Implementation and Evaluation of a Social Journey Accompanied in Breast Cancer Diagnosis (EPARS SEIN) (EPARS-SEIN)

August 7, 2020 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • Institut réginal du Cancer de Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group "intervention"
Personalized coaching coordinated by a coordinating nurse on a shutdown period of 8 months (consecutive stops).
Behavioral: personalized coaching
personalized coaching coordinated by a coordinating nurse on a shutdown period of 8 months (consecutive stops).
No Intervention: Group "standard"
conventional support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
describe the conditions of the resumption of work
Time Frame: through study completion, an average of 5 years
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
through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Collaborators

Cemka-Eval

Investigators

  • Study Chair: William JACOT, Institut Regional du Cancer de Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

August 10, 2020

Last Update Submitted That Met QC Criteria

August 7, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM-URC-2014/33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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