[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566999":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":39,"locations":30,"responsibleParty":48,"collaborators":30,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":30,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":30,"enrollmentInfo":61,"targetDuration":30,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":76,"whyStopped":30,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":30},{"fullName":5,"class":6},"Grigore T. Popa University of Medicine and Pharmacy","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"cognitive stimulation arm","ACTIVE_COMPARATOR","will engage in exercises like sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks",[13],"Other: 1. cognitive stimulation",{"label":15,"type":10,"description":16,"interventionNames":17},"psychoeducation and cognitive stimulation arm","will engage in exercises like sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks and also hold open group meetings for psychoeducation (1 meeting every 2 weeks, 6 meetings in total).",[18],"Other: 2. psychoeducation and cognitive stimulation",{"label":20,"type":21,"description":22,"interventionNames":23},"placebo","PLACEBO_COMPARATOR","is considered a control group, consisting of people who maintained their lifestyle up until their inclusion in the study without following additional measures",[24],"Other: 3. no intervention",[26,31,35],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"1. cognitive stimulation","sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks",[9],null,{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"2. psychoeducation and cognitive stimulation","sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks and also hold open group meetings for psychoeducation (1 meeting every 2 weeks, 6 meetings in total)",[15],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"3. no intervention","maintaines their lifestyle up until their inclusion in the study without following additional measures",[20],[40,45],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"DIANA IOANA BOBOC, MD","CONTACT","+40740882640","dianaiboboc@gmail.com",{"name":46,"role":42,"phone":30,"phoneExt":30,"email":47},"Simona Ruxandra Volovat, MD","simonavolovat@gmail.com",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Diana Ioana Boboc","Medical Oncologist, PhD Student, Investigator in Clinical Trials","100566999","cognitive-impairment-in-treated-breast-cancer-survivors-possible-approaches-100566999",false,"NCT06662474","Cognitive Impairment in Treated Breast Cancer Survivors: Possible Approaches","Evaluation of Cognitive Dysfunction in Patients with Breast Cancer Undergoing Systemic Therapy","Inclusion Criteria:\n\n* female patients aged 18 years or older\n* histologically confirmed treated invasive non-metastatic HR positive\n* provided written informed consent\n* (ECOG) performance status 0 -2\n* adequate hematologic functions\n* the patients must have completed the treatment (surgery or chemotherapy) for a minimum of 6 months and a maximum of 3 years before enrolling in the study\n* patients who received chemotherapy for at least 3 months, including both dose-dense regimens and those administered every 3 weeks, as part of their disease treatment.\n* patients are considered eligible for study continuation if, in 1 month of screening procedures, the tests to identify depression and severe anxiety do not indicate a severe status for them.\n\nExclusion Criteria:\n\n* history of neoplasia other than breast cancer\n* brain metastases\n* acute neurological diseases, neuro-degenerative or major psychiatric conditions such as stroke, autism, ADHD, Alzheimer's disease, Parkinson's disease, dementia, obsessive-compulsive disorder, post-traumatic stress disorder, schizophrenia, and those with a history of craniocerebral trauma\n* associated pathologies who may receive any form of treatment\n* the administration of psychotropic or pain medications in the II and III categories\n* (ECOG) ≧3\n* laboratory tests that contraindicate the administration of active oncological treatment","FEMALE","18 Years",{"count":62,"type":63},120,"ESTIMATED","INTERVENTIONAL",[66],"NA","The investigators aim is to conduct a prospective study with three arms, involving non-metastatic breast cancer patients who underwent chemotherapy as part of their treatment and were on a form of hormone therapy at the time of study inclusion. The trial consists of identifying the presence of cognitive decline and following up on methods of preventing its accentuation. The goal of this clinical trial is to assess if psychoeducation and cognitive stimulation work to decrease the intensity of cognitive impairment. It aims to answer the following main questions:\n\n* The implementation of such interventions improves both the dysfunction quantified by objective tests but also the individual's perception of it.\n* The implementation changes the patients' quality of life. Researchers will compare three study groups, each with instructions to complete one of the related 12-week programs, to see if there are any changes.\n\nDepending on the group in which the patient was randomly assigned, the interventions are :\n\n* First group - will engage in exercises like sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks\n* the second group will engage in exercises like sudoku, word games, and painting by numbers for 30 minutes per day, three days per week, for a duration of 12 weeks and also hold open group meetings for psychoeducation (1 meeting every 2 weeks, 6 meetings in total).\n* Group 3 is considered a control group, consisting of people who maintained their lifestyle up until their inclusion in the study without following additional measures",[69,70],"Cognitive Impairment","Chemobrain",[72,73,74,75],"breast cancer","cognitive impairment","quality of life","intervention","NOT_YET_RECRUITING","2024-10-28",{"date":79,"type":80},"2024-10-30","ACTUAL",{"date":82,"type":63},"2024-11-01",{"date":84,"type":63},"2026-12-31",{"name":5,"class":6}]