Evaluation of the Impact of a Pharmaceutical Interview on the Adherence to Hormonotherapy in Women With Breast Cancer (HORMONOVILLE)

Breast cancer is the first cancer in women and 60% of new cases occurring in women 50 to 74 years old. With about 50,000 new cases, it is the second cancer the most serious cancers. In the therapeutic strategy, hormone therapy takes pride of place by allowing a significant reduction in the recurrence rate.

For the hormonotherapy be effective, patient compliance should be optimal during treatment. Different factors or barriers may lead to a lack of adherence, such as the occurrence of adverse effects, treatment fatigue, a difficult relationship with the health care team, beliefs about success or the need for treatment.

In order to facilitate the compliance of hormonoherapy treatment by patients, it is important to include different health professionals such as pharmacists.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Other: interview

Detailed Description

Hormonotherapy adherence to breast cancer patients could be improved by :

• the use of electronic pill dispensers since the first prescription to visualize the level of compliance of each patient and study with her the various factors that can limit it.
• motivational, semi-directed and scheduled drug interviews at regular intervals throughout the study over a period of 18 months to visualize the compliance rate (ratio of the number of tablets taken by the patient on the number of tablets to be taken theoretically over the period), to evaluate the presence or absence of iatrogenesis specific to hormone therapy and to ensure adequate medical follow-up.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Centre Georges Francois Leclerc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Woman, over 18 years old.
2. With non-metastatic breast cancer.
3. Treated by hormone therapy, regardless of the molecule (cancer RH positive).
4. In primary prescription of hormone therapy.
5. First prescription by a medical oncologist, surgeon or radiation therapist from the CGFL.
6. Pharmacy of the patient located in the perimeter defined in the context of the study (Residents in the Burgundy region between a triangle delimited by the towns of Chatillon sur Seine, Dole and Chalon sur Saone.
7. Woman who received information about the study and gave her written consent.
8. Affiliation to a social security scheme.
9. Participant Agreement of the referent city pharmacy of the patient.

Exclusion Criteria:

1. Metastatic patient.
2. Patient participating in another epidemiological or clinical study of adherence and / or hormone therapy.
3. Patient under guardianship, curatorship or safeguard of justice.
4. Patient with severe psychiatric disorders or who does not speak the French language
5. Refusal to participate in the study.
6. Refusal of participation of the referent city pharmacy of the patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmaceutical Interview; Pharmaceutical Interview to motivate patient in his hormonotherapy's compliance	Other: interview; interviews with patient's pharmacist to motivate in the hormonotherapy's compliance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient compliance	data from electronic pillboxes	18 months

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Actual): February 7, 2023
• Study Completion (Actual): February 7, 2023

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Compliance; Hormonotherpy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HORMONOVILLE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No