The WISDOM study pilot: Evaluating a preference-tolerant RCT of risk-based vs. annual breast cancer screening.

Abstract

e13035 Background: The goal of the WISDOM study (Women Informed to Screen Depending on Measures of risk) is to examine the effectiveness of a personalized approach to breast cancer screening and to bring clarity and objective recommendations to the current debate regarding mammography screening frequency. The WISDOM study, funded by PCORI, is a randomized trial with a preference-tolerant design that aims to determine if risk-based (RBS), vs. annual screening, is as safe, less morbid, enables prevention and is preferred by women. A pilot was conducted to test the logistics and examine the acceptance of the study. Methods: Women were recruited from the UCSF site of the Athena Breast Health Network, a clinical care-research cohort including 100,000 women from the 5 UC Medical Centers and Sanford Health. We recruited women 40 -74 years of age that had no history of breast cancer and had a normal mammogram in the past year. The Breast Cancer Surveillance Consortium model (standard risk factors, ethnicity, breast density and SNP risk alleles) in addition to gene panel testing was used to calculate breast cancer risks to inform the start and frequency of screening. Results: An online electronic enrollment process, e-Consent and patient engagement portal was successfully implemented. To date, 623 women were invited, 220 registered, and 159 have completed intake. 72% chose to be randomized, and 28% chose to self-assign, of whom 70% chose annual screening. Mean age of pilot participants was 56 years old. The ethnic breakdown of the cohort is: 80% White, 10% Asian, 4% Latino, 3% Black, and 3% other. 30% of participants identify as having Jewish ancestry. Initial patient interviews reveal overall enthusiasm for the study and provide ongoing feedback to improve the study materials. The pilot will conclude April 2016 when the full trial is launched. Additional data on distribution of personal risk estimates, and exit survey data evaluating uptake of screening recommendations will be presented. Conclusions: Our pilot reveals that the majority of women are willing to be randomized to answer the important question on optimal breast cancer screening. This pilot study is designed to inform the implementation of the 100,000 women WISDOM Study. Clinical trial information: NCT02620852.