Recruiting
Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer
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.
ClinicalTrials.gov IDNCT04794075
PhaseNA
Enrollment300
SponsorCentre Hospitalier Emile Roux
Age18 Years
SexFEMALE
Conditions studied
Neoplasm of Breast
About this study
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.
Interventions
- 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.
Primary outcomes
- To compare the effectiveness of adding a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone on the management of adverse events related to adjuvant hormone therapy. (For a year)
Eligibility information
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
Study locations
- Centre Hospitalier de Bourg-en-Bresse / Fleyriat, Bourg-en-Bresse, 01000 France
- Clinique De L'infirmerie Protestante De Lyon, Caluire-et-Cuire, 69300 France
- CH de Carcassonne, Carcassonne, France
- CHAL - Centre Hospitalier Alpes Léman, Contamine-sur-Arve, 74130 France
- Centre Hospitalier Emile Roux, Le Puy-en-Velay, 43000 France
- Centre Hospitalier François Quesnay, Mantes-la-Jolie, 78200 France
- Groupement Hospitalier Portes de Provence, Montélimar, 26200 France
- Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord, Saint-Priest-en-Jarez, 42270 France
- Médipôle Lyon-Villeurbanne, Villeurbanne, 69100 France
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.