Trial Review

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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 information initially 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] 283144 0
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 290003 0
Condition category
Condition code
Public Health 290387 290387 0 0
Health promotion/education
Cancer 290388 290388 0 0
Breast
Mental Health 290389 290389 0 0
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] 287878 0
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] 290410 0
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] 290410 0
Timepoint: at 2 weeks post intervention
Secondary outcome [1] 304453 0
Secondary Outcome 1: Participation in mammography screening, by self report
Timepoint [1] 304453 0
Timepoint: at 6 months, 1 and 2 years post intervention
Secondary outcome [2] 304454 0
Secondary Outcome 2: Anticipated regret, (i) about screening and (ii) about not screening, assessed using items from a validated scale (Sandberg 2009)
Timepoint [2] 304454 0
Timepoint: at 2 weeks post intervention
Secondary outcome [3] 304455 0
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] 304455 0
Timepoint: at 2 weeks post intervention
Secondary outcome [4] 304456 0
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] 304456 0
Timepoint: at 2 weeks post intervention
Secondary outcome [5] 304457 0
Secondary Outcome 5: Breast cancer worry, assessed using a validated single item (Sutton 1994)
Timepoint [5] 304457 0
Timepoint: at 2 weeks post intervention
Secondary outcome [6] 304458 0
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] 304458 0
Timepoint: at 2 weeks post intervention
Secondary outcome [7] 304459 0
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] 304459 0
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] 287899 0
Government body
Name [1] 287899 0
National Health and Medical Research Council
Country [1] 287899 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 286626 0
None
Name [1] 286626 0
Address [1] 286626 0
Country [1] 286626 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289839 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 289839 0
Level 6, Jane Foss Russell Building (G02)
The University of Sydney
NSW 2006
Ethics committee country [1] 289839 0
Australia
Date submitted for ethics approval [1] 289839 0
Approval date [1] 289839 0
21/08/2012
Ethics approval number [1] 289839 0
15055
Ethics committee name [2] 309514 0
NSW Population & Health Services Research Ethics Committee
Ethics committee address [2] 309514 0
Level 9, 8 Central Ave
Australian Technology Park
Eveleigh NSW 2015
Ethics committee country [2] 309514 0
Australia
Date submitted for ethics approval [2] 309514 0
18/01/2018
Approval date [2] 309514 0
16/04/2018
Ethics approval number [2] 309514 0
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 42682 0
Prof Kirsten McCaffery
Address 42682 0
School of Public Health, Edward Ford Building (A27). The University of Sydney. Camperdown, NSW 2006
Country 42682 0
Australia
Phone 42682 0
+61 2 93517220
Fax 42682 0
Email 42682 0
[email protected]
Contact person for public queries
Name 42683 0
Dr Jolyn Hersch
Address 42683 0
School of Public Health, Edward Ford Building (A27). The University of Sydney. Camperdown, NSW 2006
Country 42683 0
Australia
Phone 42683 0
+61 2 90369042
Fax 42683 0
Email 42683 0
[email protected]
Contact person for scientific queries
Name 42684 0
Prof Kirsten McCaffery
Address 42684 0
School of Public Health, Edward Ford Building (A27). The University of Sydney. Camperdown, NSW 2006
Country 42684 0
Australia
Phone 42684 0
+61 2 93517220
Fax 42684 0
Email 42684 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13333Study protocolHersch 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.  
13334Informed consent form  [email protected]
13335Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Hersch J, Barratt A, Jansen J, Irwig L, McGeechan ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHow information about overdetection changes breast cancer screening decisions: A mediation analysis within a randomised controlled trial.2017https://dx.doi.org/10.1136/bmjopen-2017-016246
EmbaseUse of a decision aid including information on overdetection to support informed choice about breast cancer screening: A randomised controlled trial.2015https://dx.doi.org/10.1016/S0140-6736%2815%2960123-4
N.B. These documents automatically identified may not have been verified by the study sponsor.