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RECRUITINGINTERVENTIONAL

Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer

Programme d'Éducation Thérapeutique et d'Accompagnement Infirmier Vers Les Soins de Support, Chez Les Patientes Sous Hormonothérapie Pour un Cancer du Sein Non métastatique

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To compare the efficacy of the addition of a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone, on the management of adverse events (AEs) related to adjuvant hormone therapy during the first year of treatment in patients with non-metastatic breast cancer.

Who May Be Eligible (Plain English)

Who May Qualify: - Female patients aged 18 to 75 years inclusive - 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 Who Should NOT Join This Trial: - Patient with metastatic cancer (stage IV) - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Female patients aged 18 to 75 years inclusive * 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 with metastatic cancer (stage IV) * 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

Treatments Being Tested

OTHER

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.

Locations (9)

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