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Clinical Trials/NCT01788878
NCT01788878UnknownNot Applicable

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

Centre Oscar Lambret16 sites in 1 country46 target enrollmentStarted: February 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
46
Locations
16
Primary Endpoint
Main psycho-medical and socio-professional determinants associated with return to work at 18 months after diagnosis
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Time Frame: At month 18

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (16)

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Cancer of the Upper Aero-digestive Tract... | Clinical Trial