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

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Behavioral: personalized coaching

• Registration Number: NCT02893527
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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

Study Timeline

• Study Start: 2015-02-24
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group "intervention"	personalized coaching	Personalized coaching coordinated by a coordinating nurse on a shutdown period of 8 months (consecutive stops).

Primary Outcome Measures

Name	Time	Method
Evaluate and compare the return to work rate	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

Secondary Outcome Measures

Name	Time	Method
describe the conditions of the resumption of work	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

Trial Locations

Locations (1)

Institut réginal du Cancer de Montpellier; 🇫🇷 Montpellier, France