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Examination of Australian women's intentions and psychological outcomes related to breast density notification with mammography screening results: An online randomised experiment

Examination of Australian women's intentions and psychological outcomes related to breast density notification with mammography screening results: An online randomised experiment

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000253808
Enrollment
1505
Registered
2021-03-09
Start date
2021-07-04
Completion date
2021-08-30
Last updated
2022-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is investigating how different formats of information provision on breast density affect women’s screening intentions, psychological outcomes and knowledge of breast density. Who is it for? You may be eligible for this trial if you are female, aged 40-74 years, live outside Western Australia and have no prior history of breast cancer or ductal carcinoma in situ. Study details Participants in this study will complete an online questionnaire and during which will be presented with a hypothetical scenario of undergoing a routine screening mammogram and receiving the results. Participants will be randomised to receive control information (screening mammogram result without the breast density messaging) or one of two versions of the intervention with breast density information via notification messaging. Participants will then be asked to complete questions in response to the information they have received. It is hoped this study will inform researchers of how different formats of information on breast density impact women's screening intentions and psychological outcomes.

Interventions

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 b

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.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
40 Years to 74 Years
Healthy volunteers
Yes

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.

Exclusion criteria

Male, aged under 40 or over 74, lives in Western Australia, has a prior history of breast cancer or DCIS

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026