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Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer

Recruiting
18 - 75 years of age
Female
Phase N/A

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Overview

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.

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 quality of life. The achievement of this objective is based on therapeutic education and nursing follow-up throughout the first year of treatment, which, thanks to active listening and coordination of the various players, will enable global and personalized patient care.

Eligibility

Inclusion Criteria:

  • 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)
  • Patient who has been informed and has given written consent to participate in the study

Exclusion Criteria:

  • Patient with metastatic cancer
  • 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

Study details

Neoplasm of Breast

NCT04794075

Centre Hospitalier Emile Roux

19 March 2024

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