[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594291":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":52,"studyPopulation":52,"armGroups":61,"interventions":80,"overallOfficials":52,"centralContacts":91,"locations":97,"responsibleParty":113,"collaborators":52,"id":117,"slug":52,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":52,"enrollmentInfo":126,"targetDuration":52,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":141,"whyStopped":52,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Universidad de Extremadura","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":52},[9,13],{"measure":10,"description":11,"timeFrame":12},"Subjetive Cognitive function","It will be assessed using subjective cognitive function measured by Functional Assessment of Cancer Therapy-Cognition (FACT-Cog) scale.","- Baseline - 12 weeks for intervention group - 16 weeks for control group",{"measure":14,"description":15,"timeFrame":12},"Objective Cognitive Function","It will be assessed with Near Infrared Spectroscopy (regional cerebral oxygen saturation).",[17,20,23,26,29,32,36,39,42,45,48],{"measure":18,"description":19,"timeFrame":12},"Fatigue","It will be measured with the Fatigue Symptom Inventory (FSI), which assesses the frequency, severity, and perceived interference of fatigue in daily life over the past week",{"measure":21,"description":22,"timeFrame":12},"Sleep quality","It will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a well-validated questionnaire that evaluates sleep across seven components, including latency, duration, efficiency, disturbances, and the use of sleep medications",{"measure":24,"description":25,"timeFrame":12},"Insomnia","It will be assessed using the Insomnia Severity Index (ISI). This validated questionnaire consists of seven items that evaluate difficulties with sleep onset, sleep maintenance, and early morning awakening, as well as satisfaction with sleep patterns, interference with daily functioning, perceived impairment, and distress caused by sleep problems",{"measure":27,"description":28,"timeFrame":12},"Psychological distress","Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS).\n\nThe HADS consists of 14 items, each scored from 0 to 3, yielding subscale scores for anxiety (HADS-A) and depression (HADS-D) that each range from 0 to 21, with higher scores indicating greater psychological distress (worse outcome). The total score ranges from 0 to 42.",{"measure":30,"description":31,"timeFrame":12},"Quality of life (QoL)","It will be measured using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)",{"measure":33,"description":34,"timeFrame":35},"Abdominal flexor endurance","It will be assessed using the McQuade Test (seconds)","- Baseline - 12 weeks for intervention group",{"measure":37,"description":38,"timeFrame":35},"Upper body and back muscular strength","It will be assessed using trunk dynamometry (kg)",{"measure":40,"description":41,"timeFrame":35},"Lower body endurance","It will be assessed using the 30-second sit-to-stand test (number of repetitions). The outcome is the number of repetitions completed, with a higher score indicating better lower limb strength and endurance.",{"measure":43,"description":44,"timeFrame":35},"Perceived physical fitness","It will be assessed using the International Fitness Scale (IFIS). It comprises 5 items that evaluate overall fitness, cardiorespiratory fitness, muscular strength, speed-agility, and flexibility. Each item is rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher scores indicate better perceived physical fitness.",{"measure":46,"description":47,"timeFrame":35},"Functional exercise capacity","It will be assessed using the Six-Minute Walk Test (6MWT) (metres)",{"measure":49,"description":50,"timeFrame":51},"Perceived effort","It will be assessed using the Borg Scale of Perceived Exertion.","- 12 weeks for intervention group",null,{"allocation":54,"interventionModel":55,"interventionModelDescription":52,"primaryPurpose":56,"observationalModel":52,"timePerspective":52,"maskingInfo":57},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":58,"maskingDescription":52,"whoMasked":59},"SINGLE",[60],"OUTCOMES_ASSESSOR",[62,68,72,77],{"label":63,"type":64,"description":65,"interventionNames":66},"Cognitive training + exercise group during chemotherapy","EXPERIMENTAL","Al list two cycles of chemotherapy.",[67],"Other: Cognitive training",{"label":69,"type":64,"description":70,"interventionNames":71},"Cognitive training + exercise group after chemotherapy","Al list six months after the completion of chemotherapy.",[67],{"label":73,"type":74,"description":65,"interventionNames":75},"Psychoeducational therapy during chemotherapy","ACTIVE_COMPARATOR",[76],"Other: Psychoeducational therapy",{"label":78,"type":74,"description":70,"interventionNames":79},"Psychoeducational therapy after chemotherapy",[76],[81,87],{"type":6,"name":82,"description":83,"armGroupLabels":84,"otherNames":85},"Cognitive training","Combined Intervention of Cognitive Training and Supervised Physical Exercise",[69,63],[86],"Adapted physical activity",{"type":6,"name":88,"description":89,"armGroupLabels":90,"otherNames":52},"Psychoeducational therapy","According to standard clinical practice",[78,73],[92],{"name":93,"role":94,"phone":95,"phoneExt":52,"email":96},"Noelia Durán-Gómez, PhD","CONTACT","+34924289466","nduran@unex.es",[98],{"facility":99,"status":52,"city":100,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Facultad de Medicina y Ciencias de la Salud","Badajoz","06006","Spain","ES",{"type":105,"coordinates":106},"Point",[107,108],-6.97061,38.87789,{"lat":108,"lon":107},[111],{"name":112,"role":94,"phone":95,"phoneExt":52,"email":96},"Noelia Durán-Gómez",{"type":114,"investigatorFullName":115,"investigatorTitle":116,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"PRINCIPAL_INVESTIGATOR","Noelia Durán","Principal Investigator","100594291",false,"NCT07017530","Cognitive Training and Exercise for Women With Breast Cancer and Cognitive Impairment","Combined Intervention of Cognitive Training and Supervised Physical Exercise for Women With Breast Cancer and Chemotherapy-Related Cognitive Impairment: Study Protocol for a Randomized Controlled Trial","CHEMO-CogEx","Inclusion Criteria:\n\n* Women aged 18 years or older who were diagnosed with stage 0 to IV breast cancer.\n* Women undergoing chemotherapy (at least two cycles) or having completed it at least six months earlier.\n* Cognitive impairment must be reported, with scores below 54 on the FACT-Cog scale\n\nExclusion Criteria:\n\n* Women with significant neurological conditions.\n* Women with psychiatric conditions.\n* Women with contraindications for physical exercise.","FEMALE","18 Years",{"count":127,"type":128},220,"ESTIMATED","INTERVENTIONAL",[131],"NA","Chemotherapy-related cognitive impairment is a prevalent and distressing condition among breast cancer survivors, adversely affecting memory, attention, and overall cognitive function, thereby diminishing quality of life. Emerging evidence suggests that multimodal interventions combining cognitive training and adapted physical exercise may mitigate these cognitive deficits and associated symptoms. This study aims to evaluate the efficacy of a 12-week structured intervention integrating cognitive training and supervised physical exercise in improving cognitive function, fatigue, sleep quality, psychological distress, and overall well-being in women with breast cancer. Furthermore, it seeks to determine the optimal timing for such interventions to maximize their effectiveness. A randomized controlled trial involving 220 participants will assess subjective and objective cognitive outcomes, brain activity, and physical performance. The findings from this research may contribute to the development of evidence-based rehabilitation strategies, enhancing cognitive health and quality of life in breast cancer patients.",[134],"Breast Cancer",[136,137,138,139,140],"Breast cancer","Chemotherapy-Related Cognitive Impairment","Cognitive Training","Exercise","Oncology Nursing","NOT_YET_RECRUITING","2025-06-03",{"date":144,"type":145},"2025-06-12","ACTUAL",{"date":147,"type":128},"2025-09-01",{"date":149,"type":128},"2028-08-31",{"name":5,"class":6},1]