[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100398991":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":27,"responsibleParty":92,"collaborators":94,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":10,"enrollmentInfo":110,"targetDuration":10,"studyType":113,"phases":10,"briefSummary":114,"conditions":115,"keywords":10,"overallStatus":30,"whyStopped":10,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Comprehensive Cancer Centre The Netherlands","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Cervical cancer patients and their partners",null,"520 cervical cancer patients will complete questionnaires, online food diary and wear a fitbit after diagnosis, after 6 months, and after 1, 2, 5 and 10 years. In addition, a subsample (n=116) will donate blood samples and a scalp hair sample after diagnosis and 6, 12 and 24 months. We expect 312 partners of cervical cancer patients to included in the study and complete questionnaires after diagnosis, after 6 months, and after 1, 2, 5 and 10 years",[13],{"name":14,"affiliation":15,"role":16},"Nicole Ezendam","Netherlands Comprehensive Cancer Organisation","PRINCIPAL_INVESTIGATOR",[18,23],{"name":19,"role":20,"phone":21,"phoneExt":10,"email":22},"Nicole Ezendam, PhD","CONTACT","+31 88 234 6096","N.Ezendam@iknl.nl",{"name":24,"role":20,"phone":25,"phoneExt":10,"email":26},"Belle de Rooij, PhD","+31 88 234 6057","B.deRooij@iknl.nl",[28,40,48,59,70,81],{"facility":29,"status":30,"city":31,"state":10,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":10},"Amphia","RECRUITING","Breda","Netherlands","NL",{"type":35,"coordinates":36},"Point",[37,38],4.77596,51.58656,{"lat":38,"lon":37},{"facility":41,"status":30,"city":42,"state":10,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":43,"geoPoint":47,"contacts":10},"Catharina Hospital","Eindhoven",{"type":35,"coordinates":44},[45,46],5.47778,51.44083,{"lat":46,"lon":45},{"facility":49,"status":30,"city":50,"state":10,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"University Medical Center Groningen","Groningen",{"type":35,"coordinates":52},[53,54],6.56667,53.21917,{"lat":54,"lon":53},[57],{"name":58,"role":20,"phone":10,"phoneExt":10,"email":10},"R Yigit",{"facility":60,"status":30,"city":61,"state":10,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"MUMC","Maastricht",{"type":35,"coordinates":63},[64,65],5.68889,50.84833,{"lat":65,"lon":64},[68],{"name":69,"role":20,"phone":10,"phoneExt":10,"email":10},"Peggy Vos van Steenwijk",{"facility":71,"status":30,"city":72,"state":10,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"RadboudUMC","Nijmegen",{"type":35,"coordinates":74},[75,76],5.85278,51.8425,{"lat":76,"lon":75},[79],{"name":80,"role":20,"phone":10,"phoneExt":10,"email":10},"Petra Zusterzeel",{"facility":82,"status":30,"city":83,"state":10,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"UMC Utrecht","Utrecht",{"type":35,"coordinates":85},[86,87],5.12222,52.09083,{"lat":87,"lon":86},[90],{"name":91,"role":20,"phone":10,"phoneExt":10,"email":10},"Eleonora van Dorst, Dr.",{"type":16,"investigatorFullName":14,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Principal Investigator",[95,97],{"name":96,"class":6},"Tilburg University",{"name":98,"class":99},"Netherlands Organisation for Scientific Research","OTHER_GOV","100398991","distress-in-cervical-cancer-patients-and-partners-100398991",false,"NCT04475354","Distress In CErvical Cancer Patients and Partners","Mechanisms Explaining Psychological Distress In CErvical Cancer Patients and Partners (DICE): a Population-based Prospective Study","DICE","Patients\n\nInclusion Criteria:\n\n* Newly diagnosed with cervical cancer stage I, II or III\n* \\>18 years or older\n\nExclusion Criteria:\n\n* Participants with cognitive impairment will not be included because of expected difficulties in completing the questionnaires without assistance.\n* Participants who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire.\n\nPartners\n\nInclusion Criteria:\n\n* Partner of patient participating in the study\n* \\>18 years\n\nExclusion Criteria:\n\n* Participants with cognitive impairment will not be included because of expected difficulties in completing the questionnaires without assistance.\n* Participants who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire.","ALL","18 Years",{"count":111,"type":112},832,"ESTIMATED","OBSERVATIONAL","Rationale: A growing number of cervical cancer patients live years beyond their cancer diagnosis and ultimately survive their disease. Cervical cancer patients report higher levels of psychological distress compared to other (gynecological) cancer types, resulting in physical and psychosocial limitations. The mechanisms explaining why some patients do, and others do not experience persistent psychological distress after cervical cancer remain unclear.\n\nObjective: Gain insight into the mechanisms explaining psychological distress (i.e. anxiety, depression, cancer worry, perceived stress) in a prospective population-based sample of cervical cancer patients. Factors to be studied include characteristics of the individual (demographical and clinical, including comorbidities), characteristics of the environment ((sexual) relationships), biological function (cortisol, melatonin and sex hormone production assessed in scalp hair, inflammation and telomere length assessed in blood, overall quality of life (EORTC QLQ-C30), symptoms (EORTC QLQ-CX24), functional status (physical activity and sleep measured using the Actigraph activity tracker, and food intake measured using the online 'Eetmeter'), and general health perceptions (B-IPQ). The second aim is to assess the impact of cervical cancer on partners' distress (cancer worry, illness perceptions, relationship quality, dyadic coping).",[116,117,118,119,120],"Cervical Cancer","Psychologic Stress","Psychological Distress","Survivorship","Quality of Life","2023-12-05",{"date":123,"type":124},"2023-12-06","ACTUAL",{"date":126,"type":124},"2020-11-01",{"date":128,"type":112},"2030-01",{"name":5,"class":6},6]