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

Sponsor
University Hospital, Lille (Other)
Overall Status
Unknown status
CT.gov ID
NCT03246516
Collaborator
University of Lille Nord de France (Other)
300
10
1
60
30
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Individual and Socio-economic Determinants of Patient Delay in Doctor Consultation in Oeso-gastric Cancers
Actual Study Start Date :
Feb 1, 2017
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Questionnaire

Auto and hetero questionnaire

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

Outcome Measures

Primary Outcome Measures

  1. Time limit of first doctor consultation [baseline]

    Median time between date of symptoms appearance and date of first consultation

Secondary Outcome Measures

  1. Time limit of system of care [baseline]

    Median time between date of he beginning of clinical investigations and the beginning of treatment

  2. cTNM Stage [baseline]

    Stage TNM by distinguishing the early stages (I, II) vs. (III, IV)

  3. clinical variables (i.e medical history, symptoms, entry into care pathway) [baseline]

    clinical variables associated with time of first doctor consultation

  4. Socio-cognitive variables [baseline]

    Socio-cognitive variables associated with time of first doctor consultation

  5. Emotional variables [baseline]

    Emotional variables associated with time of first doctor consultation

  6. Survival [At 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier de Boulogne sur mer Boulogne-sur-Mer France
2 Centre hospitalier de Béthune Béthune France
3 Centre hospitalier de Calais Calais France
4 centre Léonard de Vinci Dechy France
5 Centre d 'oncologie Dunkerquois Dunkerque France
6 CHRU, Hôpital Claude Huriez Lille France 59037
7 Centre oscar Lambret Lille France
8 Centre hospitalier de Roubaix Roubaix France
9 Centre Hospitalier de Seclin Seclin France
10 Centre hospitalier de valenciennes Valenciennes France

Sponsors and Collaborators

  • University Hospital, Lille
  • University of Lille Nord de France

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT03246516
Other Study ID Numbers:
  • 2015_74
  • 2015-A01986-43
First Posted:
Aug 11, 2017
Last Update Posted:
Aug 26, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2020