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

Официальное название

Programme d'Éducation Thérapeutique et d'Accompagnement Infirmier Vers Les Soins de Support, Chez Les Patientes Sous Hormonothérapie Pour un Cancer du Sein Non métastatique

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Therapeutic Education and Nursing Support Program for Supportive Care
  In addition to the conventional oncology follow-up, patients will participate in an initial educational assessment day within 15 days before or after their first dose of hormone therapy. A discussion between the patient and the pivot nurse will then make it possible to define personalized objectives, thus guiding the choice of workshops in the outpatient educational program.

Первичные конечные точки

• To compare the effectiveness of adding a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone on the management of adverse events related to adjuvant hormone therapy. [Срок оценки: For a year]

Вторичные конечные точки (10)

• To compare the effectiveness of adding the program to conventional management alone in terms of quality of life for patients on hormone therapy at baseline (Day 0), Month 6 and Month 12. [Срок оценки: Change from baseline at Month 6 and Month 12]
• To compare the effectiveness of adding the program to conventional management alone in terms of sleep quality at baseline (Day 0), Month 6 and Month 12. [Срок оценки: Change from baseline at Month 6 and Month 12]
• To compare the effectiveness of adding the program to conventional management alone in terms of drug use for the management of adverse events throughout the study. [Срок оценки: From date of first Hormone Therapy intake to 12 months]
• To compare the effectiveness of adding the program to conventional management alone in terms of therapeutic compliance at Month 6 and Month 12. [Срок оценки: Change from Month 6 and Month 12]
• To compare the effectiveness of adding the program to conventional management alone in terms of patients' confidence regarding the use of hormone therapy at Day 0, Month 6 and Month 12. [Срок оценки: Change from baseline at Month 6 and Month 12]
• To compare the effectiveness of adding the program to conventional management alone in terms of patients' level of knowledge about the disease and treatment. [Срок оценки: Change from baseline at Month 2]
• To compare the effectiveness of adding the program to conventional management alone in terms of patients' satisfaction with their care at Month 12. [Срок оценки: For a year]
• To compare the effectiveness of adding the program to conventional management alone in terms of medico-economic impact of the program, in terms of cost-utility. [Срок оценки: For a year]
• To assess patient interest in and adherence to the proposed program in the experimental group. [Срок оценки: For a year]
• To describe the non-drug means used by patients to manage their adverse events and their use of supportive care during the study. [Срок оценки: For a year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 9 центров

• Centre Hospitalier de Bourg-en-Bresse / Fleyriat — Bourg-en-Bresse
• Clinique De L'infirmerie Protestante De Lyon — Caluire-et-Cuire
• CH de Carcassonne — Carcassonne
• CHAL - Centre Hospitalier Alpes Léman — Contamine-sur-Arve
• Centre Hospitalier Emile Roux — Le Puy-en-Velay
• Centre Hospitalier François Quesnay — Mantes-la-Jolie
• Groupement Hospitalier Portes de Provence — Montélimar
• Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord — Saint-Priest-en-Jarez
• … и ещё 1 центр

Идентификаторы

NCT: NCT04794075 · RIPH2_BREYSSE_ETAPH · 2020-A03074-35

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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