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Trial registered on ANZCTR

Registration number

ACTRN12613001035718

Ethics application status

Approved

Date submitted

16/09/2013

Date registered

17/09/2013

Date last updated

23/09/2021

Date data sharing statement initially provided

23/09/2021

Date results provided

23/09/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Communicating the benefits and harms of breast cancer screening: a randomised controlled trial evaluating an information booklet designed to help women approaching age 50 to make an informed decision about screening

Scientific title

Informed choice in mammography screening for breast cancer: comparing effects of breast screening information booklets with and without information on overdiagnosis among women approaching and entering the target age range for screening

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1146-8716

Trial acronym

Linked study record

Health condition

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

Women’s decision-making about mammography screening for breast cancer

Condition category

Condition code

Public Health

Health promotion/education

Cancer

Breast

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The trial intervention is a purpose-designed screening information booklet containing information on breast screening benefits and harms over 20 years of participation, including evidence-based quantitative estimates of breast cancer mortality benefit, false positives, and overdiagnosis. Overdiagnosis – also called overdetection – means finding a breast cancer through screening that would otherwise never cause any symptoms or health problems for the woman during her life.

Intervention code [1]

Behaviour

Comparator / control treatment

The trial comparator is a purpose-designed screening information booklet containing information on breast screening benefits and harms over 20 years of participation, including evidence-based quantitative estimates of breast cancer mortality benefit and false positives (as in the intervention) but with NO overdiagnosis information.

Control group

Active

Outcomes

Primary outcome [1]

Primary Outcome: Informed choice, assessed as the proportion of participants who make an informed choice about whether to screen or not. For the individual, making an informed choice is defined as (i) having adequate knowledge and (ii) expressing intentions that are consistent with one’s attitudes. Knowledge will be measured by assessing women’s understanding of the conceptual and numerical information in the booklets, using items adapted from previous screening decision aid trials (Mathieu 2007; Smith 2010). Attitudes towards breast screening will be assessed using a validated, theory-based generic screening attitudes scale (Dormandy 2006). A single item will measure intentions about having a screening mammogram (or not) within the next 2-3 years, using a set of 5 response options (Gwyn 2003; Watson 2006).

Timepoint [1]

Timepoint: at 2 weeks post intervention

Secondary outcome [1]

Secondary Outcome 1: Participation in mammography screening, by self report

Timepoint [1]

Timepoint: at 6 months, 1 and 2 years post intervention

Secondary outcome [2]

Secondary Outcome 2: Anticipated regret, (i) about screening and (ii) about not screening, assessed using items from a validated scale (Sandberg 2009)

Timepoint [2]

Timepoint: at 2 weeks post intervention

Secondary outcome [3]

Secondary Outcome 3: Anxiety, assessed using the widely used and well validated short form of the Spielberger State Trait Anxiety Inventory (Marteau 1992)

Timepoint [3]

Timepoint: at 2 weeks post intervention

Secondary outcome [4]

Secondary Outcome 4: Perceived lifetime risk of breast cancer, (i) in absolute terms (Ziarnowski 2009) and (ii) relative to an average woman the same age (Lipkus 2005)

Timepoint [4]

Timepoint: at 2 weeks post intervention

Secondary outcome [5]

Secondary Outcome 5: Breast cancer worry, assessed using a validated single item (Sutton 1994)

Timepoint [5]

Timepoint: at 2 weeks post intervention

Secondary outcome [6]

Secondary Outcome 6: Decision process, assessed using the validated Decisional Conflict Scale (O’Connor 1993) and Decision Self-Efficacy Scale (O’Connor 1995)

Timepoint [6]

Timepoint: at 2 weeks post intervention

Secondary outcome [7]

Secondary Outcome 7: Acceptability and utilisation of materials, assessed by items used successfully in prior screening decision aid studies (Mathieu 2010; Smith 2009)

Timepoint [7]

