Clinical trial NCT01788878: Cancer of the Upper Aero-digestive Tract and Socio-professional Future
Official title: Cancer of the Upper Aero-digestive Tract and Socio-professional Future
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Aerodigestive Tract Neoplasms
Keywords: socio-professional future
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: University Lille 3
name: Région Nord-Pas de Calais, France
name: University Hospital, Lille
First posted: 2013-02-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Main psycho-medical and socio-professional determinants associated with return to work at 18 months after diagnosis
timeFrame: At month 18
Secondary outcomes:
measure: Period until return to work (also part-time work)
timeFrame: At month 6, month 12, month 18
measure: Modalities, period and stability of this return to work
timeFrame: At month 6, month 12, month 18
measure: Alternatives to return to work (retirement, disability, etc ...)
timeFrame: At month 6, month 12, month 18
measure: Psychological factors that might interfere with the behaviors to return to work
timeFrame: At baseline, Month 6, Month 12, Month 18
measure: Information collected in the perceived support part of the questionnaire
timeFrame: At baseline, Month 6, Month 12, Month 18
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
city: Caen
country: France
facility: Centre François Baclesse
city: Le Havre
country: France
facility: Hôpital privé de l'Estuaire
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: CHRU de Lille
city: Marseille
country: France
facility: Hôpital de la Timone
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
affiliation: CHRU de Lille
name: Sophie FANTONI, Pr
role: STUDY_DIRECTOR
affiliation: Centre Oscar Lambret
name: Jean-Louis LEFEBVRE, Pr
role: STUDY_DIRECTOR
References: