NCT04794075Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 22 Feb 2021
- Start date
- 9 Aug 2021
- Primary completion date
- Aug 2028
- Lead sponsor
- Centre Hospitalier Emile Roux
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04794075
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 9 Aug 2021 to the primary completion date, Aug 2028
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient undergoing neoadjuvant hormone therapy
- Patient who started hormone therapy prior to inclusion in the study
Other illness
- Patient with metastatic cancer (stage IV)
- Patient with a history of other cancer treated by radiotherapy, chemotherapy or hormone therapy, with an end of treatment less than 2 years ago.
- Patient with a documented history of cognitive or psychiatric disorders
Other
- 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
- Refusal to participate, protected adult patient, under guardianship or curatorship
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de Bourg-en-Bresse / Fleyriat Coordinator of this site? Confirm its status | Bourg-en-Bresse | France | Recruiting |
| Clinique De L'infirmerie Protestante De Lyon Coordinator of this site? Confirm its status | Caluire-et-Cuire | France | Recruiting |
| CH de Carcassonne Coordinator of this site? Confirm its status | Carcassonne | France | Recruiting |
| CHAL - Centre Hospitalier Alpes Léman Coordinator of this site? Confirm its status | Contamine-sur-Arve | France | Not yet recruiting |
| Centre Hospitalier Emile Roux Coordinator of this site? Confirm its status | Le Puy-en-Velay | France | Recruiting |
| Centre Hospitalier François Quesnay Coordinator of this site? Confirm its status | Mantes-la-Jolie | France | Recruiting |
| Groupement Hospitalier Portes de Provence Coordinator of this site? Confirm its status | Montélimar | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| Médipôle Lyon-Villeurbanne Coordinator of this site? Confirm its status | Villeurbanne | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.