Albert Lea

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are studying the immediate and long-term effects of structured breathing exercises on mental health symptoms such as anxiety, depression, stress, and sleep quality. The study focuses on healthcare professionals experiencing burnout and aims to assess how these breathing practices might support their mental well-being. This behavioral intervention is sponsored by Mayo Clinic and targets adults aged 18 to 85 years. Participants will engage in self-guided structured breathing sessions lasting 15, 30, or 36 minutes, tailored to their personal skill level. The study monitors the feasibility, acceptability, and appropriateness of these breathing exercises over a four-month period. The intervention is delivered via a mobile app, allowing participants to practice breathing exercises on their own schedule. During the study, participants will be assessed on recruitment ease, retention, mobile app engagement, satisfaction with the breathing intervention, and adherence to the program. Researchers will collect data through mobile app usage metrics and self-reported measures to evaluate how well the intervention fits into the participants routines. The total participation time for each individual is four months, during which their progress and experience with the breathing practice will be closely monitored.

Researchers are evaluating quality of life differences in men with localized prostate cancer treated with two different radiation therapies. The study compares near margin-less adaptive radiation therapy ART, which adapts treatment based on information gathered during therapy and uses smaller margins to limit radiation to healthy tissue, against standard stereotactic ablative body radiotherapy SABR, a precise external radiation delivered over several days. The goal is to see if the shorter ART treatment can provide similar cancer control with fewer side effects impacting quality of life. Participants are randomly assigned to one of two groups one receives near margin-less ART in 2 treatments spaced at least 3 days apart, including imaging with cone beam CT and possibly CT or MRI scans the other receives standard SABR in 5 treatments spaced at least 2 days apart, with CT or MRI imaging. Treatments continue only if there is no disease progression or unacceptable side effects. After treatment, participants are followed with visits at 1, 3, and 6 months, then every 6 months for up to 5 years. Throughout the study, participants complete questionnaires assessing early and late changes in bowel and urinary quality of life, financial impact, erectile function, and prostate symptoms. Researchers also monitor physician-reported toxicities, biochemical markers of cancer progression, and survival. Imaging and dosimetry data are collected to explore treatment effects. This thorough monitoring aims to capture both patient experiences and clinical outcomes over up to 5 years.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.

Researchers are comparing two types of radiation therapy, proton beam radiation therapy PBT and intensity modulated photon radiotherapy IMRT, to treat patients with stage I to IVA esophageal cancer. The study aims to find out whether PBT improves overall survival and causes fewer serious heart and lung side effects compared to IMRT. Additional goals include examining symptom burden, quality of life, tumor response, cost-effectiveness, hospitalization length, lymphocyte levels, and rates of treatment failures and complications. Participants are randomly assigned to one of two groups. One group receives PBT over 28 treatment sessions, five days a week for 5.5 weeks, combined with chemotherapy chosen by the patient and their doctor. The other group receives IMRT on the same schedule with similar chemotherapy options. After chemoradiation, patients may have surgery to remove the esophagus tumor if they are eligible. Throughout the study, blood samples and imaging scans PETCT or CT are collected. Participants are closely monitored during treatment and followed for up to eight years. Follow-up visits occur every 3 to 6 months for the first three years and annually thereafter. The study measures overall survival, heart and lung side effects, symptom changes, tumor response, hospitalization time, immune cell counts, and quality-adjusted life years. The study also collects biospecimens for future research on treatment complications and assesses economic factors related to each radiation therapy.

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.

This research aims to evaluate the feasibility of a structured breathing intervention called Seokmun Hoheup in adolescents aged 12 to 17 years diagnosed with mild to moderate anxiety andor depression. The study focuses on both rural and non-rural adolescents who receive care at outpatient pediatric and childadolescent psychiatry clinics. The purpose is to understand how this breathing practice might support mental health in this group. Participants will follow the structured breathing program at least three times per week. The practice begins with 15-minute sessions and gradually increases to 30 and then 36 minutes over the course of the program. This intervention is behavioral and is designed to be performed regularly by the adolescent patients throughout the study. During the study, researchers will assess feasibility, acceptability, and appropriateness of the breathing intervention after four months using standardized measures. They will also monitor recruitment and retention rates, system usability, total log-ins, and completion rates of assigned breathing sessions. Participants will be involved over four months, with evaluations based on their engagement and feedback regarding the breathing practice.

Researchers are investigating how changes in the gut bacteria microbiome might be linked to fatigue and chemotherapy-induced nausea CIN in women with early stage breast cancer. Since patients receiving chemotherapy often experience these symptoms, this observational study aims to explore why some patients have more fatigue and nausea than others, focusing on the role of the gut microbiome. The study is supported by Mayo Clinic and collects data before and after chemotherapy treatment. Participants provide stool and blood samples before starting chemotherapy and again 3 to 5 days after chemotherapy begins. They also complete questionnaires about their symptoms, food intake, exercise, and other health factors. The study observes changes in gut bacteria composition and metabolites to understand their connection to fatigue and CIN during chemotherapy. During the study, patients are asked to complete questionnaires and provide biological samples at two time points before chemotherapy and shortly after treatment starts. Researchers monitor the bacterial makeup of stool samples and compare demographic and clinical characteristics between patients who do and do not report fatigue or nausea. The study tracks recruitment, retention, and the completion of study assessments over up to 24 months, aiming to better understand symptom differences related to chemotherapy.

Researchers are evaluating a new artificial intelligence AI algorithm designed to automatically outline normal structures in computed tomography CT scans used for radiation therapy planning. This observational study aims to measure how useful this AI tool is by collecting feedback on its performance and function from clinical staff involved in segmentation tasks. Participants in the study will not receive any treatment but will complete surveys to provide their observations about the AI algorithms accuracy and usability in normal tissue segmentation. The study involves clinical staff employed at Mayo Clinic locations who participate in normal tissue segmentation as part of their routine work. During the study, participants will complete surveys regarding the AI algorithms functionality and effectiveness in segmenting normal structures. The main measure is the proportion of success based on baseline observations. The study is expected to continue until November 2027 and includes healthy volunteers. Participants feedback will help assess the AI tools practical utility in radiation treatment planning.