Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy (PEPs HORMONO)

Institut de Cancérologie de la Loire

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: therapeutic education program

Study type: Interventional

Funder types: Other

Identifiers

NCT02300675

2013-A00887-38 (Other Identifier)

2013-01

Details and patient eligibility

About

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.

Enrollment: 352 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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352 participants in 2 patient groups

control arm

No Intervention group

Description:

Patients follow the classic support prescription of hormonotherapy

therapeutic education program

Experimental group

Description:

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.

Treatment:

Behavioral: therapeutic education program