Screening participant and health service impact of population-based breast density notification in Australia: a randomised controlled trial in BreastScreen Queensland - Trial ANZCTR12623000001695

Timeline & Enrollment

Primary Outcome

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, Vachon CM, Breitkopf CR. Breast Density Awareness, Knowledge, and Attitudes Among US Women: National Survey Results Across 5 Years. Journal of the American College of Radiology. 2020;17(3):391-404;; Health service use (GP visitation) Health service use in terms of GP visitation will be measured using the following items (depending on time of measurement): After recently receiving your screening mammogram result letter, are you planning to talk to your GP about it? (Timepoint 1: intention) Yes/No/Don't know Since receiving the screening mammogram result letter about 1 year ago, have you spoken to your GP about it? (Timepoints 2 and 3: actual use) Yes/No/Don't know Reference: Dolan H, McCaffery K, Houssami N, Cvejic E, Brennan M, Hersch J, et al. Australian Women's Intentions and Psychological Outcomes Related to Breast Density Notification and Information: A Randomized Clinical Trial. JAMA Netw Open. 2022;5(6):e2216784;; Health service use (supplemental screening) Health service use in terms of supplemental screening is a composite outcome comprising of five elements: intention to go for/actual use of supplemental screening, choice of extra tests, willingness to pay/actual paying out of pocket, the outcome of any supplemental screening, and frequency of supplemental screening. For Timepoint 1 (intention): Participants will be asked if they would go for extra tests (supplemental screening) after receiving their mammogram result letter (Yes/No/Don't know). If they choose yes, they will be further prompted to choose which extra test (ultrasound, MRI, ultrasound and MRI, digital breast tomosynthesis, other, don't know). Participants will also be asked if they are willing to pay out of pocket for supplemental screening. For Timepoints 2 and 3 (actual use): Participants will be asked if they have gone for extra tests (supplemental screening) after receiving their mammogram result letter (Yes/No/Don't know). If they choose yes, they will be further prompted to choose which extra test (Ultrasound, MRI, Ultrasound and MRI, Digital breast tomosynthesis, Other, Don't know). They will also be asked the outcome of the further screening (Negative result - no abnormalities detected/Positive result - DCIS or breast cancer detected/Further investigation was required - e.g. needle biopsy/Unsure), the frequency of tests they attended (1-2/3-4/5-6/7+), and if they paid for the extra screening out of pocket (Yes/No/Don't know). Reference: Dolan H, McCaffery K, Houssami N, Cvejic E, Brennan M, Hersch J, et al. Australian Women's Intentions and Psychological Outcomes Related to Breast Density Notification and Information: A Randomized Clinical Trial. JAMA Netw Open. 2022;5(6):e2216784

Summary

This study aims to assess the effect of notifying women participating in population-based breast cancer screening of their breast density on their psychosocial outcomes and health services use; and to determine whether using different modes of communication (hard-copy vs online) alters these effects. Study details: You may be eligible for this study if you are a woman attending BreastScreen Queensland Sunshine Coast Service for a mammogram and are found to have dense breasts (BI-RADS category C or D - heterogeneously dense or extremely dense). Please note that this study is not enrolling women who have been diagnosed with breast cancer or ductal carcinoma in-situ. Participants will be randomly allocated to one of three arms: 1) standard care in BreastScreen Australia (no notification of breast density) vs. 2) notification of breast density plus a hard-copy written health literacy sensitive information vs. 3) notification of breast density plus online written and video-based health literacy sensitive information. Participants will then be followed up for over 2 years and be asked to complete questionnaires assessing their anxiety, health service usage and changes in knowledge and breast screening habits. It is hoped that findings from this study will help determine the utility and effects of providing breast density information to women as part of population-based breast screening.

ICD-10 Classifications