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

This study has been terminated.
(lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01647477
First received: July 19, 2012
Last updated: July 28, 2016
Last verified: July 2016
  Purpose
This study aims to determine the impact of sociocognitive and emotional factors on the time of the initial consult

Condition Intervention
Upper Aerodigestive Tract Cancer
Behavioral: interview
Behavioral: questionnaires

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Determinants of the Consultation Delay in Cancers of the Upper Aero Digestive Tract

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • time of first consultation [ Time Frame: baseline ] [ Designated as safety issue: No ]
    median time between date of symptoms appearance and date of first consultation


Secondary Outcome Measures:
  • identify variables associated with time of consultation [ Time Frame: baseline ] [ Designated as safety issue: No ]
    medical data : medical history, symptoms, entry into care pathway sociodemographic and emotional indicators


Enrollment: 90
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01647477     History of Changes
Other Study ID Numbers: DEREDIA - 1110 
Study First Received: July 19, 2012
Last Updated: July 28, 2016
Health Authority: France: Committee for the Protection of Personnes
France: The Commission nationale de l’informatique et des libertés
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on August 23, 2016