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

Recruiting now · Not applicable

Conditions studied: Neoplasm of Breast

In brief

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.

Key facts

Study ID

NCT04794075

Run by

Centre Hospitalier Emile Roux

People needed

300

Starts

2021-08-09

Expected to finish

2029-08-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Médipôle Lyon-Villeurbanne — Villeurbanne, France (enrolling)
• Clinique De L'infirmerie Protestante De Lyon — Caluire-et-Cuire, France (enrolling)
• CH de Carcassonne — Carcassonne, France (enrolling)
• Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord — Saint-Priest-en-Jarez, France (enrolling)
• Centre Hospitalier de Bourg-en-Bresse / Fleyriat — Bourg-en-Bresse, France (enrolling)
• Centre Hospitalier Emile Roux — Le Puy-en-Velay, France (enrolling)
• Centre Hospitalier François Quesnay — Mantes-la-Jolie, France (enrolling)
• CHAL - Centre Hospitalier Alpes Léman — Contamine-sur-Arve, France
• Groupement Hospitalier Portes de Provence — Montélimar, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.