Greenwood

Researchers are evaluating an Internet-based pain coping skills program combined with enhanced usual care to see if it improves pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain. The study also investigates how this program affects opioid and other pain medication use, quality of life, self-confidence in managing pain, and other factors such as fatigue, sleep, emotional distress, and cognitive function. The study plans to enroll 250 participants who have had invasive cancer treated with surgery, radiation, chemotherapy, or other therapies. Participants in the study will be randomly assigned to either receive the 8-session Internet-based pain management program along with enhanced usual care or receive enhanced usual care alone. The program is designed to help participants better manage their cancer-related pain through online sessions. Each participant will be involved for about 9 months, from the initial randomization to the final follow-up assessment at week 34. During the study, participants will complete assessments evaluating pain severity and pain interference using the Brief Pain Inventory. Researchers will also measure medication use, quality of life, pain management confidence, and other health factors through questionnaires and interviews. Participants are expected to complete follow-up assessments at 22 and 34 weeks. The study includes monitoring for safety and adherence to the pain management program, and those without reliable internet access may receive tablets to participate.

Researchers are studying the effects of the drug velmanase alfa (Lamzede4) in children under 3 years old who have Alpha-Mannosidosis, a rare genetic condition. This observational study focuses on how the drug influences a disease marker called GlcNAc(Man)2 after one year of treatment and explores how the child's body responds to the therapy. The study also gathers additional data from other studies and reports to better understand the treatment's impact in real-world settings. Velmanase alfa (Lamzede) is given as an intravenous enzyme replacement therapy at a dose of 1 mg per kilogram of body weight once a week. The study includes children who started treatment between birth and just before turning 3 years old. Participants' disease marker levels are measured before starting treatment and again after at least six weeks of therapy. During the study, parents or legal guardians provide routine clinical test results related to their child's health and treatment with velmanase alfa. Researchers monitor the pharmacodynamic response to the drug over 52 weeks, focusing on changes in the disease marker. This monitoring helps assess how the drug interacts with the body over time and collects information on safety and treatment effects.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are comparing two approaches of standard therapy for patients with stage II to IIIB non-small cell lung cancer (NSCLC) that can be surgically removed. This phase III trial evaluates whether giving chemotherapy and immunotherapy before and after surgery (perioperative) is more effective than giving the same treatments only after surgery (adjuvant). The study aims to find out which method leads to better event-free survival and overall survival over several years. Participants are randomly assigned to one of two groups. In the adjuvant group, patients have surgery first, followed by up to four cycles of platinum-based chemotherapy and up to one year of immune checkpoint inhibitor treatment if there is no disease progression or unacceptable side effects. In the perioperative group, patients receive chemotherapy combined with immune checkpoint inhibitors before surgery, then have surgery, and continue immune checkpoint inhibitor therapy for up to one year afterward. Chemotherapy drugs used may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, or vinorelbine, and immunotherapy drugs may include nivolumab, pembrolizumab, or atezolizumab. During the study, patients undergo imaging tests such as CT scans, MRI, or PET/CT scans to monitor their condition. After completing treatment, they are followed for up to 10 years with check-ups every six months. Researchers measure event-free survival at three years, overall survival up to 10 years, surgical outcomes, side effects, and other treatment-related factors to understand which approach offers better results for patients with resectable NSCLC.

Researchers are evaluating an online educational program called Current Together After Cancer (CTAC) designed to help patients who have had surgery for stage II or III colorectal cancer receive follow-up care that follows current medical guidelines. This phase III trial aims to see if CTAC improves patients' knowledge about surveillance, their confidence in managing their care, and satisfaction with support received from a chosen adult supporter. Proper surveillance after colorectal cancer surgery is important to detect any return of the disease early, but many survivors do not receive recommended follow-up care, possibly due to lack of information or support. Participants are randomly assigned to one of two groups. One group receives access to the CTAC intervention website, which includes educational content and interactive modules to help manage post-surgery surveillance. The other group accesses a control website with general health education. Both patients and their chosen supporters can use their assigned website as often as they like for up to 16 months. Supporters are adult individuals identified by the patient who help with their cancer journey. During the study, researchers will measure how many patients receive surveillance care that follows guidelines at 12 and 16 months. They will also assess patients' knowledge about surveillance, confidence in managing their care, and satisfaction with supporter involvement at 3 and 16 months. Surveys and interviews will be conducted to gather this information. The study will also explore how well the intervention fits into clinical practice and how supporter participation affects outcomes.

