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Trial registered on ANZCTR


Registration number
ACTRN12610000339055
Ethics application status
Approved
Date submitted
21/04/2010
Date registered
28/04/2010
Date last updated
29/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing cervical cancer risks: a toolkit for a young woman
Scientific title
A randomised trial of web-based toolkit for applying evidence in the general practice cervical cancer prevention visit
Secondary ID [1] 251642 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical cancer 256867 0
Condition category
Condition code
Cancer 257018 257018 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women in the intervention group will be receiving an online decision tool prior to the consultation. They will be sent a study ID to access the online tool as soon as they register to the trial. They can visit the website as many times as they like before their Pap visit. The tool will be a one-stop source of information for cervical cancer prevention.It will incorporate evidence-based information cervical cancer risk reduction options such as lifestyle factors, Pap smear (conventional and LBC), HPV vaccination. The tool will also use epidemiological estimates of cumulative risks and text based information with quantitative estimates of outcomes. We will show women in absolute terms the chances of low-grade intraepithelial lesion (LSIL), high-grade intraepithelial lesion (HSIL and cervical cancer at their age and their reduction in risk with Pap smear, Liquid based cytology (LBC), Human papillomavirus (HPV) vaccine and lifestyle changes (smoking cessation, condom use...).
The overall duration of the study will be 6 months. Two months for recruiting participants, 2 months for collecting data and 2 months follow up for participants who have not attended their Pap smear consultation.
Intervention code [1] 256062 0
Prevention
Comparator / control treatment
Usual care: it involves women routine one on one Pap consultation with their General Practitioner (GP). The duration of the consultation will differ on a case by case basis.
Control group
Active

Outcomes
Primary outcome [1] 257911 0
Proportion of young women adequately informed about Human papillomavirus (HPV) without increasing consultation time. HPV knowledge will be assessed using an online questionnaire that women will have to complete after their Pap visit. The consultation time will be collected from GPs softwares by a data extraction tool called Canning which is modified specifically for the purpose of this study by Canning Division.
Timepoint [1] 257911 0
Within a week after women's consultation
Secondary outcome [1] 263381 0
Knowledge about cervical cancer test accuracy and co-factors. This outcome will be assessed by an online questionnaire that women will have to complete after their Pap visit.
Timepoint [1] 263381 0
Within a week after women's consultation
Secondary outcome [2] 263382 0
HPV vaccine uptake. This outcome will be collected from GPs softwares by a data extraction tool called Canning which is modified specifically for the purpose of this study by Canning Division.
Timepoint [2] 263382 0
Within a week after women's consultation
Secondary outcome [3] 263383 0
Uptake of liquid-based cytology. This outcome will be collected from GPs softwares by a data extraction tool called Canning which is modified specifically for the purpose of this study by Canning Division.
Timepoint [3] 263383 0
Within a week after women's consultation
Secondary outcome [4] 263384 0
Self reported change in smoking and other co-factor behaviours. This outcome will be assessed by an online questionnaire that women will have to complete after their Pap visit.
Timepoint [4] 263384 0
Within a week after women's consultation
Secondary outcome [5] 263385 0
Provider communication. This outcome measures young women's perceptions
of communication with the GP regarding Pap smear. This outcome will be assessed using Provider-Adolescent Communication Scale (PACS) questionnaire. This will be completed online by women after their Pap visit.
Timepoint [5] 263385 0
Within a week after women's consultation

Eligibility
Key inclusion criteria
19-26 year old women living in Australia who have internet access and a reasonnable command of the english language and who are considering to have cervical cancer prevention visit.
Minimum age
19 Years
Maximum age
26 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No internet access , poor english, younger than 19 years or older than 26 years.

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)
Elegible participants who agree to be in the study will be asked a few questions, including their age, mailing and email adress. Participant will be assigned then an ID code generated by computer. Women in the intervention arm will be sent a passeword to access the online cervical cancer prevention toolkit before their Pap test visit. Once participants have registred and completed the online consent, they will be randomised into either intervention or control group using an algorithm which will ensure equal distribution of the intervention and control arm of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
890
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 256567 0
Charities/Societies/Foundations
Name [1] 256567 0
Cancer Council NSW
Country [1] 256567 0
Australia
Primary sponsor type
Individual
Name
Lyndal Trevena
Address
Room 321b Edward Ford Building (A27)
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 255863 0
Individual
Name [1] 255863 0
Kirsten McCaffery
Address [1] 255863 0
Edward Ford Building (A27)
University of Sydney NSW 2006
Country [1] 255863 0
Australia
Other collaborator category [1] 1139 0
Individual
Name [1] 1139 0
Alexandra Barratt
Address [1] 1139 0
Edward Ford Building (A27)
University of Sydney NSW 2006
Country [1] 1139 0
Australia
Other collaborator category [2] 1140 0
Individual
Name [2] 1140 0
Julie-Anne Leask
Address [2] 1140 0
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country [2] 1140 0
Australia
Other collaborator category [3] 1141 0
Individual
Name [3] 1141 0
Julia Brotherton
Address [3] 1141 0
Level 1, 250 Victoria Pde, East Melbourne 3002
Country [3] 1141 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258604 0
University of Sydney HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 258604 0
Ethics committee country [1] 258604 0
Australia
Date submitted for ethics approval [1] 258604 0
Approval date [1] 258604 0
05/03/2005
Ethics approval number [1] 258604 0
10696

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30871 0
Address 30871 0
Country 30871 0
Phone 30871 0
Fax 30871 0
Email 30871 0
Contact person for public queries
Name 14118 0
Lyndal Trevena
Address 14118 0
Room 321b Edward Ford Building (A27)
University of Sydney NSW 2006
Country 14118 0
Australia
Phone 14118 0
+61 2 9351 7788
Fax 14118 0
+61 2 9351 5049
Email 14118 0
[email protected]
Contact person for scientific queries
Name 5046 0
Lyndal Trevena
Address 5046 0
Room 321b Edward Ford Building (A27)
University of Sydney NSW 2006
Country 5046 0
Australia
Phone 5046 0
+61 2 9351 7788
Fax 5046 0
+61 2 9351 5049
Email 5046 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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