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

Breast Cancer Clinical Trial

— HORMONOVILLE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04142476
• Other study ID #: HORMONOVILLE
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: August 7, 2024

Study information

• Verified date: October 2023
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: August 7, 2024
• Est. primary completion date: August 7, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• interview
interviews with patient's pharmacist to motivate in the hormonotherapy's compliance.

Locations

Country	Name	City	State
France	Centre Georges Francois Leclerc	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient compliance	data from electronic pillboxes	18 months