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

July 28, 2016 updated by: Centre Oscar Lambret

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Arras, France, 62000
        • Centre Marie Curie
      • Beuvry, France, 62880
        • centre Pierre Curie
      • Dechy, France, 59187
        • Centre Leonard de Vinci
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Valenciennes, France, 59300
        • Centre Hospitalier
      • Valenciennes, France, 59300
        • Nouvelle Clinique Des Dentellières
      • Villeneuve d'Ascq, France, 59657
        • Hopital Prive de Villeneuve d'Ascq

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Standard group
routine monitoring with questionnaires
Behavioral: Questionnaires
Questionnaires
Active Comparator: 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
Behavioral: Questionnaires
Questionnaires
Behavioral: interviews with a psychologist
interviews with a psychologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: At 24 months
At 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

University Hospital, Lille

Investigators

  • Study Director: Sophie FANTONI, MD, PhD, CHRU / Université Lille 2
  • Study Director: Jacques BONNETERRE, MD, PhD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimate)

January 30, 2013

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APAPI-1202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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