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

Upper Aerodigestive Tract Neoplasms Clinical Trial

— CARDEL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01788878
• Other study ID #: CARDEL-1211
• Status: Active, not recruiting
• Phase: N/A
• First received: January 31, 2013
• Last updated: July 25, 2016
• Start date: February 2014
• Est. completion date: May 2018

Study information

• Verified date: July 2016
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: May 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Upper Aerodigestive Tract Neoplasms

Intervention

Behavioral:
• Questionnaires
A first series of questionnaires will be given by the investigator at patients before treatment (inclusion visit) and then the questionnaires will be given at the follow-up visits planned at 6 months, 12 months and 18 months. Medical data will be collected via the CRF.

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	CHU de Caen	Caen
France	Hôpital privé de l'Estuaire	Le Havre
France	Centre Oscar Lambret	Lille
France	CHRU de Lille	Lille
France	Hôpital de la Timone	Marseille
France	Centre Antoine Lacassagne	Nice
France	CHU de Rouen	Rouen

Sponsors (4)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Région Nord-Pas de Calais, France, University Hospital, Lille, University Lille 3

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main psycho-medical and socio-professional determinants associated with return to work at 18 months after diagnosis		At month 18	No
Secondary	Period until return to work (also part-time work)		At month 6, month 12, month 18	No
Secondary	Modalities, period and stability of this return to work		At month 6, month 12, month 18	No
Secondary	Alternatives to return to work (retirement, disability, etc ...)		At month 6, month 12, month 18	No
Secondary	Psychological factors that might interfere with the behaviors to return to work		At baseline, Month 6, Month 12, Month 18	No
Secondary	Information collected in the perceived support part of the questionnaire		At baseline, Month 6, Month 12, Month 18	Yes