A randomized controlled trial of shared decision-making treatment planning process to enhance shared decision-making in patients with MBC.

PURPOSE: Opportunities exist for patients with metastatic breast cancer (MBC) to engage in shared decision-making (SDM). Presenting patient-reported data, including patient treatment preferences, to oncologists before or during a treatment plan decision may improve patient engagement in treatment decisions. METHODS: This randomized controlled trial evaluated the standard-of-care treatment planning process vs. a novel treatment planning process focused on SDM, which included oncologist review of patient-reported treatment preferences, prior to or during treatment decisions among women with MBC. The primary outcome was patient perception of shared decision-making. Secondary outcomes included patient activation, treatment satisfaction, physician perception of treatment decision-making, and use of treatment plans. RESULTS: Among the 109 evaluable patients from December 2018 to June 2022, 28% were Black and 12% lived in a highly disadvantaged neighborhood. Although not reaching statistical significance, patients in the intervention arm perceived SDM more often than patients in the control arm (63% vs. 59%; Cramer's V = 0.05; OR 1.19; 95% CI 0.55-2.57). Among patients in the intervention arm, 31% were at the highest level of patient activation compared to 19% of those in the control arm (V = 0.18). In 82% of decisions, the oncologist agreed that the patient-reported data helped them engage in SDM. In 45% of decision, they reported changing management due to patient-reported data. CONCLUSIONS: Oncologist engagement in the treatment planning process, with oncologist review of patient-reported data, is a promising approach to improve patient participation in treatment decisions which should be tested in larger studies. TRIAL REGISTRATION: NCT03806738.

Associations between geography, decision-making style, and interest in cancer clinical trial participation.

BACKGROUND: Clinical trials offer novel treatments, which are essential to high quality cancer care. Patients living in rural areas are often underrepresented in clinical trials due to several factors. This study evaluated the association between rurality and interest in clinical trial participation, change in interest, and treatment decision-making style preference. METHODS: This cohort study included patients with cancer receiving oncology care at the University of Alabama at Birmingham from 2017 to 2019. Associations between treatment decision-making preference and the interaction between rurality and area deprivation were analyzed using multinomial logistic regression. Initial interest in clinical trial participation and change in interest were analyzed using modified Poisson regressions with robust standard errors. Initial interest model was stratified by Area Deprivation Index (ADI; higher vs. lower disadvantaged). RESULTS: In adjusted models, patients in rural versus urban areas had similar initial interest in clinical trials, both those in higher (40% vs. 50%) and lower disadvantaged settings (54% vs. 62%). Additionally, rural versus urban patients had similar change of clinical trial interest for both those who changed from uninterested-to-interested (31% vs. 26%) and interested-to-uninterested (47% vs. 42%). CONCLUSION: This study compares the interest in clinical trial participation among patients living in rural and urban settings. Lack of interest may be secondary to barriers that patients in rural areas face (e.g., transportation, financial, access). Most rural patients prefer a shared treatment decision-making style, which should be considered when identifying interventions to increase enrollment of underserved rural patients in clinical trials.

Physician Perspectives on Reducing Curative Cancer Treatment Intensity for Populations Underrepresented in Clinical Trials.

BACKGROUND: Historically, clinical trials involved adding novel agents to standard of care to improve survival. There has been a shift to an individualized approach with testing less intense treatment, particularly in breast cancer where risk of recurrence is low. Little is known about physician perspectives on delivering less intense treatment for patients who are not well represented in clinical trials. METHODS: Open-ended, individual qualitative interviews with medical oncologists explored their perspectives on trials that test less intense treatment for patients with cancer, with a focus on breast cancer. Interviews were audio-recorded and transcribed. Four independent coders utilized a content analysis approach to analyze transcripts using NVivo. Major themes and exemplary quotes were extracted. RESULTS: Of the 39 participating physicians, 61.5% felt comfortable extrapolating, 30.8% were hesitant, and 7.7% would not feel comfortable extrapolating trial outcomes to underrepresented populations. Facilitators of comfort included the sentiment that "biology is biology" (such that the cancer characteristics were what mattered), the strength of the evidence, inclusion of subset analysis on underrepresented populations, and prior experience making decisions with limited data. Barriers to extrapolation included potential harm over the patient's lifetime, concerns about groups that had minimal participants, application to younger patients, and extending findings to diverse populations. Universally, broader inclusion in trials testing lowering chemotherapy was desired. CONCLUSIONS: The majority (92%) of physicians reported that they would de-implement treatment for patients poorly represented in clinical trials testing less treatment, while expressing concerns about applicability to specific subpopulations. Further work is needed to increase clinical trial representation of diverse populations to safely and effectively optimize treatment for patients with cancer. TRIAL REGISTRATION: NCT03248258.

Exclusion criteria of breast cancer clinical trial protocols: a descriptive analysis.

