HealthyRISCOLAIRE2NCT02434211
Interventional Research in Schools - Second Part
A study testing Questionnaire and focus group in people with Healthy, run by Institut de Cancérologie de la Loire.
Trial 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). Read more about this study
- Who is it for?
- Ages 9 to 11 years
- Conditions the study is for
- Healthy
- What is being tested?
- Questionnaire and focus group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children enrolled in classes CM1 and CM2 of the departments of Loire, Essonne, Rhone and Ain
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read the detailed description
- exper judges by DELPHI method for content validity
- pre-testing for appearence validity
- testing for construct validity
- Conditions
- Healthy
- Being tested
- Questionnaire and focus group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and focus groupOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire and focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire validity
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 291 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire ACTé, Education Nationale
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434211
- Sponsor's protocol ID
- 2013-03
- Acronym
- RISCOLAIRE2
- Status last verified
- Apr 2015
- First submitted
- 30 Apr 2015
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Research in Schools - Second Part
- ClinicalTrials.gov ID
- NCT02434211
- Acronym / sponsor ID
- RISCOLAIRE2 / 2013-03
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 291 participants (estimated)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Collaborators
- Laboratoire ACTé, Education Nationale
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire and Focus group | Experimental | Other: Questionnaire and focus groupThe 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. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children enrolled in classes CM1 and CM2 of the departments of Loire, Essonne, Rhone and Ain
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and focus group | Other | Questionnaire and Focus group |
Primary outcome
Questionnaire validity
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and focus group in people with Healthy, run by Institut de Cancérologie de la Loire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Céline BEZZAZ (04 77 91 74 76, celine.bezzaz@icloire.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire validity (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.