Holmdel

Researchers are evaluating two digital mindfulness-based interventions to improve mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III randomized trial focuses on women diagnosed at or before age 50, who completed primary cancer treatments at least six months earlier. The study aims to compare the effectiveness of live instructor-led sessions via Zoom and a self-paced app-based program, exploring which approach best supports psychological health in this population. Participants will be assigned to one of three groups the live online mindfulness sessions MAPs LO conducted weekly for 6 weeks via Zoom, the MAPs App delivering the same content in shorter sessions over 6 weeks, or a meditation-only control group accessing guided audio meditations. Both English and Spanish speakers can participate in the live online and meditation groups, while the app is only available in English. Tablets and internet hotspots are provided if needed. All groups have access to the UCLA MARC mindfulness meditation app throughout the 6-month follow-up. During the study, participants will attend weekly sessions for the live group or engage with app content at home, with usage tracked to measure intervention dose. Researchers will assess depressive symptoms shortly after the intervention and again up to 6 months later, along with fatigue symptoms. They will also investigate factors influencing intervention effects, such as baseline distress and social determinants, and evaluate the cost-effectiveness of the programs. The total study duration includes a 6-week intervention period plus follow-up assessments out to 6 months.

Researchers are evaluating lung cancer screening uptake among patients aged 50 to 80 who are at risk due to smoking history. The study aims to improve lung screening knowledge, awareness, and uptake by using a Social Determinants of Health SDoH screening tool embedded in the Emergency Departments Electronic Health Record EHR. This pilot Type 1 Hybrid Effectiveness-Implementation Trial will first assess the reach of this approach and then test its preliminary effectiveness compared to enhanced usual care. Participants will be randomly assigned to one of two groups. One group will use LungTalk, an interactive iPad-based educational tool tailored to smoking status and barriers, featuring audio, video, and animations to improve lung screening knowledge and beliefs. The other group will receive a non-tailored lung screening pamphlet via email and follow-up navigation support within 48 hours. Both interventions aim to encourage lung cancer screening through education and patient navigation. During the study, participants will be assessed at 1 week, 1 month, and 6 months after the intervention. Researchers will measure lung cancer screening uptake and participants stage of adoption of lung screening. Additional assessments include health literacy, medical mistrust, perceived stigma and risk, benefits and barriers to screening, self-efficacy, knowledge about lung cancer, and fatalism. The study involves data collection from randomized trial methods and EHR records to evaluate outcomes over time.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are studying targeted genomic analysis of blood and tissue samples from patients with cancer, focusing on rare cancers with poor prognosis or limited treatment options. This observational research aims to identify genetic changes using genomic sequencing to help understand cancer development and to provide clinicians with mutation data that may guide treatment or referral to relevant studies. The study also collects clinical outcomes and tumor genome data for future analysis and cancer model development. The study involves analyzing previously collected tumor tissue samples using next-generation sequencing to detect mutations. Patients may also provide blood samples for analysis of circulating cell-free DNA and circulating tumor cells. These procedures support the identification of actionable mutations that may have available targeted therapies. The research includes correlative laboratory biomarker analysis. Participants are followed after study completion every 3 months for 2 years, then every 6 months for up to 15 years to monitor clinical outcomes and mutation frequencies. Researchers measure the frequency of specific mutations and the rate of actionable mutations in rare or poor prognosis cancers over this period. This long-term follow-up helps correlate genomic findings with patient outcomes and supports future research developments.