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

NCT03420157 | Completed

• 1 other identifier: INCA17-JB/APACHE-4/FG
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Cervix

Keywords

Cervical cancer screening; vaginal self-sampling; Focus group; communication

Outcome Measures

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.

  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)

Study Arms (1)

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

Focus Group OTHER

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

Focus Group 1 & 2

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Follow-up in progress for positive screening

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

UH Tours

Tours, Indre-et-Loire, 37000, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Communication

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Julie Boyard

  Centre de coordination des dépistages des cancers, CHRU de Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: February 5, 2018
• Study Start: January 24, 2018
• Primary Completion: February 8, 2018
• Study Completion: February 8, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

FR (1)