Background: The WISDOM Study (Women Informed to Screen Depending on Measures of risk) aims to examine the effectiveness of personalized breast cancer screening and to bring objective recommendations to the current mammography screening debate. The WISDOM Study is a 100,000 woman randomized trial with a preference-tolerant design that will determine if risk-based screening (RBS) vs. annual screening, is as safe, less morbid, enables prevention and is preferred by women. A pilot was conducted to test the logistics of online participation and examine the acceptance of the study design and approach.
Methods: Women were recruited from the UCSF site of the Athena Breast Health Network, a clinical care-research cohort of 110,000 women from the 5 University of California Medical Centers and Sanford Health. The pilot recruited women via email who were 40 -74 years of age with no history of breast cancer and a normal mammogram in the past year. Those interested visited the WISDOM Study website (wisdomstudy.org), signed up, elected randomization or self-selection, provided electronic consent using DocuSign (eConsent), and completed genetic testing (RBS arm). The Breast Cancer Surveillance Consortium (BCSC) model (standard risk factors, ethnicity, and breast density) in addition to genetic testing (9 genes and 75 SNPs) was used to calculate breast cancer risks that informed the start and frequency of screening for women in the RBS arm. BCSC was also used in the annual screening arm but did not inform mammography screening recommendations. The pilot used a mixed method approach (using enrollment data, Exit Survey data, individual interviews and focus groups) to assess enrollment preferences, randomization acceptance and overall study workflow.
Results: The online electronic enrollment process and patient engagement portal was successfully implemented. In total, 639 women were invited, 235 registered (34%), and 171 (27%) consented to the pilot. Of these, 74% (127) elected to be randomized, and 26% chose to self-assign (66% chose annual screening (29)). Mean age was 56 years and the ethnic breakdown of the cohort was: 79% White, 10% Asian, 7% Latino, 3% Black, 1% other. 92% of those in the risk-based arm of the study completed genetic testing and were given results; only one genetic mutation was identified and occurred in CHEK2. Within the RBS arm (78), mammography recommendations were: 61% no further mammography until the age of 50, 22% biennial, 11% annual, and 6% every 6 month alternating MRI and mammogram. Exit Survey data illuminated confusion in study arm names (risk-based vs. annual), randomization acceptance (74%), annual arm preference in the self-selection group (66%), eConsent satisfaction (90%), enrollment process ease of use (88%), and website content, navigation and appearance satisfaction (66%). The pilot concluded in May 2016 to allow for refinements prior to the full trial.
Conclusion: Our pilot demonstrates that the majority of women are willing to be randomized and participate in an online screening study to answer the important question on optimal breast cancer screening. The pilot study results will inform implementation of the 100,000 women WISDOM Study which launches in fall of 2016.
Citation Format: Stover Fiscalini A, Theiner S, Kaplan C, Sarrafan S, Sawyer S, Liang A, Rosenberg-Wohl S, Gordon D, Frick M, Borowsky A, Anton-Culver H, Naeim A, LaCroix A, Cink T, Collaboration Athena Breast Health Network and Advocate Partners, Esserman L, van 't Veer L. Evaluating the feasibility of a web-based preference-tolerant randomized trial of risk-based vs. annual breast cancer screening: WISDOM study pilot [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-02-03.
