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Determinants of Patient Delay in Doctor Consultation in Oeso-gastric Cancers (DELOGAST)

Primary Purpose

Oesophageal Carcinoma, Gastric Adenocarcinoma

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oesophageal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier de Boulogne sur mer
  • Centre hospitalier de Béthune
  • Centre hospitalier de Calais
  • centre Léonard de Vinci
  • Centre d 'oncologie Dunkerquois
  • CHRU, Hôpital Claude Huriez
  • Centre oscar Lambret
  • Centre hospitalier de Roubaix
  • Centre Hospitalier de Seclin
  • Centre hospitalier de valenciennes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Questionnaire

Arm Description

Auto and hetero questionnaire

Outcomes

Primary Outcome Measures

Time limit of first doctor consultation
Median time between date of symptoms appearance and date of first consultation

Secondary Outcome Measures

Time limit of system of care
Median time between date of he beginning of clinical investigations and the beginning of treatment
cTNM Stage
Stage TNM by distinguishing the early stages (I, II) vs. (III, IV)
clinical variables (i.e medical history, symptoms, entry into care pathway)
clinical variables associated with time of first doctor consultation
Socio-cognitive variables
Socio-cognitive variables associated with time of first doctor consultation
Emotional variables
Emotional variables associated with time of first doctor consultation
Survival

Full Information

First Posted
August 8, 2017
Last Updated
October 21, 2022
Sponsor
University Hospital, Lille
Collaborators
University of Lille Nord de France
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1. Study Identification

Unique Protocol Identification Number
NCT03246516
Brief Title
Determinants of Patient Delay in Doctor Consultation in Oeso-gastric Cancers
Acronym
DELOGAST
Official Title
Individual and Socio-economic Determinants of Patient Delay in Doctor Consultation in Oeso-gastric Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
University of Lille Nord de France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oesophageal Carcinoma, Gastric Adenocarcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Questionnaire
Arm Type
Experimental
Arm Description
Auto and hetero questionnaire
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Auto and hetero questionnaires: STAI Y B, State-Trait Anxiety Inventoriage Brief COPE RHHI-24, Revised Health Hardiness Inventory IPQ-R, Illness Perception Questionnaire
Primary Outcome Measure Information:
Title
Time limit of first doctor consultation
Description
Median time between date of symptoms appearance and date of first consultation
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Time limit of system of care
Description
Median time between date of he beginning of clinical investigations and the beginning of treatment
Time Frame
baseline
Title
cTNM Stage
Description
Stage TNM by distinguishing the early stages (I, II) vs. (III, IV)
Time Frame
baseline
Title
clinical variables (i.e medical history, symptoms, entry into care pathway)
Description
clinical variables associated with time of first doctor consultation
Time Frame
baseline
Title
Socio-cognitive variables
Description
Socio-cognitive variables associated with time of first doctor consultation
Time Frame
baseline
Title
Emotional variables
Description
Emotional variables associated with time of first doctor consultation
Time Frame
baseline
Title
Survival
Time Frame
At 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Piessen, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Boulogne sur mer
City
Boulogne-sur-Mer
Country
France
Facility Name
Centre hospitalier de Béthune
City
Béthune
Country
France
Facility Name
Centre hospitalier de Calais
City
Calais
Country
France
Facility Name
centre Léonard de Vinci
City
Dechy
Country
France
Facility Name
Centre d 'oncologie Dunkerquois
City
Dunkerque
Country
France
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre oscar Lambret
City
Lille
Country
France
Facility Name
Centre hospitalier de Roubaix
City
Roubaix
Country
France
Facility Name
Centre Hospitalier de Seclin
City
Seclin
Country
France
Facility Name
Centre hospitalier de valenciennes
City
Valenciennes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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