Abstract PD2-14: Participation in a personalized breast cancer screening trial does not increase anxiety at baseline
Authors: Naeim A , Sepucha K , Wenger N , Eklund M , Annette S , Madlensky L , van't Veer L , Parker B , Yau C , Cink T , Anton-Culver H , Borowsky A , Petruse A , Sarrafan S , Stover-Fiscalini A , LaCroix A , Adduci K ,   Wisdom Advocate Partners, Laura E 
Published: February 2018

Abstract
Introduction: The purpose of this study is to examine whether participation in a personalized screening trial is associated with anxiety or breast cancer worry. The Patient Centered Outcomes Research Institute recently funded WISDOM (Women Informed to Screen Depending On Measures of risk), which is a randomized trial that tests the safety and efficacy of basing starting age, stopping age, frequency and modality of breast cancer screening on individual risk (Clinical Trials Identifier NCT02620852).
Methods: In WISDOM, participants can be randomized to annual screening or personalized screening arm, or self-select an arm an observational cohort. This interim analysis examined the first 1817 participants to determine if the personalized risk arm is acceptable and to explore whether baseline anxiety was associated with study arm. For acceptability our target was to have &gt;60% of participants agree to randomization. Participants completed questions about their Risk Perception, the PROMIS Anxiety short form 8a (total scores 8-40 with higher scores indicating more anxiety), and Breast Cancer Risk Worry (BCRW) survey (total scores 5-20) with higher scores indicating more worry) at baseline and before they were given information on their personal risk or study assignment. For the purposes of these analyses, we defined high anxiety to be the percentage of participants scoring =&gt;22 on the PROMIS and &gt;8 on the BCRW.
Results: The participants were recruited from three sites (UCSD, UCSF, Sanford Health). Of the 1817 initial participants, 1643 completed the baseline questionnaire. Participants has a mean age of 57 years (SD 9). 15.8% felt their chances of developing breast cancer was high, 19.5% felt their chance of developing breast cancer was greater than the average women, and 56.6% felt their lifetime risk of developing breast cancer was &gt;25. Risk perception was not significantly different between women who opted to be randomized versus the observational arm.
The majority of participants were willing to be randomly assigned to an arm (1071/1643, 65.1%). Of those who joined the observational cohort, the majority selected personalized risk arm (474/572, 82.9%). Overall, PROMIS anxiety scores were low at baseline (14.0 MEAN (SD 4.6)) as were the Breast Cancer Risk Worry scores (5.7 MEAN (SD 1.05)). Less than 8% of participants had PROMIS scores &gt;22 and that did not vary across the randomized or observational groups (P=0.2)). About 2% of participants had a BCRW scores &gt;8. Women who worried with breast cancer were more likely to select to be in the observational (3.5%) than randomized (1.7%) arm of the study (P=0.02).
Conclusions: For the women approached to participate in Wisdom, personalized screening was acceptable alternative to annual mammography. Participants in general overestimated their lifetime risk of breast cancer, had very low anxiety and low breast cancer worry. Those who were worried about breast cancer opted more often for the observational arm of the study to allow them to choose between the personalized versus annual arm. Future analyses will follow participants prospectively to determine adherence to assigned or selected arm, and whether anxiety changes after receipt of their personalized risk information.
Citation Format: Naeim A, Sepucha K, Wenger N, Eklund M, Annette S, Madlensky L, van't Veer L, Parker B, Yau C, Cink T, Anton-Culver H, Borowsky A, Petruse A, Sarrafan S, Stover-Fiscalini A, LaCroix A, Adduci K, Wisdom Advocate Partners, Laura E. Participation in a personalized breast cancer screening trial does not increase anxiety at baseline [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr PD2-14.