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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2018-01-31

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

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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)

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Standard group

routine monitoring with questionnaires

Group Type PLACEBO_COMPARATOR

Questionnaires

Intervention Type BEHAVIORAL

Questionnaires

Interviews with 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

Group Type ACTIVE_COMPARATOR

interviews with a psychologist

Intervention Type BEHAVIORAL

interviews with a psychologist

Questionnaires

Intervention Type BEHAVIORAL

Questionnaires

Interventions

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interviews with a psychologist

Intervention Type BEHAVIORAL

Questionnaires

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No