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Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer
RECRUITINGN/ASponsored by Centre Hospitalier Emile Roux
Actively Recruiting
PhaseN/A
SponsorCentre Hospitalier Emile Roux
Started2021-08-09
Est. completion2026-08
Eligibility
Age18 Years – 75 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04794075
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.
Eligibility
Age: 18 Years – 75 YearsSex: FEMALEHealthy volunteers accepted
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
Conditions3
Breast CancerCancerNeoplasm of Breast
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Actively Recruiting
PhaseN/A
SponsorCentre Hospitalier Emile Roux
Started2021-08-09
Est. completion2026-08
Eligibility
Age18 Years – 75 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04794075