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 evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

This research aims to compare the effects of regional radiotherapy versus no regional radiotherapy in women with low-risk breast cancer who are receiving usual care. The study focuses on women with node-positive or T3N0 breast cancer who have undergone breast-conserving surgery or mastectomy, to see if avoiding regional radiotherapy works as well at preventing the cancer from returning. Participants receive either whole breast irradiation with or without regional radiotherapy to lymph nodes after surgery, or no regional radiotherapy following mastectomy or breast-conserving surgery. The study involves random assignment to these treatment groups and evaluates the impact of adding or omitting regional radiotherapy as part of their care. During the study, researchers will monitor breast cancer recurrence-free interval over 9.5 years, along with other outcomes such as invasive disease-free survival, mortality, overall survival, and quality of life. Patient-reported outcomes, arm mobility, adverse events, and cost-effectiveness are also assessed. Treatment adherence, follow-up visits, and collection of tumor tissue and blood samples are part of the participant's involvement throughout the trial.

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 evaluating whether brain MRI scans alone can effectively monitor small cell lung cancer compared to the combination of MRI scans with preventive brain radiation called prophylactic cranial irradiation (PCI). This phase III trial aims to see if using MRI surveillance alone can maintain overall survival and reduce side effects, potentially prolonging patients' lives. The study also looks at cognitive function, brain metastasis-free survival, and treatment toxicities. Participants are randomly assigned to one of two groups. One group receives PCI radiation therapy to the brain over two weeks along with scheduled MRI scans at 3, 6, 9, 12, 18, and 24 months. The other group only undergoes MRI scans at the same time points without PCI. Some patients in the PCI group may receive hippocampal avoidance radiation to spare cognitive function. During the study, participants undergo regular MRI scans and cognitive testing to track brain health and cancer spread. Researchers monitor survival rates, cognitive failure-free survival, brain metastases occurrence, and adverse events for up to two years after randomization. Blood samples may be collected for banking. The total follow-up includes multiple visits and assessments to evaluate the effects of MRI surveillance alone versus combined PCI and MRI monitoring.

Researchers are evaluating treatments for patients with high-risk stage III-IV head and neck squamous cell carcinoma, especially those negative for p16 in oropharyngeal cancer. This phase II/III trial compares the usual post-surgery treatment of radiation therapy with cisplatin chemotherapy against alternative combinations including docetaxel with cetuximab, and the addition of an immunotherapy drug called atezolizumab. The study aims to improve disease-free and overall survival while assessing side effects and quality of life. Participants are randomly assigned to one of three main treatment groups: radiation therapy with cisplatin weekly for six weeks; radiation with docetaxel plus cetuximab; or radiation with cisplatin plus atezolizumab given every three weeks for up to eight doses starting one week before radiation. Radiation is delivered using intensity-modulated radiation therapy (IMRT) daily, five days a week for six weeks. The docetaxel-only arm was closed after phase II. Blood samples are collected regularly, and imaging and biopsies may be performed as needed. During the study, participants undergo medical exams, blood tests, and imaging scans to monitor their response and safety. They are followed up closely after treatment completion at 1 and 3 months, then every 3 months for 2 years, every 6 months for 3 years, and annually thereafter. The primary outcomes measured include disease-free survival and overall survival up to seven years, along with assessments of symptom burden, quality of life, and treatment side effects throughout and after therapy.

Researchers are evaluating stereotactic radiosurgery (SRS) compared to whole brain radiotherapy that avoids the hippocampus (HA-WBRT) combined with memantine for treating small cell lung cancer that has spread to the brain. This phase III trial aims to determine if SRS, which targets tumors with a high dose of radiation in a single session, reduces cognitive decline and memory problems compared to the standard HA-WBRT plus memantine approach. The study also explores effects on brain disease progression, survival, symptom burden, and side effects in patients with brain metastases from small cell lung cancer. Participants are randomly assigned to one of two groups. One group receives SRS over one or several days, with blood samples and MRI scans collected during the study. The other group receives HA-WBRT once daily for two weeks along with memantine taken orally once or twice daily for up to 24 weeks, also with blood samples and MRI monitoring. Treatments continue unless there is disease progression or unacceptable side effects. After treatment, patients are followed every 2-3 months for one year, then every six months afterward. Throughout the study, participants undergo neurocognitive testing using a series of memory and thinking assessments, as well as patient surveys on cognitive difficulties and symptom burden. Researchers monitor brain scans, blood tests, and adverse events to compare outcomes between groups. The main measurement is the time until neurocognitive failure within one year, with additional follow-up on disease progression, survival, neurologic death, and treatment complications for up to ten years.

This trial investigates treatment options for men with high-risk prostate cancer. It compares a shorter radiation therapy called stereotactic body radiation therapy (SBRT), delivered in five treatments over two weeks, against the usual longer radiation therapy given in 20 to 45 treatments over 4 to 9 weeks. The study aims to see if the shorter treatment can prevent cancer from returning as well as the standard approach, while also evaluating outcomes like survival and side effects. Participants are randomly assigned to one of two groups. One group receives SBRT with precise delivery of higher radiation doses over a short period. The other group receives conventional external beam radiation therapy (EBRT) over several weeks. Both groups undergo imaging scans such as bone scans, CT, MRI, or PET/CT during screening and treatment to monitor the cancer. Optional blood and urine samples may be collected. During the study, patients are followed every six months for five years to assess outcomes including metastasis-free survival, overall survival, urinary and bowel function, fatigue, and treatment side effects. Patient-reported quality of life and treatment burden are also measured. The study tracks long-term effects and compares survival and cancer progression between the two radiation methods.

Researchers are evaluating treatments 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 adding stereotactic body radiation therapy (SBRT) to the usual treatment, which includes conventional image guided radiation therapy (IGRT), chemotherapy, and immunotherapy with durvalumab or targeted therapy with osimertinib. The study aims to see if adding SBRT improves overall survival and progression-free survival compared to the usual treatment alone. Participants are randomly assigned to one of two groups. One group receives conventional IGRT along with chemotherapy drugs such as paclitaxel, carboplatin, pemetrexed, cisplatin, or etoposide, followed by consolidation immunotherapy with durvalumab or targeted therapy with osimertinib. The other group receives SBRT followed by conventional IGRT and the same chemotherapy and consolidation therapies. SBRT delivers high-dose, precise radiation to the primary tumor over a shorter period, potentially reducing damage to healthy tissue. Both groups undergo periodic CT and PET/CT scans during follow-up. During the study, participants are followed every 3 months for the first year, then every 6 months for years 2 and 3, and annually thereafter for up to 8 years. Researchers assess overall survival, progression-free survival, tumor response, local control, patterns of cancer recurrence, lung function changes, quality of life, patient-reported outcomes, and treatment side effects. Biospecimens and advanced imaging data are collected for exploratory analyses, and safety is monitored throughout the study.