Plainsboro Township

Researchers are conducting a pilot stepped-wedge cluster randomized controlled trial to study the Just ASK21 training program aimed at increasing discussions about cancer clinical trials between healthcare providers and breast cancer patients. The study focuses on assessing the feasibility and acceptability of this trial design, understanding factors influencing training completion, and measuring changes in clinical trial discussion rates before and after the training. The study involves four clusters of breast cancer care teams, each receiving the web-based Just ASK21 training at different randomized times. This training helps providers recognize assumptions about patient interest and encourages open conversations about clinical trials. Each cluster acts as its own control, with audio recordings of patient-provider encounters collected before and after training to evaluate discussion changes. Participants include oncology team members and breast cancer patients eligible for clinical trials. The study collects data through audio recordings of visits, analyzing discussion rates and elements linked to trial participation. The main outcome is the rate of clinical trial discussions, measured approximately one year after recruitment ends, with qualitative follow-up to identify factors related to patient trial participation. The trial runs from February 2026 to October 2026.

Researchers are studying two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 genetic mutations. This trial compares bilateral salpingectomy, which removes only the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The goal is to find out if removing just the fallopian tubes with delayed ovary removal is nearly as effective as removing both from the start. Participants choose between two groups one undergoes bilateral salpingectomy with the option of later ovary removal, and the other undergoes bilateral salpingo-oophorectomy. Both groups have imaging tests like pelvic ultrasounds or pelvic MRIs during screening and provide blood samples throughout the study. Follow-up visits occur at multiple time points, including 10 to 60 days, 6 months, 12 months, 24 months, and then yearly for up to 20 years. During the study, researchers track if ovarian or related cancers develop and assess symptoms related to estrogen loss, quality of life, cancer-related distress, sexual function, menopausal symptoms, medical decision making, and any adverse events. Various questionnaires and imaging tests support these evaluations. Long-term safety and cancer risk reduction are monitored for up to two decades after surgery.

Researchers are evaluating a method of cervical ripening using a Foley catheter for women who are having their first baby and are scheduled for labor induction at term 37 weeks or more. The study compares outpatient cervical ripening with a Foley catheter to the usual inpatient cervical ripening methods. The aim is to see if outpatient use of the Foley catheter reduces the rate of Cesarean delivery and lowers risks for mothers and newborns compared to inpatient care. Participants will be randomly assigned to one of two groups one group will begin cervical ripening with a Foley balloon catheter at home outpatient, while the other group will start cervical ripening in the hospital using either a Foley balloon or another cervical ripening method. The trial focuses on comparing these approaches to find the best care process for labor induction. During the study, researchers will monitor Cesarean delivery rates at delivery as the primary outcome. They will also assess maternal and neonatal health up to 6 weeks after delivery, including maternal satisfaction, perceived control during birth, length of hospital stay, and neonatal intensive care admissions. Participants will be followed closely with various assessments and questionnaires to measure these outcomes and ensure safety throughout the postpartum period.

Researchers are evaluating treatments for older adults aged 70 and above with advanced stage IIIB-IV non-small cell lung cancer that expresses PD-L1 in 1-49% of tumor cells. This phase III trial compares the effects of adding chemotherapy to immunotherapy with pembrolizumab against pembrolizumab alone. The study aims to assess improvements in overall survival, progression-free survival, response rates, toxicity, quality of life, and explore geriatric assessment factors and gut microbiome correlations. Participants are randomly assigned to one of two groups. Arm A receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. Arm B receives the same pembrolizumab schedule plus one of several chemotherapy regimens, including combinations of pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel administered intravenously on different schedules for four cycles, followed by pembrolizumab maintenance. Imaging with MRI, CT, and PET scans is performed at baseline and throughout the trial. During the study, participants undergo regular assessments including imaging scans to monitor disease status, blood tests, and quality of life questionnaires. After treatment completion, follow-up visits occur every three months for up to two years and then every six months up to five years. Researchers measure overall survival as the primary outcome and also track progression-free survival, response rates, adverse events, and patient-reported quality of life. Safety and tolerability are closely monitored along with exploratory analyses of chemotherapy dose intensity and microbiome factors.

This research aims to compare two methods of monitoring pancreatic cysts and to identify biomarkers that may help detect the risk of these cysts turning into pancreatic cancer. The study evaluates whether more frequent monitoring or less frequent monitoring leads to better patient outcomes and explores various blood and imaging biomarkers for improved risk prediction. Participants are observed through two different surveillance approaches that were previously randomized but are now closed to new enrollment. One approach involves lower intensity monitoring with MRI, CT, or endoscopic ultrasound EUS scans spaced out over years, while the other involves higher intensity monitoring with more frequent imaging based on cyst size. Throughout the study, patients may also provide blood samples and undergo biopsies, fine needle aspirations, or surgery as needed. Participants are followed up regularly for five years from registration, with imaging and blood tests at intervals depending on their assigned monitoring method. Researchers collect data on clinical features, anxiety, quality of life, financial distress, healthcare costs, and outcomes such as the development of concerning pancreatic cyst features or pancreatic cancer. The study uses these measures to assess the effectiveness of monitoring strategies and the predictive value of biomarkers.

