Breast CancerEPARS-SEINNCT02893527
Implementation and Evaluation of a Social Journey Accompanied in Breast Cancer Diagnosis (EPARS SEIN)
A study testing personalized coaching in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
Evaluate and compare the return to work rate at 12 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?
- personalized coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2015to Dec 2017
- 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 major> 18
- Have a diagnosis of localized breast cancer requiring surgery immediately adjuvant therapy sequence including chemotherapy and radiotherapy
- Being more than 3 years of retirement at diagnosis
- Have a work contract valid at the time of diagnosis (before surgery)
- Do not practice a profession
- Be in possession of his rights (excluding guardianship, curatorship)
- Raise the general social security scheme and have rights to cash benefits in the Languedoc-Roussillon region
Who cannot join
- Patient minor
- Patient diagnosed with metastatic breast cancer
- Patients refusing to sign the consent
- Patients do not have sufficient understanding of the French language
- Patients for whom it is impossible to give clear information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation and Evaluation of a Social Journey Accompanied for Women With Breast Cancer Diagnosis
Evaluate and compare the return to work rate at 12 months
Read the detailed description
Evaluate and compare the return to work rate at 12 months (from J1C1 [first day of the first adjuvant chemotherapy regimen]) between the "intervention" group (which has accompanied the career) and the standard group course
- Conditions
- Breast Cancer
- Being tested
- personalized coaching
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized coachingBehavioural
personalized coaching coordinated by a coordinating nurse on a shutdown period of 8 months (consecutive stops).
| Study group | Role | What they receive |
|---|---|---|
| Group "intervention" | Experimental | Personalized coaching coordinated by a coordinating nurse on a shutdown period of 8 months (consecutive stops). Receives: Behavioral: personalized coaching |
| Group "standard" | No intervention | conventional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate and compare the return to work rate
Evaluate and compare the return to work rate at 12 months (from J1C1 [first day of the first adjuvant chemotherapy regimen]) between the "intervention" group (which has accompanied the career) and the standard group course
Measured: through study completion, an average of 5 years
Secondary outcomes (1)
describe the conditions of the resumption of work
The study will also allow to describe the conditions of the resumption of work in 12 months for the patients concerned and to compare these conditions between the 2 groups
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start24 Feb 2015
- Primary completionDec 2016
- Study completionDec 2017
Why it stopped: An IDMC validated the premature termination of the study on 19/02/2016 for lack of inclusion, with continuation of the FU initially planned for women included
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.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cemka-Eval
- Responsible party
- Sponsor
- Investigators
- William JACOT, Study chair, Institut régional du Cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893527
- Sponsor's protocol ID
- ICM-URC-2014/33
- Acronym
- EPARS-SEIN
- Status last verified
- Aug 2020
- First submitted
- 29 Aug 2016
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Social Journey Accompanied for Women With Breast Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT02893527
- Acronym / sponsor ID
- EPARS-SEIN / ICM-URC-2014/33
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An IDMC validated the premature termination of the study on 19/02/2016 for lack of inclusion, with continuation of the FU initially planned for women included
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Collaborators
- Cemka-Eval
- Study start
- 24 Feb 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
Evaluate and compare the return to work rate at 12 months
Detailed description
Evaluate and compare the return to work rate at 12 months (from J1C1 [first day of the first adjuvant chemotherapy regimen]) between the "intervention" group (which has accompanied the career) and the standard group course
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group "intervention" | Experimental | Behavioral: personalized coachingPersonalized coaching coordinated by a coordinating nurse on a shutdown period of 8 months (consecutive stops). |
| Group "standard" | No intervention | –conventional support |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient major> 18
- Have a diagnosis of localized breast cancer requiring surgery immediately adjuvant therapy sequence including chemotherapy and radiotherapy
- Being more than 3 years of retirement at diagnosis
- Have a work contract valid at the time of diagnosis (before surgery)
- Do not practice a profession
Key exclusion criteria (5 listed)
- Patient minor
- Patient diagnosed with metastatic breast cancer
- Patients refusing to sign the consent
- Patients do not have sufficient understanding of the French language
- Patients for whom it is impossible to give clear information
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 |
|---|---|---|
| personalized coachingpersonalized coaching coordinated by a coordinating nurse on a shutdown period of 8 months (consecutive stops). | Behavioural | Group "intervention" |
Primary outcome
Evaluate and compare the return to work rate
Time frame: through study completion, an average of 5 years
Evaluate and compare the return to work rate at 12 months (from J1C1 [first day of the first adjuvant chemotherapy regimen]) between the "intervention" group (which has accompanied the career) and the standard group course
1 secondary outcome
describe the conditions of the resumption of work
Time frame: through study completion, an average of 5 years
Results and safety
The study was stopped early (reason given: An IDMC validated the premature termination of the study on 19/02/2016 for lack of inclusion, with continuation of the FU initially planned for women included). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Individual participant dataSharing planned: No
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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.
William JACOT study chair
Institut régional du Cancer de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized coaching in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 7 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: stopped early, as of the sponsor's last update on 10 Aug 2020. 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: An IDMC validated the premature termination of the study on 19/02/2016 for lack of inclusion, with continuation of the FU initially planned for women included). 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?
Evaluate and compare the return to work rate (time frame: through study completion, an average of 5 years). 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 10 Aug 2020.