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

Centre Hospitalier Emile Roux300 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

300

Conditions

Neoplasm of Breast

Interventions

Therapeutic Education and Nursing Support Program for Supportive CareOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (9)

Centre Hospitalier de Bourg-en-Bresse / Fleyriat

Bourg-en-Bresse, France

RECRUITING

Clinique De L'infirmerie Protestante De Lyon

Caluire-et-Cuire, France

RECRUITING

Outcomes

Primary Outcomes

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.

The primary endpoint is the score of the 7 adverse events (AEs), graded on a Likert scale from 0 to 4 points from the NCI-CTCAE v5.0, which will be transformed into a single composite endpoint. The 7 AEs considered here will be the most frequent and troublesome of the hormone therapy, namely: muscle and/or joint pain, hot flashes, headache, fatigue, insomnia/sleep disturbance, weight gain, nausea. This collection will be done initially (T0) and then monthly by the patients.

Time frame: For a year

Secondary Outcomes

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.

The score of the validated Quality of Life of Cancer Patients (EORTC-QLQ-C30) self-questionnaire score, performed at Day 0, Month 6 and Month 12 after initiation of hormone therapy

Time frame: 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.

the score of the validated Pittsburgh sleep quality self-questionnaire during the past month, performed at Day 0, Month 6 and Month 12 after initiation of hormone therapy

Time frame: 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.

The INN name,the daily dosage and duration (number of days) of medication taken between Day 0 and 12 months, will be assessed to compare between the experimental ans the control group in term of medication use

Time frame: From date of first Hormone Therapy intake to 12 months

Central Contacts

Émilie GADEA, PhD

CONTACT

+33 4 71 04 35 38 projetetaph@ch-lepuy.fr

Camille FARCY, PhD

CONTACT

+33 4 71 04 31 27 camille.farcy@ch-lepuy.fr

Data from ClinicalTrials.gov

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