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

Breast Cancer Clinical Trial

— APAPI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01780064
• Other study ID #: APAPI-1202
• Status: Terminated
• Phase: N/A
• Start date: February 2013
• Est. completion date: January 2018

Study information

• Verified date: June 2024
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 128
• Est. completion date: January 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• interviews with a psychologist
interviews with a psychologist
• Questionnaires
Questionnaires

Locations

Country	Name	City	State
France	Centre Marie Curie	Arras
France	Centre Pierre Curie	Beuvry
France	Centre Léonard de Vinci	Dechy
France	Centre Oscar Lambret	Lille
France	Centre Hospitalier	Valenciennes
France	Nouvelle Clinique des Dentellières	Valenciennes
France	Hôpital Privé de Villeneuve d'Ascq	Villeneuve d'Ascq

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Calculating the cost / benefit ratio of the two modes of care		At 24 months