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

Upper Aerodigestive Tract Cancer Clinical Trial

— DEREDIA  

Official title:

Determinants of the Consultation Delay in Cancers of the Upper Aero Digestive Tract

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01647477
• Other study ID #: DEREDIA - 1110
• Status: Terminated
• Phase: N/A
• First received: July 19, 2012
• Last updated: July 28, 2016
• Start date: December 2012
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: The Commission nationale de l’informatique et des libertésFrance: 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
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Upper Aerodigestive Tract Cancer

Intervention

Behavioral:
• interview
25 minutes of semi directive interview
• questionnaires
questionnaires to answer at baseline 45 minutes

Locations

Country	Name	City	State
France	Centre Hospitalier	Boulogne sur Mer
France	CH	Lens
France	Centre Hospitalier Régional et Universitaire - Hopital HURIEZ	Lille
France	La Louviere Hospital	Lille
France	Oscar Lambret Center	Lille
France	Gray Center	Maubeuge
France	Centre Médical Spécialisé du Littoral	St Martin les Boulogne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of first consultation	median time between date of symptoms appearance and date of first consultation	baseline	No
Secondary	identify variables associated with time of consultation	medical data : medical history, symptoms, entry into care pathway sociodemographic and emotional indicators	baseline	No