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

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Behavioral: Questionnaires; Behavioral: interviews with a psychologist

• 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

Arm && Interventions

Group	Intervention	Description
Standard group	Questionnaires	routine monitoring with questionnaires
Interviews with psychologist	Questionnaires	Patients have 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) and questionnaires
Interviews with psychologist	interviews with a psychologist	Patients have 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) and questionnaires

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 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

Centre Marie Curie; 🇫🇷 Arras, France