Cancer of the Upper Aero-digestive Tract and Socio-professional Future

Not Applicable

• Conditions: Upper Aerodigestive Tract Neoplasms
• Interventions: Behavioral: Questionnaires

• Registration Number: NCT01788878
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

The aim of this study is to explore the main factors associated with the return to work of patients presenting an upper aero-digestive tract cancer.

Detailed Description

Socio-professional, medical, psychological, demographic, economic, and educational data collection in patients within the care pathway of upper aero-digestive tract cancer.

A series of questionnaires will be presented at the initial consultation and then at 6 months, at 12 months and at 18 months during follow-up visits. Medical data will be collected via the CRF.

Study Timeline

• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-11
• Study Start: 2014-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26
• Primary Completion: 2016-08
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Age at diagnosis ≥ 18 to ≤ 55 years
• Employed at the entry into the care pathway
• Presenting an upper aero-digestive tract cancer (excluding nasal cavities), stage I, II and III, under a first anti-tumor treatment (surgery, radiotherapy, or chemotherapy)
• Patient mastering the French language
• Affiliated to the social security system
• Consent signed by the patient before the implementation of any specific study procedure

Exclusion Criteria

• Having been treated for another cancer before (except skin cancer and / or prostate)
• Metastatic disease from the outset
• Patient unable to submit to a regular follow-up
• Presenting psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Questionnaires	Questionnaires	completion of questionnaires

Primary Outcome Measures

Name	Time	Method
Main psycho-medical and socio-professional determinants associated with return to work at 18 months after diagnosis	At month 18

Secondary Outcome Measures

Name	Time	Method
Alternatives to return to work (retirement, disability, etc ...)	At month 6, month 12, month 18
Psychological factors that might interfere with the behaviors to return to work	At baseline, Month 6, Month 12, Month 18
Information collected in the perceived support part of the questionnaire	At baseline, Month 6, Month 12, Month 18
Period until return to work (also part-time work)	At month 6, month 12, month 18
Modalities, period and stability of this return to work	At month 6, month 12, month 18

Trial Locations

Locations (8)

Hôpital de la Timone; 🇫🇷 Marseille, France

CHRU de Lille; 🇫🇷 Lille, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

CHU de Caen; 🇫🇷 Caen, France

CHU de Rouen; 🇫🇷 Rouen, France

Centre François Baclesse; 🇫🇷 Caen, France

Hôpital privé de l'Estuaire; 🇫🇷 Le Havre, France

Centre Oscar Lambret; 🇫🇷 Lille, France