Localized Breast CancerMaVieNCT07165756
"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.
An observational study of Localized Breast Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Localized Breast Cancer
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2025to 2 Aug 2026
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 14 days
Secondary outcomes (4)
Level of understanding
After reading the documents, the level of understanding will be assessed for the period of cancer diagnosis, treatment and preservation of well-being.
Measured: 14 days
Audience of documents
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.
Measured: 14 days
Perception and comprehension of the documents
Perception and comprehension of the documents will be determined by assessing readability, perception of information and presentation.
Measured: 14 days
Patient's level of satisfaction
The patient's level of satisfaction with the documents will be measured by the evaluation questionnaire (satisfaction score for each of the two volumes).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start9 Sep 2025
- Primary completion2 Apr 2026
- Study completion2 Aug 2026
Why it stopped: Principal Investigator's departure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165756
- Sponsor's protocol ID
- 2025-A00330-49
- Acronym
- MaVie
- Status last verified
- Aug 2026
- First submitted
- 3 Sep 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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.
- ClinicalTrials.gov ID
- NCT07165756
- Acronym / sponsor ID
- MaVie / 2025-A00330-49
- Conditions
- Localized Breast Cancer
- Keywords
- Announcement of cancer and treatment, Breast cancer, Information documents
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator's departure
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Aug 2026 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
4 secondary outcomes
Level of understanding
Time frame: 14 days
Audience of documents
Time frame: 14 days
Perception and comprehension of the documents
Time frame: 14 days
Patient's level of satisfaction
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Principal Investigator's departure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Localized Breast Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator's departure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability rate (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.