Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: therapeutic education program

• Registration Number: NCT02300675
• Lead Sponsor: Institut de Cancérologie de la Loire

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-15
• Study Start: 2014-05
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-25
• Primary Completion: 2016-08
• Study Completion: 2017-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 352

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
therapeutic education program	therapeutic education program	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.

Primary Outcome Measures

Name	Time	Method
measuring changes in patient compliance	12 months	compliance measure with prescription refillment and questionnaire. At the inclusion and at the end of the study

Secondary Outcome Measures

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

Trial Locations

Locations (3)

CH Lyon Sud; 🇫🇷 Pierre Bénite, France

Institut de Cancérologie de la Loire; 🇫🇷 Saint-Priest-en-Jarez, France

Hôpital Privé de la Loire; 🇫🇷 Saint-Etienne, France