Timepoint: at 2 weeks post intervention

Eligibility

Key inclusion criteria

Female; aged 48-50 years; residing in NSW; fluent in spoken and written English

Minimum age

48 Years

Maximum age

50 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Personal history of breast cancer; any mammogram in past 2 years; strong family history of breast cancer; having been advised of being at very high risk for breast cancer; having been advised of being likely to have a breast cancer gene mutation

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Names and addresses of a random sample of NSW women aged 48-49 years will be extracted from the electoral roll. Matching telephone numbers will be retrieved from the electronic telephone directory. A database will be provided to the Hunter Valley Research Foundation (HVRF), an experienced independent non-profit organisation. HVRF interviewers will telephone women sampled randomly from the database and determine study eligibility using a series of simple questions. Eligible women will be informed about the study and invited to participate. Consent will be obtained orally and documented.
Allocation to intervention or control will occur subsequently, using a randomisation sequence generated centrally by a statistician who has no contact with participants. The HVRF interviewers conducting recruitment will not be aware of the randomisation sequence and hence will not know which booklet will be allocated.

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

A statistician who has no contact with participants will generate a permuted block randomisation sequence to allocate each participant to one of the two groups (intervention or control), using a permuted block size of 4 and 8.
A random sample of approximately 66 participants will be randomised to the intervention or control within a qualitative sub-study that captures additional outcomes via qualitative interviews.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Analysis will be by intention to treat, comparing the 2 study arms on the proportion of women who have made an informed choice about whether or not to have screening, measured at 2 weeks post intervention. Assuming conservatively that one of these proportions is 50%, we need 407 women per study arm to achieve 80% power to detect a 10% difference between the groups.
The total target sample size comprises the two arms of the main study as described above, plus the qualitative sub-study, plus additional numbers to allow for attrition between recruitment and outcome data collection.
We will use the chi-squared test to analyse binary outcomes and the two sample t test for continuous outcomes. We will use multiple imputation and sensitivity analyses to explore the impact of missing data on results.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

25/09/2013

Actual

6/01/2014

Date of last participant enrolment

Anticipated

Actual

14/07/2014

Date of last data collection

Anticipated

10/05/2017

Actual

20/03/2019

Sample size

Target

1079

Accrual to date

Final

1061

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421, Canberra, ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

The University of Sydney
NSW 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Level 6, Jane Foss Russell Building (G02)
The University of Sydney
NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/08/2012

Ethics approval number [1]

15055

Ethics committee name [2]

NSW Population & Health Services Research Ethics Committee

Ethics committee address [2]

Level 9, 8 Central Ave
Australian Technology Park
Eveleigh NSW 2015

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

18/01/2018

Approval date [2]

16/04/2018

Ethics approval number [2]

2018HRE0203

Summary

Brief summary

The purpose of this study is to evaluate a newly developed information booklet for women about breast cancer screening.

Who is it for?
People may be eligible to join this study if they are women aged 48-50 years residing in NSW. Women will not be eligible if they have a personal or strong family history of breast cancer, or if they have undergone any mammogram in the past 2 years. Potentially eligible participants will be randomly selected from the electoral roll and contacted by researchers.

Study details
Women in this study will be randomly (by chance) allocated to receive one of two different versions of a booklet. The booklets aim to provide clear and useful information about the benefits and harms of breast cancer screening, in order to enable women to make an informed decision about screening. The researchers will look at how women understand and interpret the information, as well as how it affects their screening attitudes, decisions, and experiences.

Trial website

Trial related presentations / publications

PEER-REVIEWED JOURNAL PUBLICATIONS

1)	Hersch J, Barratt A, Jansen J, Houssami N, Irwig L, Jacklyn G, Dhillon H, Thornton H, McGeechan K, Howard K, McCaffery K. The effect of information about overdetection of breast cancer on women's decision-making about mammography screening: Study protocol for a randomised controlled trial. BMJ Open. 2014 May 15; 4(5): e004990.

