Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07165756

"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.

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Localized Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Acceptability rate

    Time frame: 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.

  2. Variation in the anxiety score

    Time frame: 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 outcomes

  1. Level of understanding

    Time frame: 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.

  2. Audience of documents

    Time frame: 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.

  3. Perception and comprehension of the documents

    Time frame: 14 days

    Perception and comprehension of the documents will be determined by assessing readability, perception of information and presentation.

  4. Patient's level of satisfaction

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Denise BECHET

CONTACT

[email protected]

+33 3 83 59 86 79

Jean-Louis MERLIN

CONTACT

[email protected]

+33 3 83 59 84 00

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Acronym: MaVie

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.