No registrations found.
ID
Source
Health condition
Cervical Intraepithelial Neoplasia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Willingness to vaccinate, with or without financial contribution
Secondary outcome
Participants’ common knowledge about HPV infection
Background summary
Rationale: The Human Papilloma Virus (HPV) is essential in the carcinogenesis of cervical cancer. Among other countries, the Netherlands have implemented a nationwide vaccination programme to reduce HPV infection in girls. However, multiple parents and eligible participants refused the HPV vaccination due to possible safety concerns. Recent studies have examined the tertiary prevention properties of the HPV vaccination. Women who underwent cervical surgery due to HPV-induced precancerous lesions (Cervical Intraepithelial Neoplasia), were vaccinated. They concluded that HPV vaccination reduces subsequent HPV-related diseases. To implement tertiary prevention of cervical cancer, the willingness to vaccinate in the target group should be examined to prevent possible rejection of the HPV vaccination implementation.
Objective: To explore the willingness to receive HPV vaccination in women who were treated with cervical surgery for CIN. In addition, the level of knowledge of HPV in patients with CIN will be examined
Study design: Prospective questionnaire study
Study population: Women who underwent cervical surgery in the Catharina Hospital due to CIN II-III or High-Grade Squamous Intraepithelial Lesions (HSIL) will be included.
Intervention: A 13-item questionnaire will be used.
Main study parameters: Willingness to vaccinate, with or without financial contribution.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The questionnaire will only take approximately 5 minutes of the participants time. Therefore, there is no significant burden or risk for the participants, neither is there a possible benefit.
Study objective
Women will be willing to receive HPV vaccination to reduce the risk of recurrent HPV-related disease
Study design
After surgical treatment for Cervical Intraepithelial Neoplasia
Intervention
13-item questionnaire
Tirza Wouters
+31 6 38 54 00 34
tirza.wouters@student.maastrichtuniversity.nl
Tirza Wouters
+31 6 38 54 00 34
tirza.wouters@student.maastrichtuniversity.nl
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Cervical intraepithelial neoplasia II or III
- Cervical surgery: Large Loop Excision of the Transformation Zone (LLETZ) and conisation
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Age < 18 years
- Previous HPV vaccination
- Cervical carcinoma
- Allergy for vaccination
- Poor understanding of the Dutch language
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8481 |
| Other | MEC-U : W20.062 |