[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"proms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:proms":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,50,81,105,136,167,191,215,247],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100615172","pediatric-anesthesia-the-childs-voice-100615172",false,"NCT07289152","Pediatric Anesthesia: The Childs Voice","Pediatric Health Empowerment: Improving Children´s Perioperative Experiences With Patient-Reported Measures","PHEASE","Inclusion Criteria:\n\n* Pediatric patients aged 4-12, American Society of\n* Anesthesiologists physical status classification (ASA) I-III\n* undergoing surgery\n\nExclusion Criteria:\n\n* Children with cognitive or sensory disorders\n* children or parents who do not speak Danish,\n* patients for whom there is no consent to participate.","ALL","4 Years","12 Years",{"count":21,"type":22},250,"ESTIMATED","OBSERVATIONAL","In Denmark, around 25,000 children under 18 undergo general anesthesia annually. Hospital stays and anesthesia can induce significant anxiety and stress in children due to unfamiliar environments, procedures, and communication issues. This anxiety can be linked to postoperative complications such as emergence delirium and may negatively impact both the child and their family's well-being. Engaging patients actively in their healthcare, including pediatric cases, is essential for improving outcomes. Assessing perioperative patient and family outcomes, particularly through patient-reported outcome measures (PROM) and patient-reported experience measures (PREM), can significantly enhance the quality of care provided to children. While PROMs are widely used in adults, they are less common in pediatric settings. The Pediatric Scale for Quality of Recovery (PedSQoR), developed by Australian and American researchers, is one such tool designed to measure recovery in children. This study aims to translate andvalidate the PedSQoR for Danish children aged 4-12. Furthermore, no existing instruments comprehensively assess pediatric surgery patients' experiences under general anesthesia, particularly from the child's perspective without relying on parents as proxies. Empowering children to express their healthcare experiences gives healthcare workers an insight into what matters for children and gives children a more positive outlook on healthcare, benefiting lifelong engagement.\n\nStudy Aims and Objectives: The study aims to enhance the assessment of children's outcomes and experiences in perioperative settings, ultimately improving pediatric perioperative healthcare. The objectives include:\n\n1. Translation and Adaptation: a. Translate and adapt the PedSQoR for Danish children aged 4-12. b. Validate the Danish PedSQoR version.\n2. Development of a PREM Instrument: a. Develop a comprehensive PREM for children's experiences during surgery and anesthesia. b. Pilot-test and adjust the PREM questionnaire with a group of children aged 4-12.\n\nStudy Methods:\n\n1. PedSQoR Translation and Validation:\n\n   A single-center prospective cohort study will adapt and test the PedSQoR for Danish children. The process involves translating the 21-item scale, validating it with a sample size of 150, and ensuring reliability through various statistical methods, including Cronbach's Alpha and test-retest reliability. Data will be collected from the Department of Anesthesiology and Intensive Care at Gødstrup Hospital.\n2. PREM Instrument Development:\n\nThis study will develop a PREM instrument using the Warwick Patient Experiences Framework (WaPEF), which encompasses seven dimensions of patient experience. The process will involve forming a panel of child experts, conducting focus groups, and translating insights into a pictorial questionnaire. The PREM will undergo pilot testing with 20 children to validate its effectiveness in capturing the dimensions of the WaPEF.