Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT07165756
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Mon Parcours de Vie" Localized Breast Cancer: Announcement, Support, Information on the Disease and Treatments. Pilot Study to Assess the Value of Written Information Documents.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '14 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-09-03', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability rate', 'timeFrame': '14 days', 'description': 'Acceptability rate will be measured by the proportion of patients who accepted and read in full the 2 documents distributed; comparison of acceptability between the two information documents.'}, {'measure': 'Variation in the anxiety score', 'timeFrame': '14 days', 'description': 'Variation in the anxiety score will be assessed by the anxiety score established from questions relating to anxiety on the Hospital Anxiety and Depression Scale (HADS) at the consultation for the announcement of medical treatments (chemotherapy+/- immunotherapy+/anti-HER2 targeted therapy) with the distribution of written documents (=D0) and immediately after reading the documents (max at D14 after inclusion).'}], 'secondaryOutcomes': [{'measure': 'Level of understanding', 'timeFrame': '14 days', 'description': 'After reading the documents, the level of understanding will be assessed for the period of cancer diagnosis, treatment and preservation of well-being.'}, {'measure': 'Audience of documents', 'timeFrame': '14 days', 'description': "The audience of the documents will be assessed by the patient's interest in the documents and her expectations (interest in volume 2 and volume 3 (interested in both); also possible comparison of the audience between the two documents."}, {'measure': 'Perception and comprehension of the documents', 'timeFrame': '14 days', 'description': 'Perception and comprehension of the documents will be determined by assessing readability, perception of information and presentation.'}, {'measure': "Patient's level of satisfaction", 'timeFrame': '14 days', 'description': "The patient's level of satisfaction with the documents will be measured by the evaluation questionnaire (satisfaction score for each of the two volumes)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Announcement of cancer and treatment', 'Breast cancer', 'Information documents'], 'conditions': ['Localized Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Since late 2019, the French association "MON PARCOURS DE VIE" has developed books donated by caregivers at cancer centers in France. These documents are available online: https://www.monparcoursdevie.fr/. They are highly acclaimed by women suffering from the breast cancer, as well as by caregivers. Four volumes have been written: \'Metastatic breast cancer\', \'Localized breast cancer\', \'Preserving my well-being\', \'After breast cancer\', and finally \'Breast cancer, support and accompaniment\'.\n\nThe aim in writing these information brochures is to provide clear, concise, useful information, with pedagogy, gentleness, benevolence, humility, cheerfulness, imagination, simplicity and an innovative presentation. These documents are a new and innovative method of providing information, delivered by caregivers who work with women suffering from breast cancer. It extends the human support so necessary in this disease.\n\nIt seemed important to us to evaluate, through a clinical study, the impact of the written documents "Mon Parcours de Vie" - volume 2: Breast cancer and volume 3: Preserving my well-being, concerning the announcement of a localized breast cancer in the initial management for the first time in the breast pathway. The objectives of the clinical study are to evaluate the acceptability and impact of these two written information documents on anxiety generated by the announcement of cancer and treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be selected based on the scheduling of a medical consultation for the announcement of medical treatments (chemotherapy+/- immunotherapy+/anti-HER2 targeted therapy) for breast cancer at our Institute.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with localized breast cancer consulting for medical treatment (chemotherapy+/- immunotherapy+/anti-HER2 targeted therapy)\n* Diagnosis of invasive breast cancer for which there is an indication for local and medical treatment.\n* WHO ≤ 1\n* Patient has understood, signed and dated the consent form\n* Patient affiliated to the social security system\n\nExclusion Criteria:\n\n* Patient with metastatic breast cancer\n* History of other cancer\n* Patient unable to read or speak French\n* Persons deprived of liberty or under guardianship (including curatorship).'}, 'identificationModule': {'nctId': 'NCT07165756', 'acronym': 'MaVie', 'briefTitle': '"Mon Parcours de Vie" Localized Breast Cancer: Announcement, Support, Information on the Disease and Treatments. Pilot Study to Assess the Value of Written Information Documents.', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Cancérologie de Lorraine'}, 'officialTitle': '"Mon Parcours de Vie" Localized Breast Cancer: Announcement, Support, Information on the Disease and Treatments. Pilot Study to Assess the Value of Written Information Documents.', 'orgStudyIdInfo': {'id': '2025-A00330-49'}}, 'contactsLocationsModule': {'locations': [{'zip': '54519', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Naoual BOUJEDAINI, PhD', 'role': 'CONTACT', 'email': 'n.boujedaini@nancy.unicancer.fr', 'phone': '+33 3 83 59 86 68'}, {'name': 'Denise BECHET, PhD', 'role': 'CONTACT', 'email': 'd.bechet@nancy.unicancer.fr', 'phone': '+33 3 83 59 86 79'}, {'name': 'Lionel UWER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut de Cancérologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Jean-Louis MERLIN', 'role': 'CONTACT', 'email': 'jl.merlin@nancy.unicancer.fr', 'phone': '+33 3 83 59 84 00'}, {'name': 'Denise BECHET', 'role': 'CONTACT', 'email': 'd.bechet@nancy.unicancer.fr', 'phone': '+33 3 83 59 86 79'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Cancérologie de Lorraine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}