[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584277":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":36,"studyPopulation":28,"armGroups":37,"interventions":47,"overallOfficials":52,"centralContacts":57,"locations":63,"responsibleParty":83,"collaborators":28,"id":85,"slug":28,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":28,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":28,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":66,"whyStopped":28,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"National Cancer Institute, Naples","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"Evaluation of intestinal preparation. BBPS score (BOSTON BOWEL PREPARATION SCORE)","Compare the quality of the colonoscopy between patients who received tele-consultation (INTERVENTION Group) and those who did not receive tele-consultation (CONTROL Group) based on the BBPS score (BOSTON BOWEL PREPARATION SCORE). The BBPS score ranges from 0 to 9 based on intestinal preaparation in cecum, colon and rectum. Each section is scored on a scale of 0 to 3 (0= unprepared to 3= excellent). The total BBPS score is the sum of the scores from the three sections (score 0 to 5=Poor preparation; score 6 to 7= fair preparation; score 8 to 9=good preparation). A higher score indicates better bowel preparation, which is ideal for a successful colonoscopy.","at the end of colonoscopy up to 12 months",{"measure":14,"description":15,"timeFrame":16},"H.A.D.S. (Hospital Anxiety and Depression Scale)","Compare the quality of the emotional state between the sample of patients who received tele-consultation (INTERVENTION Group) and those who did not receive tele-consultation (CONTROL Group) based on the H.A.D.S. score (Hospital Anxiety and Depression Scale).The scale consists of 14 items, with 7 questions related to anxiety and 7 related to depression. Each item is rated on a 4-point scale (from 0=not at all to 3= most of the time). The total score for each section (anxiety and depression) can range from 0 to 21, and then the scores from both sections are combined for a total score ranging from 0 to 42.\n\nThe minimun score is 0-7 that means normal (little to no anxiety or depression). The maximum score is 15-21 that means severe (significant anxiety or depression).","baseline, before colonoscopy up to 12 months",[18,22,25],{"measure":19,"description":20,"timeFrame":21},"Financial Toxicity (FT) using the \"PROFFIT questionnaire\"","Assessment of FT through PROFFIT questionnaire. This is an Italian instrument for evaluating FT in patients in the Italian healthcare context. It includes 16 total items, 7 measuring FT (defining the PROFFIT financial score) and 9 measuring possible determinants of FT. The score range from 0-100 (the higher value means precence of FT).","baseline (before colonoscopy) up to 12 months",{"measure":23,"description":24,"timeFrame":12},"Effectiveness of a colonoscopy in detecting adenomas. Adenoma Detection Rate (ADR)","Quality of colonoscopies between patients who received tele-consultation and those who did not receive tele-consultation based on ADR. ADR represents the percentage of patients undergoing colonoscopy in which at least one adenoma is detected.",{"measure":26,"description":27,"timeFrame":12},"Rate of cecal intubation","Cecal intubation rate in patients of the 2 study groups",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":6,"observationalModel":28,"timePerspective":28,"maskingInfo":32},"RANDOMIZED","PARALLEL",{"masking":33,"maskingDescription":28,"whoMasked":34},"SINGLE",[35],"CARE_PROVIDER","The aim of this study is to evaluate the effectiveness, in daily clinical practice, of a tele-consultation procedure (defined as a telephone consultation with the patient conducted by nursing staff with an appropriate level of experience in digestive endoscopy) with the goal of:\n\n1. improving adherence to methods and timing for the correct intake of the intestinal preparation by patients undergoing elective colonoscopy;\n2. assessing whether the tele-consultation can reduce anxiety and procedure-related stress, promoting a better emotional state in patients undergoing colonoscopy.",[38,44],{"label":39,"type":40,"description":41,"interventionNames":42},"nurse tele-consultation arm","EXPERIMENTAL","Use of the nurse tele-consultation tool in the Intervention arm administered 5±2 days before the colonoscopy procedure.",[43],"Other: Tele-consultation",{"label":45,"type":46,"description":28,"interventionNames":28},"Standard arm","NO_INTERVENTION",[48],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":28},"Tele-consultation","Tele-consultation procedure is defined as a telephone consultation with the patient conducted by nursing staff with an appropriate level of experience in digestive endoscopy",[39],[53],{"name":54,"affiliation":55,"role":56},"Francesco De Falco, Nursing degree","National Cancer Institute, IRCCS Fondazione G. Pascale","PRINCIPAL_INVESTIGATOR",[58],{"name":54,"role":59,"phone":60,"phoneExt":61,"email":62},"CONTACT","0811770813","0039","endoscopia@istitutotumori.na.it",[64],{"facility":65,"status":66,"city":67,"state":28,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"S.S.D. Garoenterologia ed Endoscopia Digestiva","RECRUITING","Naples","80131","Italy","IT",{"type":72,"coordinates":73},"Point",[74,75],14.26811,40.85216,{"lat":75,"lon":74},[78,80],{"name":54,"role":59,"phone":79,"phoneExt":61,"email":62},"08117770813",{"name":81,"role":82,"phone":28,"phoneExt":28,"email":28},"Mario De Bellis, MD","SUB_INVESTIGATOR",{"type":84,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100584277",false,"NCT06887244","Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity","Evaluation of the Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity","Inclusion Criteria:\n\nSubjects eligible for outpatient pancolonoscopy:\n\n* for diagnostic purposes;\n* for screening purposes;\n* for post-polypectomy follow-up;\n* of both genders;\n* of all ethnicities;\n\nExclusion Criteria:\n\n* Patients under 18 years of age or over 80 years of age;\n* Patients on waiting lists with SHORT priority: the procedure to be provided within a short time (no more than 10 days);\n* Patients included in GOM pathways who undergo colonoscopy within 10 days;\n* Pregnancy;\n* Presence of known contraindications to bowel preparation;\n* Presence of known contraindications to performing pancolonoscopy;\n* Patients who have undergone colonic resection and\u002For have a colostomy\u002Fileostomy;\n* Patients with cognitive impairments;\n* Patients declared legally incompetent or unable to understand and make decisions;\n* Patients unable to provide informed consent.","ALL","18 Years","80 Years",{"count":95,"type":96},534,"ESTIMATED","INTERVENTIONAL",[99],"NA","This is a multicenter, non-pharmacological, experimental, prospective, randomized study, with two arms (1:1) in a single-blind design. The study aims to evaluate the effectiveness of a tele-consultation procedure in patients undergoing elective colonoscopy in terms of quality of the exam, anxiety procedure-related and financial toxicity.",[102,103],"Patient Satisfaction and Efficacy of Bowel-preparation","Colon Cancer Prevention",[105,106,107,108,109],"colonoscopy","tele-consultation procedure","colon cancer","financial toxicity","anxiety procedure-related","2025-03-21",{"date":112,"type":113},"2025-03-26","ACTUAL",{"date":115,"type":113},"2024-06-24",{"date":117,"type":96},"2026-05-31",{"name":5,"class":6},1]