Researchers are studying patients who receive fecal microbiota transplantation FMT or other gut-related microbiota products to understand the short-term and long-term safety and effectiveness of these treatments. This national data registry aims to collect detailed information on how FMT is performed, why it is done, and the baseline health of patients receiving it. The study is observational and will enroll around 4,000 patients at 75 sites across North America. Participants will undergo FMT or receive related microbiota products, and information about the donor and recipient screening, preparation, and delivery methods will be collected from each site. The registry will track patients for up to 10 years after their treatment, with follow-up data gathered from healthcare providers at 1 month, 6 months, 1 year, and 2 years post-FMT, as well as annual communication with patients for the full duration. During the study, researchers will collect data on any treatment-related side effects and whether the original disease returns after FMT. Follow-up will include regular assessments to monitor safety and effectiveness over time. Participants will be asked to provide information through healthcare provider reports and direct contact, with the total participation lasting up to 10 years to ensure long-term monitoring.

This research aims to compare two different approaches to post-hospitalization follow-up care for children hospitalized with common infections such as pneumonia, skin and soft tissue infections, acute gastroenteritis, or urinary tract infections. The study evaluates whether automatic follow-up visits scheduled at discharge or a more flexible as-needed PRN follow-up approach, where parents monitor symptoms and decide on visits, impact hospital readmission rates and other health outcomes. Participants are randomly assigned to one of two groups. One group receives a recommendation for automatic follow-up, instructing them to schedule and attend a follow-up visit regardless of symptom improvement. The other group receives a recommendation for PRN follow-up, where scheduling a visit at discharge is not required, and parents decide if a visit is necessary based on their childs symptoms. Both groups are monitored to compare outcomes over time. During the study, researchers will track hospital readmissions within 14 days of discharge as the primary outcome. Secondary outcomes include medical interventions and the childs health-related quality of life measured seven days after discharge. Additional factors like healthcare use, parent anxiety, satisfaction, and costs will also be assessed. The study includes follow-up through communications with healthcare providers and monitoring of immunizations and well-child visits. Participation lasts at least through the 14-day post-discharge period to capture these outcomes.

Researchers are evaluating the effects of foundational wellness programs on reducing clinician burnout and improving professional fulfillment among healthcare professionals at University of Pennsylvania Health Systems and Massachusetts General Hospital. This prospective, randomized clinical trial compares the Sudarshan Kriya Yoga SKY Breathing and Sahaj Meditation program to an active control group receiving a Health Education Program HEP. The study focuses on psychometric, cognitive, and physiological measures related to burnout and well-being. Participants are randomized into one of two groups the SKY intervention or the HEP control. The SKY program includes a baseline week of heart rate variability HRV and sleep tracking, followed by a 3-day online workshop totaling 10.5 hours with live instruction, then weekly 1-hour follow-up sessions for 4 weeks. Participants practice daily for 45 minutes and continuously wear an Oura Ring for physiological monitoring. The HEP group undergoes a 2-day, 3 hoursday online workshop, followed by weekly 2-hour sessions over 4 weeks, also practicing daily for 45 minutes and wearing the Oura Ring for continuous monitoring. Throughout the 6-week study, clinicians complete assessments of burnout using the Stanford Professional Fulfillment Index at baseline, midpoint, and endpoint. Daily HRV and sleep scores are collected via the Oura Ring. Additional questionnaires evaluate depression, anxiety, sleep impairment, intent to leave employment, self-valuation, impact of work on relationships, social connectedness, mindfulness, cognitive errors, and self-reported medical errors at the beginning and end of the study. Data will be statistically analyzed to determine the impact of these programs on clinician well-being and burnout.

Researchers are studying children hospitalized with bronchiolitis to compare two different strategies aimed at improving follow-up care after hospital discharge. The study focuses on increasing the use of as-needed follow-up visits prescribed by hospital physicians and reducing unnecessary routine follow-up visits, which research has shown are often not needed. This trial evaluates how these strategies may impact care and family experience for young children recovering from bronchiolitis. The study compares a moderate-resource implementation strategy with a high-resource implementation strategy. The moderate approach includes educational outreach with materials for families, clinician performance reviews, and clinical decision support tools. The high-resource strategy adds small-group facilitation and expert coach-led support to the components of the moderate strategy. These strategies are designed to encourage appropriate follow-up care decisions by hospitalists. Participants are children diagnosed primarily with bronchiolitis, discharged from general inpatient care outside intensive or emergency settings. Researchers will measure how often as-needed follow-up is prescribed and sustained within seven days after hospital discharge. Families attendance at follow-up visits will be tracked to assess if unnecessary visits decrease. The study will monitor outcomes related to follow-up care practices and their impact through the hospital stay and shortly after discharge, with participation lasting through the immediate post-hospital period.

Researchers are evaluating whether a quantitative HER2 assay can accurately distinguish responders from non-responders among patients with HER2-low metastatic breast cancer receiving T-Dxd. This observational study focuses on improving measurement methods for HER2 expression levels to better understand treatment response. Participants provide leftover tumor tissue from routine biopsies for analysis using quantitative immunofluorescence and RT-qPCR assays. The study measures HER2 expression via these tests and correlates results with real-world treatment responses and progression over up to 100 months following the start of T-Dxd therapy. During the study, researchers collect data on tumor HER2 levels and track objective response rates and progression-free survival. Imaging and biomarker assessments are used to evaluate measurable disease, including bone and brain metastases. Participants are monitored throughout their treatment with T-Dxd, with up to 100 months of follow-up to assess outcomes and associations with HER2 assay results.