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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasm of Breast
• Intervention / Treatment: Other: Therapeutic Education and Nursing Support Program for Supportive Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Émilie GADEA; Phone Number: +33 4 71 04 35 38; Email: projetetaph@ch-lepuy.fr

Study Locations

• France
  • Le Puy-en-Velay, France, 43000
    • Recruiting
    • Centre Hospitalier Emile ROUX
    • Principal Investigator: Séverine Breysse
    • Contact: Emilie Gadea; Email: projetetaph@ch-lepuy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group with the therapeutic education and nursing support program; In addition to the conventional oncology follow-up, patients will participate in an initial educational assessments day.	Other: 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.
No Intervention: Control group; Patients will have the conventional oncology follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For a year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	GIRERD's subjective compliance self-questionnaire score will be filled in at Month 6 and Month 12.	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.	Patients' confidence in their treatment, assessed on a numerical scale from 0 to 10, measured at Day 0, Month 6 and Month 12.	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.	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.	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.	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.	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.	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.	For a year
To assess patient interest in and adherence to the proposed program in the experimental group.	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.	For a year
To describe the non-drug means used by patients to manage their adverse events.	Patients' non-drug management of side effects and use of supportive care will be recorded.	For a year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Emile Roux
• Collaborators: University Hospital, Clermont-Ferrand; Walisco
• Investigators: Principal Investigator: Séverine Breysse, Centre Hospitalier Emile ROUX

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Hormone Therapy; Therapeutic Education; Nursing Support Program; Non-metastatic Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: RIPH2_BREYSSE_ETAPH; 2020-A03074-35 (Registry Identifier: IRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No