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185 A co-designed randomised controlled trial of screening participant and health service impact of population-based breast density notification in Australia
  1. Brooke Nickel1,2,
  2. Nick Ormiston-Smith3,
  3. Lisa Hammerton4,
  4. Erin Cvejic1,
  5. Paul Vardon3,
  6. Zoe Mcinally3,
  7. Paula Legerton3,
  8. Karen Baker3,
  9. Jennifer Isautier1,
  10. Emma Larsen4,
  11. Michelle Giles5,
  12. Meagan Brennan6,7,
  13. Kirsten McCaffery1,2,
  14. Nehmat Houssami2,8
  1. 1Sydney Health Literacy Lab, School of Public Health, The University of Sydney, New South Wales, Australia
  2. 2Wiser Healthcare, School of Public Health, The University of Sydney, New South Wales, Australia
  3. 3Cancer Screening Branch, Queensland Department of Health, Queensland, Australia
  4. 4BreastScreen Queensland Sunshine Coast Service, Queensland, Australia
  5. 5BreastScreen Victoria, Maroondah Service, Eastern Health, Victoria, Australia
  6. 6Westmead Breast Cancer Institute, Westmead Hospital, Sydney, Sydney, Australia
  7. 7University of Notre Dame Australia, School of Medicine Sydney, Sydney, Australia
  8. 8The Daffodil Centre, A joint venture between Cancer Council NSW and The University of Sydney, Australia

Abstract

Introduction Robust evidence on the benefits and harms of breast density notification is required to inform current and future mammography screening policy and practice. This randomised controlled trial (RCT) aims to assess the effect of notifying women with dense breasts of their breast density on their psychosocial outcomes and health services use; and to determine whether using different modes of communication alters these effects.

Methods Co-designed with breast screening services and consumers in Australia to address key national evidence gaps and priorities. Weekly meetings with partners, local consumers and practitioners, led to the design of the intervention and implementation of prospective 3-arm RCT: standard care (no notification of breast density) vs. notification of breast density plus a hard-copy written health literacy sensitive information vs. notification of breast density plus a link to online video-based health literacy sensitive information. Women (n=2856) attending population-based mammography screening classified as having dense breasts (BI-RADS density C and D) randomised. Primary outcome measures include psychological and health service use. Baseline demographic screening data and self-report data collected from women over a >2-year follow-up period (8–10- week, 12- and 27-month timepoints). A longitudinal qualitative sub-study (n=60) conducted at the three timepoints.

Results Recruitment and initial 8–10 week data collection is underway. The protocol for this co- designed RCT, and descriptive data, participation rates and preliminary 8–10 week data will be presented.

Discussion This is the first service-embedded RCT in Australia and the world to test the immediate and downstream impact of breast density notification on women and health services prior to systemic implementation. This evidence will help minimise potential harms and map out consequences of widespread breast density notification.

Conclusion Findings will directly inform Australia’s current and future policy and practice on this controversial issue, and may be relevant to screening programs in other countries.

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