NCT01780064

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

January 29, 2013

Last Update Submit

March 16, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Comparison between the two modes of care, of social inequalities:

    At 24 months

  • Calculating the cost / benefit ratio of the two modes of care

    At 24 months

Study Arms (2)

Standard group

PLACEBO COMPARATOR

routine monitoring with questionnaires

Behavioral: Questionnaires

Interviews with psychologist

ACTIVE COMPARATOR

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 psychologistBehavioral: Questionnaires

Interventions

QuestionnairesBEHAVIORAL

Questionnaires

Interviews with psychologistStandard group
interviews with a psychologistBEHAVIORAL

interviews with a psychologist

Interviews with psychologist

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centre Marie Curie

Arras, 62000, France

Location

Centre Pierre Curie

Beuvry, 62880, France

Location

Centre Léonard de Vinci

Dechy, 59187, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospitalier

Valenciennes, 59300, France

Location

Nouvelle Clinique des Dentellières

Valenciennes, 59300, France

Location

Hôpital Privé de Villeneuve d'Ascq

Villeneuve-d'Ascq, 59657, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sophie FANTONI, MD, PhD

    CHRU / Université Lille 2

    STUDY DIRECTOR

  • Jacques BONNETERRE, MD, PhD

    Centre Oscar Lambret

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2013

First Posted

January 30, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2015

Study Completion

January 1, 2018

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)