Increasing accrual of minority patients in breast cancer clinical trials.

BACKGROUND: Black and Hispanic patients participate in clinical trials at lower rates than white patients nationally; lack of diversity in clinical trials prevents appropriate safety and efficacy testing of new treatments in these populations. METHODS: The Oncology Welcomes New Haven into Trials (OWN IT) initiative at the Yale Cancer Center used a multi-tiered approach to improve breast cancer minority clinical trial accrual through community focus groups, ongoing community outreach, institutional executive council representation, grand rounds presentation, and didactic lectures with healthcare providers. Eligibility criteria of breast cancer trials at Smilow Cancer Center were reviewed using clinicaltrials.gov. Also, an anonymous, 5-min survey was conducted at regular visits with Smilow Breast Center patients to gauge awareness of and access to clinical trials. Survey data were compared to the Yale Cancer Center Clinical Trials Office, Connecticut Tumor Registry, and U.S. Census records. Two-tailed Fisher's tests were used for all analyses. RESULTS: There was a significant increase in the number of minority patients who participated in clinical trials at Smilow Cancer Center from 2016 (95/750) to 2018 (155/944) (p = 0.0325). Two hundred patients participated in the survey; response rate 92%. There was no significant difference in the rate at which patients were invited to participate in clinical trials or the rate at which they declined to participate based on race or ethnicity. Black and Hispanic patients were significantly less likely to be aware of clinical trials than white patients (p < .001). The review of eligibility criteria showed that over half of the studies reviewed had restrictions regarding increased liver function tests, and many restricted the participation of patients with other chronic conditions. CONCLUSIONS: Low participation in clinical trials among black and Hispanic patients is likely multifaceted. This study indicated that there are likely structural factors at work which can be modified with institutional effort. The role of patient education regarding clinical trials and accrual should be studied further as should eligibility criteria as a potential barrier to participation.

The impact of communication style on patient satisfaction.

BACKGROUND: Communication between patients and health providers influences patient satisfaction, but it is unknown whether similarity in communication styles results in higher patient satisfaction. METHODS: This study was conducted in the Smilow Cancer Hospital Breast Center. During routine follow-up visits, patients completed a Communication Styles Assessment (CSA), health survey (SF-12), Princess Margaret Hospital Satisfaction with Doctor Questionnaire, and brief demographic form. Physicians and Advanced Practice Providers were also asked to complete the CSA. Patients and providers were blinded to each other's responses. A communication styles concordance score was calculated as the Pearson correlation between 80 binary CSA items for each provider/patient pair. Factors affecting patient satisfaction scores were assessed in mixed-effects models. RESULTS: In total, 330 patients were invited to participate; of these 289 enrolled and 245 returned surveys. One hundred seventy-four completed all survey components, and 18 providers completed the CSA. Among the factors considered, physical health score (effect size = 0.0058, 95% CI 0.00051 to 0.0011, p = 0.032) and employment status (0.12, 95% CI - 0.0094 to 0.25, p = 0.069) had the greatest impact on patient satisfaction. However, patients who were not employed and less physically healthy had significantly elevated satisfaction scores when their communication style was more similar to their provider's (1.52, 95% CI 0.66 to 2.38, p = 0.0016). CONCLUSIONS: Patients who were physically healthy and employed were generally more satisfied with their care. The similarity in communication styles of patients and providers had a greater impact on patient satisfaction for patients who were less physically healthy and not employed.

Optimizing menstrual health and hygiene management in the U.S.: A mixed-methods study of the barriers and the role of healthcare professionals.

OBJECTIVE: Menstrual health (MH) practices have been understudied in the U.S. This study aimed to assess patient and medical staff views of MH. METHODS: The mixed-methods approach included medical staff and patient surveys, and patient interviews on MH experiences. Quantitative survey data generated descriptive statistics. Thematic content analysis (TCA) evaluated qualitative interviews. Convergent Parallel Triangulation Analysis (CPTA) evaluated both datasets in tandem. RESULTS: The medical staff survey's response rate was 72% (54 participants/75 invited staff). Only 7% (4/54) of staff consistently asked patients about menstrual products (MP), while 54% (29/54) were concerned about patients affording MP. The patient survey's response rate was 90% (186/207); 22% (40/186) of respondents showed MH insecurity, which was associated with annual income <$30,000 (p < 0.01); 45% (85/186) missed commitments during menses; 53% (98/186) never discussed MP with healthcare providers. To reach thematic saturation 10/17 invited patients were interviewed. Five themes were identified through TCA: menstruation as a social barrier; menstrual education comes from a variety of sources; MP choice is a balance of comfort, cost, and convenience; patients value relationships with their providers; adolescence is the window for establishing MH. Three threads were identified through CPTA: MH insecurity is common; MH screening and education are limited; menstruation impacts patients' ability to engage in daily activities. CONCLUSION: A holistic approach toward MH is needed; education and screening are inconsistent. Comprehensive MH can enhance a patient's understanding of and capacity to advocate for their health. These findings are specific to this population and may not be generalizable.

