Clinical Research Directory

A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)

This study aims to learn whether a handheld robotic device, called the HandX, can help surgeons safely perform a minimally invasive nipple-sparing mastectomy. This type of mastectomy uses a small incision at the side of the breast to remove breast tissue while keeping the skin and nipple in place. The goal is to lower scarring, improve comfort, and support good cosmetic results after surgery. Participants in this study will already be planning to have a therapeutic or preventive mastectomy with immediate implant-based reconstruction. All surgeries are done at Mediterraneo Hospital in Greece. During the operation, surgeons use the HandX device to assist with the endoscopic dissection. Researchers will collect information about how long the surgery takes, whether the planned approach can be completed without switching to open surgery, and whether any surgical complications occur. They will also check healing, infection, and implant-related problems for up to 365 days after surgery. Participants will complete the BREAST-Q questionnaire before surgery and at several times after surgery to share their views on comfort, well-being, and cosmetic outcomes. About 15 participants will take part. The results will help researchers understand whether this approach is practical and safe, and whether it should be studied further in a larger trial.

Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families

This trial studies how well weight management and health behavior intervention works in helping patients with hereditary breast and ovarian cancer and Lynch syndrome mutation carriers lose or maintain a healthy weight and lower their risk for cancer. Lifestyle behaviors such as physical activity, diet, and weight management may play a key role in preventing cancers and improving outcomes even in those with hereditary cancer syndromes.

Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery

This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). The goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if COVID-19 affects patient costs of breast reconstruction. This may help researchers demonstrate the financial consequences of undergoing breast surgery.