Investigating the Salience of Clinical Meaningfulness and Clinically Meaningful Outcomes in Metastatic Breast Cancer Care Delivery.

PURPOSE: As metastatic breast cancer (mBC) treatment evolves, there is a need to understand how clinical meaningfulness, or a meaningful change in a patient's daily life, and clinically meaningful outcomes inform patient-centered care. Partnering with key stakeholders ensures patient-centered research incorporates the knowledge and expertise of advisors with lived experience. We describe a multistakeholder engagement approach to examine how people living with mBC (PLWmBC), caregivers, and health care providers interpret clinical meaningfulness and clinically meaningful outcomes and their influence on mBC treatment decision making and care. METHODS: Qualitative focus groups with PLWmBC, caregivers, and health care providers were conducted and analyzed along three overarching themes: interpretations of clinical meaningfulness and clinically meaningful outcomes; treatment recommendations, preferences, and decisions; and implications for clinical practice. Patient-led and professional organizations served as research partners in study design, implementation, and interpretation of findings. RESULTS: Partnerships were established with four patient-led and three professional organizations representing diverse constituencies throughout the United States. Twenty-two focus groups were conducted with 50 PLWmBC, 24 caregivers, and 41 health care providers (oncologists, n = 11; advanced practice providers, n = 13; oncology nurses, n = 17) between March and June 2023. PLWmBC and caregivers were unfamiliar with the concepts of clinical meaningfulness and clinically meaningful outcomes. Although health care providers were familiar, they did not use the terms when discussing treatment with PLWmBC. Across groups, participants emphasized the importance of meaningful outcomes beyond overall survival, including quality of life and improvement in symptoms and functioning. Participants noted that outcomes considered meaningful are individualized and dynamic. CONCLUSION: This study offers insight into how partnering with patient advocacy and professional organizations can enhance research quality and aid translation of findings to clinical practice, thereby supporting patient-centered care.

Increasing Clinical Trial Participation of Black Women Diagnosed with Breast Cancer.

Despite racial disparities in breast cancer mortality, Black women remain underrepresented in clinical trials. In this mixed methods research, 48 Black women were engaged via focus group discussions and in-depth interviews to better understand the lived experience of women with breast cancer. The results of this qualitative study informed the development of a subsequent online survey to identify barriers, motivators, and other factors that influence decision-making by Black women diagnosed with breast cancer when considering clinical trial participation. Among the 257 Black survey participants, most (95%) were aware of clinical trials; of those, most viewed them as lifesaving (81%) and/or benefiting others (90%). Negative perceptions such as serious side effects (58%), not receiving real treatment (52%), or risk of potential harm (62%) were indicated. Barriers included financial expenses (49%), concerns that their condition could be made worse (29%), that they would receive a placebo (28%), or that treatment was unapproved (28%). Participants were more likely than their health care providers (HCPs) to initiate discussions of clinical trials (53% versus 33%), and 29% of participants indicated a need for more information about risks and benefits, even after having those conversations. The most trustworthy sources of information on clinical trials were HCPs (66%) and breast cancer support groups (64%). These results suggest that trusted communities are key for providing education on clinical trials. However, there is also a need for HCPs to proactively discuss clinical trials with patients to ensure that they are adequately informed about all aspects of participation.

Patient-Reported Experiences of Breast Cancer Screening, Diagnosis, and Treatment Delay, and Telemedicine Adoption during COVID-19.

PURPOSE: To evaluate and quantify potential sociodemographic disparities in breast cancer screening, diagnosis, and treatment due to the COVID-19 pandemic, and the use of telemedicine. METHODS: We fielded a 52-item web-based questionnaire from 14 May 2020 to 1 July 2020 in partnership with several U.S.-based breast cancer advocacy groups. Individuals aged 18 or older were eligible for this study if they: (1) received routine breast cancer screening; OR (2) were undergoing diagnostic evaluation for breast cancer; OR (3) had ever been diagnosed with breast cancer. We used descriptive statistics to understand the extent of cancer care delay and telemedicine adoption and used multivariable logistic regression models to estimate the association of sociodemographic factors with odds of COVID-19-related delays in care and telemedicine use. RESULTS: Of 554 eligible survey participants, 493 provided complete data on demographic and socioeconomic factors and were included in the analysis. Approximately half (n = 248, 50.3%) had a personal history of breast cancer. Overall, 188 (38.1%) participants had experienced any COVID-19-related delay in care including screening, diagnosis, or treatment, and 339 (68.8) reported having at least one virtual appointment during the study period. Compared to other insurance types, participants with Medicaid insurance were 2.58 times more likely to report a COVID-19-related delay in care (OR 2.58, 95% Cl: 1.05, 6.32; p = 0.039). Compared to participants with a household income of less than USD 50,000, those with a household income of USD 150,000 or more were 2.38 (OR 2.38, 95% Cl: 1.09, 5.17; p = 0.029) times more likely to adopt virtual appointments. Self-insured participants were 70% less likely to use virtual appointment compared to those in other insurance categories (OR 0.28, 95% Cl: 0.11, 0.73; p = 0.009). CONCLUSIONS: The COVID-19 pandemic has had a significant impact on breast cancer screening, diagnosis, and treatment, and accelerated the delivery of virtual care. Lower-income groups and patients with certain insurance categories such as Medicaid or self-insured could be more likely to experience care delay or less likely to use telemedicine. Careful attention must be paid to vulnerable groups to insure equity in breast cancer-related service utilization and telemedicine access during and beyond the COVID-19 pandemic.