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

NCT ID: NCT02893527

Last Updated: 2020-08-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-24
• Study Completion Date: 2017-12-31

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

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group "intervention"

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

Group Type: EXPERIMENTAL

personalized coaching

Intervention Type: BEHAVIORAL

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

Group "standard"

conventional support

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

personalized coaching

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cemka-Eval

OTHER

Sponsor Role: collaborator

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William JACOT

Role: STUDY_CHAIR

Institut régional du Cancer de Montpellier

Locations

Institut réginal du Cancer de Montpellier

Montpellier, , France

Countries

France

Other Identifiers

ICM-URC-2014/33

Identifier Type: -

Identifier Source: org_study_id