Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000146695
Ethics application status
Approved
Date submitted
24/01/2023
Date registered
14/02/2023
Date last updated
28/01/2024
Date data sharing statement initially provided
14/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
What do patients and doctors think about alternative bowel screening strategies for people needing colonoscopy?
Scientific title
Investigating patients’ and doctors’ acceptability of and attitudes toward faecal and blood-based tests to triage those requiring regular colonoscopic surveillance and those with gastrointestinal symptoms to colonoscopy
Secondary ID [1] 308821 0
None
Universal Trial Number (UTN)
Trial acronym
BHS Survey
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal diseases 328777 0
Bowel cancer surveillance 328778 0
Condition category
Condition code
Cancer 325785 325785 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 325786 325786 0 0
Health service research
Oral and Gastrointestinal 325858 325858 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will use surveys to determine the acceptability of faecal and blood-based bowel screening strategies for triaging individuals with a higher than average risk of colorectal cancer (CRC) to colonoscopy. This will include individuals requiring colonoscopy in response to abnormal gastrointestinal symptoms, a significant family history of CRC, and/or a previous finding of polyps. Individuals invited into the study will be patients who are scheduled to undergo a colonoscopy due to one of these risk factors, and clinicians who are involved in the care of people undergoing colonoscopy.

Individuals who are scheduled to undergo a colonoscopy for gastrointestinal symptoms or CRC surveillance at one of the approved study sites (Flinders Medical Centre, Noarlunga Health Service, Tennyson Centre Day Hospital, Queen Elizabeth Hospital) will be identified via clinic and colonoscopy booking lists for invitation into the study. A letter will be sent to eligible participants approximately 2-4 weeks prior to their scheduled colonoscopy to invite them to complete a survey before their procedure. All respondents to this initial survey will be invited to complete a follow-up survey approximately one month after their colonoscopy. Participants will have the option to complete the surveys online (via a link or by scanning a QR code) or through a paper copy sent to them along with a reply-paid envelope. Each survey will take approximately 20-30 minutes to complete and will measure the acceptability of different bowel screening methods along with the following variables: previous clinical testing experiences and knowledge, health beliefs, health literacy, health-related quality of life, and fear of bowel cancer.

Clinicians will be invited to complete a single online survey at their earliest convenience through direct communication (email, letter, verbal) or self-selection via advertisements in newsletters. The survey will be accessed using a website link or by scanning a QR code and will take clinicians approximately 20 minutes to complete. Survey content will measure the acceptability of different bowel testing methods along with the following variables: familiarity with and previous use of bowel testing methods, perceived effectiveness of bowel testing methods, perceived barriers to bowel screening test use, and preferences for bowel screening test attributes.
Intervention code [1] 325269 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333629 0
A primary outcome for colonoscopy consumers will be their acceptability of faecal-based bowel screening tests for use in determining their need for colonoscopy. This will be assessed within the pre- and post-colonoscopy surveys using items that have been designed specifically for this study.
Timepoint [1] 333629 0
This will be assessed 2-4 weeks prior to and 4 weeks following colonoscopy.
Primary outcome [2] 333688 0
Another primary outcome for colonoscopy consumers will be their acceptability of blood-based bowel screening tests for use in determining their need for colonoscopy. This will be assessed within the pre- and post-colonoscopy surveys using items that have been designed specifically for this study.
Timepoint [2] 333688 0
This will be assessed 2-4 weeks prior to and 4 weeks following colonoscopy.
Primary outcome [3] 333803 0
A primary outcome for clinicians will be their acceptability of faecal-based bowel screening tests for use in triaging people with abnormal gastrointestinal symptoms to colonoscopy. This will be assessed within the single clinician survey using items that have been designed specifically for this study.
Timepoint [3] 333803 0
This will be assessed at any time following study invitation.
Secondary outcome [1] 417807 0
Another primary outcome for clinicians will be their acceptability of blood-based bowel screening tests for use in triaging people with abnormal gastrointestinal symptoms to colonoscopy. This will be assessed within the single clinician survey using items that have been designed specifically for this study.
Timepoint [1] 417807 0
This will be assessed at any time following study invitation.
Secondary outcome [2] 418066 0
Colonoscopy consumers attitudes towards colonoscopies will be assessed within the pre- and post-colonoscopy surveys using items that have been designed specifically for this study and items adapted from studies published in peer-reviewed journals (Amlani et al., 2020; Tiro et al., 2005).
Timepoint [2] 418066 0
This will be assessed 2-4 weeks prior to and 4 weeks following colonoscopy.
Secondary outcome [3] 418067 0
Colonoscopy consumers fear of bowel cancer will be assessed within the pre- and post-colonoscopy surveys using the Fear of Cancer Recurrence Inventory - Short Form (FCRI-SF) published by Simard et al. (2014).
Timepoint [3] 418067 0
This will be assessed 2-4 weeks prior to and 4 weeks following colonoscopy.
Secondary outcome [4] 418068 0
Colonoscopy consumers health-related quality of life will be assessed within the pre- and post-colonoscopy surveys using a cancer-specific quality of life instrument (the EORTC QLQ-C30).
Timepoint [4] 418068 0
This will be assessed 2-4 weeks prior to and 4 weeks following colonoscopy.
Secondary outcome [5] 418359 0
Clinicians preferences for bowel screening test attributes will be assessed within the single clinician survey using items that have been designed specifically for this study.
Timepoint [5] 418359 0
This will be assessed at any time following study invitation.

