Nctid:
NCT06613581
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000015179", "term"=>"Colorectal Neoplasms"}], "ancestors"=>[{"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000007414", "term"=>"Intestinal Neoplasms"}, {"id"=>"D000005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000003108", "term"=>"Colonic Diseases"}, {"id"=>"D000007410", "term"=>"Intestinal Diseases"}, {"id"=>"D000012002", "term"=>"Rectal Diseases"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "asFound"=>"Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M17890", "name"=>"Colorectal Neoplasms", "asFound"=>"Colorectal Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M10448", "name"=>"Intestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M6336", "name"=>"Colonic Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M14844", "name"=>"Rectal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"All patients included in the study will be followed-up according to the home-based follow-up protocol. The PROMISE study is an implementation study, to further develop and improve home-based follow-up."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-07-18", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2031-09", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2029-09", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Quality of life", "timeFrame"=>"36 months", "description"=>"The primary outcome of this study is to evaluate non-inferiority of the study follow-up with respect to the EQ-5D-5L score at 36 months of follow-up, which starts within 6 months of resection of the primary tumour."}, {"measure"=>"Number of in hospital visits", "timeFrame"=>"36 months", "description"=>"The second primary outcome consists of significantly decreasing the number of in-hospital appointments, by relocating this follow-up care to the home setting. This will be assessed at 36 months postoperatively."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Colorectal carcinoma", "Home-based follow-up", "Patient-led", "Capillary blood sampling", "Biosensor", "EORTC"], "conditions"=>["Colorectal Carcinoma (CRC)"]}, "descriptionModule"=>{"briefSummary"=>"The primary goal of the patient-led follow-up from home, is the improvement of quality of life and the reduction of stress in patients, while obtaining a more complete picture of their health status.\n\nA series of assessments are performed in the home setting:\n\n* Blood withdrawal for CEA determination\n* Quality of life questionnaires to assess both mental and physical symptoms\n* Vital parameters using a Smart Sensor", "detailedDescription"=>"Primary Objective: To further develop and evaluate a personalised patient-centred surveillance programme including a feedback platform for patients after curative treatment for CRC in terms of health-related quality of life (HRQoL) and significantly decrease the number of in-hospital appointments, by relocating the follow-up care to the home-setting. The goal is for this surveillance program to be non-inferior to standard of care follow-up at 36 months, in terms of quality of life. The quality of life in patients will be assessed with the EQ 5D-5L questionnaire and compared to median EQ-5D-5L scores for patients receiving standard of care follow-up. In current literature, the median HRQoL VAS score for patients after surgery for CRC is 62.05 points (1).\n\nThe second goal of the program is to relocate part of the in-hospital follow-up care to the home-setting. In standard of care follow-up, at 36 months patients would have had 10 in-hospital appointments. The effect of the PROMISE study on the number of in-hospital appointments, will be assessed at 36 months postoperatively.\n\nThe PROMISE study is a multi-centre prospective regional implementation study of a personalised patient-centred surveillance program including a feedback platform for patients after curative treatment for CRC.\n\nAll patients who underwent surgery with curative intent for non-metastatic CRC with scheduled postoperative surveillance are potentially eligible.\n\nFollow-up in this study is performed according to the acting Dutch national guidelines. Current guidelines advocate CEA level measurements to be performed every 3-6 months for first 2 years after surgery and every 6-12 months for years 3 to 5. Medical imaging (thoracic and abdominal CT) should be performed 1 year postoperatively. Changes to the Dutch national guidelines during the course of the study will be implemented accordingly into the follow-up.