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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?
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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.
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Secondary ID [1]
293554
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None
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Universal Trial Number (UTN)
U1111-1206-2582
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer
305771
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Condition category
Condition code
Cancer
304995
304995
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
299798
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Prevention
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Intervention code [2]
299799
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Behaviour
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Comparator / control treatment
No intervention
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Control group
Active
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Outcomes
Primary outcome [1]
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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..
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Assessment method [1]
304163
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Timepoint [1]
304163
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Readiness to decrease personal risk for colorectal cancer measured via survey 2 weeks prior to commencement of intervention and again immediately following the intervention.
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Secondary outcome [1]
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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. .
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Assessment method [1]
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Timepoint [1]
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Timepoint: Preliminary survey conducted approximately 2 months prior to intervention
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Secondary outcome [2]
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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).
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Assessment method [2]
341119
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Timepoint [2]
341119
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Timepoint: Information collected via researcher-developed questionnaire immediately following the intervention.
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Eligibility
Key inclusion criteria
Aged between 35 and 74 years.
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Minimum age
35
Years
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Maximum age
74
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
No exclusion criteria other than being outside the nominated age group.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Factorial
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
2/12/2013
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Date of last participant enrolment
Anticipated
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Actual
10/01/2014
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Date of last data collection
Anticipated
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Actual
24/01/2014
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Sample size
Target
240
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Accrual to date
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Final
240
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Recruitment in Australia
Recruitment state(s)
NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
298167
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Government body
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Name [1]
298167
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South Australian Health and Medical Research Institute (SAHMRI) Beat Cancer Project: Blue Sky Cancer Research Funding
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Address [1]
298167
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North Terrace, Adelaide, SA 5000
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Country [1]
298167
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Australia
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Funding source category [2]
298171
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Charities/Societies/Foundations
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Name [2]
298171
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The Freemasons Foundation Centre for Men's Health
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Address [2]
298171
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GPO Box 496, Adelaide, SA 5005
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Country [2]
298171
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Australia
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Funding source category [3]
298172
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Government body
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Name [3]
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Cancer Council Australia
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Address [3]
298172
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PO Box 4708, Sydney, NSW 2001
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Country [3]
298172
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Australia
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Primary sponsor type
Government body
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Name
Commonwealth Scientifice and Industrial Research Organisation (CSIRO)
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Address
Kintore Avenue, Adelaide, SA 5000
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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University of Adelaide
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Address [1]
297260
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North Terrace, Adelaide, SA 5000
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Country [1]
297260
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299182
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CSIRO Animal, Food and Health Sciences Human Research Ethics Committee, Low Risk Review Panel
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Ethics committee address [1]
299182
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Kintore Avenue, Adelaide, SA 5000
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Ethics committee country [1]
299182
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Australia
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Date submitted for ethics approval [1]
299182
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25/03/2013
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Approval date [1]
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16/05/2013
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Ethics approval number [1]
299182
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LR06/13
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Summary
Brief summary
Does provision of access to information targeted to certain user segments (age and gender), and presented as a set of FAQs, have a more beneficial effect on attitudes toward reduction of risk for colorectal cancer when compared to a generic information topic list?
Aims / Objectives:
1) To determine the impact of different approaches to information provision regarding primary (e.g., diet, lifestyle) and secondary (e.g. screening) prevention of colorectal cancer
2) To assess the usability and acceptance of a web-based decision aid focussing on the strengthening of attitudes toward CRC prevention behaviours.
Hypothesis:
A website capable of delivering targeted, salient content in the form of FAQs will, when compared with the provision of generic content, improve attitudes toward prevention of colorectal cancer, specifically perceived risk and intention to participate in primary and secondary prevention.
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Trial website
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Trial related presentations / publications
Wilson C, Flight I, Zajac I, Turnbull D, Young G, Olver (2014) What do people want to know about colorectal cancer and what is the best way to organise the information they want? Abstracts from the 2014 World Cancer Congress, Melbourne, 3-6 Dec 2014. Asia-Pacific Journal of Clinical Oncology 10 (Suppl S9): 1-263, p173.
Flight I, Wilson C, Zajac I, Bastiaans K, Turnbull D, Young G, Olver I (2014) What is the best way to organise online colorectal cancer information? Abstracts from the 2014 World Cancer Congress, Melbourne, 3-6 Dec 2014. Asia-Pacific Journal of Clinical Oncology 10 (Suppl S9): 1-263, p242.
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Public notes
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Contacts
Principal investigator
Name
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Prof Carlene J Wilson
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Address
79574
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La Trobe University/Olivia Newton John Cancer Wellness and Research Centre, Austin Hospital, 145 Studley Road, Heidelberg, VIC 3084, Australia.
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Country
79574
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Australia
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Phone
79574
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+61 3 9496 9967
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Fax
79574
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Email
79574
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[email protected]
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Contact person for public queries
Name
79575
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Prof Carlene J Wilson
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Address
79575
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La Trobe University/Olivia Newton John Cancer Wellness and Research Centre, Austin Hospital, 145 Studley Road, Heidelberg, VIC 3084, Australia.
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Country
79575
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Australia
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Phone
79575
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+61 3 9496 9967
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Fax
79575
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Email
79575
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[email protected]
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Contact person for scientific queries
Name
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Prof Carlene J Wilson
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Address
79576
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La Trobe University/Olivia Newton John Cancer Wellness and Research Centre, Austin Hospital, 145 Studley Road, Heidelberg, VIC 3084, Australia.
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Country
79576
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Australia
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Phone
79576
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+61 3 9496 9967
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Fax
79576
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Email
79576
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[email protected]
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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
Source
Title
Year of Publication
DOI
Dimensions AI
Web-Based Communication Strategies Designed to Improve Intention to Minimize Risk for Colorectal Cancer: Randomized Controlled Trial
2018
https://doi.org/10.2196/cancer.8250
N.B. These documents automatically identified may not have been verified by the study sponsor.
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