1,926 Clinical Trials for Various Conditions
In this study, personalized nudges to clinicians and patients will be evaluated to help increase breast cancer screening rates in accordance with USPSTF guidelines among women with a primary care visit. In partnership with Penn Medicine (Penn) and Case Western Reserve University-University Hospitals (UH), two complementary, concurrent 6-month, cluster randomized, pragmatic trials were conducted from December 2023 to October 2024. This trial will now replicate those interventions at Lancaster General Health (LGH), incorporating learnings from the primary trials while also adapting to align with existing health system protocols and policies. The patient nudge interventions include pre- and post-visit text message reminders to encourage the patient to schedule their mammogram, and the clinician nudge intervention includes a Smart Data Element message in the electronic health record (EHR) reminding the care team that the patient is overdue and that patients are more likely to complete their screening if recommended and ordered by their clinician.
The vast majority of glaucoma cases in the United States go undetected and untreated until the late stages of the disease. Open-angle glaucoma is a progressive condition that is asymptomatic in its early to moderate stages and may be amenable to screening through telemedicine-based approaches. This study is a randomized trial to evaluate whether glaucoma screening with established tests (e.g., optical coherence tomography, fundus photography, and tonometry) is more effective for detecting undiagnosed glaucoma cases compared to education alone or delayed intervention.
Background: Fanconi anemia (FA) is a rare, inherited cancer syndrome. FA causes a range of physical issues. Children with FA may have abnormal features; these may include a small head and eyes and issues with their internal organs. Young adults have a much higher risk of cancer. To screen for these cancers, people with FA may need to pursue many visits with different doctors. This constant need for cancer screening may cause anxiety for people with FA. Objective: To learn more about anxiety related to cancer screenings in people with FA. Eligibility: Adults aged 18 years and older with FA. They must also be enrolled in FACSS. FACSS is a study that screens people with FA for cancer every year. Design: All data gathered for this study will occur during routine FACSS visits. No other visits are needed. An observer will be in the room during participants FACSS visits. The observer and participant will have a polite introduction. After that, the observer will not interact with participants in any way. The observer will note details about the participants, such as: * Body language. * Worries about screening. * Comments that suggest anxiety or depression. * Clinical environment, such as d(SqrRoot)(Copyright)cor and temperature. * Accessibility issues. These can include lights and noises as well as ease of traveling around the clinic center. * Evidence of social support, such as engaging in the FA community. * Challenges they ve had in FACSS. * Their motivation to participate in FACSS. * Relationship dynamics among clinic staff, participants, and their care partners. Data will also be collected from FACSS visit notes dating back to December 2024 and from participants medical records.
The goal of the proposed research is to 1) examine the performance of emerging screening methods for anal high-grade squamous intraepithelial lesion (aHSIL), a precancerous condition of anal cancer, among minorities with a high risk of anal cancer and 2) characterize DNA methylation, immunologic response, and social determinants associated with aHSIL.
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.
The goal of PEER-Heart is to implement and assess feasibility and preliminary effectiveness of a community peer-facilitated screening for methamphetamine-associated heart failure (MAHF) and linkage to evidence-based cardiology care for people who use methamphetamine in rural areas.
This study assesses the effectiveness of colorectal cancer (CRC) screening intervention, mobile Patient Technology for Health (mPATH™-Cloud), compared to usual care among subjects who are overdue for CRC screening according to recommendations of the United States Preventive Services Taskforce (USPSTF). The trial randomly selects and enrolls 1,000 eligible subjects served by one federally qualified health center (FQHC) in North Carolina. Subjects are randomized to two study arms, Usual Care (Arm 1) or Mobile Health Decision Support (Arm 2). Usual care consists of a visit-based screening recommendation to complete a stool test (e.g., FOBT, FIT, Cologuard) or referral to a screening colonoscopy. Subjects randomized to the Mobile Health Decision Support (Arm 2) are sent a message by text or US mail, depending on their preferred communication mode as indicated in the electronic health record (EHR), to visit the mPATH™-Cloud website. Subjects who engage with mPATH™-Cloud are invited to answer brief questions to confirm their eligibility and then view a short decision aid video designed to help people choose the CRC screening test (FIT or colonoscopy) that they would like to receive. After watching the video, subjects can choose a CRC screening test. Their primary care provider at the FQHC orders the appropriate test and, where indicated, refers the subjects to a colonoscopy. Subjects who request FIT screening and subjects who do not select any test receive a FIT mailed to their home address. The primary outcome of interest is CRC screening completion within 6 months after randomization as assessed by EHR chart review. A completed screening is any of the following: colonoscopy completion (regardless of indication); 2) at least one FIT test with a normal result; or diagnostic colonoscopy following an abnormal FIT result. We hypothesize that we will observe a higher CRC screening completion rate in the Mobile Health Decision Support intervention arm (Arm 2). This study includes up to three annual rounds of screening eligibility assessment and outreach. Repeated intervention rounds allow us to evaluate whether the intervention can improve adherence to USPSTF recommendations over time. During the 3-year intervention phase, Arm 1 receives usual care only.
