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

NCT ID: NCT01788878

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Upper Aerodigestive Tract Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Questionnaires

completion of questionnaires

Group Type EXPERIMENTAL

Questionnaires

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Lille 3

UNKNOWN

Sponsor Role collaborator

Région Nord-Pas de Calais, France

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role collaborator

Centre Oscar Lambret

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie FANTONI, Pr

Role: STUDY_DIRECTOR

CHRU de Lille

Jean-Louis LEFEBVRE, Pr

Role: STUDY_DIRECTOR

Centre Oscar Lambret

Locations

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CHU de Caen

Caen, , France

Site Status

Centre François Baclesse

Caen, , France

Site Status

Hôpital privé de l'Estuaire

Le Havre, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

CHRU de Lille

Lille, , France

Site Status

Hôpital de la Timone

Marseille, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

CHU de Rouen

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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CARDEL-1211

Identifier Type: -

Identifier Source: org_study_id

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