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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
therapeutic education program
Sponsored by
Institut de Cancérologie de la Loire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring therapeutic patient education, patient adherence, empowerment, breast cancer, oral adjuvant endocrine therapy, side effects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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).

Sites / Locations

  • CH Lyon Sud
  • Hôpital Privé de la Loire
  • Institut de Cancérologie de la Loire

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control arm

therapeutic education program

Arm Description

Patients follow the classic support prescription of hormonotherapy

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.

Outcomes

Primary Outcome Measures

measuring changes in patient compliance
compliance measure with prescription refillment and questionnaire. At the inclusion and at the end of the study

Secondary Outcome Measures

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

Full Information

First Posted
April 15, 2014
Last Updated
September 13, 2017
Sponsor
Institut de Cancérologie de la Loire
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1. Study Identification

Unique Protocol Identification Number
NCT02300675
Brief Title
Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy
Acronym
PEPs HORMONO
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de la Loire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
therapeutic patient education, patient adherence, empowerment, breast cancer, oral adjuvant endocrine therapy, side effects

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control arm
Arm Type
No Intervention
Arm Description
Patients follow the classic support prescription of hormonotherapy
Arm Title
therapeutic education program
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
therapeutic education program
Primary Outcome Measure Information:
Title
measuring changes in patient compliance
Description
compliance measure with prescription refillment and questionnaire. At the inclusion and at the end of the study
Time Frame
12 months
Secondary Outcome Measure Information:
Title
measure of the patients' competence in the management of treatment side effects
Description
measure of the patients' competence with a specific questionnaire of scenarii
Time Frame
12 months
Title
Measuring the level of knowledge of patients related to the disease, the treatment and its side effects
Description
Measuring the level of knowledge of patients with a specific quizz
Time Frame
12 months
Title
Measuring the level of patient anxiety
Description
Measuring the level of patient anxiety with HAD scale
Time Frame
12 months
Title
Measuring the level of confidence of patients related to their treatment
Description
Measuring the level of confidence with a visual analogic scale
Time Frame
12 months
Title
patients' quality of life assessment
Description
quality of life evaluated with the EQ-5D questionnaire
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie Bourmaud, MD
Organizational Affiliation
Institut de Cancérologie de la Loire
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Hôpital Privé de la Loire
City
Saint-Etienne
Country
France
Facility Name
Institut de Cancérologie de la Loire
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France

12. IPD Sharing Statement

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Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy

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