\n\nWithin this study surveillance will for the greater part be performed at home:\n\n* Serum CEA level monitoring is performed using the automatic capillary blood withdrawal device (TAP-II) - every 6 months during the first two years and every 12 months thereafter\n* Vital parameters will be measured with a LifeSignals Multi-parameter Remote Monitoring System - every 3 months during the first two years and every 6 months thereafter\n* QoL is measured with the use of questionnaires - every 3 months during the first two years and every 6 months thereafter\n* One scheduled in hospital evaluation with medical imaging (according to national guidelines) performed 1 year after surgical treatment"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"inclusion criteria\n\n* Age ≥ 21 years\n* Histologically confirmed colorectal adenocarcinoma without distant metastasis and treated with curative intent surgical resection less than 6 months ago\n* Scheduled or currently undergoing postoperative surveillance according to national guidelines\n* Written informed consent by the patient\n* Access to a smartphone\n\nExclusion criteria\n\n* Patients with a severely complicated postoperative course, needing in hospital follow- up longer than 6 months postoperatively\n* Patients enrolled in other studies that require strict adherence to any specific follow-up practice with regular imaging - yearly or more frequent - of the abdomen and/or thorax\n* Patients with comorbidity or other malignancy that requires imaging of the abdomen and/or thorax every year or more frequent\n* Patients with active implantable devices - e.g. pacemaker or implantable defibrillator\n* Inability to complete the questionnaires due to illiteracy and/or insufficient proficiency of the Dutch language"}, "identificationModule"=>{"nctId"=>"NCT06613581", "acronym"=>"PROMISE", "briefTitle"=>"Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma", "organization"=>{"class"=>"OTHER", "fullName"=>"Erasmus Medical Center"}, "officialTitle"=>"Patient-empowered Remote Oncology: the Prospective, Multicentre Implementation Study - the PROMISE", "orgStudyIdInfo"=>{"id"=>"NL84788.078.23"}, "secondaryIdInfos"=>[{"id"=>"84788", "type"=>"OTHER", "domain"=>"ToetsingOnline (ABR-form)"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Implementation of home-based follow-up", "description"=>"All patients within the PROMISE study are included in the 'experimental' arm. The study is set up as an implementation study, meaning that the home-based method of follow-up is applied to all patients in the study.", "interventionNames"=>["Other: Home-based follow-up"]}], "interventions"=>[{"name"=>"Home-based follow-up", "type"=>"OTHER", "description"=>"Follow-up after surgery for colorectal carcinoma, performed from home, within the bounds of the Dutch National guidelines", "armGroupLabels"=>["Implementation of home-based follow-up"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"4818CK", "city"=>"Breda", "state"=>"Brabant", "status"=>"NOT_YET_RECRUITING", "country"=>"Netherlands", "contacts"=>[{"name"=>"Paul Gobardhan, MD, PhD", "role"=>"CONTACT"}], "facility"=>"Amphia Hospital", "geoPoint"=>{"lat"=>51.58656, "lon"=>4.77596}}, {"zip"=>"2906ZC", "city"=>"Capelle aan den IJssel", "state"=>"Zuid Holland", "status"=>"NOT_YET_RECRUITING", "country"=>"Netherlands", "contacts"=>[{"name"=>"Pascal Doornebosch, MD, PhD", "role"=>"CONTACT"}], "facility"=>"IJsselland Hospital", "geoPoint"=>{"lat"=>51.92917, "lon"=>4.57778}}, {"zip"=>"2333ZA", "city"=>"Leiden", "state"=>"Zuid Holland", "status"=>"NOT_YET_RECRUITING", "country"=>"Netherlands", "contacts"=>[{"name"=>"Koen C.M.J. Peeters, MD, PhD", "role"=>"CONTACT"}], "facility"=>"Leiden University Medical Center", "geoPoint"=>{"lat"=>52.15833, "lon"=>4.49306}}, {"zip"=>"3015GD", "city"=>"Rotterdam", "state"=>"Zuid Holland", "status"=>"RECRUITING", "country"=>"Netherlands", "contacts"=>[{"name"=>"Dirk J. Grunhagen, MD, PhD", "role"=>"CONTACT"}], "facility"=>"Erasmus Medical Center", "geoPoint"=>{"lat"=>51.9225, "lon"=>4.47917}}, {"zip"=>"3045PM", "city"=>"Rotterdam", "state"=>"Zuid Holland", "status"=>"RECRUITING", "country"=>"Netherlands", "contacts"=>[{"name"=>"Maria Verseveld, MD, PhD", "role"=>"CONTACT"}], "facility"=>"Franciscus Gasthuis and Vlietland", "geoPoint"=>{"lat"=>51.9225, "lon"=>4.47917}}], "centralContacts"=>[{"name"=>"Elise M.H.E. van Driel, MD", "role"=>"CONTACT", "email"=>"m.h.e.vandriel@erasmusmc.nl", "phone"=>"+310107042125"}, {"name"=>"Lissa Wullaert, MD", "role"=>"CONTACT", "email"=>"l.wullaert@erasmusmc.nl", "phone"=>"0031 0107042125"}], "overallOfficials"=>[{"name"=>"Dirk J. Grunhagen, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Erasmus Medical Center"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"IPD can be shared, but exclusively upon reasonable request with the affiliated researchers"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Erasmus Medical Center", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Lifesignals Inc.", "class"=>"UNKNOWN"}, {"name"=>"YourBio Health", "class"=>"UNKNOWN"}, {"name"=>"TU Delft", "class"=>"UNKNOWN"}, {"name"=>"Amphia Hospital", "class"=>"OTHER"}, {"name"=>"Leiden University Medical Center (LUMC)", "class"=>"UNKNOWN"}, {"name"=>"Franciscus Gasthuis & Vlietland (location Rotterdam)", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Surgical oncologist, MD, PhD", "investigatorFullName"=>"D.J. (Dirk) Grünhagen", "investigatorAffiliation"=>"Erasmus Medical Center"}}}}
