None listed
Conditions
Brief summary
This study is examining the acceptability of different ways to manage and treat cervical abnormalities diagnosed through the Australian National Cervical Screening Program. Who is it for? You may be eligible for this study if you are aged 25 to 40 years old and are eligible for cervical screening. Study details Participants in this study will complete an online scenario based on a hypothetical doctor visit and cervical screening results. There are four clinical scenarios, and participants will complete one. The scenario will be assigned by chance. The entire exercise takes approximately 20 minutes, and participants will complete a number of questionnaires in the course of the activity. It is hoped this research will inform the development of resources to assist women who are diagnosed with cervical abnormalities to make informed choices with regards to their treatment and management.
Interventions
Clinical scenarios
In each scenario, participants read a description of a hypothetical visit to a doctor to receive results for a recent cervical screening test. The results show that the woman has tested positive for the Human Papillomavirus (HPV), with follow-up testing showing grade 2 abnormal cell changes in the cervix (i.e., CIN2).
The hypothetical scenarios are identical other than the terminology used to describe the clinical course of the lesions
1. Participants are told for 60% of wome
Clinical scenarios In each scenario, participants read a description of a hypothetical visit to a doctor to receive results for a recent cervical screening test. The results show that the woman has tested positive for the Human Papillomavirus (HPV), with follow-up testing showing grade 2 abnormal cell changes in the cervix (i.e., CIN2). The hypothetical scenarios are identical other than the terminology used to describe the clinical course of the lesions 1. Participants are told for 60% of women in their age group, natural clearance of HPV infection can lead to abnormal cells clearing from the body naturally within 2 years (natural clearance). 2. As 1) with the additional information that active monitoring can help avoid unnecessary treatment (natural clearance + overtreatment). 3. Participants are told for 60% of women in their age group, the body will clear itself of the HPV infection and cells will return to normal within 2 years (clearance). 4. As 3) with the additional information that active monitoring can help avoid unnecessary treatment (clearance + overtreatment). After reading the scenario, participants are asked to choose between two treatment options (surgical treatment vs active monitoring) for management of their hypothetical CIN2 diagnosis. It is anticipated reading the background information and the scenario will take participants about 10 minutes.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria are, adult women residing in Australia who: i) are eligible to have cervical screening under the revised Australian NCSP since 1st December 2017 (i.e., primary HPV-based testing with partial genotyping); ii) are proficient in spoken and written English; and iii) are able to provide informed written consent for research.
Exclusion criteria
Exclusion criteria include women who: i) have no capacity to consent; ii) cannot speak, read or write English; iii) have a previous diagnosis of cervical cancer; iv) have had an abnormal Pap-smear result in the last 5 years; or v) have had a hysterectomy.
Outcome results
None listed