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Trial registered on ANZCTR


Registration number
ACTRN12618000137291
Ethics application status
Approved
Date submitted
7/12/2017
Date registered
30/01/2018
Date last updated
30/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Decision support for colorectal cancer prevention - what is the best way to present access to online information: Frequently Asked Questions (FAQs) targeted to age and gender or a generic information topic list?
Scientific title
Online communication strategies designed to improve intention to minimize risk for colorectal cancer: a randomized controlled trial to test an FAQ prototype for information targeted by age and gender.
Secondary ID [1] 293554 0
None
Universal Trial Number (UTN)
U1111-1206-2582
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 305771 0
Condition category
Condition code
Cancer 304995 304995 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-intervention: All participants logged on to a website from a location most convenient for them, using a personally-allocated ID, and completed a single-session baseline survey that took approximately 15 minutes to complete. The primary dependent measure collected was readiness to act on perceived personal colorectal cancer risk. Two weeks later following completion of the baseline survey, participants logged on again to the website from a convenient location. Participants were randomized to 1 of 4 groups, 3 intervention arms and one control, using pre-allocated ID numbers that had previously been block randomised. A computer algorithm restricted the availability of each website to the prescribed cohort, dependent upon the ID entered. Each intervention comprised a single website session lasting approximately 30 minutes (dependent upon the time taken by the participant to review the information presented).
Intervention: A description of each intervention follows:
Arm 1: FAQs: The FAQs website opened with a page entitled “Prevention of Bowel Cancer” and provided 6 icons that could be clicked on to “Get answers to some of the most Frequently Asked Questions by people in certain age groups”. Each icon included a picture of a man or woman selected to be representative of the age group together with words identifying gender and age (e.g., “I am a woman aged 35–49”). Clicking on the icon took the participant to a page that provided a further link to information to satisfy the top information needs of this group as previously identified . This page started with the “five most frequently asked questions” for the specified cohort and associated links to answers and was followed below by links to “OTHER questions asked…” This latter set of questions was also ordered by order of importance as identified .
Arm 2: The LIST website was also entitled “Prevention of Bowel Cancer”. It was followed by the statement, “The information I want about bowel cancer is…” and a list of 10 links ordered according to the chronology of cancer diagnosis and treatment, with the exception of prevention being included at the end.
Arm 3: The CHOICE website included both the LIST of information links and the FAQs icons on the initial page with the instruction “Get answers to some of the most Frequently Asked Questions by people in certain age groups, or view a list of categories of information about bowel cancer”. The location of the icons and the list was balanced so that half of CHOICE respondents viewed the icons on the right side of the screen and the list on the left, whereas the other half viewed the reverse order. Once a selection had been made, participants were treated as though they were assigned to the FAQs or LIST condition.
Intervention code [1] 299798 0
Prevention
Intervention code [2] 299799 0
Behaviour
Comparator / control treatment
No intervention
Control group
Active

Outcomes
Primary outcome [1] 304163 0
Readiness to decrease perceived personal risk for colorectal cancer, expressed as no indication of desire to reduce risk versus indication of desire to reduce risk, as measured by an adaptation of the Precaution Adoption Process Model of decision-making..
Timepoint [1] 304163 0
Readiness to decrease personal risk for colorectal cancer measured via survey 2 weeks prior to commencement of intervention and again immediately following the intervention.
Secondary outcome [1] 341118 0
Identification and prioritization of self-nominated information needs relevant to colorectal cancer information. The following question was asked of each participant. “If someone said to you that colorectal cancer (also known as bowel cancer) is a leading cause of death in Australia, what would be [up to] five things you would like to know more about?” We included the alternative term of ‘bowel cancer’ to align with recommendations that presentation of health information materials should allow for potentially low levels of health literacy and use plain language rather than scientific terminology associated with what might be an unfamiliar topic. .
Timepoint [1] 341118 0
Timepoint: Preliminary survey conducted approximately 2 months prior to intervention
Secondary outcome [2] 341119 0
Perceived usability and acceptability of the website as measured by an adaptation of a previous measure developed by the group for a study on bowel cancer screening.
Responses to all items were measured on a 4-point Likert scale from 1 “strongly disagree” to 4 “strongly agree”. The maximum score was 84 with a higher score representing higher perceived usability and acceptability. Examples of statements are “The website is a valuable resource”, “It was easy to find the information I was looking for”. Three items measured each user’s assessment of the relevance of the information provided on the website to (1) them personally; (2) to other people in their age group; and (3) to other people outside their age group. Responses were scored on a 3-point Likert scale where 1 represented “not at all relevant”, 2 “somewhat relevant” and 3 “relevant”. One item asked the participant “If this website became generally available, how likely would you be to recommend it?” with response options varying from 1 (very unlikely) to 4 (very likely).
Timepoint [2] 341119 0
Timepoint: Information collected via researcher-developed questionnaire immediately following the intervention.