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma in this phase III trial. The study compares the effects of lenalidomide and dexamethasone given with or without daratumumab. These drugs work in different ways to stop tumor growth, and the combination with daratumumab, an immunotherapy, may better interfere with tumor cell growth and spread. The trial aims to assess overall survival, progression-free survival, treatment safety, and quality of life among participants. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on specific days across up to 24 cycles, combined with daily oral lenalidomide for 21 days and oral dexamethasone on days 1, 8, 15, and 22 for 12 cycles. The other group receives only lenalidomide and dexamethasone on the same schedule for up to 24 cycles. Treatment continues every 28 days until disease progression or unacceptable side effects occur. During the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans, and patient questionnaires to monitor treatment effects and quality of life. Researchers track overall survival for up to 15 years, evaluate minimal residual disease, and monitor medication adherence and adverse events. Follow-up visits occur every 3, 6, or 12 months after treatment ends to continue monitoring health outcomes.

Researchers are studying how low muscle mass, known as myopenia, affects chemotherapy side effects and overall survival in older adults newly diagnosed with advanced colorectal cancer. The study also looks at how genetic differences might influence the link between myopenia and chemotherapy toxicity. This research focuses on patients receiving 5-Fluorouracil (5-FU) based chemotherapy, sometimes combined with other drugs or immunotherapy. The study includes older adults with metastatic colorectal cancer who are starting or have recently started first-line treatment with 5-FU chemotherapy, alone or combined with oxaliplatin, irinotecan, or immunotherapy. Capecitabine is also allowed. The study tracks patients over time to observe chemotherapy side effects and survival, but there are no specific investigational treatments or devices involved. Participants will be monitored for chemotherapy toxicities, especially those graded 3 to 5, for up to 6 months after starting treatment. The study collects data on muscle mass, genetic factors, and treatment outcomes to understand how these affect chemotherapy side effects and survival. Participants must be able to complete questionnaires in English or Spanish and provide consent to join the study.

Researchers are investigating whether observation is as effective as continuing pembrolizumab treatment in patients with early-stage triple-negative breast cancer who achieved a complete response after preoperative chemotherapy combined with pembrolizumab. This phase III trial aims to evaluate recurrence-free survival and quality of life, as well as the value of reducing immunotherapy treatment after surgery in these patients. The study also examines differences in adverse events, overall survival, and financial impacts between treatment approaches. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group receives pembrolizumab intravenously as adjuvant therapy, while the other group undergoes observation without further treatment. Both groups have tumor biopsies and blood samples collected on study and during follow-up. Additional assessments include questionnaires and quality-of-life evaluations. During the study, researchers monitor participants for up to 10 years to measure recurrence-free survival. They assess quality of life using validated tools, track adverse events, and evaluate financial toxicity and work productivity. The study includes tumor tissue analysis, blood sample collection, and patient-reported outcomes to understand the long-term effects and value of treatment de-escalation in breast cancer care.

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 conducting a long-term observational study focused on individuals diagnosed with Rett syndrome caused by MECP2 gene mutations. This project, developed with experts from the IRSF Rett Syndrome Center of Excellence Network, aims to collect detailed information on the signs and symptoms experienced by people with Rett syndrome, as reported by both medical specialists and caregivers. The study's goal is to improve understanding of Rett syndrome, guide care recommendations, and support the creation of better clinical trials and drug development efforts for this condition. Since this is an observational registry, no specific treatments or interventions are being tested or administered during the study. Instead, the study gathers ongoing real-world data from participants over time. The collected information will help inform future research and care strategies for Rett syndrome. Participants will be followed and monitored for up to five years to document the natural progression of Rett syndrome. Data collection will include reports on symptoms and health status provided by clinicians and caregivers. The main outcome measured is the natural history of the disease over this five-year period, which will help build a foundation for consensus care guidelines and improve clinical trial design.