[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hereditary-breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hereditary-breast-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100375518","impact-of-covid-19-pandemic-on-out-of-pocket-costs-lost-wages-and-unemployment-in-patients-with-breast-cancer-undergoing-breast-surgery-100375518",false,"NCT04169542","Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery","Potential Impact of the COVID -19 Pandemic on Financial Toxicity in Breast Cancer Surgical Patients: The Impact on Out of Pocket Costs, Lost Wages and Economic Strain","Inclusion Criteria:\n\n* Have an indication for surgical treatment of invasive breast cancer or ductal breast carcinoma in situ (DCIS) or prophylaxis in the setting of genetic mutations or strong family history\n* English-speaking\n* Able to complete consent\n* Able to fill out computer survey material\n\nExclusion Criteria:\n\n* Non-English-speaking\n* Those with recurrent or metastatic disease or concurrent primary cancers\n* Patients undergoing breast conservation therapy will also be excluded from the study","FEMALE","18 Years",{"count":19,"type":20},600,"ESTIMATED","OBSERVATIONAL","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.",[24,25,26,27],"Breast Ductal Carcinoma In Situ","COVID-19 Infection","Hereditary Breast Carcinoma","Invasive Breast Carcinoma","RECRUITING","2026-04-28",{"date":31,"type":32},"2026-05-04","ACTUAL",{"date":34,"type":32},"2019-05-21",{"date":36,"type":20},"2028-03-31",{"name":38,"class":39},"M.D. Anderson Cancer Center","OTHER",4,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":62,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100615410","a-prospective-cohort-study-of-handx---assisted-endoscopic-mastectomy-feasibility-and-safety-athena-i-study-100615410","NCT07292246","A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)","ATHENA I","Inclusion Criteria:\n\n* Female sex\n* Age ≥ 18 years old\n* Indication for therapeutic or prophylactic (risk-reducing) mastectomy for:\n\n  1. early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing primary surgery\n  2. early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing surgery post systemic (neoadjuvant) therapy with clinical evidence of partial or complete response\n  3. ductal carcinoma in situ (DCIS), or\n  4. BRCA or other breast cancer - related genetic mutation carriers, or\n  5. high risk for development of breast cancer.\n* Breast volume: cup sizes A to C as defined by underwear size, expected implant volume \\\u003C550cc and glandular ptosis not exceeding Grade I Regnault's classification.\n* ECOG \u002F WHO Performance Status \\\u003C2\n* Subject with signed and dated informed consent form\n\nExclusion Criteria:\n\n* Chest wall or skin invasion\n* Extended lymph node involvement at diagnosis (cN2)\n* Inflammatory breast cancer\n* Tumor distance from nipple - areola complex \\\u003C1cm on imaging studies\n* Active smoking\u002Fnicotine use within 4 weeks pre-op (combustible tobacco, vaping, nicotine pouches, NRT)\n* BMI \\>35\n* High risk patients with severe and poorly controlled co-morbid conditions (including but not limited to diabetes, heart disease, renal failure or liver dysfunction)\n* Pregnancy or breastfeeding\n* Psychiatric, addictive, or any disorders which compromise the ability to give informed consent for participation in this study\n* Subject without signed and dated informed consent form",{"count":49,"type":20},15,"INTERVENTIONAL",[52],"NA","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.\n\nParticipants 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.\n\nDuring 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.\n\nAbout 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.",[55,56,57,26,58,59,60,61],"Breast Cancer","BRCA 1 Gene Mutation","BRCA 2 Gene Mutation","Breast Neoplasms","DCIS","Germline Mutation Abnormality","Early Breast Cancer",[63,64,65,66,67,68],"breast cancer","mastectomy","endoscopic","robotic","handx","nipple-sparing mastectomy","2025-12-05",{"date":71,"type":32},"2025-12-18",{"date":73,"type":32},"2025-09-09",{"date":75,"type":20},"2029-10",{"name":77,"class":39},"Vasileios Kalles",1]