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

Study Overview
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Brief Summary
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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
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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)

Official Title
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Active Early Individualized Psychosocial Accompaniment to Facilitate the Return to Employment of Women With Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: interviews with a psychologist
* Behavioral: Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard group<br>routine monitoring with questionnaires | Behavioral: Questionnaires<br>* Questionnaires<br>|
| Active Comparator: Interviews with psychologist<br>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 | Behavioral: interviews with a psychologist<br>* interviews with a psychologist<br>Behavioral: Questionnaires<br>* Questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between the two modes of care, social inequalities and calculating the cost / benefit ratio of the two modes of care |  | At 24 months |