Psychosocial Support to Facilitate the Return to Employment of Women With Breast Cancer

Not Applicable

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT01780064
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

The purpose of this study is to compare the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work

Detailed Description

For the group "intervention", patients have four interviews with a psychologist (at cure one of chemotherapy treatment, at cure six of chemotherapy treatment, at last radiotherapy session, and three months after the end of radiotherapy).

In the 2 arms, patients receive 4 sets of questionnaires (baseline, month 12, month 18 and month 24)

Study Timeline

• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-30
• Study Start: 2013-02
• Primary Completion: 2015-12
• Study Completion: 2018-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• Women ≥ 18 with work at the time of diagnosis
• Presenting a unilateral breast cancer exclusively local extension
• Having received surgery
• Reporting of adjuvant chemotherapy (+ / - trastuzumab)
• Reporting to radiotherapy or not (If radiotherapy, it will be done on site investigator)
• In work at the time of diagnosis (employees, traders and professionals)
• Patient affiliated to a social security scheme
• Consent signed by the patient before the implementation of any specific procedure to study

Exclusion Criteria

• Presence of in situ lesions, cancer recurrence, metastatic disease immediately, location bilateral
• Inability physical, psychological, psychiatric or cognitive responses to the questionnaires and participate in interviews
• Recognition previous ALD (due to another disease)
• Patient under guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work	At 24 months

Secondary Outcome Measures

Name	Time	Method
Calculating the cost / benefit ratio of the two modes of care	At 24 months
Comparison between the two modes of care, of social inequalities:	At 24 months	* On the quality of the return to employment (working conditions, job stability); * On individual and collective resources of patients (social encouragement received, reactions to issues, anxiety/depression, quality of life, etc)

Trial Locations

Locations (7)

Centre Marie Curie; 🇫🇷 Arras, France

Centre Pierre Curie; 🇫🇷 Beuvry, France

Centre Léonard de Vinci; 🇫🇷 Dechy, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Hospitalier; 🇫🇷 Valenciennes, France

Nouvelle Clinique des Dentellières; 🇫🇷 Valenciennes, France

Hôpital Privé de Villeneuve d'Ascq; 🇫🇷 Villeneuve d'Ascq, France