\n\nResearch Ethics: Given the vulnerability of children in research, this study will prioritize their safety and comfort, ensuring the study's benefits outweigh any potential risks. Informed consent will be obtained from both parents and children. The study will be registered with the Region Central Denmark's list of research projects and will not require approval from the Scientific Ethics Committee.",[26,27,28,29],"Pediatric Anesthesia","Pediatric Surgery","PROMs","PREMs",[31,32,33,34,35,36],"PROM","Patient-reported outcom measues","Children","child","PREM","Patient-reported experience measures","RECRUITING","2026-04-22",{"date":40,"type":41},"2026-04-23","ACTUAL",{"date":43,"type":41},"2026-01-01",{"date":45,"type":22},"2030-12-31",{"name":47,"class":48},"Gødstrup Hospital","OTHER",3,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100622652","validation-and-cultural-adaptation-of-the-koos-acl-scale-for-the-italian-population-100622652","NCT07386405","Validation and Cultural Adaptation of the KOOS-ACL Scale for the Italian Population","Italian Version of KOOS-ACL (Knee Injury and Osteoarthritis Outcomes Score - Anterior Cruciate Ligament): Translation, Cross-cultural Adaptation and Validation","VACKP","Inclusion Criteria:\n\n* Patient age 18 years or older\n* Patients who are native Italian speakers\n* Patients undergoing anterior cruciate ligament reconstruction of the knee\n* Patients who have understood and signed the informed consent to participate in the study.\n* Patients who are able to understand the study conditions and participate for the entire duration\n\nExclusion Criteria:\n\n* Patients unable to understand the text in Italian\n* Patients undergoing knee replacement surgery, corrective osteotomies, or osteosynthesis of knee fractures.\n* Patients who are drug addicts, alcoholics, suffer from psychiatric disorders, or have any clinical conditions that could compromise the success of the questionnaire.\n* Patients with orthopedic conditions of other origins","18 Years",{"count":60,"type":22},120,"Submission of the KOOS ACL questionnaires in Italian for the purpose of validation and cultural adaptation of the KOOS-ACL scale for the Italian population.",[63,64,65,28],"Scale Reliability Validity","ACL Injury","Validation and Cultural Adaptation of a Scale",[67,68,69,28],"scale reliability","ACL","KOOS-ACL","NOT_YET_RECRUITING","2026-01-27",{"date":73,"type":41},"2026-02-04",{"date":75,"type":22},"2026-01-19",{"date":77,"type":22},"2027-07-01",{"name":79,"class":48},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":80},"100597660","patient-reported-outcome-measurements-proms-impact-on-clinical-outcome-in-first-line-setting-non--small-cell-lung-cancer-nsclc-according-to-chemo--immunotherapy-regimen-100597660","NCT07061379","Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen","Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen (PROMOTING)","PROMOTING","Inclusion Criteria:\n\n* Age \\> 18 years\n* Diagnosis of Stage IV NSCLC with PD-L1 \\\u003C50%, without actionable genomic alterations\n* Signed Informed Consent Form (ICF) to the study\n* Patients eligible to receive first line treatment with combo chemo-immuno treatments as standard of care\n\nExclusion Criteria:\n\n\\- Patients unable to fill the questionnaires due to neurological comorbidities",{"count":90,"type":22},144,"A multicenter, national pharmacological observational study that has as its overall goal to implement a set of validated and agreed upon European-wide questionnaires (PROMs - patient's reported outcomes) to assess patients' perceptions of aspects of their lives based on the treatment they are receiving.\n\nSpecifically, with the research we present here, we aim to obtain data on patients' health and condition, including quality of life, symptom status, physical function, mental health (anxiety and depression), sleep quality, and sexuality as useful indicators not only of patient well-being but also of the effectiveness of the treatment itself.\n\nThe study involves the following: patients will be asked to complete online questionnaires at the following timepoints: before the start of treatment, after 4 and 8 treatment cycles, and at disease progression.\n\nData will also be collected regarding the patient's oncological medical history, treatment performed, response to treatment at CT\u002FPET reevaluations, any toxicities that arose during treatment.",[28],[94,95],"NSCLC","immunotherapy","2025-08-31",{"date":98,"type":41},"2025-09-03",{"date":100,"type":41},"2025-07-24",{"date":102,"type":22},"2031-06",{"name":104,"class":48},"IRCCS San Raffaele",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":112,"targetDuration":113,"studyType":23,"phases":4,"briefSummary":114,"conditions":115,"keywords":122,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":80},"100479104","compliance-with-eras-protocol-in-pancreatic-surgery-stress-response-and-outcomes-100479104","NCT05518643","Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes","Enhanced