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

Completed

• Conditions: Cancer Cervix
• Interventions: Other: Focus Group

• Registration Number: NCT03420157
• Lead Sponsor: University Hospital, Tours

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-17
• Study Start: 2018-01-24
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-05
• Primary Completion: 2018-02-08
• Study Completion: 2018-02-08
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

• Follow-up in progress for positive screening

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Focus Group 1 & 2	Focus Group	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.

Primary Outcome Measures

Name	Time	Method
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)	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.

Trial Locations

Locations (1)

UH Tours; 🇫🇷 Tours, Indre-et-Loire, France