Interventional Research in Schools - Second Part | NCT02434211

Studies
Interventional Research in Schools - Second Part

NCT02434211

Sponsor

Institut de Cancérologie de la Loire

Status

Unknown status

Last Update Posted

May 5, 2015Estimated

Enrollment

291Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

Questionnaire and focus group

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Apr 30, 2015

First Submission Date that Met QC Criteria

May 4, 2015

First Posted Date

May 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2015

Last Update Posted Date

May 5, 2015Estimated

Name	Class
Laboratoire ACTé	UNKNOWN
Education Nationale	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main objective this project is the development of a measurement tool. This consists of construct and validate a questionnaire to conduct a quantitative assessment of knowledge and individual conceptions of cancer enrolled in CM1 and CM2 (9-11 years).

Detailed Description

exper judges by DELPHI method for content validity
pre-testing for appearence validity
testing for construct validity

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

291Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Questionnaire and Focus group	Experimental	The children complete the questionnaire to better know their knowledge and cancer individual conceptions. Then, they will be interviewed during one hour in groups for the pre-testing phase. And after, for the testing phase, they just complete the questionnaire.	Other: Questionnaire and focus group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire and focus group	Other		Questionnaire and Focus group

Measure	Description	Time Frame
Questionnaire validity		1 hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children enrolled in classes CM1 and CM2 of the departments of Loire, Essonne, Rhone and Ain

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Céline BEZZAZ	Contact	04 77 91 74 76		celine.bezzaz@icloire.fr

Overall Officials

Not provided

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires
D017144	Focus Groups

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided