completion (≥50%) at the initial surgical consultation visit. Acceptability was determined by four study participant focus groups and one clinic team focus group (≥50% positive response). RESULTS:Ninety-three percent of participants in CORE (n = 40) completed the triaging tool. Among those triaged to a service pathway (n = 29), 62% completed their referral. Focus group feedback was primarily positive. CONCLUSIONS:The CORE clinical workflow algorithm is feasible and acceptable among women who have newly diagnosed stage I-III breast cancer with plans for surgery as first-line treatment. CORE was also acceptable among clinic staff. CLINICAL TRIALS REGISTRATION:NCT04594473.

240 Background: Debate remains about the value of Prostate-specific antigen (PSA) based prostate cancer screening among men aged 55-69 (USPSTF Grade C). However, no professional society or guideline recommends PSA based prostate cancer screening in men younger than age 40. This study aims to understand the risk of PSA testing exposure in young men, and we hypothesize that substantial low-value testing occurs in this population. Methods: We performed a retrospective analysis of claims data from the MarketScan database to identify men aged 18 to 39 without prostate cancer who received a PSA test from 2008 to 2017. For the primary analysis, men were required to be continuously in the database for least 5 years. Age groups were stratified to include: men less than 25, 25-29, 30-34, and 35-39 years. Secondary analysis did not limit subjects to those with 5 years of continuous data and explored the association of Charlson Comorbidity Index (CCI), lower urinary tract symptoms, erectile dysfunction, depression/anxiety, prostate cancer screening, infertility, and hypogonadism with PSA testing in young men. We used logistic regression to determine which of the factors were associated with PSA testing in young men. Results: We identified claims for 40,164,773 adult men who met study criteria. Of these men, 3,230,748 were continuously in the Marketscan database for at least 5 years. The cumulative risk for receiving a PSA over 5 years for men under 40 is 2.5%. Stratified by age, men aged 35-39 are at highest risk (Table). Logistic multivariable regression showed that, relative to all men between 18 and 40, patients in this age group who received a PSA were more likely to be diagnosed with hypogonadism (OR 20.55, 95% CI 20.39-20.71) or lower urinary tract symptoms (OR 9.34, 95% CI 9.26-9.41). Higher CCIs appeared to correlate with a decreased rate of PSA testing. This population was not significantly more likely to be diagnosed with infertility, depression, or anxiety. Conclusions: PSA screening for men under 40 is not uncommon, especially when associated with concomitant genitourinary symptoms. At a population level, this represents substantial low-value testing. Interventions aimed at clarifying the relationship between common urologic conditions and prostate cancer, the extremely low incidence of prostate cancer in this age group, and the lack of guidelines supporting this practice may help decrease low-value PSA testing. Funding: Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Number K08CA234431. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.[Table: see text]

The Second Generation P-Value (SGPV) measures the overlap between an estimated interval and a composite hypothesis of parameter values. We develop a sequential monitoring scheme of the SGPV (SeqSGPV) to connect study design intentions with end-of-study inference anchored on scientific relevance. We build upon Freedman's "Region of Equivalence" (ROE) in specifying scientifically meaningful hypotheses called Pre-specified Regions Indicating Scientific Merit (PRISM). We compare PRISM monitoring versus monitoring alternative ROE specifications. Error rates are controlled through the PRISM's indifference zone around the point null and monitoring frequency strategies. Because the former is fixed due to scientific relevance, the latter is a targettable means for designing studies with desirable operating characters. An affirmation step to stopping rules improves frequency properties including the error rate, the risk of reversing conclusions under delayed outcomes, and bias.

