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

Institut de Cancérologie de la Loire3 sites in 1 country352 target enrollmentMay 2014

ConditionsBreast Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Institut de Cancérologie de la Loire
Enrollment: 352
Locations: 3
Primary Endpoint: measuring changes in patient compliance
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

August 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Institut de Cancérologie de la Loire

Responsible Party

Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

measuring changes in patient compliance

Time Frame: 12 months

compliance measure with prescription refillment and questionnaire. At the inclusion and at the end of the study

Secondary Outcomes

patients' quality of life assessment(12 months)
Measuring the level of knowledge of patients related to the disease, the treatment and its side effects(12 months)
measure of the patients' competence in the management of treatment side effects(12 months)
Measuring the level of patient anxiety(12 months)
Measuring the level of confidence of patients related to their treatment(12 months)