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Trial registered on ANZCTR


Registration number
ACTRN12612001122842
Ethics application status
Approved
Date submitted
2/10/2012
Date registered
19/10/2012
Date last updated
19/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising men’s participation in faecal occult blood test screening for bowel cancer.
Scientific title
A randomised controlled trial of four mail-administered invitation techniques to compare rates of participation in FOBT-based screening for colorectal cancer amongst Australian men aged 50-74.
Secondary ID [1] 280737 0
nil
Universal Trial Number (UTN)
U1111-1131-9085
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer screening. 286786 0
Condition category
Condition code
Cancer 287098 287098 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 287099 287099 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name of intervention: gender specific mail-administered screening invitation strategies.

All participants will receive an offer to participate in a free FOBT which will be delivered by mail. Intervention arms will differ from control according to the information included in the materials accompanying the screening offer. All study participants will receive a standard screening reminder irrespective of their intervention group. Intervention materials will target specific psychosocial variables previously identified as being related to male participation in FOBT screening.

The intervention period is 14 weeks. All participants will receive a screening offer according to the following timeline.

Baseline: Advance notification letter sent
Week two: Invitation package sent
Week eight: Reminder letters sent to those who have not completed an FOBT
Week 14: Data collection ceases.

Arm 1: Control

The control arm will receive a standard offer to participate in FOBT screening designed to mimic the strategy utilised by the Australian national bowel cancer screening program (NBCSP).

The standard offer includes an advance notification letter and a screening invitation package.

The advance notification letter is sent two weeks prior to the screening invitation package and is designed to alert participants that an invitation to screen for CRC with an FOBT will soon follow. The standard advance notification letter introduces basic information about colorectal cancer and the health benefits of screening.

The screening invitation package includes a) a screening invitation letter b) an immunochemical FOBT with associated instructions c) an information booklet that describes colorectal cancer and screening and d) a participant details form. The standard invitation letter emphasises the importance of reading the information booklet prior to completing the test, provides contact details for those requiring more information and describes the meaning of a positive result on an FOBT.



Arm 2: Gender Specific (GS) 1

Participants in trial arm two will receive a gender specific advance notification letter plus the standard screening invitation package.

The gender specific advance notification letter will include messages designed to; reduce perceived barriers to FOBT screening (e.g., faecal aversion) and increase men’s engagement with sources of social support and influence (e.g., family members, general practitioners) regarding the decision to participate in screening.

Arm 3: GS2
Participants in trial arm three will receive the standard advance notification letter plus a gender specific screening invitation letter.

The gender specific invitation letter will include messages designed to increase the perceived health benefits of FOBT screening and increase participants perceived self-efficacy and competence for completing the FOBT.

Arm 4: GS3
Participants in trial arm four will receive both the gender specific advance notification and the gender specific invitation letter.

In addition to receiving a screening offer, a small subgroup of participants (n=600) from each trial arm will receive a behavioural questionnaire administed before and after the intervention.
Intervention code [1] 285164 0
Prevention
Intervention code [2] 285165 0
Behaviour
Intervention code [3] 285783 0
Early detection / Screening
Comparator / control treatment
Active control: standard treatment.
The standard approach will mimic the invitational strategy utilised by Australia’s National Bowel Cancer Screening Program and will include the standard advance notification letter, standard invitation letter and immunochemical FOBT with instructions.
Control group
Active

Outcomes
Primary outcome [1] 287419 0
Rate of FOBT participation per trial arm as assessed by number of FOBT screening tests returned.
Timepoint [1] 287419 0
At 14 weeks from baseline, 12 weeks after receiving the FOBT.
Secondary outcome [1] 298107 0
Change in psychosocial variables as assessed using a behavioural questionnaire. The questionnaire has been designed specifically for this trial to assess the influence of the study intervention on key psychosocial variables.
Timepoint [1] 298107 0
The behavioural questionnaire will be mailed to participants prior to the intervention and again upon completion of the intervention in order to assess change on psychosocial measures as a result of trial participation.

Eligibility
Key inclusion criteria
Participants will be male, aged between 50 and 74 years inclusive and residing in the major urban areas of NSW, SA, VIC, QLD and WA.
Minimum age
50 Years
Maximum age
74 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria will be the opposite of the inclusion criteria; females, those younger than 50 and older than 74 and those residing outside of the major urban areas of NSW, SA, VIC, QLD and WA will not be eligible. The study will also exclude those who report the presence of bowel cancer or other colon diseases that make the person ineligible for bowel cancer screening with a faecal occult blood test.

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)
Block randomisation performed by computer, with random intervention arms assigned to de-identified elgible participant data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation performed on de-identified eligible participant data using specialised computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
9216
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 285525 0
Government body
Name [1] 285525 0
National Health and Medical Research Council
Country [1] 285525 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] 284363 0
University
Name [1] 284363 0
Flinders University, Centre for Cancer Prevention and Control
Address [1] 284363 0
Sturt Road, Bedford Park, Adelaide, South Australia, 5001
Country [1] 284363 0
Australia
Secondary sponsor category [2] 284364 0
Other
Name [2] 284364 0
CSIRO, Preventive Health Flagship
Address [2] 284364 0
Gate 13 Kintore Avenue, Adelaide, South Australia 5000
Country [2] 284364 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287540 0
The University of Adelaide Human Research Ethics Commitee
Ethics committee address [1] 287540 0
Ethics committee country [1] 287540 0
Australia
Date submitted for ethics approval [1] 287540 0
Approval date [1] 287540 0
05/04/2012
Ethics approval number [1] 287540 0
H-2012-040

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

Contacts
Principal investigator
Name 34366 0
Address 34366 0
Country 34366 0
Phone 34366 0
Fax 34366 0
Email 34366 0
Contact person for public queries
Name 17613 0
Dr Ian Zajac
Address 17613 0
CSIRO Preventive Health Flagship
Gate 13 Kintore Ave
Adelaide SA 5000
Country 17613 0
Australia
Phone 17613 0
+61 8 8303 8775
Fax 17613 0
Email 17613 0
Ian.Zajac@csiro.au
Contact person for scientific queries
Name 8541 0
Professor Deborah Turnbull
Address 8541 0
School of Psychology, The University of Adelaide, SA 5005
Country 8541 0
Australia
Phone 8541 0
+61 8 831 31229
Fax 8541 0
Email 8541 0
deborah.turnbull@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
EmbaseTheory-based modifications of an advanced notification letter improves screening for bowel cancer in men: A randomised controlled trial.2016https://dx.doi.org/10.1016/j.socscimed.2016.06.036
N.B. These documents automatically identified may not have been verified by the study sponsor.