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

Cancer Cervix Clinical Trial

— APACHE-4/FG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420157
• Other study ID #: INCA17-JB/APACHE-4/FG
• Status: Completed
• Start date: January 24, 2018
• Est. completion date: February 8, 2018

Study information

• Verified date: July 2019
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 8, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Cervix

Intervention

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

Locations

Country	Name	City	State
France	UH Tours	Tours	Indre-et-Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)