Back to resultsEvaluation of the Impact of a Pharmaceutical Interview on the Adherence to Hormonotherapy in Women With Breast Cancer (HORMONOVILLE)
Primary Purpose
Breast Cancer
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
interview
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring Hormonotherpy, Compliance
Eligibility Criteria
Inclusion Criteria:
- Woman, over 18 years old.
- With non-metastatic breast cancer.
- Treated by hormone therapy, regardless of the molecule (cancer RH positive).
- In primary prescription of hormone therapy.
- First prescription by a medical oncologist, surgeon or radiation therapist from the CGFL.
- 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.
- Woman who received information about the study and gave her written consent.
- Affiliation to a social security scheme.
- Participant Agreement of the referent city pharmacy of the patient.
Exclusion Criteria:
- Metastatic patient.
- Patient participating in another epidemiological or clinical study of adherence and / or hormone therapy.
- Patient under guardianship, curatorship or safeguard of justice.
- Patient with severe psychiatric disorders or who does not speak the French language
- Refusal to participate in the study.
- Refusal of participation of the referent city pharmacy of the patient.
Sites / Locations
- Centre Georges Francois Leclerc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pharmaceutical Interview
Arm Description
Pharmaceutical Interview to motivate patient in his hormonotherapy's compliance
Outcomes
Primary Outcome Measures
Patient compliance
data from electronic pillboxes
Secondary Outcome Measures
Full Information
NCT ID
NCT04142476
First Posted
October 24, 2019
Last Updated
October 9, 2023
Sponsor
Centre Georges Francois Leclerc
1. Study Identification
Unique Protocol Identification Number
NCT04142476
Brief Title
Evaluation of the Impact of a Pharmaceutical Interview on the Adherence to Hormonotherapy in Women With Breast Cancer
Acronym
HORMONOVILLE
Official Title
Evaluation of the Impact of a Pharmaceutical Interview on the Adherence to Hormonotherapy in Women With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
August 7, 2024 (Anticipated)
Study Completion Date
August 7, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Hormonotherpy, Compliance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pharmaceutical Interview
Arm Type
Experimental
Arm Description
Pharmaceutical Interview to motivate patient in his hormonotherapy's compliance
Intervention Type
Other
Intervention Name(s)
interview
Intervention Description
interviews with patient's pharmacist to motivate in the hormonotherapy's compliance.
Primary Outcome Measure Information:
Title
Patient compliance
Description
data from electronic pillboxes
Time Frame
18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Woman, over 18 years old.
With non-metastatic breast cancer.
Treated by hormone therapy, regardless of the molecule (cancer RH positive).
In primary prescription of hormone therapy.
First prescription by a medical oncologist, surgeon or radiation therapist from the CGFL.
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.
Woman who received information about the study and gave her written consent.
Affiliation to a social security scheme.
Participant Agreement of the referent city pharmacy of the patient.
Exclusion Criteria:
Metastatic patient.
Patient participating in another epidemiological or clinical study of adherence and / or hormone therapy.
Patient under guardianship, curatorship or safeguard of justice.
Patient with severe psychiatric disorders or who does not speak the French language
Refusal to participate in the study.
Refusal of participation of the referent city pharmacy of the patient.
Facility Information:
Facility Name
Centre Georges Francois Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Impact of a Pharmaceutical Interview on the Adherence to Hormonotherapy in Women With Breast Cancer
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