Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT06748820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
E-CANE: a National Program of Remote Health Education Workshops
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Assess the patient's adherence to the implementation of remote health educational actions (e-TPE), in AYA patients with cancer undergoing treatment", 'timeFrame': 'Between 2 and 4 times over 18 months', 'description': 'Online self-administered satisfaction questionnaires filled out by the patients 70 questions, scores between 1 and 4, yes or no, multiple choice questions, open-ended questions.'}], 'secondaryOutcomes': [{'measure': 'Assess the suitability of the pedagogical methods', 'timeFrame': '3 times over 12 months', 'description': 'Online self-administered satisfaction questionnaires filled out by the workshop hosts (12 questions) No scores, yes or no, open-ended questions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': "About 2000 adolescents and young adults (AYA) are diagnosed with cancer each year in France. This period of life is marked by a maturation and transition phase in various areas (psychological, physical, sexual, socio-professional...). Cancer occurrence has a very particular impact. AYAs diagnosed and treated for cancer have specific medical and psychosocial needs.In response to these specific needs, Therapeutic Education (TPE), initially developed for patients with chronic disease to help them acquire and maintain skills needed to better manage their daily lives with the constraints of their disease and its treatments, has now its place in cancerology. It has been shown to promote patient independence, improve therapeutic adherence (which is particularly poor in adolescents with cancer), and strengthen the therapeutic alliance between patients and their healthcare team. The strengthening of adolescents's self-care and adaptation skills is also recognized as essential during the experience of an oncological disease. In addition, over the past few years, in the context of the increasing use of the internet and digital technologies, particularly in the daily lives of young people, the implementation of remote TPE sessions (e-TPEs) has developed significantly. In cancerology, digital health interventions have the potential to expand access to the support available to youth with cancer. E-health offers flexibility to the delivery of psychosocial care and could help strengthen youth engagement and enable them to interact with professionals and other young people in a reassuring digital context.This project aims to demonstrate the feasibility of conducting remote health education workshops (e-TPE) for AYAs with cancer, regardless of their place of care in French territory. Following an educational assessment conducted by a professional trained in TPE, three digitalized workshops from the DYNAMO program, will be offered. The adherence to this type of educational interventions, the satisfaction of the patients and the professionals involved, but also the obstacles and difficulties encountered will be analyzed. Demonstrating the feasibility of these e-workshops would allow the spread and the enrichment of this type of interventions. This could facilitate their accessibility for all AYAs in French territory. At the end of this experiment, a randomized study could provide scientific evidence that the development of such a program is a relevant strategy to help young people with cancer manage the challenges associated with their diagnosis and treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents and young adults between 15 and 25 years old with cancer followed in a French AYA center.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with cancer diagnosed for at least one month.\n* Patient followed by an AYA Coordinating Nurse in one of the 27 French AYA centres.\n* Patient with Life expectancy ≥ 6 months.\n* Patient ealth status consistent with program requirements.\n* Karnosky index \\> 60%.\n* Patient who agrees to participate in the program and benefits from social security.\n* Patient able to understand, speak and read French.\n* Patient with no major cognitive impairment (assessed by the patient's referees).\n* Patient with no sensory disability.\n* Patient with access to a computer tool (smartphone, tablet, computer) and a WiFi or 4G network.\n* Non opposition from patient or their legal representative collected.\n* Patient who has signed the Privacy Policy.\n* Patient who consented to participate in PTE program.\n\nExclusion Criteria:\n\n* Patient unable to use informatic tools.\n* Known superior cognitive function disorders.\n* Progressive psychiatric pathology\n* Drug user or alcohol abuse"}, 'identificationModule': {'nctId': 'NCT06748820', 'acronym': 'E-CANE', 'briefTitle': 'E-CANE: a National Program of Remote Health Education Workshops', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'E-CANE: a National Program of Remote Health Education Workshops for Adolescents and Young Adults With Cancer', 'orgStudyIdInfo': {'id': '24OncoHémato01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Remote Therapeutic Patient Education (e-TPE)', 'description': 'TPE is a set of practices aiming at allowing a patient to acquire and preserve abilities and skills to manage actively their disease, cares, and surveillance, in collaboration with the caregivers', 'interventionNames': ['Behavioral: Remote Therapeutic Patient Education (e-TPE)']}], 'interventions': [{'name': 'Remote Therapeutic Patient Education (e-TPE)', 'type': 'BEHAVIORAL', 'description': 'TPE is a set of practices aiming at allowing a patient to acquire and preserve abilities and skills to manage actively their disease, cares, and surveillance, in collaboration with the caregivers', 'armGroupLabels': ['Remote Therapeutic Patient Education (e-TPE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'state': 'Alpes Maritimes', 'country': 'France', 'contacts': [{'name': 'Maryline Poirée', 'role': 'CONTACT', 'email': 'poiree.m@chu-nice.fr', 'phone': '04 92 03 92 93', 'phoneExt': '+ 33'}, {'name': 'Audrey Jullian', 'role': 'CONTACT', 'email': 'jullian.a@chu-nice.fr', 'phone': '04 92 03 22 69', 'phoneExt': '+33'}], 'facility': 'CHU NICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Maryline Poirée', 'role': 'CONTACT', 'email': 'poiree.m@chu-nice.fr', 'phone': '0492039293', 'phoneExt': '+ 33'}, {'name': 'Audrey Jullian', 'role': 'CONTACT', 'email': 'jullian.a@chu-nice.fr', 'phone': '0492032269', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}