Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer
Recruiting · NCT04794075 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Emile Roux
View the official record on ClinicalTrials.gov →Interventions studied
Therapeutic Education and Nursing Support Program for Supportive Care
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
9 locations listed.
- Centre Hospitalier de Bourg-en-Bresse / Fleyriat - Bourg-en-Bresse, France
- Clinique De L'infirmerie Protestante De Lyon - Caluire-et-Cuire, France
- CH de Carcassonne - Carcassonne, France
- CHAL - Centre Hospitalier Alpes Léman - Contamine-sur-Arve, France
- Centre Hospitalier Emile Roux - Le Puy-en-Velay, France
- Centre Hospitalier François Quesnay - Mantes-la-Jolie, France
- Groupement Hospitalier Portes de Provence - Montélimar, France
- Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord - Saint-Priest-en-Jarez, France
- Médipôle Lyon-Villeurbanne - Villeurbanne, France