Eligibility
Key inclusion criteria
Inclusion for colonoscopy consumers:
1) over 18 years of age
2) undergoing a colonoscopy for the indications of symptoms and/or surveillance at an approved study site
3) willing to complete up to two surveys

Inclusion for clinicians:
1) be a currently registered medical doctor practising in Australia
2) working in colorectal, upper gastrointestinal, and/or general surgery, and/or in gastroenterology and/or general practice
3) willing to complete a single survey
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Colonoscopy consumers will be excluded if:
1) they are unable to return their survey prior to undergoing colonoscopy
2) undergoing a colonoscopy due to a positive faecal occult blood test

Clinicians will be excluded if:
1) they possess a perceived or actual conflict of interest relating to the use of non-invasive biomarker tests for gastrointestinal disease screening

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Survey responses will be summarised with descriptive statistics. Parametric and/or non-parametric tests will be used depending on the distribution of the data (normal or non-normal). Differences in bowel test preferences will be investigated with chi-square tests for categorical variables and independent samples t-tests (parametric) or Mann-Whitney U tests (non-parametric) for continuous variables. Both univariate and multivariate generalised linear modelling will be used to explore the individual and combined effects of participant characteristics (for example health beliefs and health literacy) in predicting the acceptance of certain bowel screening tests. Effect sizes will be reported as odds ratios (OR) with a 95% confidence interval (95% CI), with p values <0.05 deemed statistically significant for all analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/02/2023
Actual
27/02/2023
Date of last participant enrolment
Anticipated
20/08/2024
Actual
Date of last data collection
Anticipated
20/09/2024
Actual
Sample size
Target
2400
Accrual to date
504
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 23872 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 23873 0
Noarlunga Health Service - Noarlunga Centre
Recruitment hospital [3] 23874 0
Tennyson Centre Day Hospital - Kurralta Park
Recruitment hospital [4] 23875 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 39332 0
5011 - Woodville
Recruitment postcode(s) [2] 39331 0
5037 - Kurralta Park
Recruitment postcode(s) [3] 39329 0
5042 - Bedford Park
Recruitment postcode(s) [4] 39330 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 313044 0
Government body
Name [1] 313044 0
National Health and Medical Research Council
Country [1] 313044 0
Australia
Primary sponsor type
University
Name
Flinders University of South Australia
Address
Sturt Road
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 314730 0
None
Name [1] 314730 0
Address [1] 314730 0
Country [1] 314730 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312297 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 312297 0
Office for Research
Ward 6C, Room 6A219, Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 312297 0
Australia
Date submitted for ethics approval [1] 312297 0
07/11/2022
Approval date [1] 312297 0
11/11/2022
Ethics approval number [1] 312297 0
195.22

Summary
Brief summary
The primary purpose of this study is to determine the acceptability of different bowel testing methods including but not limited to faecal tests, blood tests, and colonoscopy.

Who is it for? Participants in this study include adults who are undergoing colonoscopy at Flinders Medical Centre, Noarlunga Health Service, Tennyson Centre Day Hospital, or the Queen Elizabeth Hospital in response to gastrointestinal symptoms or for CRC surveillance. It will also include currently registered medical doctors practising in Australia as surgeons, gastroenterologists, and/or general practitioners who are involved in the clinical care of people undergoing colonoscopy.

Study details: Eligible participants scheduled to undergo colonoscopy will be sent a letter inviting them to complete a survey 2-4 weeks prior to their colonoscopy. All study invitees who complete this initial survey will be sent a letter one month after their colonoscopy inviting them to complete a follow-up survey. Surveys will contain questions about their testing experiences and knowledge, health beliefs, health literacy, health-related quality of life, and fear of bowel cancer. Clinicians will also be invited into the study through a direct approach or self-selection via advertisements where they will be asked to complete a single survey at their earliest convenience. The clinician survey will contain questions about their familiarity with and previous use of bowel testing methods, perceived effectiveness of bowel testing methods, perceived barriers to bowel screening test use, and preferences for bowel screening test attributes.

It is hoped that the outcomes of this research will establish the level of knowledge, trust, and acceptability of colonoscopy consumers and clinicians to different bowel screening strategies. This study will obtain evidence highlighting the benefits and/or perceived barriers towards adopting a simple faecal and/or blood-based test to better determine risk of significant gastrointestinal disease. Adoption of an effective and acceptable biomarker screening test would then lead to better management of colonoscopy resources and reduced costs to the healthcare system through improved colonoscopy triaging and overall reductions in the overall number of colonoscopies performed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124154 0
A/Prof Erin Symonds
Address 124154 0
Bowel Health Service
Level 3, Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 124154 0
Australia
Phone 124154 0
+61 8 8404 2813
Fax 124154 0
Email 124154 0
erin.symonds@sa.gov.au
Contact person for public queries
Name 124155 0
Ms Maddison Dix
Address 124155 0
Bowel Health Service
Level 3, Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 124155 0
Australia
Phone 124155 0
+61 8 7421 9957
Fax 124155 0
Email 124155 0
maddi.dix@sa.gov.au
Contact person for scientific queries
Name 124156 0
Ms Maddison Dix
Address 124156 0
Bowel Health Service
Level 3, Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 124156 0
Australia
Phone 124156 0
+61 8 7421 9957
Fax 124156 0
Email 124156 0
maddi.dix@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
In the case of data sharing, only non-identifiable information will be provided to other researchers. This will include individual participant data of survey responses as reported in publication(s). No clinically identifiable colonoscopy outcomes will be shared.
When will data be available (start and end dates)?
After main results publication; no end date determined.
Available to whom?
The research team may provide non-identifiable survey responses to other researchers upon approval by the Principal Investigator.
Available for what types of analyses?
Only to achieve the aims as proposed to the Principal Investigator.
How or where can data be obtained?
Non-identifiable data may be deposited onto a publicly available data repository (as a requirement of journal publication). Other access will be subject to approval by the Principal Investigator. Approval from A/Prof Erin Symonds can be sought by emailing a proposal to erin.symonds@sa.gov.au.


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.