Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001098224
Ethics application status
Approved
Date submitted
28/06/2018
Date registered
2/07/2018
Date last updated
2/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is intention to screen for bowel cancer increased after considering the regret anticipated for not screening?
Scientific title
Considering anticipated regret may reduce colorectal cancer screening intentions: A randomised controlled trial in Australians over 45
Secondary ID [1] 294686 0
Nil known
Universal Trial Number (UTN)
U1111-1212-7166
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 307537 0
Condition category
Condition code
Cancer 306622 306622 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 306623 306623 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 306624 306624 0 0
Bowel - Anal
Public Health 306625 306625 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants completed an online questionnaire regarding their attitude to colorectal cancer screening. Measures included the intention to screen for colorectal cancer, the anticipated regret should participants choose not to screen, and the level of faecal aversion. Completion of the survey took 10-15 minutes and was undertaken in a single session.

The study had 4 arms, where the order of measurement items in each arm was varied (anticipated regret and faecal aversion were measured either before or after intention to screen).
Arm 1: Intention to screen, anticipated regret, faecal aversion
Arm 2: Faecal aversion, intention to screen, anticipated regret
Arm 3: Anticipated regret, intention to screen, faecal aversion
Arm 4: Anticipated regret, faecal aversion, intention to screen

All participants were provided with a brief textual on-screen explanation of the Australian National Bowel Cancer Screening Program and what was involved in screening, based on the Program promotional material, prior to responding.
Intervention code [1] 300981 0
Behaviour
Comparator / control treatment
Arm 1 gauged participant intention to screen without first measuring anticipated regret or faecal aversion.
Control group
Active

Outcomes
Primary outcome [1] 305624 0
Mean intention to screen in Arms 1 & 2 (AR pre-intention) vs Arms 3 & 4 (AR post-intention)

Intention was measured using a 7-point Likert-type scale following previous work.
Timepoint [1] 305624 0
During survey response
Secondary outcome [1] 348778 0
No secondary outcomes
Timepoint [1] 348778 0
N/A

Eligibility
Key inclusion criteria
- Must be fluent in English
- Must be Australian citizens or residents
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Must not have a previous diagnosis of colorectal cancer

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)
Automatic randomisation by Internet survey application (random number generator)
(i.e. allocation concealment by central randomisation by computer)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Automatic randomisation by Internet survey application (random number generator)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analysis indicated 238 participants required to answer the least powerful research question, being the interaction of measuring faecal aversion with the primary hypothesis.

The primary hypothesis was tested using t-tests comparing intention to screen in Arms 1 & 2 compared to 3 & 4.

The secondary hypotheses were tested by entering all variables into a multiple regression on intention to screen, and testing the relevant interactions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/06/2017
Date of last participant enrolment
Anticipated
Actual
12/07/2017
Date of last data collection
Anticipated
Actual
12/07/2017
Sample size
Target
238
Accrual to date
Final
803
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 299294 0
Government body
Name [1] 299294 0
CSIRO, Preventive Health Flagship
Country [1] 299294 0
Australia
Funding source category [2] 299960 0
University
Name [2] 299960 0
The University of Adelaide, School of Psychology
Country [2] 299960 0
Australia
Primary sponsor type
University
Name
The University of Adelaide, School of Psychology
Address
School of Psychology, The University of Adelaide, South Australia 5005
Country
Australia
Secondary sponsor category [1] 298561 0
Government body
Name [1] 298561 0
CSIRO, Preventive Health Flagship
Address [1] 298561 0
Gate 13 Kintore Avenue, Adelaide, South Australia 5000
Country [1] 298561 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300205 0
School of Psychology Ethics Subcommittee, The University of Adelaide
Ethics committee address [1] 300205 0
Ethics committee country [1] 300205 0
Australia
Date submitted for ethics approval [1] 300205 0
11/04/2017
Approval date [1] 300205 0
18/04/2017
Ethics approval number [1] 300205 0
18/49

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

Contacts
Principal investigator
Name 82902 0
Prof Deborah Turnbull
Address 82902 0
School of Psychology
The University of Adelaide
Adelaide SA 5005
Country 82902 0
Australia
Phone 82902 0
+61 8 8313 1229
Fax 82902 0
Email 82902 0
deborah.turnbull@adelaide.edu.au
Contact person for public queries
Name 82903 0
Hugh Hunkin
Address 82903 0
School of Psychology
The University of Adelaide
Adelaide SA 5005
Country 82903 0
Australia
Phone 82903 0
+61 8 8303 8860
Fax 82903 0
Email 82903 0
hugh.hunkin@adelaide.edu.au
Contact person for scientific queries
Name 82904 0
Hugh Hunkin
Address 82904 0
School of Psychology
The University of Adelaide
Adelaide SA 5005
Country 82904 0
Australia
Phone 82904 0
+61 8 8303 8860
Fax 82904 0
Email 82904 0
hugh.hunkin@adelaide.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
EmbaseConsidering anticipated regret may reduce colorectal cancer screening intentions: a randomised controlled trial.2020https://dx.doi.org/10.1080/08870446.2019.1649407
N.B. These documents automatically identified may not have been verified by the study sponsor.