Alaska Native men have the highest rates of colorectal cancer incidence and mortality in the US. Screening can prevent disease and improve survival. We previously developed an intervention that uses text messages to increase colorectal cancer screening in Alaska Native patients of the Southcentral Foundation healthcare system in Anchorage, Alaska. The intervention improved screening by 50% in women, but it had no effect in men. We propose to culturally tailor the intervention for Alaska Native Men, and to test it with a randomized controlled trial among 600 patients at the Southcentral Foundation. This will be the first trial of an intervention designed to increase colorectal cancer screening in Alaska Native men.
Co-design will be implemented to develop an innovative, Veteran-centered intervention (Vet Peer Connects program) that meets the needs of Black Veterans. Next, a feasibility pilot test of the Vet Peer Connects program will be conducted. The Peer will lead up to 4 group lung cancer screening orientations in community partner sites to reach around 40 lung cancer screening eligible Black Veterans. The Peer will provide one-to-one tailored support to up to 15 Veterans (coaching, goal-setting, navigation to access Veterans Affairs lung cancer screening). Then, the study team will evaluate program delivery through ethnographic observation and field notes, Peer activity logs, and weekly check-ins between the study team and Peer. Investigators will interview Veteran participants, community partners, and lung cancer screening clinical staff to explore feasibility and acceptability of the Vet Peer Connects program and solicit suggestions for improvement. Preliminary data on the outcomes of the Vet Peer Connects program will be collected by study team through administering surveys to assess change in Social Cognitive Theory constructs, and extracting lung cancer screening uptake and tobacco treatment 3 months post enrollment from VA's Corporate Data Warehouse. This work will inform a subsequent multi-site stepped-wedge trial to assess effectiveness, implementation, and cost of the Vet Peer Connects program in VA lung cancer screening sites and neighboring branches of the National Association for Black Veterans
This study aims to develop a highly sensitive, specific, and cost-effective blood assay for the early detection of esophageal adenocarcinoma and its precursor lesions, using advanced machine learning and state-of-the-art biological analyses.
Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).
The Hispanic/Latinx community (hereafter Hispanic) is the country's second-largest racial/ethnic group, accounting for 19.1% of the total population. However, they remain one of the most underserved populations with suboptimal access to healthcare and screening services due to low income, lack of health insurance, perceived discrimination, language barriers, and limited health literacy. Lung cancer is the leading cause of cancer related mortality with 1.8 million annual deaths worldwide, with Hispanic patients known to have lower survival rates compared with non-Hispanic whites. Lung cancer screening (LCS) with low dose computed tomography (LDCT) decreases this mortality rate of lung cancer by 20%. Yet many Latinx patients who are eligible for lung cancer screening are still falling through the cracks which prevents patients the ability to detect lung cancer early. This study will test and compare the effect of a multi-level intervention on ordering LDCT within 4 months after patient enrollment to those in an Enhanced Usual Care. Our proposed intervention includes: * Primary care provider notifications of patients' LCS eligibility; * Patients' education; * Patients' referral to financial navigation resources; * Patients' reminder to discuss LCS during primary care provider (PCP) visit.
The purpose of this research study is to evaluate the efficacy of a digital navigation tool, called the eNav to improve colorectal cancer screening uptake among patients treated at federally qualified health centers (FQHC)s. The digital navigation tool includes a website and text messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).
In this study, personalized nudges to clinicians and patients will be evaluated to help increase breast cancer screening rates in accordance with USPSTF guidelines among women with a primary care visit, with a particular emphasis on those at high risk for non-completion of cancer screening. In partnership with Penn Medicine (Penn) and Case Western Reserve University-University Hospitals (UH), two complementary, concurrent, 6-month, cluster-randomized, pragmatic trials will be conducted. Those assigned to the intervention arm will receive the following clinician and patient level nudge interventions: clinicians will receive a default pended order for a mammogram in the visit encounter in the EHR (Penn and UH), and patients will receive post-visit text message reminders to encourage them to schedule their mammogram (Penn). Patients identified as high risk for noncompletion will be individually randomized to receive an additional bidirectional text message nudge or the standard text messaging (Penn).
The goal of this method comparison study is to compare the detection of hrHPV collected using the Teal Wand Self-Collection device to hrHPV detected from HCP (health care provider) cervical collection using primary HPV testing assays. Participants will be asked to use the Teal Wand to provide a self-collected sample prior to a healthcare provider collected sample to be tested for hrHPV. Secondary measure will include usability and preferences.
