Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Adjuvants, Anesthesia

Central Nervous System Depressants

Psychotropic Drugs

Hormones

Midazolam

In addition to the conventional oncology follow-up, patients will participate in an initial educational assessments day.

Patients will have the conventional oncology follow-up.

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.

Therapeutic Education and Nursing Support Program for Supportive Care

Émilie GADEA

Emilie Gadea

Séverine Breysse

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.

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

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

The study sponsor is the owner of the data and no use or transmission to a third party may be made without its prior consent. All information resulting from this clinical research protocol is considered confidential.

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.

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

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

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

GIRERD's subjective compliance self-questionnaire score will be filled in at Month 6 and Month 12.

Patients' confidence in their treatment, assessed on a numerical scale from 0 to 10, measured at Day 0, Month 6 and Month 12.

Score obtained in the knowledge quizz conducted in Day 0, then at 2 months. This questionnaire is developed by our team based on Likert scales from 1 to 4.

Score of satisfaction with patient care in relation to the needs they have had over the past 12 months. This questionnaire is developed by our team based on Likert scales from 0 to 3.

the cost-utility ratio of the program will be calculated by estimating the costs incurred/avoided by this program and the evolution of the quality of life of the patients at different times.

Refusal rate and program participation rate The rate of premature exit or loss of sight The number and type of workshops attended by patients Evaluation of program content based on Likert scales ranging from 1 to 4.

Patients' non-drug management of side effects and use of supportive care will be recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer	NCT04794075	Neoplasm of Bre...	Therapeutic Edu...	18 Years - 75 Years	Centre Hospitalier Emile Roux
Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer	NCT04794075	Neoplasm of Bre...	Therapeutic Edu...	18 Years - 75 Years	Centre Hospitalier Emile Roux

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