Holmdel

Researchers are evaluating two digital mindfulness meditation programs to support mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III trial focuses on women diagnosed with breast cancer at age 50 or younger who have completed their main cancer treatments at least six months ago. The study aims to compare a live, instructor-led online program to a self-paced app-based program and also to explore factors that might influence how well these interventions work, including psychological distress levels and social factors like race and education. Participants will be assigned to one of three groups: a live online Mindful Awareness Practices (MAPs) program delivered over Zoom, a self-paced MAPs digital app, or a meditation-only control group. The live online program includes guided meditations, exercises to manage pain and emotions, and cultivating kindness, with daily home practice increasing from 5 to 20 minutes. The app program unlocks lessons sequentially as participants progress. Meditation use will be tracked across all groups to measure engagement. During the study, participants will report depressive symptoms two weeks after completing the intervention. Researchers will also collect information on emotion regulation strategies and social determinants of health, and monitor how much participants practice mindfulness to understand the programs' effects. The total intervention lasts six weeks, and participants must be able to use a digital device and communicate in English or Spanish. Safety and participation are closely monitored throughout the study.

Researchers are conducting a pilot trial called the LEAD Pilot Study to address lung cancer screening disparities by targeting eligible patients in the Emergency Department using an Electronic Health Record-embedded Social Determinants of Health screening tool. The study aims to evaluate the reach, or the number and representativeness of individuals targeted for lung screening knowledge, awareness, and uptake, and to assess the preliminary effectiveness of a tailored lung screening intervention compared to enhanced usual care. The trial uses quantitative methods including a randomized controlled trial and EHR data analysis to explore factors influencing lung screening uptake such as health literacy, mistrust, stigma, fatalism, and knowledge about lung screening.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are studying the use of targeted genomic analysis of blood and tissue samples from patients with cancer, focusing especially on rare cancers with poor prognosis or those lacking effective treatments. This research aims to identify specific genetic changes that contribute to cancer development and to improve diagnosis and treatment options by analyzing the entire genetic makeup of cancer cells. The study collects detailed genomic data to support future research and clinical care. Participants provide blood and tumor tissue samples, which undergo next-generation sequencing to detect genetic mutations. These mutations are then reviewed to find those with available targeted therapies, and this information is shared with treating doctors to guide patient care or referrals to other studies. Previously collected tissue samples may also be analyzed, and blood samples are collected to examine circulating tumor DNA and cells. After the initial sample collection and analysis, patients are followed up every three months for two years, then every six months for up to fifteen years. During this time, researchers monitor the frequency of specific mutations and combinations in related genes, as well as the rate of actionable mutations in rare or poor prognosis cancers. The study also collects clinical outcomes, tumor genome data, and tumor tissue for further research and model development.