Validation Study on Risk-Reduction Activities after Exposure to a Personalized Breast Cancer Risk-Assessment Education Tool in High-Risk Women in the WISDOM Study.

We performed a 318-participant validation study of an individualized risk assessment tool in women identified as having high- or highest-risk of breast cancer in the personalized arm of the Women Informed to Screen Depending on Measures of risk (WISDOM) trial. Per protocol, these women were educated about their risk and risk reducing options using the Breast Health Decisions (BHD) tool, which uses patient-friendly visuals and 8th grade reading level language to convey risk and prevention options. Prior to exposure to the educational tool, 4.7% of women were already taking endocrine risk reduction, 38.7% were reducing alcohol intake, and 62.6% were exercising. Three months after initial use of BHD, 8.4% of women who considered endocrine risk reduction, 33% of women who considered alcohol reduction, and 46% of women who considered exercise pursued the risk-reducing activities. Unlike lifestyle interventions which are under the control of the patient, additional barriers at the level of the healthcare provider may be impeding the targeted use of endocrine risk reduction medications in women with elevated breast cancer risk.

Elevated risk thresholds predict endocrine risk-reducing medication use in the Athena screening registry.

Risk-reducing endocrine therapy use, though the benefit is validated, is extremely low. The FDA has approved tamoxifen and raloxifene for a 5-year Breast Cancer Risk Assessment Tool (BCRAT) risk ≥ 1.67%. We examined the threshold at which high-risk women are likely to be using endocrine risk-reducing therapies among Athena Breast Health Network participants from 2011-2018. We identified high-risk women by a 5-year BCRAT risk ≥ 1.67% and those in the top 10% and 2.5% risk thresholds by age. We estimated the odds ratio (OR) of current medication use based on these thresholds using logistic regression. One thousand two hundred and one (1.2%) of 104,223 total participants used medication. Of the 33,082 participants with 5-year BCRAT risk ≥ 1.67%, 772 (2.3%) used medication. Of 2445 in the top 2.5% threshold, 209 (8.6%) used medication. Participants whose 5-year risk exceeded 1.67% were more likely to use medication than those whose risk was below this threshold, OR 3.94 (95% CI = 3.50-4.43). The top 2.5% was most strongly associated with medication usage, OR 9.50 (8.13-11.09) compared to the bottom 97.5%. Women exceeding a 5-year BCRAT ≥ 1.67% had modest medication use. We demonstrate that women in the top 2.5% have higher odds of medication use than those in the bottom 97.5% and compared to a risk of 1.67%. The top 2.5% threshold would more effectively target medication use and is being tested prospectively in a randomized control clinical trial.

Development and pilot of an online, personalized risk assessment tool for a breast cancer precision medicine trial.

Breast cancer risk reduction has been validated by large-scale clinical trials, but uptake remains low. A risk communication tool could provide personalized risk-reduction information for high-risk women. A low-literacy-friendly, visual, and personalized tool was designed as part of the Women Informed to Screen Depending On Measures of risk (WISDOM) study. The tool integrates genetic, polygenic, and lifestyle factors, and quantifies the risk-reduction from undertaking medication and lifestyle interventions. The development and design process utilized feedback from clinicians, decision-making scientists, software engineers, and patient advocates. We piloted the tool with 17 study participants, collecting quantitative and qualitative feedback. Overall, participants felt they better understood their personalized breast cancer risk, were motivated to reduce their risk, and considered lifestyle interventions. The tool will be used to evaluate whether risk-based screening leads to more informed decisions and higher uptake of risk-reduction interventions among those most likely to benefit.

Social support as a moderator of healthcare adherence and distress in long-term hematopoietic cell transplantation survivors.

BACKGROUND: Treatment with hematopoietic cell transplantation (HCT) has potentially severe effects on physical and psychosocial functioning. Poor social support has been linked with physical morbidity and mortality as well as psychological distress in HCT survivors. This study tested a theory-driven hypothesis that social support buffers adverse effects of health stressors of comorbidities and graft-versus-host disease (cGVHD) on distress and adherence to recommended healthcare among long-term HCT survivors. METHODS: This cross-sectional study analyzed baseline data from a randomized controlled trial in adult survivors 3-18 years post-HCT. Data included medical records and patient-reported outcomes including cancer and treatment distress (CTXD), healthcare adherence (HCA), comorbidity index, cGVHD, ENRICHD Social Support Instrument (ESSI), Social Activity Log, and Health Self-Efficacy. We tested hypothesized models for HCA and CTXD using blocked hierarchical linear regressions. RESULTS: Among the 781 HCT survivors completing baseline assessment, 38% had > 3 comorbidities, 8% had moderate-severe cGVHD, 30% reported low social support, 30% reported elevated distress, and 49% reported low healthcare adherence. Social support and self-efficacy were directly related to both adherence and distress. Regression models supported the hypothesized moderated relationships for distress but not for healthcare adherence. CONCLUSIONS: The two tested models confirm that the health stressors of comorbidities and cGVHD are moderated by better social support and self-efficacy in their associations with lower distress but without moderating effects for healthcare adherence. IMPLICATIONS FOR CANCER SURVIVORS: Social support and self-efficacy confer protective benefits on healthcare adherence and psychological distress. Interventions are needed that focus on maintaining social networks or finding new networks if necessary. CLINICAL TRIAL REGISTRATION NUMBER: NCT00799461.

