[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548673":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":18,"responsibleParty":34,"collaborators":38,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":21,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":18,"enrollmentInfo":57,"targetDuration":18,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":74,"whyStopped":18,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":18},{"fullName":5,"class":6},"Noordwest Ziekenhuisgroep","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"eChemoCoach Group","EXPERIMENTAL","Patients assigned to the intervention arm fill in the eChemoCoach questionnaires. They will be asked to report their side effects at baseline (2 - 4 days before their first chemotherapy cycle) and weekly thereafter. Moreover, they can report their symptoms at any time in case of potential toxicity, with a maximum of once a day. Non-responders receive reminders. Both intervention and control groups receive standard monitoring and coaching, including pre-scheduled checks for side effects before chemotherapy. Patients in both groups are asked to complete questionnaires measuring the impact on HRQoL, anxiety, distress, and patient empowerment at baseline, 10 weeks, and 20 weeks post-chemotherapy initiation. Usability of the eChemoCoach will be assessed through an online survey for patients and healthcare professionals using the System Usability Scale",[13],"Other: eChemoCoach",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Patients in the control group receive standard of care. Both intervention and control groups receive standard monitoring and coaching, including pre-scheduled checks for side effects before chemotherapy. Patients in both groups are asked to complete questionnaires measuring the impact on HRQoL, anxiety, distress, and patient empowerment at baseline, 10 weeks, and 20 weeks post-chemotherapy initiation.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"eChemoCoach","the eChemoCoach is an electronic questionnaire which is accessible for patients via the secured electronic health portal (EHP) of the EHR, which is CE-certified. By utilizing the eChemoCoach, patients (for this project we focus on breast cancer patients) have the ability to complete a questionnaire on a daily basis, when experiencing side effects. The eChemoCoach has the potential to evaluate the severity of adverse effects based on the CTCAE criteria and triage them, mimicking the decision-making process of a HCP through computer adaptive testing (CAT). Upon completing the questionnaire, the eChemoCoach translates the responses for each specific side effect into corresponding CTCAE grades. The tool then promptly offers patients personalized advice, tailored to their individual condition.",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Manon Hanrath-Komen, PhD","CONTACT","0031 72 5482872","m.m.c.komen@nwz.nl",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Rubin Verduin, drs","0625289930","rjt.verduin@nwz.nl",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Mathijs Hendriks, MD","Principal investigator",[39,41,43,45],{"name":40,"class":6},"Comprehensive Cancer Centre The Netherlands",{"name":42,"class":6},"University of Twente",{"name":44,"class":6},"Dutch Cancer Society",{"name":46,"class":47},"Borstkanker Onderzoek Groep","NETWORK","100548673","mitigating-toxicity-by-electronic-health-portal-mediated-interactive-monitoring-of-patient-reported-side-effects-100548673",false,"NCT06424054","Mitigating Toxicity by Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects","Mitigating Toxicity of (Neo)Adjuvant Chemotherapy by Applying Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects: the Prospective Randomized eChemoCoach Trial","Inclusion Criteria:\n\n* \\- Starting (neo)adjuvant treatment with chemotherapy for breast cancer according to one of the below mentioned treatment protocols:\n\n  * Four cycles of doxorubicin 60mg\u002Fm2 and cyclophosphamide 600mg\u002Fm2 (AC) dose dense q 2 weeks, followed by twelve cycles of weekly paclitaxel 80mg\u002Fm2 (also in combination with carboplatin AUC6 q 3 weeks)\n  * Nine cycles q 3 weeks of paclitaxel 80mg\u002Fm2 on day 1 and 8, carboplatin AUC 3 on day 1 and 8, trastuzumab 8mg\u002Fkg loading dose (followed by doses of 6mg\u002Fm2 at subsequent cycles) on day1 and pertuzumab loading dose of 840mg (followed by doses of 420mg at subsequent cycles) on day 1\n* Age ≥ 18 years\n* WHO PS ≤1\n* Capable of using the EHP or get help in case of low (e-)health literacy. This includes being capable of login using DigiD, a system used by the Dutch government to verify the identity of a person\n* Being able to read or get help from a relative in case of illiteracy\n\nExclusion Criteria:\n\n* \\- Participation in a trial with an investigational product (because more frequent and structured symptom reporting is performed in these studies).\n* Patients who have been treated with chemotherapy in the past (since these patients are at higher risk for developing side effects of current chemotherapy).\n* Patients that already started with their chemotherapy cycle","ALL","18 Years",{"count":58,"type":59},746,"ESTIMATED","INTERVENTIONAL",[62],"NA","Chemotherapy induces side effects varying in severity, impacting patients' quality of life and necessitating unplanned hospital care. Patient-reported outcomes (PROs) could aid in early detection and management of side effects. However, existing PRO monitoring lacks triage capabilities, leading to clinician involvement and suboptimal symptom management. The investigators propose eChemoCoach, an electronic questionnaire integrated into the electronic health portal, offering real-time symptom assessment and personalized advice based on CTCAE criteria. Our study aims to assess the impact of eChemoCoach on non-hematological CTCAE ≥ 3 graded side effects in early breast cancer patients undergoing chemotherapy. This is a randomized controlled trial involving 746 patients that will evaluate the eChemoCoach's efficacy compared to standard monitoring. Phase one will validate questionnaires and assess usability, while phase two focuses on the primary outcome. Te investigators anticipate reduced severe side effects, thereby enhancing patients' quality of life, reducing stress, and minimizing hospital visits.",[65,66,67,68],"Breast Cancer","eHealth","Symptom Monitoring","Self Management",[65,70,71,66,72,73],"remote monitoring","emonitoring","symptom management","symptom monitoring","NOT_YET_RECRUITING","2024-05-16",{"date":77,"type":78},"2024-05-21","ACTUAL",{"date":80,"type":59},"2025-06-01",{"date":82,"type":59},"2029-12-01",{"name":5,"class":6}]