Dansville

Researchers are evaluating the effect of geriatric evaluation and management combined with survivorship health education (GEM-S) compared to usual care on physical function in older cancer survivors. This phase III trial focuses on survivors aged 65 and older who have completed or will complete curative treatment for solid tumors or lymphoma within the last 6 months. The study aims to determine if GEM-S can improve physical abilities, mental well-being, and memory, as well as understand its impact on the quality of life for both patients and their caregivers. Participants are assigned based on their practice site to one of two groups. One group receives routine survivorship follow-up care through three visits over six months. The other group undergoes a one-hour GEM consultation discussing geriatric assessment results and recommendations, participates in survivorship health education sessions twice weekly for four weeks, and engages in the Exercise for Cancer Patients (EXCAP) program involving daily walking and resistance exercises. After the intervention, all participants are followed up at six months. During the study, participants complete various assessments including patient-reported physical function, cognitive function, and objective physical and cognitive tests. Researchers also evaluate survivor satisfaction with care, care coordination, referral completion, and caregiver outcomes such as distress and quality of life. Questionnaires and other measures support monitoring of these outcomes up to six months, providing comprehensive data on the intervention's effects.

Researchers are studying cancer cachexia (CC), a syndrome involving weight, muscle, and fat loss in patients with advanced colorectal, lung, or pancreatic cancer that cannot be removed by surgery or is at stage IV. This study aims to identify different diagnostic subtypes of CC based on host characteristics such as symptoms, physical activity, blood biomarkers, and body composition. The goal is to better understand the varied causes of CC to improve diagnosis and develop more effective treatments tailored to individual patients. Participants will complete surveys and physical function tests that each take about 30 minutes. They will provide blood and archived tumor samples and wear a device called an actigraph for 7 days to monitor sleep and activity. Standard care scans like CT or PET/CT will be done during the study. Data will be collected at the start and again at 3 months, with continued review of medical records up to 1 year. These procedures help researchers study changes in CC characteristics over time and explore tumor factors linked to this condition. During the study, patients will undergo assessments of weight, muscle loss, symptoms, physical activity, and function. Researchers will analyze blood samples, tumor tissue, and medical images while reviewing health records. The main outcome is identifying distinct CC subtypes and their association with survival. Follow-ups occur at 3 months and 1 year to track changes and outcomes. The study involves no treatment but focuses on observation and data collection to support future CC diagnosis and therapy improvements.

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.

This research aims to compare the effects of usual care including regional radiation therapy with no regional radiation therapy in women with low-risk breast cancer. It focuses on patients with node positive breast cancer or T3N0 disease who typically receive endocrine therapy and possibly chemotherapy to prevent cancer recurrence. The study examines whether skipping regional radiotherapy still effectively prevents breast cancer from returning, potentially reducing unnecessary treatment and side effects. Participants will be divided into two groups: one receiving radiotherapy to the breast/chest area and surrounding lymph nodes, and the other receiving no regional radiotherapy. The study evaluates standard treatments, ensuring radiation therapy starts within specific time frames after surgery or chemotherapy. Treatments include breast-conserving surgery or mastectomy, along with endocrine therapy planned for at least five years. During the study, researchers will monitor breast cancer recurrence-free intervals over approximately 9.5 years. Participants will undergo regular assessments to track cancer status, side effects, and overall health. The study includes quality of life questionnaires for some patients and requires ongoing follow-up to document treatment effects, adverse events, and long-term outcomes.

Researchers are investigating how well standard systemic therapy alone or combined with definitive treatment (prostate removal surgery or radiation therapy) works in men with prostate cancer that has spread to other parts of the body. This phase III trial aims to compare overall survival and other outcomes such as progression-free survival and quality of life between these treatment approaches. The study also explores differences in urinary function, pain, and physical functioning reported by patients over time. Participants begin with an induction period of 22 to 28 weeks receiving one of six forms of standard systemic therapy, which may include hormonal treatments, chemotherapy with docetaxel, or other approved medications. After this period, they are randomly assigned to either continue standard systemic therapy alone or receive standard systemic therapy plus definitive treatment of the primary tumor through prostatectomy within 8 weeks or radiation therapy within 4 weeks. The treatments are given according to accepted schedules, such as subcutaneous or intramuscular injections, oral medications, or intravenous infusions. During the study, participants undergo various assessments including physical exams, lab tests for prostate-specific antigen and testosterone levels, imaging scans, and patient-reported quality of life questionnaires. Researchers follow participants for up to 8 years to measure overall survival and monitor disease progression, symptoms, and side effects. Tissue and blood samples may be collected for future research. The study also tracks urinary and physical function changes and pain levels at multiple time points after starting therapy.

Researchers are evaluating two radiation therapy approaches for men with high-risk prostate cancer in this phase III trial. The study compares stereotactic body radiation therapy (SBRT), which delivers five higher-dose treatments over two weeks, to the usual radiation therapy that involves 20 to 45 treatments over 4 to 9 weeks. This trial aims to see if the shorter SBRT treatment can prevent cancer from returning as effectively as the longer conventional treatment while monitoring survival without metastasis. Participants are randomly assigned to one of two groups. One group receives SBRT with five treatments over two weeks, while the other undergoes external beam radiation therapy (EBRT) with 20 to 45 treatments over 4 to 9 weeks. Both groups have imaging scans such as bone scans, CT, MRI, or PET/CT during screening and study follow-up. Blood and urine samples may be collected optionally. Treatment continues as long as there is no disease progression or unacceptable side effects. During the study, participants have regular follow-ups every six months for five years. Researchers assess outcomes including metastasis-free survival, toxicity reported by physicians, patient-reported urinary and bowel function, fatigue, failure-free survival, overall survival, sexual function, quality of life, and treatment burden. Various questionnaires and imaging tests support these evaluations, helping to monitor safety and effectiveness over time.