A CBTH intervention for reducing stress in women with high risk in a DCE-MRI breast cancer screening study.

e22507 Background: A growing number of studies have demonstrated the diagnostic equivalency of abbreviated MRI to the full MRI protocol. We launched the Chicago Alternative Prevention Study for BReast CAncer (CAPSBRACA; clinicaltrials.gov:NCT00989638) to test the hypothesis that state-of-the-art genomic testing to identify women at increased risk, combined with state-of-the-art MRI techniques, could effectively detect and downstage aggressive interval breast cancers, and provide a personalized approach for management of high-risk women in diverse populations. In a sub-study, we randomized participants to a novel CBTH intervention designed to address acute and long-term anxiety and improve adherence. Methods: To date, the cohort consists of 142 participants (mean age 47.7±17.6) including 44 BRCA1 carriers, 42 BRCA2, 7 PALB2, 4 in other genes, 25 with PRS > 30%, and 8 for family history. 82 were randomized to intervention (I) or control (C) arm. I arm patients receive a CBT workbook and listen to a hypnosis exercise at first baseline visit before MRI. Both arms fill out Beck Depression Inventory (BDI) and State-Trait Anxiety Inventory (STAI) every 6 months, and a 10-point anxiety scale at four within-visit timepoints (before MRI and hypnosis, before MRI, during MRI, and after MRI). Blood is drawn each visit to objectively measure stress via biomarker levels (CRP, IL10, IL1β, IL6, TNFα). Primary endpoint is adherence. Statistical analysis: Baseline biomarker levels were Pearson correlated with STAI and BDI. Adherence rates were compared using Fisher’s exact test. STAI, BDI, and 10-point anxiety scores were analyzed by fitting mixed effects regression models to compare changes over time in the two arms. Anxiety scores were summed over the four within-visit timepoints. Fixed effects included in the models were treatment arm, age, race, time, and treatment-by-time interaction; subjects comprised the random effect. The treatment-by-time interaction term compares the change in scores (slopes) between the arms. Results: Mean baseline STAI±SD was 55.1±4.3, 53.2±3.2 for C and I arms, respectively. Completed BDI forms scored within 0-9 (minimal depression) for C and I arms. Baseline CRP, IL6, and IL10 were positively correlated to BDI (p = 0.04, 0.007, 0.001; R = 0.34, 0.44, 0.51). Current follow-up extends to 24 months. Adherence rates were 33/39, 23/31, 10/19, 2/5 at 6, 12, 18, 24 months in the C arm vs. 33/38, 25/30, 11/18, 0/5 in the I arm. The differences were not statistically significant (p = 1.0, 0.58, 0.85, 0.43). There were no statistical differences of scores between the C and I arms (p-value for slope difference = 0.82, 0.26, 0.38, respectively). Conclusions: We found no significant differences between the two arms in adherence or STAI, BDI, or anxiety measures over time. A CBTH intervention however added to time spent in clinic and appears to have minimal efficacy in reducing stress and maintaining adherence. Clinical trial information: NCT03729115 .