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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
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

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier de Bourg-en-Bresse / Fleyriat
Coordinator of this site? Confirm its status
Bourg-en-BresseFranceRecruiting
Clinique De L'infirmerie Protestante De Lyon
Coordinator of this site? Confirm its status
Caluire-et-CuireFranceRecruiting
CH de Carcassonne
Coordinator of this site? Confirm its status
CarcassonneFranceRecruiting
CHAL - Centre Hospitalier Alpes Léman
Coordinator of this site? Confirm its status
Contamine-sur-ArveFranceNot yet recruiting
Centre Hospitalier Emile Roux
Coordinator of this site? Confirm its status
Le Puy-en-VelayFranceRecruiting
Centre Hospitalier François Quesnay
Coordinator of this site? Confirm its status
Mantes-la-JolieFranceRecruiting
Groupement Hospitalier Portes de Provence
Coordinator of this site? Confirm its status
MontélimarFranceNot yet recruiting
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord
Coordinator of this site? Confirm its status
Saint-Priest-en-JarezFranceRecruiting
Médipôle Lyon-Villeurbanne
Coordinator of this site? Confirm its status
VilleurbanneFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.