"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.

NCT ID: NCT07165756

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-09

Study Completion Date

2026-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Localized Breast Cancer

Keywords

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Announcement of cancer and treatment Breast cancer Information documents

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut de Cancérologie de Lorraine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Louis MERLIN

Role: CONTACT

Phone: +33 3 83 59 84 00

Email: [email protected]

Denise BECHET

Role: CONTACT

Phone: +33 3 83 59 86 79

Email: [email protected]

Facility Contacts

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Naoual BOUJEDAINI, PhD

Role: primary

Denise BECHET, PhD

Role: backup

Other Identifiers

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2025-A00330-49

Identifier Type: -

Identifier Source: org_study_id