Screening for Social Weaknesses and Coordination Course of Cancer Patients (DEFCOCANCERO)

February 25, 2016 updated by: Institut de Cancérologie de la Loire

Screening for Social Weaknesses and Coordination Course of Cancer Patients: A New Approach by an Expert System IT

The main objective of the study is to validate a methodology with Psychometric tool to measure levels of patients social fragility.

This tool will be dematerialized on a tablet. The answers will be then processed by a decision support algorithm, which automatically send an alert to detection of social fragility of the patient to the nurse navigators.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • St Priest en Jarez, France, 42271
        • Institut de Cancerologie de La Loire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All new patients enter ICLN for a diagnosis of cancer
  • Patients who can read French or patients who can not read French, but accepting the translation by a close friend or family
  • Patient having signed a free and informed consent

Exclusion Criteria:

  • Refusal of participation, major patients protected under guardianship.
  • Patient can not read French without possibility of translation by a close friend or family

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Questionnaire and interview
The patient complete the questionnaire on the tablet to better know their social situation and any difficulties. Then, he will be interview during thirty minutes with a social worker and a nurse navigator. At the end of this intervention we will be offered to the patient monitoring and appropriate resources to its situation.
The aim is to detect social fragility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire validity
Time Frame: 1 hour
Outcomes are content validity by expert judges method, appearance validity through a consensus, construct validity through exploratory factor analysis, discriminant validity in relation to the social fragility through univariate analysis, internal validity through factor analysis
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Franck Chauvin, PhD-MD, Institut de Cancerologie de La Loire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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