Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000253808
Ethics application status
Approved
Date submitted
1/01/2021
Date registered
9/03/2021
Date last updated
2/12/2022
Date data sharing statement initially provided
9/03/2021
Date results provided
2/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Examination of Australian women's intentions and psychological outcomes related to breast density notification with mammography screening results: An online randomised experiment
Scientific title
Examination of Australian women's intentions and psychological outcomes related to breast density notification with mammography screening results: An online randomised experiment
Secondary ID [1] 303011 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast density 320071 0
Breast cancer screening 320537 0
Breast cancer 320668 0
Condition category
Condition code
Public Health 318000 318000 0 0
Other public health
Cancer 318394 318394 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to quantitively assess how different formats of information provision on breast density affect women’s screening intentions, psychological outcomes (anxiety and breast cancer worry) and knowledge of breast density.

This study will use a 3-arm randomised trial design. This trial will be conducted online through a survey platform. An online sample of Australian women (outside of Western Australia) will be recruited through a large market research organisation. Women will be aged between 40 to 74 years with no prior history of breast cancer or ductal carcinoma in situ (DCIS). Women will not be required to have undergone screening mammogram prior to participating in this study.

Women will be presented with a hypothetical scenario in which they were asked to imagine going for a routine mammogram screening and receiving a letter about their mammogram results. Women then will be randomised to be shown one of three example letters (written format) about mammography results.

Arm 1: Control group (standard screening mammogram result)
Women in the control group will be shown a standard screening mammogram result letter, which will show a “clear” result, i.e., no breast cancer could be seen on the mammogram. This letter will be similar to the ones that breast screening services in Australia send out to women with ‘clear’ results.

Arm 2: Intervention 1 (standard screening mammogram result + existing breast density notification messaging (e.g. WA))
Women in the intervention 1 will be shown the same letter as the control group, along with an additional breast density notification letter for women with dense breasts. This breast density letter will be identical to the ones that screening services in Western Australia send out to women who are found to have dense breast tissue. This letter includes information that the woman’s breast tissue is dense, followed by information on what breast density means, its implications and following up with a GP.

Arm 3: Intervention 2 (standard screening mammogram + health literacy sensitive breast density messaging)
Women in the intervention 2 will be shown the same letter as the control group, along with an additional breast density notification letter for women with dense breasts. This letter will be developed by the research team and will be health literacy appropriate, i.e. tailored for a reading level of grade 8. It will also incorporate health literacy strategies such as avoiding complex medical terminologies, using spaces and images or icons. This letter will include information such as woman's breast density level, what is breast density and its implications, what can be done, what are the pros and cons of additional testing and speaking with a healthcare provider.

The online intervention will be administered once only with no repeat or subsequent sessions upon completion. It will take 10-15 minutes for participants to take part in the study.

Adherence to the intervention will be ensured by forcing a response for outcome measurement items that follow the intervention and by monitoring the overall time taken to complete the online study.
Intervention code [1] 319351 0
Behaviour
Comparator / control treatment
The control group will be randomised to receive a screening mammogram result without the breast density messaging.
Control group
Active

Outcomes
Primary outcome [1] 326064 0
Screening intention

This outcome is a composite outcome comprising of four elements: intention to go for extra tests, choice of extra tests, intention to change screening frequency and intended change in screening frequency (increase or decrease).

Participants will be asked if they would go for extra tests (supplemental screening) after receiving the intervention or control messaging (Yes/No/Don't know). If they choose yes, they will be further prompted to choose which extra test (ultrasound, MRI, ultrasound and MRI, tomosynthesis, or other) they would go for. Participants will be asked whether they would change how often they go for screening mammogram after receiving the intervention or control messaging (Yes/No/Don't know) and if yes, whether they would go more frequently or less frequently.


Timepoint [1] 326064 0
Immediately after intervention
Primary outcome [2] 326065 0
Anxiety

The following item will be used to measure anxiety.

Please indicate the extent of your agreement or disagreement with the following statements.
Receiving this letter does/would make me feel anxious (uneasy, worried, nervous)*
4-point scale (1 = ‘strongly agree’ to 4 = ‘strongly disagree’)

Reference: Rhodes DJ, Jenkins SM, Hruska CB, et al. Breast Density Awareness, Knowledge, and Attitudes Among US Women: National Survey Results Across 5 Years. J Am Coll Radiol 2020;17(3):391-404. doi: 10.1016/j.jacr.2019.11.003 [published Online First: 2019/11/23]
Timepoint [2] 326065 0
Immediately after intervention
Primary outcome [3] 326066 0
Breast cancer worry

The following item will be used to measure breast cancer worry.

How worried would you be about developing breast cancer after receiving this letter?
4-point scale (1 = ‘strongly agree’ to 4 = ‘strongly disagree’)

Reference: Sutton S, Bickler G, Sancho-Aldridge J, Saidi G. Prospective study of predictors of attendance for breast screening in inner London. Journal of Epidemiology & Community Health. 1994;48(1):65-73.
Timepoint [3] 326066 0
Immediately after intervention
Secondary outcome [1] 390011 0
Breast density-related knowledge

This outcome is a composite outcome comprising of four elements: knowledge of the prevalence of women with dense breasts, knowledge that breast density is an independent risk factor of breast cancer, knowledge of dense breast tissue's masking effect on a mammogram and knowledge of breast density change with age.

