NCT02369783

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

7 months

First QC Date

February 6, 2015

Last Update Submit

February 25, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    1 hour

Study Arms (1)

Questionnaire and interview

EXPERIMENTAL

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.

Other: Questionnaire and interview

Interventions

The aim is to detect social fragility.

Questionnaire and interview

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, 42271, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and QuestionnairesInterviews as Topic

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Franck Chauvin, PhD-MD

    INSTITUT DE CANCEROLOGIE DE LA LOIRE

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 24, 2015

Study Start

July 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations