"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.

NCT07165756 | Recruiting

• 1 other identifier: 2025-A00330-49
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Breast Cancer

Keywords

Announcement of cancer and treatment; Breast cancer; Information documents

Outcome Measures

Primary Outcomes (2)

• Acceptability rate

  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.

  14 days

• Variation in the anxiety score

  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).

  14 days

Secondary Outcomes (4)

• Level of understanding

  14 days

• Audience of documents

  14 days

• Perception and comprehension of the documents

  14 days

• Patient's level of satisfaction

  14 days

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jean-Louis MERLIN

CONTACT

+33 3 83 59 84 00; jl.merlin@nancy.unicancer.fr

Denise BECHET

CONTACT

+33 3 83 59 86 79; d.bechet@nancy.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-05

Locations

FR (1)