Evaluate the impact of the patient navigation program on the proportion of patients who complete lung cancer screening (LCS), defined as undergoing a low dose computed tomography (LDCT)
A multilevel lung screening intervention that pairs Social Determinants of Health (SDoH) screening and referral with a tailored health communication and decision support tool for lung screening has the potential to significantly impact lung screening uptake among at-risk individuals in the community, particularly among those who face barriers related to SDoH. In addition, findings will advance the understanding of effective strategies for improving lung screening and prevention efforts in non-traditional settings, with the ultimate goal of reducing the burden of lung cancer. As ways to support the realization of the public health benefit of lung cancer screening are considered, multiple strategies and venues to reach, and intervene, with screening-eligible is key. The goal of this study is to compare the effectiveness of a community-based lung screening educational tool paired with a social determinants of health (SDoH) screening assessment and referral process compared to a community-based lung cancer screening (LCS) educational tool alone as part of community outreach activities to improve (a) LCS rates (primary outcome); (b) intention to screen; and (c) individual-level potential drivers of LCS (health literacy, mistrust, stigma, fatalism, knowledge, health beliefs). It is hypothesized that providing SDoH screening and referral will result in higher levels of LCS, forward movement of intention to screen, and improved individual-level drivers of LCS.
Accurate risk assessment is essential for the success of population screening programs and early detection efforts in breast cancer. Mirai is a new deep learning model based on full resolution mammograms. Mirai is a mammography-based deep learning model designed to predict risk at multiple timepoints, leverage potentially missing risk factor information, and produce predictions that are consistent across mammography machines. Mirai was trained on a large dataset from Massachusetts General Hospital (MGH) in the United States and found to be significantly more accurate than the Tyrer-Cuzick model, a current clinical standard. The primary aim of this study is to prospectively quantify the clinical benefit (i.e. MRI/CEM cancer detection rate) of Mirai-based guidelines and to compare them to the current standard of care. 1. Conduct a prospective study where patients who are identified as high risk by Mirai guidelines are invited to receive supplemental MRI within 12 months. 2. Compare cancer outcomes between patients only identified as high risk by Mirai and patients identified as high risk by existing guidelines The secondary aim is to study the impact of new guidelines by race and ethnicity, to ensure equitable improvements in cancer screening.
Project PLUS is a pilot study that aims to develop and obtain preliminary feasibility and efficacy data on an enhanced risk communication approach to promote lung cancer screening (LCS) intentions among screening-eligible individuals from environmentally burdened communities. Project PLUS will combine qualitative interviews to explore subject awareness regarding lung cancer risk and air pollution, barriers to LCS, and perceptions regarding risk communication messaging, develop a health education video, and a between-subjects experiment to compare Data from this pilot will form the basis for enhanced community engagement efforts and subsequent communication research to examine the effectiveness of incorporating the involuntary air pollution risk information in risk communication interventions. The long term goal is to reduce lung cancer burden and disparities among environmentally burdened communities within and outside of Philadelphia.
This is an international prospective, multicentre, unblinded, randomised-controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients.
The goal of this project is to measure the clinical utility of an objective and quantitative eye-tracking assay collected on a standalone, mobile investigational device to accurately screen 9-month-old infants for autism spectrum disorder and other actionable delays.
This study aims to determine the image features of cervical cells, as measured via ultraviolet microscopy, that would constitute a positive screening and a negative screening result for cervical dysplasia, a precursor to cervical cancer, as measured against liquid-based Papanicolaou testing.
Investigators are conducting a pragmatic randomized trial testing the effectiveness of patient and clinician nudge strategies on adherence to lung cancer screening (LCS) \& diagnostic follow-up across eligible primary care clinicians \& patients. Following the trial, a subsample of patients \& clinicians will be invited to one-time semi-structured interview \& survey to identify individual \& system-level factors that may restrict or enhance the impact of strategies.
The purpose of this study is to demonstrate the feasibility of introducing, implementing, and integrating a brief, existent elder mistreatment screening tool (the National Collaboratory to Address Elder Mistreatment (NCAEM)'s Elder Mistreatment - Screening And Response Tool (EM-SART) Pre-Screen) in the Memorial Herman Hospital (MHH)-Texas Medical Center (TMC)Acute Care of Elders(ACE) (MHH-TMC ACE) unit and to identify older adults who may already be suffering from abuse, neglect, and/or financial exploitation, as well as connecting the study participants to the primary Geriatric Medicine team on the ACE unit such that additional care, evaluation (including additional in-depth mistreatment screening), and intervention can be taken to prevent and minimize further harm prior to discharge. The investigators hope to reduce missed opportunities for mistreatment detection to lead to safer health outcomes and hospital discharges.
