Plainsboro Township

Researchers are conducting a pilot stepped-wedge cluster randomized controlled trial to evaluate the "Just ASK17" web-based training designed to increase healthcare providers' discussions about cancer clinical trials with breast cancer patients. This study aims to assess the feasibility and acceptability of this trial design, understand factors influencing training completion and implementation, measure rates of clinical trial discussions before and after the intervention, and identify discussion elements linked with trial participation. The study involves four oncology practice clusters, each with 5 to 10 clinic team members who offer, consent, and enroll patients in breast cancer clinical trials. Each cluster will receive the "Just ASK17" training at randomly assigned times. Team members will complete the training and develop strategies to implement the intervention. Audio recordings of 10 patient-provider encounters before and 10 after training will be collected within each cluster to evaluate cancer clinical trial discussions. Participants include oncology team members and breast cancer patients evaluated at the Abramson Cancer Center. Assessments include audio recordings of clinical encounters and analysis of discussion rates about clinical trials. The primary outcome is measuring the rate of breast cancer clinical trial discussions about one year after recruitment completion. The study monitors training impact and implementation over time, focusing on improving trial communication.

Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.

Researchers are conducting a multicenter randomized trial to compare two methods of cervical ripening in first-time pregnant women undergoing induction of labor at term (37 weeks or more). The study focuses on women planned for cervical ripening using a Foley catheter, aiming to see if outpatient use of the Foley catheter reduces the rate of Cesarean deliveries and lowers risks to mothers and newborns compared to the usual inpatient methods. Participants will be assigned to either outpatient cervical ripening with a Foley catheter or routine inpatient cervical ripening, which may involve a Foley catheter and/or other methods. This pragmatic trial evaluates the Foley catheter as a device used outside the hospital setting versus the standard care inside the hospital. Throughout the study, investigators will track the incidence of Cesarean deliveries at delivery as the primary outcome. Participants must have reliable transportation and a safe home environment for outpatient care. The study includes monitoring for maternal and neonatal health, with safety assessments during labor induction. The trial enrolls women aged 18 to 60 years, and participation involves following the assigned cervical ripening method until delivery.

Researchers are evaluating the effect of adding chemotherapy to immunotherapy (pembrolizumab) compared to using immunotherapy alone in treating older adults aged 70 and above with advanced non-small cell lung cancer (stage IIIB-IV). This phase III trial aims to determine if combining chemotherapy with pembrolizumab improves overall survival and other outcomes like progression-free survival, response rates, toxicity, and quality of life in this vulnerable patient group. Participants are randomly assigned to one of two treatment groups. In the immunotherapy-alone group, patients receive pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years if there is no disease progression or unacceptable side effects. In the combination group, patients receive pembrolizumab plus a chemotherapy regimen chosen by their doctor, including drugs such as pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel, given intravenously on specific schedules for four cycles, followed by the same pembrolizumab maintenance. Imaging scans like MRI, CT, and PET are performed at baseline and throughout the study. During the study, participants undergo various assessments including imaging scans, laboratory tests, and questionnaires to evaluate treatment effects, side effects, and quality of life. Researchers monitor overall survival for up to five years from randomization, with follow-up visits every three months for the first two years and every six months thereafter until five years. Additional exploratory analyses include safety, tolerability, and correlations with gut microbiome and geriatric assessments to better understand treatment outcomes in this population.

Researchers are evaluating two different methods for monitoring pancreatic cysts to determine which approach leads to better outcomes for patients with these cysts. The study compares a lower intensity surveillance schedule with a higher intensity surveillance schedule in patients aged 50 to 75 years. The study also aims to assess differences in surgical complications, pancreatic cancer rates, mortality, costs, healthcare use, patient quality of life, anxiety, financial distress, adherence to surveillance, and the predictive value of biomarkers and radiomic markers for cancer or dysplasia. Participants are randomly assigned to one of two surveillance arms. In the low intensity arm, patients receive MRI or CT scans at the start and one year later, then repeat imaging every two years if no abnormalities are found. If positive features appear, imaging frequency increases. In the high intensity arm, surveillance frequency varies by cyst size, ranging from MRI or CT every six months to combined imaging and endoscopic ultrasound (EUS) every 3-6 months for larger cysts. EUS is used to further evaluate cysts based on size and findings. After imaging procedures, patients are followed for five years from enrollment. During the study, patients undergo procedures including MRI, CT, and EUS, along with quality-of-life and questionnaire assessments. Researchers will monitor clinical outcomes, imaging results, healthcare utilization, costs, patient-reported outcomes, and biomarker performance. Safety and adherence to surveillance schedules will be tracked. The study lasts five years after the initial registration to capture long-term outcomes related to pancreatic cyst monitoring.

Researchers are collecting information in a national registry to study patients receiving fecal microbiota transplantation (FMT) or other gut-related microbiota products. The goal is to evaluate the short-term and long-term safety and effectiveness of these treatments. The registry will include up to 4,000 patients from 75 sites across North America and focus on conditions such as Clostridium difficile infection and gut microbiome health. Patients undergoing FMT will be enrolled and information about the procedure, including donor and recipient screening, preparation, and delivery methods, will be recorded. After the treatment, participants will be followed regularly for up to 10 years. Follow-up will include updates from healthcare providers at 1 month, 6 months, 1 year, and 2 years post-FMT, along with annual direct contact with patients to monitor outcomes. During the study, data will be collected on any treatment-related adverse events and disease recurrence over the 10-year period. Participants will be asked to provide information via internet or telephone. This long-term monitoring aims to provide valuable insight into the safety and effectiveness of FMT and related microbiota therapies.

