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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Neoplasm of Breast

Intervention / Treatment
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* Other: Therapeutic Education and Nursing Support Program for Supportive Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Quasi-experiment group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group with the therapeutic education and nursing support program<br>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<br>* 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.<br>|
| No Intervention: Control group<br>Patients will have the conventional oncology follow-up. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic Education, Nursing Support Program, Hormone Therapy, Non-metastatic Breast Cancer, Breast Cancer