Recovery Program, Patient Reported Outcomes, Surgery-specific Outcomes and Stress Response After Pancreatic Surgery: A Prospective Observational Cohort Study by the Thessalic Pancreas Study Group (ThePANas).","Inclusion Criteria:\n\n* all pancreatic surgery patients\n* above the age of 18\n* fluent greek speakers\n* without communication barriers\n\nExclusion Criteria:\n\n* younger than 18 years-old\n* unable or unwilling to participate\n* other surgical procedures\n* communication barriers\n* lost to follow-up",{"count":60,"type":22},"1 Year","The purpose of this study is to evaluate the impact of compliance with enhanced recovery after surgery (ERAS) program on patient reported outcomes (PROs), surgery-specific outcomes and stress response after pancreatic surgery.\n\nThis prospective observational study will include all consecutive patients undergoing pancreatic surgery over a period of three years (2022 - 2025) at two sites, namely University General Hospital of Larissa and IASO Thessalias, in Greece. Patients will be prospectively enrolled after written informed consent. Data will be collected on patient characteristics, surgical and anaesthetic techniques, complications, and length of stay. Quality of life questionnaires will be administered to patients preoperatively, on the fith postoperative day, first follow-up after discharge, one month and six months after the operation. The stress response will be assessed by measuring the Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio (NLR and PLR) preoperatively, and on the first five postoperative days. Data will be collected on pancreatic surgery-specific complications such as delayed gastric emptying (DGE), post-pancreatectomy haemorrhage (PPH) and postoperative pancreatic fistula (POPF) formation. Anonymised data will be uploaded by the principal investigator on a protected excel spreadsheet for analysis.",[116,117,118,119,120,121,28],"ERAS","Pancreas Cancer","Pancreas; Fistula","Delayed Gastric Emptying","Surgery-Complications","Pancreatic Hemorrhage",[116,117,28,123,120,124,125,126],"Stress response to surgery","PLR","NLR","Quality of Life","2025-04-16",{"date":129,"type":41},"2025-04-22",{"date":131,"type":41},"2022-07-15",{"date":133,"type":22},"2025-06",{"name":135,"class":48},"University of Thessaly",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":146,"conditions":147,"keywords":152,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":80},"100569867","validation-of-the-greek-postoperative-quality-of-recovery-score-15-100569867","NCT06699823","Validation of the Greek Postoperative Quality of Recovery Score 15","Cultural Adaptation and Validation of the Greek Version of the Postoperative Quality of Recovery Score 15 (QoR-15Gr)","(QoR-15Gr)","Inclusion Criteria:\n\n* Age\\>18 years old\n* Scheduled elective general surgery under general anesthesia\n\nExclusion Criteria:\n\n* Emergency surgery\n* Poor Greek comprehension\n* Inability to give consent\n* A psychiatric or neurological condition that precludes cooperation\n* Known history of alcohol or drug dependence\n* Life-threatening postoperative complications\n* Postoperative admission to ITU",{"count":145,"type":22},150,"The goal of this observational study is to translate a patient questionnaire about recovery after an operation into Greek and assess how accurate, reliable, acceptable, and feasible this Greek version is.",[148,149,28,150,151],"Postoperative Recovery","Quality of Recovery From Anaesthesia","Validation Study","Cultural Adaptation",[153,154,155,156,157],"quality of recovery","patient reported outcomes","QoR-15","validation","cultural adaptation","2024-11-22",{"date":160,"type":41},"2024-11-26",{"date":162,"type":22},"2024-12-01",{"date":164,"type":22},"2025-02-28",{"name":166,"class":48},"IASO Thessalias",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":80},"100456492","patient-experience-data-in-radiation-oncology-100456492","NCT05224297","Patient Experience Data in Radiation Oncology","PEDRO","Inclusion Criteria:\n\n* all patients receiving external beam radiotherapy\n\nExclusion Criteria:\n\n* unable to independently answer questionnaires on radiation-induced side effects","100 Years",{"count":176,"type":22},6000,"The project is part of the overarching goal of improving patient-centric radiation oncology. This pilot project aims to develop an instrument that can be used to collect clinically relevant