Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000033640
Ethics application status
Approved
Date submitted
24/11/2022
Date registered
12/01/2023
Date last updated
28/06/2023
Date data sharing statement initially provided
12/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Older Australian women's intentions and psychological outcomes related to breast screening
Scientific title
The impact of information about transitioning out of Australia's national breast cancer screening program on informed choice: A randomised online trial with older women
Secondary ID [1] 308276 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer screening 328056 0
Condition category
Condition code
Cancer 325116 325116 0 0
Breast
Public Health 325117 325117 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to investigate the impact of information that provides older women with a rationale for no longer being invited to participate in the BreastScreen program on informed choice and psychological outcomes (worry, perceived risk).

The design of the study is 3x1, a randomised trial with 3 arms. The trial will be conducted online through the Qualtrics survey platform. An online sample of older women living in Australia will be recruited through a large social research organisation that utilises panels. Eligible participants will be women aged 70-74 years with no personal history of breast cancer or ductal carcinoma in situ (DCIS) who have screened for breast cancer at least once in the past 5 years.

Eligible women will be presented with a hypothetical scenario. They will be asked to imagine they have gone for a routine mammogram screening and are now receiving a letter with their results. Participants will then be randomised to one of three letters.

Group 1 (control): the final letter women receive from Breast Screen that highlights women are invited for screening from 50 to 74 years and shows a "negative" result - i.e., no breast cancer could be seen on the mammogram.

Group 2 (control + intervention 1): final BreastScreen letter + brief text informing women they will no longer receive reminders to screen because associated risks outweigh the benefits. This information will include the main points in brief dot-point form that are covered in the animation video (intervention 2) and will be developed by the research team (including experts in health communication, breast physicians, a general practitioner and geriatrician, and older female consumers) in collaboration with BreastScreen NSW.

Group 3 (control + intervention 2): final BreastScreen letter + an animated video (2 minutes in length) informing women they will no longer receive reminders to screen, including more detailed information about the benefit/risk ratio. This information will be developed by the research team in collaboration with BreastScreen NSW.

The online intervention will be administered once only with no repeat or subsequent sessions upon completion. It will take 15-20 minutes for participants to complete the questionnaire.

Adherence to the intervention will be ensured by utilising the forced response tool in Qualtrics for outcome measurement. The overall time taken to complete the online study will also allow the researchers to determine adherence to the intervention.
Intervention code [1] 324730 0
Behaviour
Comparator / control treatment
The control group will received the generic final letter women receive from Breast Screen that highlights women are invited for screening from 50 to 74 years.
Control group
Active

Outcomes
Primary outcome [1] 333207 0
Informed choice.

This is a composite outcome comprising of three elements (from Qualtrics survey): intention to screen beyond 74 years, conceptual knowledge and screening attitudes.

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):1642-52.
Timepoint [1] 333207 0
Immediately after intervention
Secondary outcome [1] 416167 0
Intention to speak to GP (yes/no/don't know) - from Qualtrics survey
After receiving this letter, would you plan to talk to your GP about it?

Dolan H, McCaffery K, Houssami N, Cvejic E, Brennan M, Hersch J, Dorrington M, Verde A, Vaccaro L, Nickel B. Australian Women’s intentions and psychological outcomes related to breast density notification and information: a randomized clinical trial. JAMA network open. 2022 Jun 1;5(6):e2216784-.
Timepoint [1] 416167 0
Immediately after intervention
Secondary outcome [2] 416168 0
Intention to talk to GP (free-text) - What is one question you might like to ask your GP? (from Qualtrics survey)
Timepoint [2] 416168 0
Immediately after intervention
Secondary outcome [3] 416169 0
Perceived risk (from Qualtrics survey)
Compared to other women your age, race and sex, what do you think is your chance of getting breast cancer in your lifetime if you received this letter?

