Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer
NCT ID: NCT04794075
Last Updated: 2025-08-03
Study Results
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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RECRUITING
NA
300 participants
INTERVENTIONAL
2021-08-09
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental group with the therapeutic education and nursing support program
In addition to the conventional oncology follow-up, patients will participate in an initial educational assessments day.
Therapeutic Education and Nursing Support Program for Supportive Care
In addition to the conventional oncology follow-up, patients will participate in an initial educational assessment day within 15 days before or after their first dose of hormone therapy.
A discussion between the patient and the pivot nurse will then make it possible to define personalized objectives, thus guiding the choice of workshops in the outpatient educational program.
Control group
Patients will have the conventional oncology follow-up.
No interventions assigned to this group
Interventions
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Therapeutic Education and Nursing Support Program for Supportive Care
In addition to the conventional oncology follow-up, patients will participate in an initial educational assessment day within 15 days before or after their first dose of hormone therapy.
A discussion between the patient and the pivot nurse will then make it possible to define personalized objectives, thus guiding the choice of workshops in the outpatient educational program.
Eligibility Criteria
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Inclusion Criteria
* Patients with non-metastatic breast cancer for whom adjuvant hormone therapy (anti-oestrogen or anti-aromatase) is indicated, depending on the decision of the multidisciplinary consultation meeting.
* Performance status (ECOG) ≤ 2
* Patient able to read and understand French (common use)
* Patient with access to an internet connection (for collection of adverse events and responses to questionnaires on the electronic platform)
* Patient who has been informed and has given written consent to participate in the study
* Patient affiliated to the French social security system or equivalent
Exclusion Criteria
* Patient undergoing neoadjuvant hormone therapy
* Patient who started hormone therapy prior to inclusion in the study
* Patient with a history of other cancer treated by radiotherapy, chemotherapy or hormone therapy, with an end of treatment less than 2 years ago.
* For patients in the experimental group: Inability of the patient to travel to the hospital to attend the initial assessment day and the proposed group outpatient workshops; follow-up of the program difficult for geographical, physical or other reasons (at the discretion of the investigator).
* For patients in the control group: patients for whom telephone nursing follow-up is planned for 2 months or more or more than 4 sessions of therapeutic education.
* Pregnant and breastfeeding women
* Patient with a documented history of cognitive or psychiatric disorders
* Refusal to participate, protected adult patient, under guardianship or curatorship
18 Years
75 Years
FEMALE
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Walisco
UNKNOWN
Centre Hospitalier Emile Roux
OTHER
Responsible Party
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Principal Investigators
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Séverine Breysse
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Emile Roux
Locations
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Centre Hospitalier de Bourg-en-Bresse / Fleyriat
Bourg-en-Bresse, , France
Clinique De L'infirmerie Protestante De Lyon
Caluire-et-Cuire, , France
CH de Carcassonne
Carcassonne, , France
CHAL - Centre Hospitalier Alpes Léman
Contamine-sur-Arve, , France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, , France
Centre Hospitalier François Quesnay
Mantes-la-Jolie, , France
Groupement Hospitalier Portes de Provence
Montélimar, , France
Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord
Saint-Priest-en-Jarez, , France
Médipôle Lyon-Villeurbanne
Villeurbanne, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-A03074-35
Identifier Type: REGISTRY
Identifier Source: secondary_id
RIPH2_BREYSSE_ETAPH
Identifier Type: -
Identifier Source: org_study_id
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