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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

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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