ClinicalTrials.gg
CompletedNCT03420157APACHE-4/FGUpdated Jul 18, 2019

Carrying Out of Focus Group to Improve Cervical Screening Proposal by Vaginal Self-sampling (APACHE-4/FG).

An observational study in Cancer Cervix, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-18.

Sponsored by University Hospital, Tours · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
20
Ages
30 Years to 65 Years
Sex
Female
01

Study 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). 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.

02

Conditions studied

  • Cancer Cervix

Keywords

  • Cervical cancer screening
  • vaginal self-sampling
  • Focus group
  • communication
03

In context

Uterine Cervical Neoplasms

2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.

This study's enrollment of 20 is below the median of 225 across 529 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

University Hospital, Tours is the lead sponsor of 307 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Follow-up in progress for positive screening
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Focus Group

Interventions

  • OtherFocus Group

    Focus Group of 2 hours. Women will be asked to give their opinion about the communication media of the vaginal self-sampling kit.

06

What researchers measure

Primary outcomes

  1. 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.

    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)

07

Study locations

1 site
  • UH Tours
    Tours, Indre-et-Loire 37000, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Feb 2018, 0 months.

Of 189 non-industry observational studies under Uterine Cervical Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 158. This study's 0 months is below that.

Counting every sponsor, half of 213 studies reached it within 58 months; a quarter within 28 and three quarters within 158.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2018
First posted
Feb 5, 2018
StartActual
Jan 24, 2018
Primary completionActual
Feb 8, 2018
CompletionActual
Feb 8, 2018
Last update
Jul 18, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03420157
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
Jan 24, 2018
Primary completion
Feb 8, 2018
Completion
Feb 8, 2018
Last update
Jul 18, 2019

Study contacts

Julie Boyard
principal investigator · Centre de coordination des dépistages des cancers, CHRU de Tours

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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