Breast CancerEPOPEENCT04228432
E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer.
A study testing Dedicated and coordinated monitoring in people with Breast Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial summary
This is a monocentric, prospective cohort study evaluating the feasibility of an E-monitoring protocol in patients with breast cancer treated by adjuvant hormonotherapy . 45 patients will be included. Patients will be followed during 6 months. 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?
- Dedicated and coordinated monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2020to 21 Jul 2021
- 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
- Patient treated for hormone-dependent localized breast cancer with adjuvant HT (tamoxifen or anti-aromatase +/- LHRH agonist)
- Patient equipped with a computer or tablet computer and an internet connection at home
- Age > 18 years old
- Patient affiliated to the french social security system
- Patient who has signed informed consent before inclusion in the study and before any specific procedures for the study
- Women of childbearing age should have effective contraception under hormonotherapy
Who cannot join
- Patient with breast cancer who does not require adjuvant hormonotherapy
- Patient with metastatic breast cancer
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- Patient previously treated for breast cancer (infiltrating or in-situ) with adjuvant HT or not
- Patient protected by law.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer: Pilot Study
This is a monocentric, prospective cohort study evaluating the feasibility of an E-monitoring protocol in patients with breast cancer treated by adjuvant hormonotherapy .
45 patients will be included.
Patients will be followed during 6 months.
- Conditions
- Breast Cancer
- Being tested
- Dedicated and coordinated monitoring
- Keywords
- Breast Cancer, Hormonotherapy, E-monitoring
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dedicated and coordinated monitoringOther
- Coordinated monitoring performed by a dedicated nurse: consultation before hormonotherapy initiation
- Monitoring at home over a period of 6 months using an e-monitoring tool: assessment of adverse events and completion of GIRERD questionnaire at week 3 and week 6.
| Study group | Role | What they receive |
|---|---|---|
| Patients with breast cancer treated by adjuvant hormonotherapy | Experimental | Not described Receives: Other: Dedicated and coordinated monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who do not fail the E-Monitoring protocol
Measured: 6 months per patient
Secondary outcomes (2)
Number of medical consultations required over 6 months
Measured: 6 months per patient
Rate of hormonotherapy adherence evaluated by the GIRERD questionnaire
Measured: 6 months per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start28 Feb 2020
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228432
- Sponsor's protocol ID
- 19 SEIN 14
- Acronym
- EPOPEE
- Status last verified
- Jul 2021
- First submitted
- 10 Jan 2020
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer: Pilot Study
- ClinicalTrials.gov ID
- NCT04228432
- Acronym / sponsor ID
- EPOPEE / 19 SEIN 14
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Hormonotherapy, E-monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 14 Jan 2020 (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.
This is a monocentric, prospective cohort study evaluating the feasibility of an E-monitoring protocol in patients with breast cancer treated by adjuvant hormonotherapy .
45 patients will be included.
Patients will be followed during 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with breast cancer treated by adjuvant hormonotherapy | Experimental | Other: Dedicated and coordinated monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient treated for hormone-dependent localized breast cancer with adjuvant HT (tamoxifen or anti-aromatase +/- LHRH agonist)
- Patient equipped with a computer or tablet computer and an internet connection at home
- Age > 18 years old
- Patient affiliated to the french social security system
- Patient who has signed informed consent before inclusion in the study and before any specific procedures for the study
Key exclusion criteria (5 listed)
- Patient with breast cancer who does not require adjuvant hormonotherapy
- Patient with metastatic breast cancer
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- Patient previously treated for breast cancer (infiltrating or in-situ) with adjuvant HT or not
- Patient protected by law.
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 |
|---|---|---|
| Dedicated and coordinated monitoring* Coordinated monitoring performed by a dedicated nurse: consultation before hormonotherapy initiation * Monitoring at home over a period of 6 months using an e-monitoring tool: assessment of adverse events and completion of GIRERD questionnaire at week 3 and week 6. | Other | Patients with breast cancer treated by adjuvant hormonotherapy |
Primary outcome
Rate of patients who do not fail the E-Monitoring protocol
Time frame: 6 months per patient
2 secondary outcomes
Number of medical consultations required over 6 months
Time frame: 6 months per patient
Rate of hormonotherapy adherence evaluated by the GIRERD questionnaire
Time frame: 6 months per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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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 Dedicated and coordinated monitoring in people with Breast Cancer, run by Institut Claudius Regaud 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 27 Jul 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of patients who do not fail the E-Monitoring protocol (time frame: 6 months per patient). 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 27 Jul 2021.