Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility and the effectiveness of a patient education program on patients' adherence to adjuvant hormone therapy (anti-estrogen or aromatase inhibitors) for breast cancer, in collaboration with teams of sociologists, patient education and medical oncologists.

Official Title
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Development and Evaluation of a Therapeutic Education Intervention Focused on the Accession of Patients Treated With Hormonal Therapy in the Management of Breast Cancer: PEPs Hormonotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: therapeutic education program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged over 18 History of breast cancer Medical prescription for an adjuvant hormonal treatment (anti-estrogens and / or aromatase inhibitors) as monotherapy or in combination with other treatments Affiliated to a social security scheme Exclusion Criteria: Refusal to participate, patient protected by guardianship. Patient unable to understand the study or unable to follow the education sessions. Patient with documented cognitive or psychiatric history. Geographical remotness (more than 100 Kms).

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control arm<br>Patients follow the classic support prescription of hormonotherapy | |
| Experimental: therapeutic education program<br>Patients follow the 4 sessions of PEP hormonotherapy. The therapeutic education prgram is led by a trained educational team, inside a prevention center : Hygée centre. | Behavioral: therapeutic education program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measuring changes in patient compliance | compliance measure with prescription refillment and questionnaire. At the inclusion and at the end of the study | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure of the patients' competence in the management of treatment side effects | measure of the patients' competence with a specific questionnaire of scenarii | 12 months | 
| Measuring the level of knowledge of patients related to the disease, the treatment and its side effects | Measuring the level of knowledge of patients with a specific quizz | 12 months | 
| Measuring the level of patient anxiety | Measuring the level of patient anxiety with HAD scale | 12 months | 
| Measuring the level of confidence of patients related to their treatment | Measuring the level of confidence with a visual analogic scale | 12 months | 
| patients' quality of life assessment | quality of life evaluated with the EQ-5D questionnaire | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapeutic patient education, patient adherence, empowerment, breast cancer, oral adjuvant endocrine therapy, side effects