Breast CancerHORMONOVILLENCT04142476
Evaluation of the Impact of a Pharmaceutical Interview on the Adherence to Hormonotherapy in Women With Breast Cancer
A study testing interview in people with Breast Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2019to 7 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- interview
- Keywords
- Hormonotherpy, Compliance
- Medical subject headings
- Breast Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
interviews with patient's pharmacist to motivate in the hormonotherapy's compliance.
| Study group | Role | What they receive |
|---|---|---|
| Pharmaceutical Interview | Experimental | Pharmaceutical Interview to motivate patient in his hormonotherapy's compliance Receives: Other: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient compliance
data from electronic pillboxes
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start25 Jun 2019
- Primary completion7 Feb 2023
- Study completion7 Feb 2023
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142476
- Sponsor's protocol ID
- HORMONOVILLE
- Acronym
- HORMONOVILLE
- Status last verified
- Feb 2025
- First submitted
- 24 Oct 2019
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Pharmaceutical Interview on the Adherence to Hormonotherapy in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT04142476
- Acronym / sponsor ID
- HORMONOVILLE / HORMONOVILLE
- Conditions
- Breast Cancer
- Keywords
- Hormonotherpy, Compliance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmaceutical Interview | Experimental | Other: interviewPharmaceutical Interview to motivate patient in his hormonotherapy's compliance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interviewinterviews with patient's pharmacist to motivate in the hormonotherapy's compliance. | Other | Pharmaceutical Interview |
Primary outcome
Patient compliance
Time frame: 18 months
data from electronic pillboxes
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interview in people with Breast Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient compliance (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.