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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Centre Oscar Lambret
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01647477
First received: July 19, 2012
Last updated: March 6, 2014
Last verified: July 2012
  Purpose

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


Condition Intervention
Non Treated Cancer of Upper Aero Digestive Tract
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

Resource links provided by NLM:


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


Estimated Enrollment: 2000
Study Start Date: December 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: April 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Véronique CHRISTOPHE, MD PhD +33 (0)3.20.41.67.06 veronique.christophe@univ-lille3.fr

Locations
France
Centre Hospitalier Active, not recruiting
Boulogne sur Mer, France, 62 231
CH Active, not recruiting
Lens, France, 62307
Oscar Lambret Center Recruiting
Lille, France, 59 020
Contact: Dune Lemettre, CRA    +33 (0)3 20 29 59 35    d-lemettre@o-lambrer.fr   
Principal Investigator: Morbize JULIERON, MD         
Sub-Investigator: Sophie EL BEDOUI, MD         
Centre Hospitalier Régional et Universitaire - Hopital HURIEZ Active, not recruiting
Lille, France, 59 037
La Louviere Hospital Recruiting
Lille, France, 59 042
Contact: Jean TON VAN, MD    +33 (0)3.20.31.69.82    jeantonvan@free.fr   
Principal Investigator: Jean TON VAN, MD         
Gray Center Active, not recruiting
Maubeuge, France, 59 600
Centre Médical Spécialisé du Littoral Recruiting
St Martin les Boulogne, France, 62280
Contact: Bassam EL RASSI, MD    33 3 21 31 87 79    rassi2caps@orange.fr   
Principal Investigator: Bassam EL RASSI, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Study Director: Veronique CHRISTOPHE, MDPhD Lille 3 University
  More Information

No publications provided

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: March 6, 2014
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

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

ClinicalTrials.gov processed this record on September 18, 2014