Study 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
Implementation and Evaluation of a Social Journey Accompanied in Breast Cancer Diagnosis (EPARS SEIN)
EPARS-SEIN
1 other identifier
interventional
11
1 country
1
Brief Summary
Evaluate and compare the return to work rate at 12 months
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2015
CompletedFirst Submitted
Initial submission to the registry
August 29, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 10, 2020
August 1, 2020
1.8 years
August 29, 2016
August 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
through study completion, an average of 5 years
Secondary Outcomes (1)
describe the conditions of the resumption of work
through study completion, an average of 5 years
Study Arms (2)
Group "intervention"
EXPERIMENTALPersonalized coaching coordinated by a coordinating nurse on a shutdown period of 8 months (consecutive stops).
Group "standard"
NO INTERVENTIONconventional support
Interventions
personalized coaching coordinated by a coordinating nurse on a shutdown period of 8 months (consecutive stops).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut du Cancer de Montpellier - Val d'Aurellelead
- Cemka-Evalcollaborator
Study Sites (1)
Institut réginal du Cancer de Montpellier
Montpellier, 34298, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
William JACOT
Institut régional du Cancer de Montpellier
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2016
First Posted
September 8, 2016
Study Start
February 24, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
August 10, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share