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

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: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Questionnaires; Behavioral: interviews with a psychologist

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

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

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

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	At 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between the two modes of care, of social inequalities:	On the quality of the return to employment (working conditions, job stability); On individual and collective resources of patients (social encouragement received, reactions to issues, anxiety/depression, quality of life, etc)	At 24 months
Calculating the cost / benefit ratio of the two modes of care		At 24 months

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: January 29, 2013
• First Submitted That Met QC Criteria: January 29, 2013
• First Posted (Estimated): January 30, 2013

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic; Surveys and Questionnaires
• Other Study ID Numbers: APAPI-1202; 2012-A00315-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO