Uterine Cervical NeoplasmsFOSFORENCT02907970
Perceived Barriers of Cervical Cancer Screening in Reunion Island and Key Levers for Improvment
An observational study of Uterine Cervical Neoplasms, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
FOSFORE study aims at identifying the barriers of cervical cancer screening in Reunion Island and key levers for improvment. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Uterine Cervical Neoplasms
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2017to 30 Jun 2017
- Phase
- Observational
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Telephone survey from a sounding board of women living in Reunion Island
Who may be able to join
- Women aged between 25 and 65 yo
- living in Reunion Island
- speaking French, Creole or Shimaore language
- able to answer phone
Who cannot join
- history of hysterectomy
- history of incomplete or total conisation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification Des barrières au dépistage du Cancer du Col utérin à la Réunion et Des Leviers d'amélioration
FOSFORE study aims at identifying the barriers of cervical cancer screening in Reunion Island and key levers for improvment.
Read the detailed description
FOSFORE is a cross sectional KABP (Knowledge, Attitudes, Beliefs and Practices) telephone survey on cervical cancer screening from a sounding board of women aged between 25 and 65 years and living in Reunion Island.
Sample size was estimated from local datas on cervical cancer screening.
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Cervical cancer, Screening, Barriers
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of barriers in cervical cancer screening
Telephone survey with a KABP-like questionnaire
Measured: 6 months
Proportion of barriers in cervical cancer screening
Telephone survey with a KABP-like questionnaire
Measured: 6 months
Secondary outcomes (2)
Type of levers in cervical cancer screening
Telephone survey with a KABP-like questionnaire
Measured: 6 months
Proportion of levers in cervical cancer screening
Telephone survey with a KABP-like questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start20 Feb 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907970
- Sponsor's protocol ID
- 2014/CHU/FOSFORE
- Acronym
- FOSFORE
- Status last verified
- Sep 2018
- First submitted
- 9 Sep 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification Des barrières au dépistage du Cancer du Col utérin à la Réunion et Des Leviers d'amélioration
- ClinicalTrials.gov ID
- NCT02907970
- Acronym / sponsor ID
- FOSFORE / 2014/CHU/FOSFORE
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Cervical cancer, Screening, Barriers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 20 Sep 2016 (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.
FOSFORE study aims at identifying the barriers of cervical cancer screening in Reunion Island and key levers for improvment.
Detailed description
FOSFORE is a cross sectional KABP (Knowledge, Attitudes, Beliefs and Practices) telephone survey on cervical cancer screening from a sounding board of women aged between 25 and 65 years and living in Reunion Island.
Sample size was estimated from local datas on cervical cancer screening.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Telephone survey from a sounding board of women living in Reunion Island
Key inclusion criteria (4 listed)
- Women aged between 25 and 65 yo
- living in Reunion Island
- speaking French, Creole or Shimaore language
- able to answer phone
Key exclusion criteria (2 listed)
- history of hysterectomy
- history of incomplete or total conisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type of barriers in cervical cancer screening
Time frame: 6 months
Telephone survey with a KABP-like questionnaire
Proportion of barriers in cervical cancer screening
Time frame: 6 months
Telephone survey with a KABP-like questionnaire
2 secondary outcomes
Type of levers in cervical cancer screening
Time frame: 6 months
Proportion of levers in cervical cancer screening
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Neoplasms, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of barriers in cervical cancer screening (time frame: 6 months). The study lists 2 primary outcomes in all. 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 Sep 2018.