2)	Hersch J, Jansen J, Barratt A, Irwig L, Houssami N, Jacklyn G, Thornton H, Dhillon H, McCaffery K. Overdetection in breast cancer screening: Development and preliminary evaluation of a decision aid. BMJ Open. 2014 Sep 25; 4(9): e006016.

3)	Hersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G, Thornton H, Dhillon H, Houssami N, McCaffery K. Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: A randomised controlled trial. The Lancet. 2015 Apr 25; 385(9978): 1642-1652.

4)	Hersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G, Thornton H, Dhillon H, Houssami N, McCaffery K. The importance of enabling informed decision making for women considering breast cancer screening. Journal of Medical Screening. 2016 Mar; 23(1): 55.

5)	Hersch J, Jansen J, McCaffery K. Informed and shared decision making in breast screening. In: Houssami N, Miglioretti D, eds. Breast cancer screening: Making sense of complex and evolving evidence. Elsevier, 2016: 403-420.

6)	Hersch JK, Nickel BL, Ghanouni A, Jansen J, McCaffery KJ. Improving communication about cancer screening: Moving towards informed decision making. Public Health Research and Practice. 2017 Jul 26; 27(3): e2731728.

7)	Hersch J, McGeechan K, Barratt A, Jansen J, Irwig L, Jacklyn G, Houssami N, Dhillon H, McCaffery K. How information about overdetection changes breast cancer screening decisions: a mediation analysis within a randomised controlled trial. BMJ Open. 2017 Oct 6; 7(10): e016246.

8)	Hersch J, McCaffery K. Using a decision aid may prompt some younger women (38–50 years) to rethink breast cancer screening plans. Evidence-Based Nursing. 2018 Jan; 21(1): 10-11.

9)	Hersch J, Jansen J, McCaffery K. Decision-making about mammographic screening: Pursuing informed choice. Climacteric. 2018 Jun; 21(3): 209-213.

10)	Hersch J, Barratt A, McGeechan K, Jansen J, Houssami N, Dhillon H, Jacklyn G, Irwig L, McCaffery K. Informing women about overdetection in breast cancer screening: Two-year outcomes from a randomized trial. Journal of the National Cancer Institute. 2021 Apr 19: djab083. doi: 10.1093/jnci/djab083. Online ahead of print.

Public notes

Contacts

Principal investigator

Name

Prof Kirsten McCaffery

Address

School of Public Health, Edward Ford Building (A27). The University of Sydney. Camperdown, NSW 2006

Country

Australia

Phone

+61 2 93517220

Fax

kirsten.mccaffery@sydney.edu.au

Contact person for public queries

Name

Jolyn Hersch

Address

School of Public Health, Edward Ford Building (A27). The University of Sydney. Camperdown, NSW 2006

Country

Australia

Phone

+61 2 90369042

Fax

jolyn.hersch@sydney.edu.au

Contact person for scientific queries

Name

Kirsten McCaffery

Address

School of Public Health, Edward Ford Building (A27). The University of Sydney. Camperdown, NSW 2006

Country

Australia

Phone

+61 2 93517220

Fax

kirsten.mccaffery@sydney.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Email
13333	Study protocol	Hersch J, Barratt A, Jansen J, Houssami N, Irwig L, Jacklyn G, Dhillon H, Thornton H, McGeechan K, Howard K, McCaffery K. The effect of information about overdetection of breast cancer on women's decision-making about mammography screening: Study protocol for a randomised controlled trial. BMJ Open. 2014 May 15; 4(5): e004990.
13334	Informed consent form		jolyn.hersch@sydney.edu.au
13335	Ethical approval		jolyn.hersch@sydney.edu.au

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	Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: A randomised controlled trial.	2015	https://dx.doi.org/10.1016/S0140-6736%2815%2960123-4
Embase	How information about overdetection changes breast cancer screening decisions: A mediation analysis within a randomised controlled trial.	2017	https://dx.doi.org/10.1136/bmjopen-2017-016246

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

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