Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
A randomised trial of web-based toolkit for applying evidence in the general practice cervical cancer prevention visit
Query!
Secondary ID [1]
251642
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cervical cancer
256867
0
Query!
Condition category
Condition code
Cancer
257018
257018
0
0
Query!
Cervical (cervix)
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
256062
0
Prevention
Query!
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.
Query!
Control group
Active
Query!
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.
Query!
Assessment method [1]
257911
0
Query!
Timepoint [1]
257911
0
Within a week after women's consultation
Query!
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.
Query!
Assessment method [1]
263381
0
Query!
Timepoint [1]
263381
0
Within a week after women's consultation
Query!
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.
Query!
Assessment method [2]
263382
0
Query!
Timepoint [2]
263382
0
Within a week after women's consultation
Query!
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.
Query!
Assessment method [3]
263383
0
Query!
Timepoint [3]
263383
0
Within a week after women's consultation
Query!
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.
Query!
Assessment method [4]
263384
0
Query!
Timepoint [4]
263384
0
Within a week after women's consultation
Query!
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.
Query!
Assessment method [5]
263385
0
Query!
Timepoint [5]
263385
0
Within a week after women's consultation
Query!
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.
Query!
Minimum age
19
Years
Query!
Query!
Maximum age
26
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
No internet access , poor english, younger than 19 years or older than 26 years.
Query!
Study design
Purpose of the study
Educational / counselling / training
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
1/07/2010
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
890
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Funding & Sponsors
Funding source category [1]
256567
0
Charities/Societies/Foundations
Query!
Name [1]
256567
0
Cancer Council NSW
Query!
Address [1]
256567
0
153 Dowling Street Woolloomooloo
NSW 2011
Query!
Country [1]
256567
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
Lyndal Trevena
Query!
Address
Room 321b Edward Ford Building (A27)
University of Sydney NSW 2006
Query!
Country
Australia
Query!
Secondary sponsor category [1]
255863
0
Individual
Query!
Name [1]
255863
0
Kirsten McCaffery
Query!
Address [1]
255863
0
Edward Ford Building (A27)
University of Sydney NSW 2006
Query!
Country [1]
255863
0
Australia
Query!
Other collaborator category [1]
1139
0
Individual
Query!
Name [1]
1139
0
Alexandra Barratt
Query!
Address [1]
1139
0
Edward Ford Building (A27)
University of Sydney NSW 2006
Query!
Country [1]
1139
0
Australia
Query!
Other collaborator category [2]
1140
0
Individual
Query!
Name [2]
1140
0
Julie-Anne Leask
Query!
Address [2]
1140
0
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Query!
Country [2]
1140
0
Australia
Query!
Other collaborator category [3]
1141
0
Individual
Query!
Name [3]
1141
0
Julia Brotherton
Query!
Address [3]
1141
0
Level 1, 250 Victoria Pde, East Melbourne 3002
Query!
Country [3]
1141
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
258604
0
University of Sydney HUMAN RESEARCH ETHICS COMMITTEE
Query!
Ethics committee address [1]
258604
0
Camperdown
2006 NSW
Query!
Ethics committee country [1]
258604
0
Australia
Query!
Date submitted for ethics approval [1]
258604
0
Query!
Approval date [1]
258604
0
05/03/2005
Query!
Ethics approval number [1]
258604
0
10696
Query!
Summary
Brief summary
This study looks the effectiveness of a web-based toolkit for young women, explaining how to reduce the risks of cervical cancer. You can join this study if you are a woman aged 19-26 years, have access to the internet and are considering a GP visit to discuss cervical cancer prevention. Trial details Participants visiting their GP will be divided into two groups. One group will be provided with an online ‘decision tool’ prior to the consultation. The other group will have a standard consultation only. The web-based toolkit will be a one-stop source of information for the latest information about cervical cancer, and will also provide feedback on consultation length, HPV knowledge, etc. Women will ideally learn to access the tool before their Pap test every two years. The aim is see whether the toolkit is effective in increasing the proportion of young women adequately informed about HPV without increasing the consultation time. The preparation of patients before the consultation is an important model that could be transferable to other aspects of general practice.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
30871
0
Query!
Address
30871
0
Query!
Country
30871
0
Query!
Phone
30871
0
Query!
Fax
30871
0
Query!
Email
30871
0
Query!
Contact person for public queries
Name
14118
0
Lyndal Trevena
Query!
Address
14118
0
Room 321b Edward Ford Building (A27)
University of Sydney NSW 2006
Query!
Country
14118
0
Australia
Query!
Phone
14118
0
+61 2 9351 7788
Query!
Fax
14118
0
+61 2 9351 5049
Query!
Email
14118
0
[email protected]
Query!
Contact person for scientific queries
Name
5046
0
Lyndal Trevena
Query!
Address
5046
0
Room 321b Edward Ford Building (A27)
University of Sydney NSW 2006
Query!
Country
5046
0
Australia
Query!
Phone
5046
0
+61 2 9351 7788
Query!
Fax
5046
0
+61 2 9351 5049
Query!
Email
5046
0
[email protected]
Query!
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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF