Australian Women’s Intentions and Psychological Outcomes Related to Breast Density Notification and Information

Key Points Question What is the effect of mammographic breast density notification and information provision on women’s intention to seek supplemental screening and self-reported psychological outcomes? Findings In this randomized clinical trial of 1420 women living in Australian jurisdictions without widespread breast density notification, women who viewed a hypothetical screening mammogram results letter with breast density notification and information were significantly more likely to report intention to seek supplemental screening and feeling anxious, uneasy, confused, and worried about developing cancer. Meaning The findings of this trial indicate that more evidence on overall benefits and harms of notification, as well as adequate and equitable service planning and communication strategies, is warranted to inform decisions on widespread breast density notification.


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] Behaviour
Comparator / control treatment The control group will be randomised to receive a screening mammogram result without the breast density messaging.

Outcomes Primary outcome [1]
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.

Primary outcome [2] Anxiety
The following item will be used to measure anxiety.

Primary outcome [3]
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.

Secondary outcome [1]
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.

Secondary outcome [2]
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

Secondary outcome [3]
Breast cancer perceived risk will be measured using the following items:

Timepoint [3]
Immediately after the intervention

Secondary outcome [4]
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') 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.

Trial related presentations / publications
Public notes

Contacts
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.