Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001277235
Ethics application status
Approved
Date submitted
19/07/2018
Date registered
30/07/2018
Date last updated
2/12/2019
Date data sharing statement initially provided
30/11/2018
Date results information initially provided
2/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A survey of participants enrolled in the Southern Co-Operative Program for the Prevention of Colorectal Cancer (or SCOOP program) to assess attitudes toward their current surveillance intervals and methods.
Scientific title
Investigating attitudes and surveillance preferences for patients aged 18 - 75 years who have been identified with an increased risk of developing colorectal cancer and who are enrolled in the Southern Co-Operative Program for the Prevention of Colorectal Cancer (SCOOP program).
Secondary ID [1] 295552 0
Nil
Universal Trial Number (UTN)
Trial acronym
SCOOP Survey
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 308816 0
Condition category
Condition code
Cancer 307747 307747 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 307748 307748 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Eligible participants will be those who are part of The Southern Co-operative Program for the Prevention of Colorectal Cancer (SCOOP) program run through Southern Adelaide Local Health Network and who already receive surveillance for colorectal cancer through regular colonoscopy and faecal occult blood tests (FOBT). All patient details are entered into a clinical recall database. As part of SCOOP, risk profiles of all registrants are continually reviewed and updated to ensure that all have been assigned a CRC risk level that is accurate and reflects current knowledge.
We will screen the recall database to exclude those who have had CRC in the past or currently, are deceased and those who are under the age of 18 or over the age of 75 years. Following this, there will be a random selection of 800 people from the database who receive FOBTs and regular colonoscopies.
The randomly selected invitees will be posted an invitation pack containing Letter of Invitation, an Opt-Out slip, the survey and a reply paid envelope. A reminder letter will be send after 4 weeks to all those who did not complete the survey or the Opt-Out slip.The survey will take approximately 20 minutes to complete.
Intervention code [1] 301848 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306736 0
Enrolee attitudes towards different scenarios of timings for bowel cancer surveillance methods. This will be assessed with questions within a survey that have been specifically designed for this study.
Timepoint [1] 306736 0
Assessed at single survey.
Primary outcome [2] 306904 0
Enrolee preferences for different methods for bowel cancer surveillance. This will be assessed with the Quality of Colorectal Cancer Screening Decisions instrument (CRC-DQI) as published by Sepucha et al (2014), and a five-factor general colorectal cancer screening model as published by Tiro et al (2005).
Timepoint [2] 306904 0
Assessed at single survey
Secondary outcome [1] 349393 0
Fear of cancer for the different demographics of enrolled participants. This will be assessed with the Fear of Cancer recurrence Inventory tool as published by Simard et al (2014).
Timepoint [1] 349393 0
Assessed at single survey.
Secondary outcome [2] 349394 0
Trust in health care for the different demographics of enrolled participants will be measured according to the validated survey the “Trust in Physician scale”. This is an 11-item self-report instrument developed to assess an individual's trust in his/her physician (Authors: Anderson and Dedrick. Psychological Reports. 1990)
Timepoint [2] 349394 0
Assessed at single survey.

Eligibility
Key inclusion criteria
Males and females enrolled in SCOOP through Southern Adelaide Local Health Network between 18 and 75 years old.
Patients that are currently receiving and /or are suitable for FOBTs and colonoscopy.
Individuals with family history of bowel cancer and /or having had an adenoma.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
High risk for colorectal cancer (genetic predisposed to CRC, or previously having had CRC or cancerous cells)
Patients who have had bowel surgery and have a stoma in place
Patients diagnosed with inflammatory bowel disease (IBD)
Patients under 18 and over 75
Patients who are ineligible for FOBTs

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics (including mean, standard deviation, median and range) will be presented by sub-groups and the whole sample. According to the distribution of scores, parametric or non-parametric tests (i.e. the Kruskal Wallis test and the Mann–Whitney U test) will be adopted to compare the scores for sub-groups. Multivariate analysis for predictive modelling will be applied where indicated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/12/2018
Actual
17/12/2018
Date of last participant enrolment
Anticipated
1/09/2019
Actual
25/09/2019
Date of last data collection
Anticipated
1/09/2019
Actual
25/09/2019
Sample size
Target
800
Accrual to date
Final
407
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11443 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 23453 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 300127 0
University
Name [1] 300127 0
Flinders Foundation - Small Research Grant Scheme
Country [1] 300127 0
Australia
Primary sponsor type
Individual
Name
Dr Erin Symonds
Address
Bowel Health Service
c/o Level 3 Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 299527 0
None
Name [1] 299527 0
Address [1] 299527 0
Country [1] 299527 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300966 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 300966 0
Ward 6C, Room 6A219
Flinders Medical Centre
Flinders Drive,
Bedford Park SA 5042
Ethics committee country [1] 300966 0
Australia
Date submitted for ethics approval [1] 300966 0
06/12/2017
Approval date [1] 300966 0
06/11/2018
Ethics approval number [1] 300966 0
330.17

Summary
Brief summary
The primary purpose of this study is to Investigate consumer opinions and preferences on screening and surveillance type and frequency.

Who is it for? Participants for this study will be people who are part of the SCOOP program who are between 18 and 75 years old, who are at mild to moderate risk for colorectal cancer and who undergo regular surveillance and screening with colonoscopy and FOBT.

Study details: All study invitees will be sent via mail a study invitation letter and a questionnaire. The questionnaire contains questions about their previous experiences with colonoscopy and FOBT, attitudes toward managing health, fear of cancer, levels of anxiety, trust in the healthcare system, and basic demographic questions (including age, education level, country of birth). A four week period will be allowed following the mail out of letters for return of completed questionnaires. If the questionnaire has not been returned during this time, then a reminder letter will be sent.

The findings of this trial will determine consumer preference for colorectal cancer surveillance. This information will help to guide the clinicians in any policy changes related to surveillance programs, such as with plans to extend surveillance colonoscopy frequency.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85446 0
Dr Erin Symonds
Address 85446 0
Bowel Health Service
c/o Level 3 Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 85446 0
Australia
Phone 85446 0
+61 8 8404 2813
Fax 85446 0
Email 85446 0
[email protected]
Contact person for public queries
Name 85447 0
Dr Erin Symonds
Address 85447 0
Bowel Health Service
c/o Level 3 Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 85447 0
Australia
Phone 85447 0
+61 8 8404 2813
Fax 85447 0
Email 85447 0
[email protected]
Contact person for scientific queries
Name 85448 0
Dr Erin Symonds
Address 85448 0
Bowel Health Service
c/o Level 3 Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 85448 0
Australia
Phone 85448 0
+61 8 8404 2813
Fax 85448 0
Email 85448 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data / or any raw data will be shared without appropriate future consent and/or ethical approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
576     A study report is proposed to be presented and pub... [More Details]



Results publications and other study-related documents

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