patient-reported outcome data on adverse effects during and after RT. This real-world evidence (RWE) database will be the basis to monitor and evaluate future technological developments, combination treatments (e.g. radioimmunotherapy, etc.), or changes in treatment protocols. The pseudonymized data will be linked to data in the oncological information system and dosimetric data from the treatment planning system. In this way, they represent a basic building block of patient-oriented development of clinical radiotherapy.",[179,28],"Radiotherapy Side Effect",[181,182],"radiation oncology","patient reported outcome","2024-11-19",{"date":158,"type":41},{"date":186,"type":41},"2020-10-01",{"date":188,"type":22},"2025-01-01",{"name":190,"class":48},"Medical University of Vienna",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":198,"maxAge":199,"enrollmentInfo":200,"targetDuration":201,"studyType":23,"phases":4,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":80},"100523113","validation-of-the-italian-version-of-the-forgotten-joint-score-fjs-12-in-total-ankle-replacement-100523113","NCT06091397","Validation of the Italian Version of the Forgotten Joint Score (FJS-12) in Total Ankle Replacement","Validation of the Italian Version of the Forgotten Joint Score (FJS-12) as a Patient-reported Outcome Measure in Total Ankle Replacement: a Study on an Italian Population","Inclusion Criteria:\n\n* Patients of either gender, aged between 25 and 80 years;\n* Patients who have undergone total ankle replacement surgery for tibio-tarsal joint pathology starting from 2018, as well as new patients on the waiting list.\n* Signed informed consent for participation in the study;\n* Patients who are prepared and motivated to attend the scheduled follow-up visits and complete the study questionnaires.\n\nExclusion Criteria:\n\n* Patients unable to understand or consent;\n* BMI \\> 40.\n* Refusal to complete the study consent form.\n* Substance abuse or psychological disorders that could interfere with the ability to comply with rehabilitation programs and postoperative assessments.\n* Known sensitivity to device materials.\n* Presence of an active or suspected latent infection in or around the affected ankle joint.","25 Years","80 Years",{"count":60,"type":22},"60 Months","The arthritic pathology of the tibio-tarsal joint has a prevalence of approximately 1% in the general population, and its incidence has been increasing over the years. Advanced-stage arthritis causes pain, impairs mobility, and has an extremely negative impact on patients' quality of life, resulting in significant social and economic costs. Unlike hip and knee arthritis, ankle arthritis is often secondary to traumatic events, affecting younger patients. An emerging treatment for severe ankle arthritis is ankle prosthetic replacement, and patient-reported outcome measures (PROMs) are increasingly used to assess patient outcomes. The study focuses on the validity and reproducibility of the Italian versione of the Forgotten Joint Score (FJS) in ankle prostheses, obtained through the translation-back-translation method, with a sample size of 120 patients.",[28,204,205],"Total Ankle Replacement","Italian Forgotten Joint Score","2024-07-31",{"date":208,"type":41},"2024-08-02",{"date":210,"type":41},"2022-07-01",{"date":212,"type":22},"2028-01",{"name":214,"class":48},"Istituto Ortopedico Rizzoli",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":225,"phases":226,"briefSummary":228,"conditions":229,"keywords":232,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":80},"100537032","implementing-proms-and-prems-in-routine-clinical-care-assessment-of-requirements-and-impact-100537032","NCT06272552","Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact","Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact.","PROMs & PREMs","Inclusion Criteria:\n\n* Being an active patient of the nephrology service, prostate cancer service, breast cancer service, or bariatric surgery service\n* In possession of an email account and having basic knowledge of how to manage emails\n* In possession of a smartphone, computer, or tablet with access to the Internet\n* Fluent and able to read in Spanish\n\nExclusion Criteria:\n\n\\- Under 18 years of age",{"count":224,"type":22},1440,"INTERVENTIONAL",[227],"NA","There has been increasing interest in the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such implementation.