Researchers are evaluating the best approach to post-hospitalization follow-up care for children hospitalized due to common infections like pneumonia, skin and soft tissue infections, acute gastroenteritis, or urinary tract infections. The study compares automatic follow-up visits, which are routinely scheduled after discharge, against as-needed (PRN) follow-ups where parents monitor symptoms and decide if a visit is necessary. This trial aims to see if the PRN approach is as effective as automatic visits in preventing hospital readmissions and ensuring continuity of care, while also considering the burden of missed work, school, and extra costs for families. Children enrolled in the study are randomly assigned to either receive a recommendation for automatic follow-up visits or a recommendation for PRN follow-up at hospital discharge. The automatic group is instructed to schedule and attend a follow-up visit regardless of symptom improvement, whereas the PRN group is advised that follow-up visits are not required unless symptoms warrant it. The study involves a total of 2,674 children, with half in each group, to compare the outcomes of these two follow-up strategies. Participants and their families will be monitored for hospital readmission within 14 days after discharge, which is the primary outcome. Researchers will also assess additional medical interventions, child quality of life, symptom duration, healthcare use, parent anxiety and confidence, satisfaction with care, and communications with medical providers. Safety outcomes such as medical errors and infection-related readmissions will be tracked. The study includes assessments of time and cost burdens on parents and children, and will gather extensive information through questionnaires and medical records during the follow-up period.

Researchers are evaluating the effects of foundational wellness programs on reducing burnout and improving professional fulfillment among healthcare clinicians from University of Pennsylvania Health Systems and Massachusetts General Hospital. This randomized, controlled trial focuses on clinicians including physicians, advanced practice providers, nurse practitioners, physician assistants, and psychologists. The study measures both psychological and physiological markers of well-being, such as depression, anxiety, sleep quality, cognitive function, mindfulness, heart rate variability, and sleep scores. Participants are randomly assigned to one of two groups: the Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation group or the active control group receiving a Health Education Program (HEP). The SKY group undergoes a baseline week of heart rate variability and sleep monitoring, followed by a 3-day online workshop with a live instructor, and then weekly one-hour follow-up sessions for four weeks, practicing daily for 45 minutes while wearing an Oura Ring. The HEP group receives a 2-day online workshop followed by weekly two-hour sessions for four weeks, also practicing daily for 45 minutes and wearing an Oura Ring. Both groups have assessments at baseline, midpoint, and endpoint. Participants complete assessments using the Professional Fulfillment Index and other questionnaires measuring depression, anxiety, sleep impairment, intent to leave, self-valuation, impact of work on relationships, social connectedness, mindfulness, cognitive errors, and self-reported medical errors. Heart rate variability and sleep data are collected continuously via the Oura Ring. The study follows participants for six weeks with evaluations at week 1, week 4, and week 6 to analyze the impact of the programs on clinician burnout and well-being.

Researchers are studying children aged 0 to 2 years who have been hospitalized for bronchiolitis, a common lung infection. The study compares two different strategies designed to improve how doctors prescribe follow-up care that families can use as needed after hospital discharge. This is important because many automatic follow-up visits may not be necessary, and the study aims to reduce unnecessary visits while supporting families' preferences. The study tests two approaches: a moderate-resource strategy and a high-resource strategy. The moderate approach provides education for doctors and families, review of doctors' performance, and materials to help with clinical decisions. The high-resource strategy includes all these components plus additional small-group sessions and expert coaching to support doctors in follow-up care decisions. Participants will be monitored to see how well these strategies increase as-needed follow-up prescriptions within 7 days after leaving the hospital. Families and doctors will be supported with educational and decision-making materials. The study focuses on improving care after hospital discharge while minimizing unnecessary clinic visits, aiming for better, more personalized follow-up care for children with bronchiolitis.

Researchers are evaluating the safety and effectiveness of a Novel Endoscopic Bite Block designed to be used during routine outpatient upper endoscopy procedures. This feasibility study aims to determine whether the device's innovative design can reduce complications related to bite block positioning, potentially improving both procedural efficiency and patient safety for individuals undergoing upper endoscopy, particularly those with gastric disease. During the procedure, the endoscopist will use the single-use, disposable Novel Endoscopic Bite Block throughout the upper endoscopy. The study focuses on observing how well the device performs during the procedure and whether it prevents dental injuries. The bite block is the only intervention involved, and its use is limited to the duration of the scheduled upper endoscopy. Participants will be assessed on the day of the procedure to confirm successful completion of the upper endoscopy using the Novel Endoscopic Bite Block and the absence of dental injury. The study requires informed consent and ensures participants comply with all procedures and remain available for the study duration. Safety will be monitored closely, and the primary outcomes focus on procedural success and patient safety during the endoscopy.