Lipkus IM, Kuchibhatla M, McBride CM, et al. Relationships among Breast Cancer Perceived Absolute Risk, Comparative Risk, and Worries. Cancer Epidemiology Biomarkers & Prevention 2000;9(9):973-75
Timepoint [3] 416169 0
Immediately after intervention
Secondary outcome [4] 416170 0
Cancer worry - How worried would you be about developing breast cancer after receiving this letter? (from Qualtrics survey

Sutton S, Bickler G, Sancho-Aldridge J, et al. Prospective study of predictors of attendance for breast screening in inner London. Journal of Epidemiology & Community Health 1994;48(1):65-73.
Timepoint [4] 416170 0
Immediately after intervention
Secondary outcome [5] 416171 0
Emotion - BERRI (Petrova et al., 2022):
How do you feel about this letter from BreastScreen? (from Qualtrics survey)

Petrova D, Cokely ET, Sobkow A, Traczyk J, Garrido D, Garcia-Retamero R. Measuring feelings about choices and risks: The Berlin Emotional Responses to Risk Instrument (BERRI). Risk Anal. 2022 May 23. doi: 10.1111/risa.13946. Epub ahead of print. PMID: 35606164.
Timepoint [5] 416171 0
Immediately after intervention

Eligibility
Key inclusion criteria
Women living in Australia aged 70-74 years, screened for breast cancer at least once in the past 5 years.
Minimum age
70 Years
Maximum age
74 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Personal history of breast cancer or DCIS

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)
Central randomisation by computer: Qualtrics survey software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Qualtrics survey software utilizes the Mersenne Twister pseudorandom number generator to randomise participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome will be informed choice, defined by adequate conceptual knowledge and screening intention that aligns with attitudes toward breast screening. Secondary outcomes will be intention to speak with a doctor, perceived risk of developing breast cancer and breast cancer worry. All measures will be either validated and/or previously used where possible. Using a conservative estimate that 50% of participants in one of the study groups will make an informed choice, we will require 110 participants per group (330 total) to detect a 20% difference in informed choice between groups (80% power, a of 5%, two-sided test).

We will test for overall differences between randomised conditions using multinomial regression models for ordinal outcomes, and linear regression models for continuous variables. All statistical models will include intervention group (usual care, written information, animation video information) as categorical covariates. Planned simple contrasts will also be conducted to test where any differences may lie between the different intervention groups. A Bonferroni-adjusted significance threshold of p=0.017 will be employed for multiple pairwise comparisons. In addition, a sensitivity analysis will be conducted. Responses from participants from Western Australia will be removed to test whether the outcomes differ (to account for the fact that older women in Western Australia receive information about the upper age of screening programs).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2023
Actual
8/03/2023
Date of last participant enrolment
Anticipated
Actual
29/03/2023
Date of last data collection
Anticipated
Actual
29/03/2023
Sample size
Target
376
Accrual to date
Final
376
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312524 0
Other Collaborative groups
Name [1] 312524 0
Australian Association of Gerontology
Country [1] 312524 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
School of Public Health
Edward Ford Building A27
The University of Sydney
NSW
2006
Country
Australia
Secondary sponsor category [1] 314350 0
None
Name [1] 314350 0
Address [1] 314350 0
Country [1] 314350 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311858 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 311858 0
Ethics committee country [1] 311858 0
Australia
Date submitted for ethics approval [1] 311858 0
14/10/2022
Approval date [1] 311858 0
07/02/2023
Ethics approval number [1] 311858 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122622 0
Prof Kirsten McCaffery
Address 122622 0
Room 128B, Edward Ford Building A27
The University of Sydney NSW 2006
Country 122622 0
Australia
Phone 122622 0
+61 2 9351 7220
Fax 122622 0
Email 122622 0
[email protected]
Contact person for public queries
Name 122623 0
Jenna Smith
Address 122623 0
Room 128C, Edward Ford Building A27
The University of Sydney NSW 2006
Country 122623 0
Australia
Phone 122623 0
+61 2 8627 0095
Fax 122623 0
Email 122623 0
[email protected]
Contact person for scientific queries
Name 122624 0
Jenna Smith
Address 122624 0
Room 128C, Edward Ford Building A27
The University of Sydney NSW 2006
Country 122624 0
Australia
Phone 122624 0
+61 2 8627 0095
Fax 122624 0
Email 122624 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
In line with our ethics approval, participant data will be made anonymous and will be aggregated for the purpose of statistical analyses. Findings will be reported at the group/condition level rather than the individual participant level.


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
No additional documents have been identified.