Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
NCT04794075

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

Led by Centre Hospitalier Emile Roux · Updated on 2025-08-03

300

Participants Needed

9

Research Sites

311 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Emile Roux

Lead Sponsor

U

University Hospital, Clermont-Ferrand

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 75 years inclusive
  • Patients with non-metastatic breast cancer for whom adjuvant hormone therapy is indicated
  • Performance status (ECOG) of 2 or less
  • Patient able to read and understand French
  • Patient with access to an internet connection
  • Patient informed and provided written consent
  • Patient affiliated with the French social security system or equivalent
Not Eligible

You will not qualify if you...

  • Patient with metastatic cancer (stage IV)
  • Patient undergoing neoadjuvant hormone therapy
  • Patient who started hormone therapy prior to inclusion in the study
  • History of other cancer treated less than 2 years ago with radiotherapy, chemotherapy, or hormone therapy
  • For experimental group: inability to attend initial assessment day or group workshops due to travel or other reasons
  • For control group: planned telephone nursing follow-up for 2 months or more or more than 4 therapeutic education sessions
  • Pregnant or breastfeeding women
  • History of documented cognitive or psychiatric disorders
  • Refusal to participate, protected adult, under guardianship or curatorship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Centre Hospitalier de Bourg-en-Bresse / Fleyriat

Bourg-en-Bresse, France, 01000

Actively Recruiting

2

Clinique De L'infirmerie Protestante De Lyon

Caluire-et-Cuire, France, 69300

Actively Recruiting

3

CH de Carcassonne

Carcassonne, France

Actively Recruiting

4

CHAL - Centre Hospitalier Alpes Léman

Contamine-sur-Arve, France, 74130

Not Yet Recruiting

5

Centre Hospitalier Emile Roux

Le Puy-en-Velay, France, 43000

Actively Recruiting

6

Centre Hospitalier François Quesnay

Mantes-la-Jolie, France, 78200

Actively Recruiting

7

Groupement Hospitalier Portes de Provence

Montélimar, France, 26200

Not Yet Recruiting

8

Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord

Saint-Priest-en-Jarez, France, 42270

Actively Recruiting

9

Médipôle Lyon-Villeurbanne

Villeurbanne, France, 69100

Actively Recruiting

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Research Team

É

Émilie GADEA, PhD

CONTACT

C

Camille FARCY, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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