Interventional Study Collecting Quantitative and Qualitat... | NCT01647477

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

NCT01647477

Sponsor

Centre Oscar Lambret

Status

Terminated

Last Update Posted

Mar 13, 2026Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Upper Aerodigestive Tract Cancer

Interventions

interview
questionnaires

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-A00005-38	Other Identifier	ANSM

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of enrollment

Expanded Access Info

Start Date

Dec 2012Actual

Primary Completion Date

Oct 2014Actual

Completion Date

Feb 2017Actual

First Submitted Date

Jul 19, 2012

First Submission Date that Met QC Criteria

Jul 19, 2012

First Posted Date

Jul 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2026

Last Update Posted Date

Mar 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
questionnaires	Active Comparator	4 questionnaires to answer at baseline 45 minutes approx.	Behavioral: questionnaires
interview	Experimental	semi directive interview 105 patients	Behavioral: interview Behavioral: questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
interview	Behavioral	25 minutes of semi directive interview	interview

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time of first consultation	median time between date of symptoms appearance and date of first consultation	baseline

Secondary Outcomes

Measure	Description	Time Frame
identify variables associated with time of consultation	medical data : medical history, symptoms, entry into care pathway sociodemographic and emotional indicators	baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Veronique CHRISTOPHE, MDPhD	Lille 3 University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier		Boulogne-sur-Mer		62 231	France
Oscar Lambret Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007818	Laryngeal Diseases

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007407	Interviews as Topic
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided