- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01788878
Cancer of the Upper Aero-digestive Tract and Socio-professional Future (CARDEL)
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Caen, France, 14076
- Centre Francois Baclesse
-
Caen, France, 14 033
- CHU de Caen
-
Le Havre, France, 76620
- Hôpital Privé de l'Estuaire
-
Lille, France, 59020
- Centre Oscar Lambret
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Lille, France, 59037
- CHRU de Lille
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Marseille, France, 13385
- Hôpital de la Timone
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Nice, France, 06054
- Centre Antoine Lacassagne
-
Rouen, France, 760310
- CHU de Rouen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Sponsor
Investigators
- Study Director: Sophie FANTONI, Pr, CHRU de Lille
- Study Director: Jean-Louis LEFEBVRE, Pr, Centre Oscar Lambret
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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