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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
personalized coaching
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut réginal du Cancer de Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group "intervention"

Group "standard"

Arm Description

Personalized coaching coordinated by a coordinating nurse on a shutdown period of 8 months (consecutive stops).

conventional support

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 29, 2016
Last Updated
August 7, 2020
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators
Cemka-Eval
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1. Study Identification

Unique Protocol Identification Number
NCT02893527
Brief Title
Implementation and Evaluation of a Social Journey Accompanied in Breast Cancer Diagnosis (EPARS SEIN)
Acronym
EPARS-SEIN
Official Title
Implementation and Evaluation of a Social Journey Accompanied for Women With Breast Cancer Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why 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
Study Start Date
February 24, 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators
Cemka-Eval

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group "intervention"
Arm Type
Experimental
Arm Description
Personalized coaching coordinated by a coordinating nurse on a shutdown period of 8 months (consecutive stops).
Arm Title
Group "standard"
Arm Type
No Intervention
Arm Description
conventional support
Intervention Type
Behavioral
Intervention Name(s)
personalized coaching
Intervention Description
personalized coaching coordinated by a coordinating nurse on a shutdown period of 8 months (consecutive stops).
Primary Outcome Measure Information:
Title
Evaluate and compare the return to work rate
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
Time Frame
through study completion, an average of 5 years
Secondary Outcome Measure Information:
Title
describe the conditions of the resumption of work
Description
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
Time Frame
through study completion, an average of 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William JACOT
Organizational Affiliation
Institut régional du Cancer de Montpellier
Official's Role
Study Chair
Facility Information:
Facility Name
Institut réginal du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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