Menstrual Health and Hygiene among Adolescents in the United States.

STUDY OBJECTIVE: Menstrual health in adolescents has been understudied in the United States. We aimed to assess patient and provider perspectives surrounding menstrual health management and screening. DESIGN: Our mixed-methods approach consisted of provider surveys, patient surveys, and patient interviews. SETTING: Participants were recruited from a pediatric gynecology practice or an adolescent medicine clinic at an urban tertiary academic center. PARTICIPANTS: Providers were pediatrics faculty or residents. Patients aged 13-24 years were eligible. INTERVENTION: Participants completed an anonymous survey or semi-structured interview about their experiences with menstrual health. MAIN OUTCOME MEASURES: Descriptive statistics and thematic content analysis were used for quantitative and qualitative data, respectively. Convergent parallel analysis elucidated key findings in both data sets. RESULTS: The provider survey response rate was 65% (69/106); 15% (9/69) of providers consistently asked patients about menstrual products, whereas 44% (27/68) were concerned patients could not afford products. The patient survey response rate was 85% (101/119); 19% (19/101) of respondents reported menstrual hygiene insecurity, 55% (55/101) missed commitments during menses, and 45% (45/101) discussed menstrual products with providers. Fifteen patients were invited for qualitative interviews; 10 were conducted, and thematic saturation occurred. Interviews highlighted the importance of comprehensive early menstrual health education and providers' role in menstrual management. CONCLUSION: Adolescence is a crucial point of entry into health care. Because taboos surrounding menstruation could limit access to health care, menstrual health education must be emphasized. Menstrual health education is provided piecemeal by parents, schools, and providers. Current practice should be reevaluated to consider comprehensive educational approaches in which health care leads.

The Effect of Black Cohosh on Ki67 expression and Tumor Volume: A Pilot Study of Ductal Carcinoma in Situ Patients.

BACKGROUND: Black cohosh (BC) (Cimicifuga racemosa) may prevent and treat breast cancer through anti-proliferative, pro-apoptotic, anti-estrogenic, and anti-inflammatory effects. This study sought to evaluate the effect of BC on tumor cellular proliferation, measured by Ki67 expression, in a pre-operative window trial of ductal carcinoma in situ (DCIS) patients. METHODS: Patients were treated pre-operatively for 2 to 6 weeks with BC extract. Eligible subjects were those who had DCIS on core biopsy. Ki67 was measured using automated quantitative immunofluorescence (AQUA) pre/post-operatively. Ki67, tumor volume, and hormone changes were assessed with 2-sided Wilcoxon signed-rank tests, α = .05. RESULTS: Thirty-one patients were treated for an average of 24.5 days (median 25; range 15-36). Ki67 decreased non-significantly (n = 26; P = .20; median pre-treatment 1280, post-treatment 859; range pre-treatment 175-7438, post-treatment 162-3370). Tumor volume, estradiol, and FSH did not change significantly. No grade 3 or 4 adverse events were reported. CONCLUSIONS: BC use showed no significant impact on cellular proliferation, tumor volume, or invasive disease upgrade rates in DCIS patients. It was well-tolerated, with no observed significant toxicities. Further study is needed to elucidate BC's role in breast cancer treatment and prevention.ClinicalTrials.gov Identifier: NCT01628536https://clinicaltrials.gov/ct2/show/NCT01628536.

Monitoring InBaskets With Feedback to Providers Enhances the Timeliness of Patient Care.

PURPOSE: Electronic health records have changed providers' workflow. Epic's InBasket supplants traditional communication and is a central hub for clinical information. Failure to promptly complete records impairs communication and revenue collection. By tracking providers' InBasket activities and offering feedback, we hoped to improve InBasket management and interdisciplinary communication. METHODS: We created a report to track 273 providers' InBasket activities, including ambulatory transcriptions, chart cosignatures, order cosignatures, patient calls, results, and billable encounters. The report showed how often and for how long each activity was delinquent. We completed three Plan-Do-Study-Act cycles. During cycle 1 (November to December 2015), we sent all providers automated e-mails with their monthly results. During cycle 2 (January to April 2016), we focused solely on billable encounter closure and sent targeted e-mails to providers with > 50 delinquent encounters. The e-mails stated that providers had 30 days to complete encounters or their practices would be closed to new patients; at 30 days, noncompliant providers had 60 days before practice suspension. During cycle 3 (May to September 2016), we continued to monitor and send targeted e-mails to providers who accumulated > 50 encounters. We modeled the financial impact of the intervention using net closure data, the report's aging function, and billing logs. RESULTS: InBasket monitoring with structured feedback decreased open encounters by 53.43%. We did not see improvements in the other metrics that the report tracked. We estimate that $231,724 was saved as a result of the intervention and $349,179 was lost to filing deadlines. CONCLUSION: Automated e-mails did not reduce open encounters; targeted e-mails to providers improved InBasket management.