Status:
RECRUITING
Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer
Lead Sponsor:
Centre Hospitalier Emile Roux
Collaborating Sponsors:
University Hospital, Clermont-Ferrand
Walisco
Conditions:
Neoplasm of Breast
Eligibility:
FEMALE
18-75 years
Phase:
NA
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) r...
Detailed Description
The main objective of the ETAPH project is to offer breast cancer patients multidisciplinary care that will limit the impact of adverse effects related to hormone therapy treatment and improve their q...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04794075
Start Date
August 9 2021
End Date
August 1 2027
Last Update
August 3 2025
Active Locations (9)
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1
Centre Hospitalier de Bourg-en-Bresse / Fleyriat
Bourg-en-Bresse, France, 01000
2
Clinique De L'infirmerie Protestante De Lyon
Caluire-et-Cuire, France, 69300
3
CH de Carcassonne
Carcassonne, France
4
CHAL - Centre Hospitalier Alpes Léman
Contamine-sur-Arve, France, 74130