Engagement with INSPIRE, an Online Program for Hematopoietic Cell Transplantation Survivors.

In a secondary analysis of a randomized controlled trial (RCT), we examined participants' engagement with INSPIRE, a personalized online program for hematopoietic cell transplantation (HCT) survivors that focuses on cancer-related distress, depression, fatigue, and health care needs. We approached all adult, 3- to 18-year HCT survivors treated for hematologic malignancy without relapse or second cancer in the previous 2 years for participation in an RCT with either immediate or delayed access to INSPIRE. Participants with immediate access could view the online material at any time. Data included page view tracking, medical records, and patient-reported outcomes, including the Short Form 36 and Cancer and Treatment Distress (CTXD) measures. Of 1322 eligible HCT survivors, 771 (58%) completed the baseline assessment, and 451 received immediate INSPIRE access and were included in analyses. The cohort was 56% male, with a mean age of 52 ± 12.2 years, and 26% received an autologous transplant. Most (77%) logged into the INSPIRE site at least once, and 48% viewed ≥8 pages. Survivors who viewed ≥2 pages were more likely to be age ≥40 years (relative risk [RR], 1.41; 95% confidence interval [CI], 1.10 to 1.80), to be female (RR, 1.22; 95% CI, 1.07 to 1.40), to have chronic graft-versus-host disease (RR, 1.28; 95% CI, 1.08 to 1.51), to be less than 10 years post-HCT (RR, 1.19; 95% CI, 1.01 to 1.39), and to have moderate CTXD distress (RR, 1.34; 95% CI, 1.14 to 1.57). Engagement did not differ by race, education, income, rural/urban residence, computer experience, donor type, or depression (all P ≥ .50). The INSPIRE online program was widely used, including by those who often have reduced access to care after treatment.

Total skin-sparing mastectomy and immediate breast reconstruction: an evolution of technique and assessment of outcomes.

BACKGROUND: Total skin-sparing mastectomy (TSSM) with preservation of the breast and nipple-areolar complex (NAC) skin was developed to improve aesthetic outcomes for mastectomy. Over time, indications for TSSM broadened and our technique has evolved with a series of systematic improvements. METHODS: We reviewed all cases of TSSM with immediate breast reconstruction performed from 2005 to 2012. Patient comorbidities, treatment characteristics, postoperative complications, and outcomes were obtained prospectively and through medical chart review. Locoregional recurrences, distant recurrences, and patient survival were analyzed with Kaplan-Meier methods. RESULTS: During this 8-year period, 633 patients (981 cases) underwent TSSM with median follow-up time of 29 (interquartile range 14-54) months. Immediate breast reconstruction was performed with tissue expander placement (89 %), pedicle TRAM (5 %), free flap (5 %), permanent implant (0.3 %), or latissimus flap (0.2 %). The incidences of postoperative complications decreased significantly over time. In 2012, these were down to 3.5 % for superficial nipple necrosis, 1.0 % for complete nipple necrosis, 3.0 % for minor skin flap necrosis, 4.4 % for major skin flap necrosis, 13.3 % for infections requiring oral antibiotics, 9.9 % for infections requiring intravenous antibiotics, 3.4 % for infections requiring operative intervention, and 8.5 % for expander/implant. Overall 5-year cumulative incidences of recurrence were 3.0 % (locoregional) and 4.2 % (distant), and there were no recurrences in the NAC skin. CONCLUSIONS: Systematic changes in our technique of TSSM and immediate breast reconstruction have decreased postoperative complications over time. Oncologic outcomes of locoregional and distal recurrences remain similar to skin-sparing mastectomy techniques.

Patient-reported outcomes and satisfaction after total skin-sparing mastectomy and immediate expander-implant reconstruction.

BACKGROUND: Total skin-sparing mastectomy (TSSM) with preservation of the nipple-areolar complex skin has become more widely accepted. Few studies looking at outcomes after TSSM and immediate reconstruction have focused on patient-reported outcomes and trends in satisfaction over time. METHODS: Prospective evaluation of patients undergoing TSSM and immediate expander-implant reconstruction was performed. Patients completed the BREAST-Q questionnaire preoperatively and again at 1 month, 6 months, and 1 year postoperatively. Mean scores in each BREAST-Q domain were assessed at each time point. Domains were scored on a 0- to 100-point scale. RESULTS: Survey completion rate was 55%; BREAST-Q scores were calculated from responses from 28 patients. Mean overall satisfaction with breasts declined at 1 month (69.8 to 46.1, P<0.001), but then returned to baseline by 1 year. Mean scores also declined at 1 month in the psychosocial (75.7-67.4, P=0.2) and sexual (58.3-46.7, P=0.06) domains, but returned to baseline by 1 year. Mean nipple satisfaction score was 76.4 at 1 year, with 89% of patients reporting satisfaction with nipple appearance. Satisfaction with nipple position and sensation was lower, with only 56% of patients reporting satisfaction with nipple position and 40% with nipple sensation. CONCLUSIONS: After TSSM and immediate reconstruction, patient satisfaction with their breasts, as well as psychosocial and sexual well-being, returns to baseline by 1 year. Although overall nipple satisfaction is high, patients often report dissatisfaction with nipple position and sensation; appropriate preoperative counseling is important to set realistic expectations.