Cancer CervixAPACHE-4/FGNCT03420157
Carrying Out of Focus Group to Improve Cervical Screening Proposal by Vaginal Self-sampling (APACHE-4/FG).
An observational study of Cancer Cervix, run by University Hospital, Tours at 1 site in France.
Trial summary
Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Cervix
- What is being tested?
- Focus Group
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2018to 8 Feb 2018
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twenty women living near the city of Tours not screened by pap smear (ideally since at least 3 years). Women who could be interested by the vaginal self-sampling screening alternative.
Who may be able to join
- women from 30 to 65 years old
- women living in french territorial division 37 ("Indre-et-Loire")
- no pap smear made in the three last years (ideally)
Who cannot join
- Follow-up in progress for positive screening
Trial locations and contacts
1 site in 1 country.
About this study
Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with oncogenic High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening. The investigators hypothesize that it is possible to optimize participation rate by improving the communication media associated to the vaginal self-sampling kit. This is why the accompanying letter and the leaflet explaining how to perform the vaginal self-sampling will be submit to women opinion by using the Focus Group method. The objective is to identify improvement ideas of these two communication media.
- Conditions
- Cancer Cervix
- Being tested
- Focus Group
- Keywords
- Cervical cancer screening, vaginal self-sampling, Focus group, communication
- Medical subject headings
- Uterine Cervical Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupOther
Focus Group of 2 hours. Women will be asked to give their opinion about the communication media of the vaginal self-sampling kit.
| Study group | Role | What they receive |
|---|---|---|
| Focus Group 1 & 2 | Each Focus Group of 10 women will be led by a psychologist according to a semi-directive interview pattern. This interview guideline specifies in details the ideal proceedings of Focus Group, as well as the various predetermined topics to be addressed in the form of questions and / or relaunches. The interview guideline is divided into 2 parts: the accompanying letter and the leaflet explaining how to perform the vaginal self-sampling. Receives: Other: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focus group methodology (structured questionnaire) will use to identify group norms or a range of views and to capitalise on the interaction within the group to identify levers and brakes and improve communication media (10 women for each focus group)
The transcripts of the discussions will be reviewed by the psychologist to identify the emerging themes (anxiety, motivating information, ...) to identify levers and brakes and improve communication media.
Measured: A systematic text analysis of the transcripts will be performed after data saturation was reached (projection: 2 focus group of 2 hours in two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start24 Jan 2018
- Primary completion8 Feb 2018
- Study completion8 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer CervixStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Boyard, Principal investigator, Centre de coordination des dépistages des cancers, CHRU de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420157
- Sponsor's protocol ID
- INCA17-JB/APACHE-4/FG
- Acronym
- APACHE-4/FG
- Status last verified
- Jul 2019
- First submitted
- 17 Jan 2018
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carrying Out of Focus Group to Improve Cervical Screening Proposal by Vaginal Self-sampling (APACHE-4/FG).
- ClinicalTrials.gov ID
- NCT03420157
- Acronym / sponsor ID
- APACHE-4/FG / INCA17-JB/APACHE-4/FG
- Conditions
- Cancer Cervix
- Keywords
- Cervical cancer screening, vaginal self-sampling, Focus group, communication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- 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.
Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with oncogenic High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening. The investigators hypothesize that it is possible to optimize participation rate by improving the communication media associated to the vaginal self-sampling kit. This is why the accompanying letter and the leaflet explaining how to perform the vaginal self-sampling will be submit to women opinion by using the Focus Group method. The objective is to identify improvement ideas of these two communication media.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus Group 1 & 2 | – | Other: Focus GroupEach Focus Group of 10 women will be led by a psychologist according to a semi-directive interview pattern. This interview guideline specifies in details the ideal proceedings of Focus Group, as well as the various predetermined topics to be addressed in the form of questions and / or relaunches. The interview guideline is divided into 2 parts: the accompanying letter and the leaflet explaining how to perform the vaginal self-sampling. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty women living near the city of Tours not screened by pap smear (ideally since at least 3 years). Women who could be interested by the vaginal self-sampling screening alternative.
Key inclusion criteria (3 listed)
- women from 30 to 65 years old
- women living in french territorial division 37 ("Indre-et-Loire")
- no pap smear made in the three last years (ideally)
Key exclusion criteria (1 listed)
- Follow-up in progress for positive screening
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 |
|---|---|---|
| Focus GroupFocus Group of 2 hours. Women will be asked to give their opinion about the communication media of the vaginal self-sampling kit. | Other | Focus Group 1 & 2 |
Primary outcome
Focus group methodology (structured questionnaire) will use to identify group norms or a range of views and to capitalise on the interaction within the group to identify levers and brakes and improve communication media (10 women for each focus group)
Time frame: A systematic text analysis of the transcripts will be performed after data saturation was reached (projection: 2 focus group of 2 hours in two weeks)
The transcripts of the discussions will be reviewed by the psychologist to identify the emerging themes (anxiety, motivating information, ...) to identify levers and brakes and improve communication media.
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 18 Jul 2019.
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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.
Julie Boyard principal investigator
Centre de coordination des dépistages des cancers, CHRU de Tours
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 Cancer Cervix, run by University Hospital, Tours 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 3 inclusion and 1 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 18 Jul 2019. 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?
Focus group methodology (structured questionnaire) will use to identify group norms or a range of views and to capitalise on the interaction within the group to identify levers and brakes and improve communication media (10 women for each focus group) (time frame: A systematic text analysis of the transcripts will be performed after data saturation was reached (projection: 2 focus group of 2 hours in two weeks)). 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 18 Jul 2019.