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

RecruitingNAAges 18 Years - 75 YearsFemaleCentre Hospitalier Emile Roux
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Therapeutic Education and Nursing Support Program for Supportive Care
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Where

9 sites
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

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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