The Black community has higher rates of colorectal cancer and lower rates of colorectal cancer screenings than whites. Getting screened through FIT testing may help catch colorectal cancer earlier, when it is easier to treat. MSK has created a program to help people who have been FIT tested to also help their peers (family, friends, and colleagues) in their community get FIT tested. The researchers think that training people on peer outreach, such as telling people in your social network about FIT testing and how to get it, may increase the rate of colorectal cancer screening. The purpose of this study is to see if training people on peer outreach increases the number of people who get screened for colorectal cancer through FIT testing.
The prevalence of childhood hearing loss in rural Alaska is disproportionately high and predominately infection-related. With preventive screenings and access to health care, much of childhood hearing loss is preventable. Although state-mandated school screening helps identify children with hearing loss, loss to follow-up is pervasive and exacerbated by a scarcity of specialists in rural regions. A mixed methods cluster randomized trial conducted in northwest Alaska demonstrated that telemedicine can significantly reduce loss to follow-up. This stepped wedge trial, in partnership with Southcentral Foundation, will build on this existing work to develop a model that can be scaled in diverse environments. We will adapt and implement a new telemedicine intervention called Specialty Telemedicine Access for Referrals (STAR). This trial will be conducted in 3 regions in rural Alaska that represent multiple healthcare systems. Based on stakeholder feedback and evidence generated from the previous trial, an enhanced mobile health (mHealth) hearing screening will be implemented in all participating schools prior to the STAR intervention, and the telemedicine referral to specialty care (STAR intervention) will be moved from the clinic directly into the school. This stepped-wedge cluster randomized trial is part of a larger hybrid type 1 effectiveness-implementation trial. The stepped wedge trial will evaluate the effectiveness of the STAR intervention in reducing loss to follow-up from referred school hearing screening in 3 regions of Alaska: Kodiak, Petersburg and Lower Yukon (n=23 schools, \~2,015 K-12 students/year). The STAR Intervention will be compared to the standard referral of a letter home to families. Cluster randomization at the level of school will be performed, with schools (clusters) randomized to one of two sequences. The effectiveness outcome (i.e., proportion of children who receive follow-up) will be evaluated over three academic years (2023-2026), with STAR rolled out in a stepwise manner for each of the two sequences (academic year 2024-2025 for sequence 1 and academic year 2025-2026 for sequence 2). The control periods for each sequence will be academic year 2023-2024 for sequence 1 and academic years 2023-2024 and 2024-2025 for sequence 2. Enhanced screening will be rolled out to both sequences at the same time (i.e., non-randomized) beginning academic year 2023-2024. An implementation evaluation will be conducted to refine and adapt the enhanced hearing screening and STAR intervention throughout the trial. Implementation data will be collected starting academic year 2022-2023 and then annually for each of the subsequent years.
The objective of this study is to evaluate self-collection of vaginal samples for HPV testing as an alternative cervical cancer screening strategy for persons with HIV and/or limited access to care. Self-collection kits will be offered to persons who refuse a Pap smear or are overdue (\>=6 months) for cervical cancer screening, with screening uptake recorded as a primary outcome. Kits will be offered in-clinic to individuals who refuse a Pap smear, and individuals overdue for screening will have the option to receive and return kits in the mail. The investigators will additionally administer a phone-based survey to evaluate knowledge about HPV and cervical cancer, barriers and facilitators to screening, and attitudes towards screening. Data from medical records will be abstracted to describe the clinical characteristics of the sample and measure receipt of follow-up procedures. Focus groups will be conducted with clinic administrators, staff, and HIV and women's health experts to evaluate clinic and provider barriers and facilitators to cervical cancer screening. The investigators hypothesize that HPV self-sampling will result in favorable patient-centered outcomes and could reduce disparities in access to screening.
The investigators will use a mixed methods study i.e. focus groups involving CHC staff as well as quantitative study which involves analyzing data that is available from the EHR and DRVS population management platform.
This protocol is a prospective, case-control multi-center diagnostic study to assess the sensitivity and specificity of blood-based screening tests for the early detection of multiple cancers.
This trial will evaluate a multilevel intervention (STAR model) that combines mobile health (mHealth) hearing screening tools with telemedicine technology for specialty care access in rural Kentucky schools. An initial version of the model was used in rural Alaska where telemedicine-based specialty referral improved both proportion of children receiving follow-up and time to follow-up. The refined STAR model will utilize an enhanced mHealth screening protocol that includes tympanometry for the detection of middle ear disease. The STAR model will also include a specialty telemedicine referral process in schools for children who refer school screening.