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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03246516
Other study ID # 2015_74
Secondary ID 2015-A01986-43
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date May 2025

Study information

Verified date October 2022
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 258
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
France Centre hospitalier de Béthune Béthune
France Centre Hospitalier de Boulogne sur mer Boulogne-sur-Mer
France Centre hospitalier de Calais Calais
France centre Léonard de Vinci Dechy
France Centre d 'oncologie Dunkerquois Dunkerque
France Centre oscar Lambret Lille
France CHRU, Hôpital Claude Huriez Lille
France Centre hospitalier de Roubaix Roubaix
France Centre Hospitalier de Seclin Seclin
France Centre hospitalier de valenciennes Valenciennes

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille University of Lille Nord de France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time limit of first doctor consultation Median time between date of symptoms appearance and date of first consultation baseline
Secondary Time limit of system of care Median time between date of he beginning of clinical investigations and the beginning of treatment baseline
Secondary cTNM Stage Stage TNM by distinguishing the early stages (I, II) vs. (III, IV) baseline
Secondary clinical variables (i.e medical history, symptoms, entry into care pathway) clinical variables associated with time of first doctor consultation baseline
Secondary Socio-cognitive variables Socio-cognitive variables associated with time of first doctor consultation baseline
Secondary Emotional variables Emotional variables associated with time of first doctor consultation baseline
Secondary Survival At 3 years
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