Localized Breast Cancer
Conditions
Keywords
Announcement of cancer and treatment, Breast cancer, Information documents
Brief summary
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.
Interventions
None listed
Sponsors
Institut de Cancérologie de Lorraine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability rate | 14 days | 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. |
| Variation in the anxiety score | 14 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Level of understanding | 14 days | After reading the documents, the level of understanding will be assessed for the period of cancer diagnosis, treatment and preservation of well-being. |
| Audience of documents | 14 days | 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. |
| Perception and comprehension of the documents | 14 days | Perception and comprehension of the documents will be determined by assessing readability, perception of information and presentation. |
| Patient's level of satisfaction | 14 days | The patient's level of satisfaction with the documents will be measured by the evaluation questionnaire (satisfaction score for each of the two volumes). |
Countries
France
Outcome results
None listed