ANZCTR - Registration

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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

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]

Nil

Universal Trial Number (UTN)

Trial acronym

SCOOP Survey

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Colorectal cancer

Condition category

Condition code

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Public Health

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]

Early Detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Assessed at single survey.

Primary outcome [2]

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]

Assessed at single survey

Secondary outcome [1]

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]

Assessed at single survey.

Secondary outcome [2]

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]

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?

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)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders Foundation - Small Research Grant Scheme

Address [1]

Flinders Drive
Bedford Park SA 5042
Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Ward 6C, Room 6A219
Flinders Medical Centre
Flinders Drive, 
Bedford Park SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/12/2017

Approval date [1]

06/11/2018

Ethics approval number [1]

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

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

Phone

+61 8 8404 2813

Fax

Erin.Symonds@sa.gov.au

Contact person for public queries

Name

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

Phone

+61 8 8404 2813

Fax

Erin.Symonds@sa.gov.au

Contact person for scientific queries

Name

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

Phone

+61 8 8404 2813

Fax

Erin.Symonds@sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
576					A study report is proposed to be presented and pub... [More Details]

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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