Canandaigua

Researchers are studying older adults aged 75 years and older with advanced chronic kidney disease to find out which educational program better supports their kidney therapy decision-making. The study also aims to see if either program can reduce hospital and emergency room visits within the first six months and possibly improve end-of-life care for these patients. This research explores the first palliative care intervention integrated into routine nephrology care to help patients express their treatment preferences and address unanswered questions. Participants will be randomly assigned to one of two programs. Program A includes information from the National Kidney Foundation and meetings with a kidney therapy educator. Program B offers a video and paper decision aid along with coaching from a decision-support specialist who helps with kidney therapy decisions. Both programs focus on supporting patients in making informed choices about their treatment. During the study, participants decision-making process will be assessed at baseline, 4 to 6 weeks, and 12 weeks using the Decisional Conflict Scale. Researchers will also track changes in patients well-being, hospital admissions, intensive care admissions, emergency room visits, and end-of-life care over six months. The study includes surveys and verbal assessments, and participants progress will be monitored to understand the impact of each program on their care and treatment choices.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

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.

This research aims to compare two approaches to support Veterans facing both mental health and relationship challenges in primary care. It focuses on Veterans in committed relationships where at least one partner has mental health concerns like depression, PTSD, alcohol misuse, or suicidal thoughts. The study examines if a brief couples-based program can better reduce suicide risk factors at both the relationship and individual levels compared to a current standard individual-based care. The study compares a three-session couples program called the Brief Relationship Checkup BRC, designed to improve relationship health and reduce suicide risk factors, with three sessions of Co-Located Collaborative Care CCC provided to the Veteran alone, which is the existing standard care. BRC uses brief, structured 30-minute couple therapy sessions, while CCC includes functional assessments and action plans for the Veteran. Participants are randomized to either BRC or CCC and complete follow-up assessments at post-treatment, 3 months, and 6 months. Participants attend three treatment sessions according to their assigned group and complete evaluations of relationship functioning and emotional intimacy at several points up to 7.5 months after randomization. Researchers monitor treatment engagement and collect data through baseline, post-treatment, and follow-up assessments. The study aims to develop tools to measure how well the BRC program is delivered and its impact on suicide-related risk and protective factors.

Researchers are investigating treatments for small cell lung cancer that has spread to the brain, focusing on whether stereotactic radiosurgery SRS is better at preserving memory and thinking abilities compared to whole brain radiation therapy that avoids the hippocampus HA-WBRT combined with the drug memantine. This phase III trial evaluates cognitive function, symptom burden, survival outcomes, and side effects in patients receiving these treatments. The study also explores brain imaging biomarkers and the economic impact of therapies. Participants are randomly assigned to one of two groups. One group receives stereotactic radiosurgery, which delivers a high dose of radiation directly to brain tumors over one or several days. The other group receives hippocampal-avoidant whole brain radiation daily for two weeks along with memantine taken orally once or twice daily for up to 24 weeks. Both groups undergo blood sample collection and magnetic resonance imaging MRI throughout the study period. During the study, participants complete neurocognitive tests measuring memory and thinking skills, as well as patient-reported questionnaires about cognitive difficulties and symptoms. After treatment, follow-up visits occur every 2 to 3 months for one year and then every six months thereafter to monitor disease progression, survival, adverse events, and other outcomes. The main measurement focuses on the time until neurocognitive failure, assessed up to one year after treatment.

Researchers are comparing two radiation therapy approaches for men with high-risk prostate cancer to see if a shorter treatment duration can prevent cancer recurrence as effectively as the usual longer radiation schedule. This phase III trial evaluates stereotactic body radiation therapy SBRT, which delivers higher doses in five treatments over two weeks, against standard external beam radiation therapy EBRT, which involves 20 to 45 treatments over 4 to 9 weeks. The study includes men with specific high-risk features and uses advanced imaging to assess outcomes. Participants are randomly assigned to one of two groups. One group receives SBRT, involving five precise radiation treatments over two weeks, while the other group receives EBRT with 20 to 45 treatments over 4 to 9 weeks. Both groups undergo imaging tests such as bone scans, CT, MRI, or PETCT during screening and on study. Optional blood and urine samples may be collected during the trial. During the study, participants are followed every six months for up to five years to monitor metastasis-free survival, treatment effects on urinary, bowel, and sexual functions, fatigue, and overall quality of life. Various patient questionnaires and physician assessments track side effects and treatment burden. The trial also includes long-term evaluations of survival and disease progression, with imaging and laboratory tests supporting these assessments.

Researchers are evaluating whether adding stereotactic body radiation therapy SBRT to the usual treatment improves outcomes for patients with locally advanced, inoperable non-small cell lung cancer NSCLC that has spread to nearby tissues or lymph nodes. This phase III trial compares the effect of SBRT combined with conventional image guided radiation therapy IGRT, chemotherapy, and immunotherapy or targeted therapy against the usual treatment alone. The study aims to assess overall survival, progression-free survival, tumor response, lung function, quality of life, and treatment-related side effects. Participants are randomly assigned to one of two groups. In the first group, patients receive conventional IGRT and chemotherapy with drugs such as paclitaxel, carboplatin, pemetrexed, cisplatin, or etoposide during radiation, followed by immunotherapy with durvalumab or targeted therapy with osimertinib. The second group receives SBRT combined with conventional IGRT and similar chemotherapy, followed by the same immunotherapy or targeted therapy options. Both groups undergo CT andor PETCT scans during follow-up. Chemotherapy schedules vary by drug, including weekly or every 21-day dosing during radiotherapy, with consolidation treatments lasting up to one year. Throughout the study, participants undergo assessments including lung function tests FEV1 and DLCO, quality of life questionnaires, imaging scans, and monitoring for side effects using standard criteria. Follow-up visits occur every three months for the first year, every six months during years two and three, and annually thereafter, continuing for the duration of the study. Biospecimens and advanced imaging data are collected for exploratory analyses, including development of machine learning tools for radiation planning. Overall survival and progression-free survival are the primary outcomes measured up to eight years after randomization.

This trial studies patients with extensive stage small cell lung cancer that has spread outside the lung. It compares the effects of adding radiation therapy to the usual maintenance treatment with atezolizumab versus using atezolizumab alone. Researchers aim to see if combining radiation with immunotherapy can extend the time before the cancer grows or spreads, and improve overall survival. The study is a phase IIIII randomized trial sponsored by the National Cancer Institute. Participants are randomly assigned to one of two groups. One group receives atezolizumab intravenously every 21 days. The other group receives the same atezolizumab treatment plus radiation therapy once daily on days 1 through 5 during the first five weeks. Both groups undergo imaging scans including PETCT, CT, and MRI, as well as blood and tissue collections during the trial. Throughout the study, participants are monitored closely with scans and lab tests. After treatment ends, follow-up visits occur every 3 months for 2 years, then every 6 months for 3 years, and annually thereafter. Researchers measure progression-free survival and overall survival up to 6 years, along with side effects and how tumor characteristics may affect outcomes. The trial evaluates the benefits and risks of combining radiation with atezolizumab for this cancer.