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

Primary Purpose

Upper Aerodigestive Tract Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Aerodigestive Tract Neoplasms focused on measuring socio-professional future

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Caen
  • Centre François Baclesse
  • Hôpital privé de l'Estuaire
  • Centre Oscar Lambret
  • CHRU de Lille
  • Hôpital de la Timone
  • Centre Antoine Lacassagne
  • CHU de Rouen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Questionnaires

Arm Description

completion of questionnaires

Outcomes

Primary Outcome Measures

Main psycho-medical and socio-professional determinants associated with return to work at 18 months after diagnosis

Secondary Outcome Measures

Period until return to work (also part-time work)
Modalities, period and stability of this return to work
Alternatives to return to work (retirement, disability, etc ...)
Psychological factors that might interfere with the behaviors to return to work
Information collected in the perceived support part of the questionnaire

Full Information

First Posted
January 31, 2013
Last Updated
July 25, 2016
Sponsor
Centre Oscar Lambret
Collaborators
University Lille 3, Région Nord-Pas de Calais, France, University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT01788878
Brief Title
Cancer of the Upper Aero-digestive Tract and Socio-professional Future
Acronym
CARDEL
Official Title
Cancer of the Upper Aero-digestive Tract and Socio-professional Future
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
University Lille 3, Région Nord-Pas de Calais, France, University Hospital, Lille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Aerodigestive Tract Neoplasms
Keywords
socio-professional future

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Questionnaires
Arm Type
Experimental
Arm Description
completion of questionnaires
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Intervention Description
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.
Primary Outcome Measure Information:
Title
Main psycho-medical and socio-professional determinants associated with return to work at 18 months after diagnosis
Time Frame
At month 18
Secondary Outcome Measure Information:
Title
Period until return to work (also part-time work)
Time Frame
At month 6, month 12, month 18
Title
Modalities, period and stability of this return to work
Time Frame
At month 6, month 12, month 18
Title
Alternatives to return to work (retirement, disability, etc ...)
Time Frame
At month 6, month 12, month 18
Title
Psychological factors that might interfere with the behaviors to return to work
Time Frame
At baseline, Month 6, Month 12, Month 18
Title
Information collected in the perceived support part of the questionnaire
Time Frame
At baseline, Month 6, Month 12, Month 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie FANTONI, Pr
Organizational Affiliation
CHRU de Lille
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jean-Louis LEFEBVRE, Pr
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14 033
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Hôpital privé de l'Estuaire
City
Le Havre
ZIP/Postal Code
76620
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06054
Country
France
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
760310
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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