Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02300675

Acronym

PEPs HORMONO

Enrollment

352

Registered

2014-11-25

Start date

2014-05-31

Completion date

2017-08-31

Last updated

2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

therapeutic patient education, patient adherence, empowerment, breast cancer, oral adjuvant endocrine therapy, side effects

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.

Interventions

BEHAVIORALtherapeutic education program

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Measuring the level of confidence of patients related to their treatment	12 months	Measuring the level of confidence with a visual analogic scale
patients' quality of life assessment	12 months	quality of life evaluated with the EQ-5D questionnaire
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 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
Measuring the level of patient anxiety	12 months	Measuring the level of patient anxiety with HAD scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026