Clinical trial · Observational
"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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal Investigator's departure
Summary
Brief summary (as posted)
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'. The 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. It 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- 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).
Secondary outcomes (4)
- measure
- Level of understanding
- timeFrame
- 14 days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with localized breast cancer consulting for medical treatment (chemotherapy+/- immunotherapy+/anti-HER2 targeted therapy) * Diagnosis of invasive breast cancer for which there is an indication for local and medical treatment. * WHO ≤ 1 * Patient has understood, signed and dated the consent form * Patient affiliated to the social security system Exclusion Criteria: * Patient with metastatic breast cancer * History of other cancer * Patient unable to read or speak French * Persons deprived of liberty or under guardianship (including curatorship).
References
Publications (0)
Data not yet available