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Trial registered on ANZCTR


Registration number
ACTRN12618002043213
Ethics application status
Approved
Date submitted
17/12/2018
Date registered
20/12/2018
Date last updated
15/11/2019
Date data sharing statement initially provided
20/12/2018
Date results information initially provided
15/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Management options for cervical abnormalities
Scientific title
Preferences for surgical treatment or active surveillance for management of cervical intraepithelial neoplasia (CIN) 2: a randomised experimental study
Secondary ID [1] 296189 0
None
Universal Trial Number (UTN)
U1111-1223-4015
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Cervical intraepithelial neoplasia (CIN) 2 309822 0
Condition category
Condition code
Public Health 308612 308612 0 0
Health service research
Cancer 309161 309161 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312852 0
Behaviour
Comparator / control treatment
No control group; participants randomised to one of four hypothetical scenarios. The hypothetical scenarios are identical other than the terminology used to describe the clinical course of the lesions (clearance vs clearance + overtreatment vs natural clearance vs natural clearance + overtreatment).
Control group
Active

Outcomes
Primary outcome [1] 308026 0
Treatment choice will be measured as a direct dichotomous choice between surgery and active monitoring.
Timepoint [1] 308026 0
Post-scenario
Secondary outcome [1] 353687 0
Treatment choice anxiety.

Measured on a purpose-designed Visual Analog Scale with anchored end-points from not anxious at all to extremely anxious, where participants will be able to move a cursor along the scale and place it at one of 11 points.
Timepoint [1] 353687 0
Post-scenario.
Secondary outcome [2] 353688 0
Perceived seriousness of testing positive for HPV with grade 2 abnormal cells.

Measured via one item with four response categories slightly/moderately/quite a bit/ extremely serious, based on a measure adapted from Ziarnowski et al., 2009
Timepoint [2] 353688 0
Post-scenario
Secondary outcome [3] 353689 0
Anticipated regret (action regret) about attending for cervical screening.

Measured via a purposed-designed, adapted one item measure; with responses ranging from strongly agree to strongly disagree, as per Sanberg et al., 2009 and Ziarnowski et al., 2009.
Timepoint [3] 353689 0
Post-scenario
Secondary outcome [4] 353690 0
Anticipated regret (inaction regret) about NOT attending for cervical screening.

Measured via a purpose-designed, adapted one item measure; with responses ranging from “strongly agree” to “strongly disagree”, as per Sanberg et al., 2009 and Ziarnowski et al., 2009.
Timepoint [4] 353690 0
Post-scenario
Secondary outcome [5] 353691 0
Preferences for frequency of monitoring.

Measured via a single purpose-designed, forced-choice item (response options = every 3/ 6/ 9/ 12/ 24 months)
Timepoint [5] 353691 0
Post-scenario
Secondary outcome [6] 353692 0
Reasons for treatment choice/s.

Elicited via open-ended questions with accompanying free-text boxes.
Timepoint [6] 353692 0
Post-scenario
Secondary outcome [7] 354065 0
Perceived risk of cervical cancer in lifetime and compared to women the same age

Measured via two items with response options "no chance to high chance" and "much below average to much above average" as per Hersch et al., 2014, Ziarnowski et al., 2009, Lipkus et al,. 2005
Timepoint [7] 354065 0
Post-scenario
Secondary outcome [8] 355134 0
Diagnosis anxiety.

Measured on a purpose-designed Visual Analog Scale with anchored end-points from not anxious at all to extremely anxious, where participants will be able to move a cursor along the scale and place it at one of 11 points.
Timepoint [8] 355134 0
Post-scenario

Eligibility
Key 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.
Minimum age
25 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised to one of the four hypothetical scenarios using survey software. The researcher will be unaware of which condition participants are randomised to as randomisation occurred after participants had clicked on the link to complete the online intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using survey software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants randomised (1:1:1:1) to one of four hypothetical scenarios.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Questionnaire data will be analysed using SPSS version 24. To characterise the sample, frequency analyses will be used to analyse all categorical variables (e.g., highest level of education obtained, area of professional practice), whilst descriptive analyses will be used to analyse all continuous variables (e.g., age, years of professional practice).
Responses for treatment choice will be analysed across the two treatment options: surgical treatment and active monitoring. Analysis of variance will be used to compare mean anxiety scores across the two terminologies (“clearance” vs “natural clearance”).
Logistic regression models will be used to estimate the impact of the diagnosis given (e.g., HPV + CIN2) and the terminology used (e.g., “clearance” versus “natural clearance” framing; use of term “overtreatment” or not), and whether these vary by the characteristics of the women.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2019
Actual
25/10/2019
Date of last participant enrolment
Anticipated
Actual
3/11/2019
Date of last data collection
Anticipated
Actual
3/11/2019
Sample size
Target
1600
Accrual to date
Final
1638
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300779 0
Government body
Name [1] 300779 0
The National Health and Medical Research Council
Country [1] 300779 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 300746 0
None
Name [1] 300746 0
Address [1] 300746 0
Country [1] 300746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301561 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 301561 0
Human Ethics Office
Margaret Telfer Building (K07)
The University of Sydney
NSW 2006
Ethics committee country [1] 301561 0
Australia
Date submitted for ethics approval [1] 301561 0
30/10/2018
Approval date [1] 301561 0
23/11/2018
Ethics approval number [1] 301561 0
2018/857

Summary
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.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 87394 0
Dr Rachael Dodd
Address 87394 0
Room 127A
Edward Ford Building (A27)
The University of Sydney
NSW 2006 AUSTRALIA
Country 87394 0
Australia
Phone 87394 0
+61 2 9351 5102
Fax 87394 0
Email 87394 0
rachael.dodd@sydney.edu.au
Contact person for public queries
Name 87395 0
Rachael Dodd
Address 87395 0
Room 127A
Edward Ford Building (A27)
The University of Sydney
NSW 2006 AUSTRALIA
Country 87395 0
Australia
Phone 87395 0
+61 2 9351 5102
Fax 87395 0
Email 87395 0
rachael.dodd@sydney.edu.au
Contact person for scientific queries
Name 87396 0
Rachael Dodd
Address 87396 0
Room 127A
Edward Ford Building (A27)
The University of Sydney
NSW 2006 AUSTRALIA
Country 87396 0
Australia
Phone 87396 0
+61 2 9351 5102
Fax 87396 0
Email 87396 0
rachael.dodd@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In line with our ethics approval, participant data will be made anonymous and will be aggregated for the purpose of statistical analyses. Findings will be reported at the group/condition level rather than the individual participant level.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseActive surveillance as a management option for cervical intraepithelial neoplasia 2: An online experimental study.2021https://dx.doi.org/10.1016/j.ygyno.2021.01.010
EmbaseUnderstanding women's choices for management of cervical intraepithelial neoplasia 2 (CIN2): Qualitative analysis of a randomised experimental study.2022https://dx.doi.org/10.1111/ajo.13440
N.B. These documents automatically identified may not have been verified by the study sponsor.