Supportive care program for patients with non-metastatic breast cancer undergoing hormone therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a therapeutic education program combined with nursing support via phone follow-ups for patients receiving hormone therapy for non-metastatic breast cancer. The goal is to manage adverse events related to hormone therapy and enhance the quality of life for these patients during the first year of treatment. By providing personalized care and active listening, the program seeks to improve overall patient outcomes compared to conventional management alone.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre Hospitalier de Bourg-en-Bresse / Fleyriat
  Bourg-en-Bresse, France Recruiting
• Clinique De L'infirmerie Protestante De Lyon
  Caluire-et-Cuire, France Recruiting
• CH de Carcassonne
  Carcassonne, France Recruiting
• Centre Hospitalier Emile Roux
  Le Puy-en-Velay, France Recruiting
• Centre Hospitalier François Quesnay
  Mantes-la-Jolie, France Recruiting
• Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord
  Saint-Priest-en-Jarez, France Recruiting

Study contacts

• Principal investigator: Séverine Breysse — Centre Hospitalier Emile Roux
• Study coordinator: Émilie GADEA, PhD
• Email: projetetaph@ch-lepuy.fr
• Phone: +33 4 71 04 35 38

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.