Although selective estrogen receptor modulators (SERMs) reduce the risk of developing breast cancer (BC) in women at increased risk of the disease, there are also risks to consider. Guidelines suggest that such women should be counseled on risk-reducing options including SERMs. However, overall uptake is low. Previous results of DMP-1 showed that the health care provider’s (HCP) recommendation plays an important role in a woman’s decision to use a SERM. In this secondary analysis we aimed to better understand the counseling process of HCPs in the clinical care setting.
Women (N = 1,023) and their HCP discussed SERM use for BC risk reduction and were asked about the counseling, including risks and benefits presented and whether the HCP recommended SERM use. HCPs were also asked to report on the reasons for their recommendation and if the patient was likely to take a SERM or not. We describe the counseling and evaluate the agreement between the HCPs’ and women’s responses.
HCPs reported on 1,022 counseling sessions. Benefits of SERMs in BC risk reduction were discussed in 96% of consultations; the risk of thromboembolism, endometrial cancer, and menopausal symptoms was discussed in > 86%; the risk of cataracts and decrease in libido in < 58%. Five HCPs reported no SERM discussion and were excluded. 66% of HCPs based their recommendation of SERM use on the Gail model risk score. Data for 895 participants were available to evaluate agreement. There was a modest agreement between the women’s and the HCPs’ statements on SERM recommendation (kappa=0.50), with fair agreement on the strength of the recommendation (weighted kappa=0.22) and substantial agreement between a woman’s decision and the HCP’s assumption of what his/her patient would do (kappa=0.65).
Most severe medical risks associated with SERM use were discussed during the counseling. The fairly low percentage of discussions about potential sexual consequences was comparable to that of other studies. Overall, there was fair to moderate agreement between HCPs and women’s perceptions of the counseling. Of note, HCPs had a good sense of what treatment the counseled women would choose. Support: U10CA180868, -180822; UG1-CA189867.
Clinical trial identification
NRG Oncology/NSABP DMP-1; NCT01399359; Opened to accrual: 8-1-11.
Legal entity responsible for the study
NRG Oncology via NIH Grants: U10CA180868, -180822; UG1-CA189867.
All authors have declared no conflicts of interest.