Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT04393116
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2020-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patients' Guidance With Onco-Coaching and CANKADO on Systemic Chemotherapy for Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-11', 'studyFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Development of patients' Distress", 'timeFrame': '6 months', 'description': 'Evaluated using the Screening Tool for Measuring Distress described by the Practice Guidelines in Oncology - v. 1.2005 by the National Comprehensive Cancer Network'}], 'secondaryOutcomes': [{'measure': "Patient's Quality of Life (QoL)", 'timeFrame': '6 months', 'description': 'Evaluated using the EORTC QLQ-C30, which is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials. The five functional scales, three symptom scales, one global health status / QoL scale, and six single items are calculated according to the scording procedures defined by the QL Coordinator, Quality of Life Unit, EORTC Data Center.'}, {'measure': "Patient's global health status", 'timeFrame': '6 months', 'description': "Evaluated using the EQ visual analogue scale (EQ-VAS Scale), a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' (maximum value = 100) and 'The worst health you can imagine' (minimum value = 0)."}]}, 'conditionsModule': {'conditions': ['Metastatic Colorectal Cancer']}, 'descriptionModule': {'briefSummary': "This is a prospective, single arm, non-interventional project to evaluate the benefit/influence of individualized patient education and guidance with a web-based e-Health platform called CANKADO on patient reported outcomes (PRO) for patients with metastatic colorectal cancer. The focus will be on patient reported outcomes (PRO), distress, Quality of Life (QoL), Global Health Status, complaints and therapy relevant decisions. All patients will be medically treated according to the standards. The experimental arm will include 40 patients. Those patients will receive one initial coaching before start of therapy. Further appointments for coaching will be scheduled depending on individual patient's need. During treatment period the patient is encouraged of joining therapy actively documenting his state of health and occurring health complaints via CANKADO to give the physician a better overview on the process of patient's health behaviour and preparing him for the next doctor-patient consultation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with metastatic colorectal cancer in first line treatment treated in "Gemeinschaftspraxis für Hämatologie und Onkologie Langen" or "Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg"', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minumum age of 18 years\n* Patient with metastatic colorectal cancer\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04393116', 'acronym': 'POSCA', 'briefTitle': "Patients' Guidance With Onco-Coaching and CANKADO on Systemic Chemotherapy for Metastatic Colorectal Cancer", 'organization': {'class': 'INDUSTRY', 'fullName': 'Cankado GmbH'}, 'officialTitle': "Patients' Guidance With Onco-Coaching and CANKADO on Systemic Chemotherapy for Metastatic Colorectal Cancer", 'orgStudyIdInfo': {'id': 'CAN-17-02'}}, 'contactsLocationsModule': {'locations': [{'zip': '63739', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '63225', 'city': 'Langen', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis für Hämatologie und Onkologie', 'geoPoint': {'lat': 49.98955, 'lon': 8.66852}}], 'overallOfficials': [{'name': 'Timo Schinköthe, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cankado GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cankado GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}