search
Back to results

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

Primary Purpose

Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire and interview
Sponsored by
Institut de Cancérologie de la Loire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cancer

Eligibility Criteria

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

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

Sites / Locations

  • Institut de Cancerologie de la Loire

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Questionnaire and interview

Arm Description

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.

Outcomes

Primary Outcome Measures

Questionnaire validity
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

Secondary Outcome Measures

Full Information

First Posted
February 6, 2015
Last Updated
February 25, 2016
Sponsor
Institut de Cancérologie de la Loire
search

1. Study Identification

Unique Protocol Identification Number
NCT02369783
Brief Title
Screening for Social Weaknesses and Coordination Course of Cancer Patients
Acronym
DEFCOCANCERO
Official Title
Screening for Social Weaknesses and Coordination Course of Cancer Patients: A New Approach by an Expert System IT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de la Loire

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Questionnaire and interview
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaire and interview
Intervention Description
The aim is to detect social fragility.
Primary Outcome Measure Information:
Title
Questionnaire validity
Description
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
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Chauvin, PhD-MD
Organizational Affiliation
INSTITUT DE CANCEROLOGIE DE LA LOIRE
Official's Role
Study Director
Facility Information:
Facility Name
Institut de Cancerologie de la Loire
City
St Priest en Jarez
ZIP/Postal Code
42271
Country
France

12. IPD Sharing Statement

Learn more about this trial

Screening for Social Weaknesses and Coordination Course of Cancer Patients

We'll reach out to this number within 24 hrs