ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000628246

Ethics application status

Approved

Date submitted

22/07/2009

Date registered

28/07/2009

Date last updated

5/09/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Increasing appropriate screening for colorectal cancer patients and their first degree relatives. A randomised controlled trial.

Scientific title

The effect of an educational intervention versus minimal ethical care on the level of appropriate screening for colorectal cancer patients and their first degree relatives. A randomised controlled trial.

Universal Trial Number (UTN)

Trial acronym

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)

Cancer

Bowel - Anal

Cancer

Bowel - Small bowel (duodenum and ileum)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

People with bowel cancer and their first degree relatives will be allocated to an intervention or minimal ethical care group. Those in the intervention group will be posted a detailed information booklet about screening tests recommended by the National Health and Medical Research Council (NHMRC). A corresponding information booklet will also be mailed to their General Practitioner (GP) and for index cases only, cancer surgeon. This tailored advice on screening will be provided to participants and their clinicians within 4 weeks of recruitment, and 12 and 24 months later.

Intervention code [1]

Prevention

Intervention code [2]

Early detection / Screening

Comparator / control treatment

Those allocated to the minimal ethical care group will each receive one standard pamphlet about bowel cancer within four weeks of recruitment.

Control group

Active

Outcomes

Primary outcome [1]

Proportion of first degree relatives and index cases who have screening in line with NHMRC guideline recommendations will be assessed through self-report.

Accuracy of self-report will be tested for a random sub-sample. This will be carried out by cross-checking self-reported screening with clinician records.

Timepoint [1]

Measured at baseline, 12, 24 and 36 months after intervention.

Secondary outcome [1]

Nil

Timepoint [1]

Nil

Eligibility

Key inclusion criteria

Index Cases - People who have received a confirmed diagnosis of bowel cancer no more than 6 months previously.

First degree relatives - Of people with bowel cancer particpating in the trial.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Index cases - People with familial adenomatous polyposis or hereditary non-polyposis colorectal cancer (HNPCC). Non-English speaking.

First-degree Relatives - Those with familial adenomatous polyposis or hereditary non-polyposis colorectal cancer (HNPCC), ulcerative colitis, Crohn’s disease, inflammatory bowel disease or a previous diagnosis of bowel cancer. Non-English speaking.

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)

Allocation will be concealed as participants will be randomly allocated to groups by central randomisation with a computer.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

31/08/2009

Actual

10/01/2010

Date of last participant enrolment

Anticipated

Actual

30/10/2012

Date of last data collection

Anticipated

Actual

22/12/2013

Sample size

Target

4800

Accrual to date

Final

1572

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Newcastle

Address

University Drive
Callaghan,
Newcastle, NSW, 2308

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Cancer Council Victoria Human Research Ethics Committee

Ethics committee address [1]

1 Rathdowne St,
Carlton,
Victoria, 3053

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/07/2008

Ethics approval number [1]

HREC 0810

Ethics committee name [2]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [2]

University Drive,
Callaghan,
Newcastle, 
NSW, 2308

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

H-2008-047

Summary

Brief summary

This research aims to improve adherence to guideline recommendations for surveillance for people with colorectal cancer and screening of their first degree relatives using an educational intervention. People with colorectal cancer and their first degree relatives will be randomly assigned to receive tailored educational materials on screeening (intervention group) or standard pamphlets (minimal ethical care group). It is expected that those in the intervention group will have 10%, 12% and 15% higher levels of adherence to screening/surveillance recommendations at 1, 2, and 3 years post recruitment respectively, when compared with those in the minimal ethical care group.

Trial website

Trial related presentations / publications

Carey M, Sanson-Fisher R, Macrae F, Hill D, D’Este C, Paul C, Doran C. 2012. Improving adherence to surveillance and screening recommendations for people with colorectal cancer and their first degree relatives: A randomized controlled trial. BMC Cancer 12:62.

Courtney R, Paul C, Carey M, Sanson-Fisher R, Macrae F, D’Este C, Hill D, Barker D, Simmons J. 2013. A population-based cross-sectional study of colorectal cancer screening practices of first-degree relatives of colorectal cancer patients. BMC Cancer 13:13.

Courtney RJ, Paul CL, Sanson-Fisher RW, Carey ML, Macrae FA, Yoong SL. 2012. Community approaches to increasing colorectal screening uptake: a review of the methodological quality and strength of current evidence.  Cancer Forum, 36(1):27-35.

Cameron E, Rose S, Carey M. 2014. Assessment of family history of colorectal cancer in primary care: Perceptions of first degree relatives of people with colorectal cancer. Patient Education and Counseling 94 (3) 427-431.

Paul C, Courtney R, Sanson-Fisher R, Carey M, Hill D, Simmons J, Rose S. 2014.  A randomized controlled trial of the effectiveness of a pre-recruitment primer letter to increase participation in a study of colorectal screening and surveillance.  BMC Medical Research Methodology, 14:44.

Paul C, Cameron E, Doran C, Hill D, Macrae F, Carey M, Sanson-Fisher R. 2016. Experiences of colorectal cancer patients in the 2 years post-diagnosis and patient factors predicting poor outcome. Supportive Care in Cancer: 1-8.

Carey M, Sanson-Fisher R, Macrae F, Cameron E, Hill D, D’Este C, Simmons J, Doran C. 2016. Can a print-based intervention increase appropriate screening for first degree relatives of people with colorectal cancer? Results of randomised controlled trial. Australian and New Zealand Journal of Public Health. DOI: 10.1111/1753-6405.12579 

Carey, M., Sanson-Fisher, R., Macrae, F., Cameron, E., Hill, D., D’Este, C., & Doran, C. 2017. Improving adherence to colorectal cancer surveillance guidelines: results of a randomised controlled trial. BMC Cancer, 17(1).

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Rob Sanson-Fisher

Address

Rm 267, Level 2,
David Maddison Building,
Cnr King & Watt Streets,
Newcastle,
NSW, 2300

Country

Australia

Phone

+61 2 4913 8678

Fax

+ 61 2 4913 6779

Rob.Sanson-Fisher@newcastle.edu.au

Contact person for scientific queries

Name

Rob Sanson-Fisher

Address

Rm 267, Level 2,
David Maddison Building,
Cnr King & Watt Streets,
Newcastle,
NSW 2300

Country

Australia

Phone

+61 2 4913 8678

Fax

+ 61 2 4913 6779

Rob.Sanson-Fisher@newcastle.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

Source	Title	Year of Publication	DOI
Embase	Improving adherence to surveillance and screening recommendations for people with colorectal cancer and their first degree relatives: A randomized controlled trial.	2012	https://dx.doi.org/10.1186/1471-2407-12-62

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically