NCT01788878

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

2.5 years

First QC Date

January 31, 2013

Last Update Submit

July 25, 2016

Conditions

Upper Aerodigestive Tract Neoplasms

Keywords

socio-professional future

Outcome Measures

Primary Outcomes (1)

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

    At month 18

Secondary Outcomes (5)

  • 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

  • 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

Study Arms (1)

Questionnaires

EXPERIMENTAL

completion of questionnaires

Behavioral: Questionnaires

Interventions

QuestionnairesBEHAVIORAL

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.

Questionnaires

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CHU de Caen

Caen, 14 033, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Hôpital privé de l'Estuaire

Le Havre, 76620, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

CHRU de Lille

Lille, 59037, France

Location

Hôpital de la Timone

Marseille, 13385, France

Location

Centre Antoine Lacassagne

Nice, 06054, France

Location

CHU de Rouen

Rouen, 760310, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sophie FANTONI, Pr

    CHRU de Lille

    STUDY DIRECTOR

  • Jean-Louis LEFEBVRE, Pr

    Centre Oscar Lambret

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2013

First Posted

February 11, 2013

Study Start

February 1, 2014

Primary Completion

August 1, 2016

Study Completion

May 1, 2018

Last Updated

July 26, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(8)