NCT02696863

Brief Summary

The main objective is to identify obstacles and elements facilitating the implementation of a tracking device Broncho Pulmonary Cancer during the course of care. The secondary objective is to assess patient knowledge and information received on their previous occupational exposure during their professional activity. This is a prospective multicenter study of qualitative methodology through in-depth interviews conducted with patients treated at ICLN and CHU Saint-Etienne

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

February 8, 2016

Last Update Submit

September 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Interview

    Obstacles and elements facilitating the establishment of a work-related bronchopulmonary cancer tracking device during the course of care. These are collected in an interview with a sociologist. It will be analyse with NVivo.

    45 minutes

Study Arms (1)

filling a questionnaire and interview

The questionnaire is tracking occupational carcinogens. It consists of 30 questions , fills an average of 3 minutes and includes three response categories: "yes", "no" and "do not know". A questionnaire will be added social and professional issues. Interviews will be conducted with the patient to identify obstacles and facilitating elements

Behavioral: questionnaire

Interventions

questionnaireBEHAVIORAL
filling a questionnaire and interview

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primitive CBP Patients

You may qualify if:

  • primitive CBP Patients;
  • Patients employees or have been employees of the general scheme and / or the agricultural social security system;
  • Patients understand French.

You may not qualify if:

  • Patients recognized occupational disease for CBP;
  • recognized disability in patients for CBP by the social security system;
  • Patients who have never been employees of the General or the agricultural social security system plan
  • Patients already included in phase 1 of the study;
  • Refusal of participation, signed consent major patients protected under guardianship;
  • Patients unable to understand the course of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Saint-Etienne

Saint-Etienne, France

RECRUITING

ICLN

Saint-Priest-en-Jarez, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Carole PELISSIER, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2016

First Posted

March 2, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations