Determinants of Patient Delay in Doctor Consultation in O... | NCT03246516

Studies
Determinants of Patient Delay in Doctor Consultation in Oeso-gastric Cancers

NCT03246516

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Dec 23, 2025Actual

Enrollment

258Actual

Phase

Not Applicable

Conditions

Oesophageal Carcinoma
Gastric Adenocarcinoma

Interventions

Questionnaire

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
2015-A01986-43	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2017Actual

Primary Completion Date

Feb 7, 2025Actual

Completion Date

Feb 7, 2025Actual

First Submitted Date

Aug 8, 2017

First Submission Date that Met QC Criteria

Aug 8, 2017

First Posted Date

Aug 11, 2017Actual

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

Dec 16, 2025

Last Update Posted Date

Dec 23, 2025Actual

Name	Class
University of Lille Nord de France	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 evaluates the role of socioeconomic and individual factors in the onset of the first symptoms of cancer and the first consultation with a doctor (patient delay) in oeso-gastric cancer.

Detailed Description

Reducing the time between the onset of the first symptoms of cancer and the first consultation with a doctor (patient delay) is essential to improve the vital prognosis and quality of life of patients. Recent data suggest that some sociocognitive and emotional determinants may explain patient delay from a complementary point of view. The main objective of this study is to assess whether, in oeso-gastric cancer, patient delay is linked to these sociocognitive and emotional factors, in addition to previously known factors.

We intend to include in this study 300 patients with a not yet treated oeso-gastric cancer diagnosed in one of 10 health centres in the North of France region. The collected data will be analysed to underline the differences between patients who consulted a doctor earlier versus those who consulted later with a cut off at 8 weeks.

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

258Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Questionnaire	Experimental	Auto and hetero questionnaire	Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Auto and hetero questionnaires: STAI Y B, State-Trait Anxiety Inventoriage Brief COPE RHHI-24, Revised Health Hardiness Inventory IPQ-R, Illness Perception Questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time limit of first doctor consultation	Median time between date of symptoms appearance and date of first consultation	baseline

Secondary Outcomes

Measure	Description	Time Frame
Time limit of system of care	Median time between date of he beginning of clinical investigations and the beginning of treatment	baseline
cTNM Stage	Stage TNM by distinguishing the early stages (I, II) vs. (III, IV)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age ≥ 18 years
oesophageal, oeso-gastric junction or gastric cancer non treated cancer
patient informed of his diagnosis
speak fluent french

Exclusion Criteria:

history of cancer
psychological history
patient under guardianship-
fortuitous diagnosis of cancer

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
Guillaume Piessen, MD, PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre hospitalier de Béthune		Béthune			France
Centre Hospitalier de Boulogne sur mer

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
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
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