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Completed

NCT Number: NCT02300675

Therapeutic Education Intervention in 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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Empowerment Health Behavior Neoplasms Neoplasms by Site Patient Acceptance of Health Care Patient Compliance Skin Diseases Skin and Connective Tissue Diseases Social Behavior Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CH Lyon Sud, Pierre-Bénite, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

therapeutic education program

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de la Loire

Other

Registry information

Official study 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

Acronym: PEPs HORMONO

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Nov 25, 2014
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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