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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02300675
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: therapeutic education program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. Measuring the level of patient anxiety [ Time Frame: 12 months ]
    Measuring the level of patient anxiety with HAD scale

  4. 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

  5. patients' quality of life assessment [ Time Frame: 12 months ]
    quality of life evaluated with the EQ-5D questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300675


Locations
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France
CH Lyon Sud
Pierre Bénite, France, 69495
Hôpital Privé de la Loire
Saint-Etienne, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, France, 42270
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Investigators
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Principal Investigator: Aurélie Bourmaud, MD Institut de Cancérologie de la Loire

Publications of Results:
Other Publications:

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Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT02300675     History of Changes
Other Study ID Numbers: 2013-01
2013-A00887-38 ( Other Identifier: Agence Nationale de Sécurité du Médicament )
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by Institut de Cancérologie de la Loire:
therapeutic patient education
patient adherence
empowerment
breast cancer
oral adjuvant endocrine therapy
side effects

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases