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Interventional Study Collecting Quantitative and Qualitative Data About Patient With Non Treated Cancer (DEREDIA)

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ClinicalTrials.gov Identifier: NCT01647477
Recruitment Status : Terminated (lack of enrollment)
First Posted : July 23, 2012
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:
This study aims to determine the impact of sociocognitive and emotional factors on the time of the initial consult

Condition or disease Intervention/treatment Phase
Upper Aerodigestive Tract Cancer Behavioral: interview Behavioral: questionnaires Not Applicable

Detailed Description:
identify wich sociocognitive factors influence the delay to go to a doctor after the emergence of first symptoms

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Determinants of the Consultation Delay in Cancers of the Upper Aero Digestive Tract
Study Start Date : December 2012
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Active Comparator: questionnaires
4 questionnaires to answer at baseline 45 minutes approx.
Behavioral: questionnaires
questionnaires to answer at baseline 45 minutes
Experimental: interview
semi directive interview 105 patients
Behavioral: interview
25 minutes of semi directive interview
Behavioral: questionnaires
questionnaires to answer at baseline 45 minutes



Primary Outcome Measures :
  1. time of first consultation [ Time Frame: baseline ]
    median time between date of symptoms appearance and date of first consultation


Secondary Outcome Measures :
  1. identify variables associated with time of consultation [ Time Frame: baseline ]
    medical data : medical history, symptoms, entry into care pathway sociodemographic and emotional indicators



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 18 years
  • oral cavity cancer, oropharynx cancer, hypopharynx cancer, larynx cancer
  • non treated cancer
  • patient informed of his diagnosis
  • speak fluent french
  • patient covered by health insurance
  • signed informed consent

Inclusion Criteria for "interviewed " patients :

  • no speech troubles
  • patient consents being recorded

Exclusion Criteria:

  • history of cancer
  • psychological history
  • patient under guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647477


Locations
France
Centre Hospitalier
Boulogne sur Mer, France, 62 231
CH
Lens, France, 62307
Oscar Lambret Center
Lille, France, 59 020
Centre Hospitalier Régional et Universitaire - Hopital HURIEZ
Lille, France, 59 037
La Louviere Hospital
Lille, France, 59 042
Gray Center
Maubeuge, France, 59 600
Centre Médical Spécialisé du Littoral
St Martin les Boulogne, France, 62280
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Study Director: Veronique CHRISTOPHE, MDPhD Lille 3 University

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01647477     History of Changes
Other Study ID Numbers: DEREDIA - 1110
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Oscar Lambret:
non treated cancer
oral cavity
oropharynx
hypopharynx
larynx
first consultation