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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

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.

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
04

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.

05

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)

06

Study locations

1 site
  • UH Tours
    Tours, Indre-et-Loire 37000, France
07

Registry details

Key details

Study ID
NCT03420157
Lead sponsor
University Hospital, Tours
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 ↗

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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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