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

September 13, 2017 updated by: Institut de Cancérologie de la Loire

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

352

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre Bénite, France, 69495
        • CH Lyon sud
      • Saint-Etienne, France
        • Hôpital privé de la Loire
      • Saint-Priest-en-Jarez, France, 42270
        • Institut de Cancerologie de La Loire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control arm
Patients follow the classic support prescription of hormonotherapy
Experimental: 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.
Behavioral: therapeutic education program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de la Loire

Investigators

  • Principal Investigator: Aurélie Bourmaud, MD, Institut de Cancerologie de La Loire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 25, 2014

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-01 (Other Identifier: AP HM)
  • 2013-A00887-38 (Other Identifier: Agence Nationale de Sécurité du Médicament)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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