Clinical trial NCT01780064: Psychosocial Support to Facilitate the Return to Employment of Women With Breast Cancer
Official title: Active Early Individualized Psychosocial Accompaniment to Facilitate the Return to Employment of Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
First posted: 2013-01-30
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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)

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work
timeFrame: At 24 months
Secondary outcomes:
measure: Comparison between the two modes of care, of social inequalities:
timeFrame: At 24 months
measure: Calculating the cost / benefit ratio of the two modes of care
timeFrame: At 24 months
Other outcomes:
Locations:
city: Arras
country: France
facility: Centre Marie Curie
city: Beuvry
country: France
facility: Centre Pierre Curie
city: Dechy
country: France
facility: Centre Léonard de Vinci
city: Lille
country: France
facility: Centre Oscar Lambret
city: Valenciennes
country: France
facility: Centre Hospitalier
city: Valenciennes
country: France
facility: Nouvelle Clinique des Dentellières
city: Villeneuve d'Ascq
country: France
facility: Hôpital Privé de Villeneuve d'Ascq
Study officials:
affiliation: CHRU / Université Lille 2
name: Sophie FANTONI, MD, PhD
role: STUDY_DIRECTOR
affiliation: Centre Oscar Lambret
name: Jacques BONNETERRE, MD, PhD
role: STUDY_DIRECTOR
References: