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TerminatedNCT04142476HORMONOVILLEUpdated Feb 17, 2025

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

An interventional study of interview in Breast Cancer, sponsored by Centre Georges Francois Leclerc. Terminated at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.

Sponsored by Centre Georges Francois Leclerc · Not applicable, Interventional, and Other

Why this study was terminated
insufficient recruitment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jun 2019, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Breast Cancer

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Keywords

  • Hormonotherpy
  • Compliance
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 105 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Centre Georges Francois Leclerc is the lead sponsor of 75 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    Pharmaceutical Interview

    Pharmaceutical Interview to motivate patient in his hormonotherapy's compliance

    Other: interview

Interventions

  • Otherinterview

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

06

What researchers measure

Primary outcomes

  1. Patient compliance

    data from electronic pillboxes

    Time frame: 18 months

07

Study locations

1 site
  • Centre Georges Francois Leclerc
    Dijon, 21000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04142476
Lead sponsor
Centre Georges Francois Leclerc
Responsible party
Sponsor
First posted
Oct 29, 2019
Start date
Jun 25, 2019
Primary completion
Feb 7, 2023
Completion
Feb 7, 2023
Last update
Feb 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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