OBJECTIVES:To pilot and assess the feasibility, acceptability, and preliminary effects of the Rural Adult and Youth Sun (RAYS) protection program, a multilevel skin cancer preventive intervention for young children living in rural U.S. communities, delivered through community-organized team sports. METHOD:Three rural counties in Utah participated with two receiving the intervention and the third serving as a control. Youth sports leagues were recruited through recreation departments and the study took place from May through October 2021. Intervention leagues received sun protection supplies for players and coaches, educational materials for parents, and coaches were offered training on skin cancer and sun protection behaviors. RESULTS:The RAYS program is both feasible to deliver and acceptable to coaches, parents, and players. The intervention also demonstrates beneficial preliminary effects on components of observed child sun-protective behaviors, coach sun protection behaviors, knowledge of skin cancer prevention recommendations, and self-efficacy in skin cancer prevention. CONCLUSIONS:Multilevel interventions for skin cancer prevention among young children can be successfully delivered through community organizations and their settings. A priority moving forward is the identification of ways to optimize delivery of such programs to positively influence skin cancer preventive behaviors among children living in diverse rural areas. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Background:Using a health systems approach to investigate low-value care (LVC) may provide insights into structural drivers of this pervasive problem. Objective:To evaluate the influence of service area practice patterns on low-value mammography and prostate-specific antigen (PSA) testing. Design:Retrospective study analyzing LVC rates between 2008 and 2018, leveraging physician relocation in 3-year intervals of matched physician and patient groups. Setting:U.S. Medicare claims data. Participants:8254 physicians and 56 467 patients aged 75 years or older. Measurements:LVC rates for physicians staying in their original service area and those relocating to new areas. Results:Physicians relocating from higher-LVC areas to low-LVC areas were more likely to provide lower rates of LVC. For mammography, physicians staying in high-LVC areas (LVC rate, 10.1% [95% CI, 8.8% to 12.2%]) or medium-LVC areas (LVC rate, 10.3% [CI, 9.0% to 12.4%]) provided LVC at a higher rate than physicians relocating from those areas to low-LVC areas (LVC rates, 6.0% [CI, 4.4% to 7.5%] [difference, -4.1 percentage points {CI, -6.7 to -2.3 percentage points}] and 5.9% [CI, 4.6% to 7.8%] [difference, -4.4 percentage points {CI, -6.7 to -2.4 percentage points}], respectively). For PSA testing, physicians staying in high- or moderate-LVC service areas provided LVC at a rate of 17.5% (CI, 14.9% to 20.7%) or 10.6% (CI, 9.6% to 13.2%), respectively, compared with those relocating from those areas to low-LVC areas (LVC rates, 9.9% [CI, 7.5% to 13.2%] [difference, -7.6 percentage points {CI, -10.9 to -3.8 percentage points}] and 6.2% [CI, 3.5% to 9.8%] [difference, -4.4 percentage points {CI, -7.6 to -2.2 percentage points}], respectively). Physicians relocating from lower- to higher-LVC service areas were not more likely to provide LVC at a higher rate. Limitation:Use of retrospective observational data, possible unmeasured confounding, and potential for relocating physicians to practice differently from those who stay. Conclusion:Physicians relocating to service areas with lower rates of LVC provided less LVC than physicians who stayed in areas with higher rates of LVC. Systemic structures may contribute to LVC. Understanding which factors are contributing may present opportunities for policy and interventions to broadly improve care. Primary Funding Source:National Cancer Institute of the National Institutes of Health.

You have accessJournal of UrologyHealth Services Research: Quality Improvement & Patient Safety II (MP33)1 May 2024MP33-14 THE RELATIONSHIP BETWEEN MARKET COMPETITION AND LOW-VALUE PROSTATE AND BREAST CANCER SCREENING Nicole Murray, Joshua Horns, Jiaming Li, Jonathan Chipman, Hailie Gill, and Brock O'Neil Nicole MurrayNicole Murray , Joshua HornsJoshua Horns , Jiaming LiJiaming Li , Jonathan ChipmanJonathan Chipman , Hailie GillHailie Gill , and Brock O'NeilBrock O'Neil View All Author Informationhttps://doi.org/10.1097/01.JU.0001009520.30626.80.14AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Market competition of physicians has been shown to be related to prices and quality in health care. This study investigates the relationship of primary care provider competition to the receipt of low value PSA testing and mammography. METHODS: We conducted a retrospective cohort study using Medicare data. Low-value care was defined as PSA and mammograms ordered for men and women above the age of 75, without a history of prostate or breast cancer respectively. We identified internal medicine and family practice providers using Medicare claims and made note of whether LVC imaging was ordered for that patient within each calendar years. Patient-provider units were categorized into health service areas (HSA) based on the zip code of the physician. We then used National Provider Identifier files to calculate competition within each HSA. Competition was calculated using the Hirschman-Herfindahl Index (HHI), with low values representing competitive markets and high values representing concentrated markets. HHI was categorized into deciles and modeled as a factor. We then ran logistic regression models, modeling receipt of LVC against HHI. Separate models were also run for low-value PSA and mammogram. Patients' cancer risks were defined by the family history of prostate or breast cancer, depending on the model. RESULTS: Providers located in areas with higher market competition (low HHI) were found to deliver more LVC PSA testing. This rate decreased as the market competition concurrently decreased, with the exception of the lowest HHI decile. A relationship between market competition and LVC mammogram imaging was not observed. CONCLUSIONS: Primary care physicians are less likely to order low-value PSA testing in areas with lower healthcare competition. However, there does appear to be an exception in markets with the least competition, suggesting that there is an ideal market-competition level where LVC is least likely to be provided. That our analysis did not find a significant association between low-value mammography and market competition argues for further study to understand the complex relationship between healthcare competition and LVC. Download PPT Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e565 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Nicole Murray More articles by this author Joshua Horns More articles by this author Jiaming Li More articles by this author Jonathan Chipman More articles by this author Hailie Gill More articles by this author Brock O'Neil More articles by this author Expand All Advertisement PDF downloadLoading ...

IntroductionSCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).Methods and analysisThe trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2×2×2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2×2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.Ethics and disseminationThe protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.Trial registration numberClinicalTrials.gov:NCT05533918andNCT05533359.

Recent examples for unplanned external events are the global COVID-19 pandemic, the war in Ukraine, or most recently Hurricane Ian in Puerto Rico. Disruptions due to unplanned external events can lead to violation of assumptions in clinical trials. In certain situations, randomization tests can provide nonparametric inference that is robust to violation of the assumptions usually made in clinical trials. The ICH E9 (R1) Addendum on estimands and sensitivity analyses provides a guideline for aligning the trial objectives with strategies to address disruptions in clinical trials. In this article, we embed randomization tests within the estimand framework to allow for inference following disruptions in clinical trials in a way that reflects recent literature. A stylized clinical trial is presented to illustrate the method, and a simulation study highlights situations when a randomization test that is conducted under the intention-to-treat principle can provide unbiased results.