Winston-Salem

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating a culturally-tailored, home-based physical activity program designed to improve physical fitness in Hispanic or Latino/Latina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects such as weight gain, fatigue, and reduced fitness after cancer treatment, with Hispanic or Latino/Latina individuals potentially at higher risk. The study aims to increase moderate to vigorous physical activity (MVPA) through a mobile health and social media intervention. The study has two stages. Stage 1 involves developing the intervention using feedback from 20 Latinx survivors who speak either English or Spanish. Stage 2 is a randomized controlled trial comparing the intervention group with a control group that only uses a Fitbit tracker. The intervention group receives Fitbit trackers, weekly reminders, goal-setting sessions, social media peer support 2-3 times a week, badges, monthly Zoom meetings, and may choose a physical activity partner who also receives support. After 12 weeks, a 4-week maintenance phase continues these supports with less structure. The control group wears a Fitbit daily for 12 weeks without additional support. Participants wear Fitbit trackers daily, attend weekly sessions, post on social media, and complete interviews and questionnaires. Researchers measure changes in physical activity levels, sedentary time, quality of life, and cardiometabolic health indicators. Data is collected using Fitbit devices, interviews, and surveys, with follow-up over 12 weeks plus maintenance. Safety and acceptability of the intervention are also assessed throughout the study.

This research aims to evaluate a decision-making support intervention called the University of Rochester-Geriatric Oncology assessment for Acute Myeloid Leukemia (UR-GOAL) in older adults diagnosed with acute myeloid leukemia (AML) and their caregivers. The study is a multicenter randomized controlled trial conducted at four sites, comparing UR-GOAL to an attention control. The purpose is to see if UR-GOAL can reduce patient distress, improve shared decision making between patients and healthcare providers, and reduce decisional conflict. Participants will be randomly assigned to either the UR-GOAL intervention or the attention control group. Those in the UR-GOAL group will watch an AML educational video, complete preference assessments, and receive a summary report to review and discuss during upcoming clinical visits. Caregivers, if involved, will also view the video and receive a summary report. Oncologists will be provided with the summary report to support discussions with patients. This approach is behavioral and designed to enhance decision-making support. During the study, participants will be assessed using the Distress Thermometer Questionnaire at one month to measure distress levels. The study involves patient and caregiver participation in viewing materials and discussing care plans with oncologists. The researchers will monitor shared decision making, patient distress, and decisional conflict to understand the impact of the intervention. The total participation duration aligns with the study visits and assessments over the course of initial treatment decisions.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are studying the prevalence, risk factors, and effects of chronic post-surgical pain in children aged 0 to 16 years undergoing common pediatric surgeries such as laparoscopic appendicectomy, scrotal exploration, orchidopexy, hypospadias repair, and circumcision. The study aims to understand how factors like parent and child anxiety, existing pain, and acute post-operative care relate to the development of chronic pain over time. This knowledge will help improve care and reduce the risk of long-term pain in children after surgery. The study involves completing questionnaires at six different times, starting before surgery, then at Day 2, 3-4 weeks, 3-4 months, and finally 10-12 months post-surgery. These questionnaires assess pain levels, function, and related factors. The study is conducted across multiple international centers and focuses on both elective and emergency surgeries. Participants will be involved in providing information through these questionnaires over about one year. Researchers will measure outcomes like the presence of chronic pain 10-12 months after surgery. The study will also monitor the impact of chronic pain on children's quality of life, emotional well-being, and social functioning. Families unable to complete follow-up surveys or those with language barriers may not participate, ensuring accurate and complete data collection.

Researchers are evaluating a remote behavioral intervention called MORPH aimed at improving physical activity, pain interference, body weight, and physical function in older adults aged 65 and above who experience chronic knee or hip osteoarthritis pain. This Phase 2 trial addresses important gaps from previous smaller studies by involving a larger sample size and a longer duration to assess efficacy and durability of health improvements. The study focuses on participants who have chronic pain with associated inactivity and overweight or obesity conditions. The study compares the MORPH intervention, which combines weekly group or individual remote coaching sessions with digital health tools to promote better diet and increased activity throughout the day, against an enhanced usual care group that receives only a body weight scale and wearable activity monitor. The intervention period lasts 6 months, followed by a 12-month no-contact maintenance period where participants attempt to sustain their behavior changes independently. Participants will be involved in assessments of daily steps measured by ActivPAL at baseline, after 6 months, and after 18 months. Researchers will track changes in pain interference, body weight, and physical function. Study visits, questionnaires, and monitoring of physical activity and diet adherence are part of the evaluation. Safety and eligibility are confirmed through screening questionnaires and medical approval, with overall participation lasting 18 months including the follow-up period.

Researchers are evaluating the effectiveness of mPATH-Lung, a mobile patient health technology, in increasing lung cancer screening rates among high-risk patients aged 50 to 77 years. This pragmatic, randomized controlled trial is conducted across an academic Learning Health System and focuses on diverse groups, including racial/ethnic minorities and rural residents. The study also compares three outreach methods to engage these populations and assesses additional revenue generated by increased screenings as well as the impact of applying HEDIS-based exclusion criteria to prevent over-screening. Participants will be assigned to one of several groups: receiving a portal message with reminder text messages, a text message with reminder texts, portal message only, or usual care. Reminder text messages are timed depending on whether participants have upcoming appointments, with messages sent several days after initial contact, before appointments, and during program progress if not completed. The usual care group receives standard care without additional messaging. During the study, participants' lung cancer screening completion within 90 days will be tracked. Eligibility requires having a patient portal account or cellphone number and being affiliated with the Atrium Health Wake Forest Baptist health network. Researchers will monitor outreach effectiveness, screening rates, and revenue impact. The study involves data collection from electronic health records, reminders sent via messages, and evaluation of screening patterns over the study period.