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

July 25, 2016 updated by: Centre Oscar Lambret
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14076
        • Centre François Baclesse
      • Caen, France, 14 033
        • CHU de Caen
      • Le Havre, France, 76620
        • Hopital Prive de l'Estuaire
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France, 59037
        • CHRU de Lille
      • Marseille, France, 13385
        • Hôpital de la timone
      • Nice, France, 06054
        • Centre Antoine Lacassagne
      • Rouen, France, 760310
        • CHU de Rouen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Questionnaires
completion of questionnaires
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Main psycho-medical and socio-professional determinants associated with return to work at 18 months after diagnosis
Time Frame: At month 18
At month 18

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

University Hospital, Lille
Région Nord-Pas de Calais, France
University Lille 3

Investigators

  • Study Director: Sophie FANTONI, Pr, CHRU de Lille
  • Study Director: Jean-Louis LEFEBVRE, Pr, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

August 1, 2016

Study Completion (ANTICIPATED)

May 1, 2018

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

February 8, 2013

First Posted (ESTIMATE)

February 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARDEL-1211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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