Effect of Inquiry-Based Stress Reduction on Well-being and Views on Risk-Reducing Surgery Among Women With BRCA Variants in Israel: A Randomized Clinical Trial.

Importance: The high risk for breast and ovarian cancers conferred by being a carrier of BRCA1 or BRCA2 germline variant can negatively impact physical and psychological well-being. Novel nonpharmacological interventions on well-being in women with BRCA variants have rarely been reported. Objective: To determine the effect of a 12-week inquiry-based stress reduction (IBSR) program on psychological well-being, sleep quality, psychosocial variables, and attitudes toward risk-reducing surgical procedures among women in Israel who carried BRCA variants. Design, Setting, and Participants: This randomized clinical trial had a 12-week intervention period and a 12-week follow-up period. It was conducted between April 1, 2017, and July 31, 2020. Participants were recruited from the Meirav Breast Center at the Sheba Medical Center, Israel, and the intervention was conducted in Tel Aviv, Israel. The cohort included women with BRCA variants. Data were analyzed from August 1 to December 1, 2020. Interventions: Women were randomly assigned to the 12-week IBSR program or standard care. The IBSR technique is based on the skills of mindfulness, inquiry, and cognitive reframing. The intervention included standardized, weekly group meetings conducted throughout 12 weeks. Standard care included semi-annual breast examinations and breast magnetic resonance imaging (alternating), a gynecological examination, a transvaginal ultrasonographic examination, and CA-125 serum determination. Differences between the groups were tested using mixed-effects models in an intent to treat analysis. Main Outcomes and Measures: The primary outcome was psychological well-being, including 6 parameters: autonomy, personal growth, positive relationships, control of the environment, goals in life, and self-acceptance. Secondary outcomes included sleep quality, attitudes toward risk-reducing surgical procedures, and psychosocial variables. Questionnaires were administered at baseline (T1), at completion of the 12-week intervention (T2), and 12 weeks after completion of the intervention (T3). Results: Overall, 100 women (mean [SD] age, 41.37 [11.06] years) completed the study, with 50 randomized to the intervention group and 50 randomized to the control group. Mean (SD) time from variant discovery was 4.7 (3.3) years. There were no differences between the intervention and control groups in baseline mean (SD) scores of psychological well-being parameters (autonomy: 55.20 [11.12] vs 56.77 [9.90]; environmental control: 56.30 [11.98 vs 58.51 [11.41]; positive relationships: 63.10 [15.91] vs 68.10 [9.86]; goals in life: 60.00 [14.12] vs 64.82 [10.57]; self-acceptance: 55.02 [16.62] vs 60.32 [13.50]) except personal growth (63.70 [14.66] vs 68.85 [8.07]). The IBSR group, compared with the control group, experienced better mean (SD) scores on all psychological well-being parameters at T2 (autonomy: 63.64 [8.35] vs 54.73 [10.41]; environmental control: 63.95 [10.05] vs 57.45 [11.43]; personal growth: 73.00 [8.34] vs 65.76 [10.95]; positive relationships 71.17 [9.99] vs 65.06 [12.58]; goals in life: 67.57 [8.88] vs 61.18 [12.87]; self-acceptance: 66.93 [11.15] vs 58.09 [15.55]) and at T3 (autonomy: 62.68 [9.05] vs 56.12 [10.64]; environmental control: 64.55 [10.28] vs 59.35 [12.98]; personal growth: 72.00 [8.06] vs 67.15 [11.82]; positive relationships: 71.24 [9.78] vs 66.92 [12.37]; goals in life: 68.33 [8.54] vs 62.92 [13.24]; self-acceptance: 66.84 [11.35] vs 58.97 [17.03]). Individuals in the IBSR group also experienced statistically significant improvements in sleep quality (mean [SD]: T1, 7.35 [3.97]; T3, 4.63 [3.21], P < .001), whereas the control group experienced no statistically significant difference. Women in the intervention group had a more favorable consideration of risk-reducing oophorectomy, from 7 women (14%) who refused to consider oophorectomy at T1 to 1 woman (2%) who refused to consider it at T3 (P = .04), and similar change in consideration of mastectomy: from 23 women (46%) who refused to consider mastectomy at T1 to 13 women (29%) who refused to consider it at T3 (P < .001). Conclusions and Relevance: This randomized clinical trial found that IBSR improved psychological well-being and led to a more favorable view on risk-reducing surgical procedures for at least 6 months among women in Israel who carried BRCA variants. These results suggest that IBSR may be implemented as a self-practice tool to enhance the well-being of individuals who carry BRCA variants and support them in their decision-making processes. Trial Registration: ClinicalTrials.gov Identifier: NCT03162276.

Do health policy advisors know what the public wants? An empirical comparison of how health policy advisors assess public preferences regarding smoke-free air, and what the public actually prefers.

BACKGROUND: Health policy-making, a complex, multi-factorial process, requires balancing conflicting values. A salient issue is public support for policies; however, one reason for limited impact of public opinion may be misperceptions of policy makers regarding public opinion. For example, empirical research is scarce on perceptions of policy makers regarding public opinion on smoke-free public spaces. METHODS: Public desire for smoke-free air was compared with health policy advisor (HPA) perception of these desires. Two representative studies were conducted: one with the public (N = 505), and the other with a representative sample of members of Israel's health-targeting initiative, Healthy Israel 2020 (N = 34), in December 2010. Corresponding questions regarding desire for smoke-free areas were asked. Possible smoke-free areas included: 100% smoke-free bars and pubs; entrances to health facilities; railway platforms; cars with children; college campuses; outdoor areas (e.g., pools and beaches); and common areas of multi-dweller apartment buildings. A 1-7 Likert scale was used for each measure, and responses were averaged into a single primary outcome, DESIRE. Our primary endpoint was the comparison between public preferences and HPA assessment of those preferences. In a secondary analysis, we compared personal preferences of the public with personal preferences of the HPAs for smoke-free air. RESULTS: HPAs underestimated public desire for smoke-free air (Public: Mean: 5.06, 95% CI:[4.94, 5.17]; HPA: Mean: 4.06, 95% CI:[3.61, 4.52]: p < .0001). Differences at the p = .05 level were found between HPA assessment and public preference for the following areas: 100% smoke-free bars and pubs; entrances to healthcare facilities; train platforms; cars carrying children; and common areas of multi-dweller apartment buildings. In our secondary comparison, HPAs more strongly preferred smoke-free areas than did the public (p < .0001). CONCLUSIONS: Health policy advisors underestimate public desire for smoke-free air. Better grasp of public opinion by policy makers may lead to stronger legislation. Monitoring policy-maker assessment of public opinion may shed light on incongruities between policy making and public opinion. Further, awareness of policy-maker misperceptions may encourage policy-makers to demand more accurate information before making policy.