\n\nObjective: To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management.\n\nDesign: Randomized control trial. Setting: In and outpatient departments of a public hospital in Spain.\n\nParticipants: 1,440 adult patients managed for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery.\n\nIntervention: Patients will monthly complete, through an App from their smartphones, PROMs and PREMs (arm A, n=480), or only PREMs (arm B, n=480). Responses to PROMs will be transformed into a graphic summary, accessible for physicians and patients at the follow-up visits of the project (9 and 18 months after recruitment).\n\nMain outcome measures: Comparison of change among arms on the assessment variables - such as health-related quality of life (EQ-5D-5L), satisfaction with care, or patient-professionals communication. These constructs will be measured at recruitment and at follow up visits for all patients, regardless of their arm allocation (arm C would only be administered these questionnaires, without intervention, n=480).\n\nExpected results: Incorporating PROMs and PREMs in routine clinical care may improve patients\\' and health professionals\\' experiences on health care, as well as improve patients\\' health.",[28,29,230,231],"Implementation Research","Impact Evaluation",[233,230,234,28,29,235,236,237],"PRMs Implementation","Implementation evaluation","Impact evaluation","RCT","Health Services Research","2024-02-21",{"date":240,"type":41},"2024-02-22",{"date":242,"type":41},"2023-10-25",{"date":244,"type":22},"2027-10",{"name":246,"class":48},"Parc de Salut Mar",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":254,"minAge":255,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":225,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":278},"100335402","partial-breast-versus-no-irradiation-for-women-with-early-breast-cancer-100335402","NCT03646955","Partial Breast Versus no Irradiation for Women With Early Breast Cancer","The DBCG RT Natural Trial: Partial Breast Versus no Irradiation for Women >=60 Years Operated With Breast Conservation for an Early Breast Cancer: a Clinically Controlled Randomized Phase III Trial","Inclusion Criteria:\n\nFemale patient \\>=60 years\n\nPrimary tumour characteristics by conventional histopathology\n\n* unilateral and unifocal non-lobular histology grade 1-2\n* maximum microscopic size \\\u003C=20mm\n* node negative determined by sentinel node or axillary lymph node dissection\n* estrogen receptor \\>=10% positive\n* HER2 negative (by IHC and\u002For in situ hybridization)\n* resection margin \\>=2 mm for invasive carcinoma and any ductal carcinoma in situ associated with the cancer\n\nSurgical type is breast conservation\n\nPerformance status ECOG 0-2\n\nNo evidence of distant metastasis\n\nExclusion Criteria:\n\n* multifocal or multicentric invasive carcinoma or ductal carcinoma in situ\n* evidence of clinical or pathological T4 breast cancer\n* grade 3 malignancy\n* previous breast cancer or DCIS irrespective of disease-free interval\n* previous radiation therapy to the breast or thorax,\n* previous neoplasm within 5 years except carcinoma in situ of the cervix, endometrium or coli, melanoma in situ.\n* comorbidity precluding the patient from radiation therapy (e.g. cardiovascular or pulmonary disease, scleroderma, systemic lupus erythematosus).\n* mental\u002Fpsychiatric disorder which precludes the patient from understanding the randomization and the follow up.\n* documented hereditary breast cancer or with high genetic risk of breast cancer\n* life expectancy \\\u003C10 years","FEMALE","60 Years",{"count":257,"type":22},926,[227],"All early breast cancer patients are offered adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer. Breast cancer is heterogeneous, and selected patients have a very low gain from RT, whilst they still have risk of acute and late side effects from RT. This trial will try identify selection criteria for low risk breast cancer patients who can safely omit adjuvant RT without unacceptable high risk of local failure.",[261,262,263,264,265,266,267,268,28],"Local Neoplasm Recurrence","Distantly Metastatic Malignant Neoplasm","Death","Fibrosis Breast","Depigmentation\u002FHyperpigmentation of Skin","Telangiectasia","Scar","Pain","2020-10-05",{"date":271,"type":41},"2020-10-06",{"date":273,"type":41},"2018-09-05",{"date":275,"type":22},"2035-09-01",{"name":277,"class":48},"Danish Breast Cancer Cooperative Group",17]