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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04142476
Acronym
HORMONOVILLE
Enrollment
105
Registered
2019-10-29
Start date
2019-06-25
Completion date
2023-02-07
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Hormonotherpy, Compliance

Brief 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.

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.

Interventions

OTHERinterview

interviews with patient's pharmacist to motivate in the hormonotherapy's compliance.

Sponsors

Centre Georges Francois Leclerc
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient compliance18 monthsdata from electronic pillboxes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026