Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer
ETAPH
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
2 other identifiers
interventional
300
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedStudy Start
First participant enrolled
August 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
August 3, 2025
July 1, 2025
5 years
February 22, 2021
July 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the effectiveness of adding a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone on the management of adverse events related to adjuvant hormone therapy.
The primary endpoint is the score of the 7 adverse events (AEs), graded on a Likert scale from 0 to 4 points from the NCI-CTCAE v5.0, which will be transformed into a single composite endpoint. The 7 AEs considered here will be the most frequent and troublesome of the hormone therapy, namely: muscle and/or joint pain, hot flashes, headache, fatigue, insomnia/sleep disturbance, weight gain, nausea. This collection will be done initially (T0) and then monthly by the patients.
For a year
Secondary Outcomes (10)
To compare the effectiveness of adding the program to conventional management alone in terms of quality of life for patients on hormone therapy at baseline (Day 0), Month 6 and Month 12.
Change from baseline at Month 6 and Month 12
To compare the effectiveness of adding the program to conventional management alone in terms of sleep quality at baseline (Day 0), Month 6 and Month 12.
Change from baseline at Month 6 and Month 12
To compare the effectiveness of adding the program to conventional management alone in terms of drug use for the management of adverse events throughout the study.
From date of first Hormone Therapy intake to 12 months
To compare the effectiveness of adding the program to conventional management alone in terms of therapeutic compliance at Month 6 and Month 12.
Change from Month 6 and Month 12
To compare the effectiveness of adding the program to conventional management alone in terms of patients' confidence regarding the use of hormone therapy at Day 0, Month 6 and Month 12.
Change from baseline at Month 6 and Month 12
- +5 more secondary outcomes
Study Arms (2)
Experimental group with the therapeutic education and nursing support program
EXPERIMENTALIn addition to the conventional oncology follow-up, patients will participate in an initial educational assessments day.
Control group
NO INTERVENTIONPatients will have the conventional oncology follow-up.
Interventions
In addition to the conventional oncology follow-up, patients will participate in an initial educational assessment day within 15 days before or after their first dose of hormone therapy. A discussion between the patient and the pivot nurse will then make it possible to define personalized objectives, thus guiding the choice of workshops in the outpatient educational program.
Eligibility Criteria
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Emile Rouxlead
- University Hospital, Clermont-Ferrandcollaborator
- Waliscocollaborator
Study Sites (9)
Centre Hospitalier de Bourg-en-Bresse / Fleyriat
Bourg-en-Bresse, 01000, France
Clinique De L'infirmerie Protestante De Lyon
Caluire-et-Cuire, 69300, France
CH de Carcassonne
Carcassonne, France
CHAL - Centre Hospitalier Alpes Léman
Contamine-sur-Arve, 74130, France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000, France
Centre Hospitalier François Quesnay
Mantes-la-Jolie, 78200, France
Groupement Hospitalier Portes de Provence
Montélimar, 26200, France
Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270, France
Médipôle Lyon-Villeurbanne
Villeurbanne, 69100, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Séverine Breysse
Centre Hospitalier Emile Roux
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2021
First Posted
March 11, 2021
Study Start
August 9, 2021
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2027
Last Updated
August 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
The study sponsor is the owner of the data and no use or transmission to a third party may be made without its prior consent. All information resulting from this clinical research protocol is considered confidential.