Breast density-related knowledge will be measured using both the custom-designed and previously validated items. The items will measure participants' knowledge in relation to the prevalence of women with dense breasts, breast density being an independent risk factor of breast cancer, breast density masking effect on a mammogram and change with age.

Reference: Rhodes DJ, Jenkins SM, Hruska CB, et al. Breast Density Awareness, Knowledge, and Attitudes Among US Women: National Survey Results Across 5 Years. J Am Coll Radiol 2020;17(3):391-404.
Timepoint [1] 390011 0
Immediately after intervention
Secondary outcome [2] 390012 0
Intention to talk to a doctor about breast density will be measured using a single item.

Would you plan to talk to your doctor or nurse about this letter?
Yes/No/Don't know
Timepoint [2] 390012 0
Immediately after intervention
Secondary outcome [3] 390020 0
Breast cancer perceived risk will be measured using the following items:

What do you think is your chance of getting breast cancer in your lifetime if you received this letter?
Below average/Average/Above average

Compared to other people your age, race and sex, what do you think is your chance of getting breast cancer in your lifetime if you received this letter?
Below average/Average/Above average

Reference: Lipkus IM, Kuchibhatla M, McBride CM, Bosworth HB, Pollak KI, Siegler IC, et al. Relationships among Breast Cancer Perceived Absolute Risk, Comparative Risk, and Worries. Cancer Epidemiology Biomarkers & Prevention. 2000;9(9):973-975.
Timepoint [3] 390020 0
Immediately after the intervention
Secondary outcome [4] 390021 0
Other psychological impacts of breast density messaging will be measured using the following items:

The following item will be used to measure anxiety.

Please indicate the extent of your agreement or disagreement with the following statements.
Receiving this letter does/would make me feel informed to make decisions regarding my breast health
4-point scale (1 = ‘strongly agree’ to 4 = ‘strongly disagree’)

Receiving this letter does/would make me feel confused about what to do regarding my breast health
4-point scale (1 = ‘strongly agree’ to 4 = ‘strongly disagree’)

Reference: Rhodes DJ, Jenkins SM, Hruska CB, et al. Breast Density Awareness, Knowledge, and Attitudes Among US Women: National Survey Results Across 5 Years. J Am Coll Radiol 2020;17(3):391-404. doi: 10.1016/j.jacr.2019.11.003 [published Online First: 2019/11/23]
Timepoint [4] 390021 0
Immediately after the intervention

Eligibility
Key inclusion criteria
Australian women aged 40-74, live outside Western Australia and no prior history of breast cancer or DCIS. Women will not be required to have undergone a screening mammogram prior to participation in the study.
Minimum age
40 Years
Maximum age
74 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Male, aged under 40 or over 74, lives in Western Australia, has a prior 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 using Qualtrics survey software.

Researchers will have no direct contact with participants. Once a participant agrees to take part in the study they will be randomly assigned to be immediately sent a questionnaire containing either one of two versions of the intervention or the control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Qualtrics computer software will randomly allocate each participant to one of the arms of the trial as they enter the study.
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 proposed sample (n=1398) provides 80% with an adjusted alpha of 0.025 to account for multiple comparisons between either intervention arm and the control. Statistical analysis will be conducted using planned contrasts between intervention arms and control and implemented in regression models. All data will be analysed by researchers at the University of Sydney and compiled for publication and dissemination.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2021
Actual
4/07/2021
Date of last participant enrolment
Anticipated
1/06/2021
Actual
30/08/2021
Date of last data collection
Anticipated
1/06/2021
Actual
30/08/2021
Sample size
Target
1398
Accrual to date
Final
1505
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,VIC

Funding & Sponsors
Funding source category [1] 307422 0
University
Name [1] 307422 0
The University of Sydney
Country [1] 307422 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] 308088 0
None
Name [1] 308088 0
Address [1] 308088 0
Country [1] 308088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307504 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 307504 0
Ethics committee country [1] 307504 0
Australia
Date submitted for ethics approval [1] 307504 0
16/11/2020
Approval date [1] 307504 0
24/02/2021
Ethics approval number [1] 307504 0
2020/858

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

Contacts
Principal investigator
Name 107470 0
Dr Brooke Nickel
Address 107470 0
Room 127A, Edward Ford Building A27 | The University of Sydney | NSW | 2006
Country 107470 0
Australia
Phone 107470 0
+61 2 9351 7829
Fax 107470 0
Email 107470 0
[email protected]
Contact person for public queries
Name 107471 0
Brooke Nickel
Address 107471 0
Room 127A, Edward Ford Building A27 | The University of Sydney | NSW | 2006
Country 107471 0
Australia
Phone 107471 0
+61 2 9351 7789
Fax 107471 0
Email 107471 0
[email protected]
Contact person for scientific queries
Name 107472 0
Brooke Nickel
Address 107472 0
Room 127A, Edward Ford Building A27 | The University of Sydney | NSW | 2006
Country 107472 0
Australia
Phone 107472 0
+61 2 9351 7789
Fax 107472 0
Email 107472 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
SourceTitleYear of PublicationDOI
EmbaseAustralian Women's Intentions and Psychological Outcomes Related to Breast Density Notification and Information: A Randomized Clinical Trial.2022https://dx.doi.org/10.1001/jamanetworkopen.2022.16784
N.B. These documents automatically identified may not have been verified by the study sponsor.