Eligibility
Key inclusion criteria
Aged between 35 and 74 years.
Minimum age
35 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria other than being outside the nominated age group.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was conducted by an offsite recruitment company who had no knowledge, other than ID, of the identity of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Results were analysed using non-parametric (Chi-square) and parametric (independent samples t-tests and one-way between groups ANOVA), as appropriate. Web analytics software “Clicky”TM was used to track the preference for information layout (FAQ or LIST) within Group 3 (CHOICE condition). Change in decision stage for readiness to decrease risk for CRC colorectal cancer from baseline to endpoint was measured as movement from any ‘lower’ stage directly to ‘action’ stage vs. no movement to action. The independent variables for this analysis were study group (with respondents in the CHOICE group allocated to FAQ or LIST as they chose), age band (35–49; 50–59; 60–74 years) and gender.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/12/2013
Date of last participant enrolment
Anticipated
Actual
10/01/2014
Date of last data collection
Anticipated
Actual
24/01/2014
Sample size
Target
240
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 298167 0
Government body
Name [1] 298167 0
South Australian Health and Medical Research Institute (SAHMRI) Beat Cancer Project: Blue Sky Cancer Research Funding
Country [1] 298167 0
Australia
Funding source category [2] 298171 0
Charities/Societies/Foundations
Name [2] 298171 0
The Freemasons Foundation Centre for Men's Health
Country [2] 298171 0
Australia
Funding source category [3] 298172 0
Government body
Name [3] 298172 0
Cancer Council Australia
Country [3] 298172 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientifice and Industrial Research Organisation (CSIRO)
Address
Kintore Avenue, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 297260 0
University
Name [1] 297260 0
University of Adelaide
Address [1] 297260 0
North Terrace, Adelaide, SA 5000
Country [1] 297260 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299182 0
CSIRO Animal, Food and Health Sciences Human Research Ethics Committee, Low Risk Review Panel
Ethics committee address [1] 299182 0
Ethics committee country [1] 299182 0
Australia
Date submitted for ethics approval [1] 299182 0
25/03/2013
Approval date [1] 299182 0
16/05/2013
Ethics approval number [1] 299182 0
LR06/13

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

Contacts
Principal investigator
Name 79574 0
Prof Carlene J Wilson
Address 79574 0
La Trobe University/Olivia Newton John Cancer Wellness and Research Centre, Austin Hospital, 145 Studley Road, Heidelberg, VIC 3084, Australia.
Country 79574 0
Australia
Phone 79574 0
+61 3 9496 9967
Fax 79574 0
Email 79574 0
carlene.wilson@flinders.edu.au
Contact person for public queries
Name 79575 0
Carlene J Wilson
Address 79575 0
La Trobe University/Olivia Newton John Cancer Wellness and Research Centre, Austin Hospital, 145 Studley Road, Heidelberg, VIC 3084, Australia.
Country 79575 0
Australia
Phone 79575 0
+61 3 9496 9967
Fax 79575 0
Email 79575 0
carlene.wilson@flinders.edu.au
Contact person for scientific queries
Name 79576 0
Carlene J Wilson
Address 79576 0
La Trobe University/Olivia Newton John Cancer Wellness and Research Centre, Austin Hospital, 145 Studley Road, Heidelberg, VIC 3084, Australia.
Country 79576 0
Australia
Phone 79576 0
+61 3 9496 9967
Fax 79576 0
Email 79576 0
carlene.wilson@flinders.edu.au

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
SourceTitleYear of PublicationDOI
Dimensions AIWeb-Based Communication Strategies Designed to Improve Intention to Minimize Risk for Colorectal Cancer: Randomized Controlled Trial2018https://doi.org/10.2196/cancer.8250
N.B. These documents automatically identified may not have been verified by the study sponsor.