PURPOSE: 3-8% of US adults with cancer are enrolled in a clinical trial due to various barriers to enrollment. The purpose of this study is to evaluate the variability of eligibility criteria, which currently have no standard guidelines. METHODS: This descriptive analysis utilized all therapeutic breast protocols offered at the University of Alabama at Birmingham between 2004 and 2020. Exclusion criteria were abstracted using OnCore and ClinicalTrials.gov. Laboratory values included liver function tests and hematologic labs. Comorbid conditions included congestive heart failure, cardiovascular disease, central nervous system (CNS) metastases, and prior cancer history. Comorbid conditions were further analyzed by amount of time protocols required participants to be from diagnosis or exacerbation-free. RESULTS: 102 protocols were eligible. Among liver laboratory values, bilirubin (78%) was included in most protocols ranging from institutional upper limit of normal (ULN) (9%) to 3xULN (2%), with 1.5xULN (56%) being most common. Similar variability was observed in alanine transaminase and aspartate transaminase. Among hematological labs, 82% of protocols defined a lower limit of acceptable absolute neutrophil count ranging from 500 µL (1%) to 1800 µL (1%), with 1500 µL (64%) being most common. Of the comorbid conditions, exclusion criteria varied for congestive heart failure (49%), an acute exacerbation of cardiovascular disease (80%), CNS metastases (59%), and a prior cancer (66%). The allowable timeframe varied between protocols for cardiovascular disease and prior cancer. CONCLUSION: Substantial heterogeneity was observed across laboratory values and comorbid variables among protocols. Future research should focus on defining standardized eligibility criteria while allowing for deviation based on drug specificity.

Facilitators and barriers to reducing chemotherapy for early-stage breast cancer: a qualitative analysis of interviews with patients and patient advocates.

BACKGROUND: As the combination of systemic and targeted chemotherapies is associated with severe adverse side effects and long-term health complications, there is interest in reducing treatment intensity for patients with early-stage breast cancer (EBC). Clinical trials are needed to determine the feasibility of reducing treatment intensity while maintaining 3-year recurrence-free survival of greater than 92%. To recruit participants for these trials, it is important to understand patient perspectives on reducing chemotherapy. METHODS: We collected qualitative interview data from twenty-four patients with Stage II-III breast cancer and sixteen patient advocates. Interviews explored potential barriers and facilitators to participation in trials testing reduced amounts of chemotherapy. As the COVID-19 pandemic struck during data collection, seventeen participants were asked about the potential impact of COVID-19 on their interest in these trials. Interviews were audio-recorded and transcribed, and researchers used qualitative content analysis to code for dominant themes. RESULTS: Seventeen participants (42.5%) expressed interest in participating in a trial of reduced chemotherapy. Barriers to reducing chemotherapy included (1) fear of recurrence and inefficacy, (2) preference for aggressive treatment, (3) disinterest in clinical trials, (4) lack of information about expected outcomes, (5) fear of regret, and (6) having young children. Facilitators included (1) avoiding physical toxicity, (2) understanding the scientific rationale of reducing chemotherapy, (3) confidence in providers, (4) consistent monitoring and the option to increase dosage, (5) fewer financial and logistical challenges, and (6) contributing to scientific knowledge. Of those asked, nearly all participants said they would be more motivated to reduce treatment intensity in the context of COVID-19, primarily to avoid exposure to the virus while receiving treatment. CONCLUSIONS: Among individuals with EBC, there is significant interest in alleviating treatment-related toxicity by reducing chemotherapeutic intensity. Patients will be more apt to participate in trials testing reduced amounts of chemotherapy if these are framed in terms of customizing treatment to the individual patient and added benefit-reduced toxicities, higher quality of life during treatment and lower risk of long-term complications-rather than in terms of taking treatments away or doing less than the standard of care. Doctor-patient rapport and provider support will be crucial in this process.

Evaluating the implementation and impact of navigator-supported remote symptom monitoring and management: a protocol for a hybrid type 2 clinical trial.

BACKGROUND: Symptoms in patients with advanced cancer are often inadequately captured during encounters with the healthcare team. Emerging evidence demonstrates that weekly electronic home-based patient-reported symptom monitoring with automated alerts to clinicians reduces healthcare utilization, improves health-related quality of life, and lengthens survival. However, oncology practices have lagged in adopting remote symptom monitoring into routine practice, where specific patient populations may have unique barriers. One approach to overcoming barriers is utilizing resources from value-based payment models, such as patient navigators who are ideally positioned to assume a leadership role in remote symptom monitoring implementation. This implementation approach has not been tested in standard of care, and thus optimal implementation strategies are needed for large-scale roll-out. METHODS: This hybrid type 2 study design evaluates the implementation and effectiveness of remote symptom monitoring for all patients and for diverse populations in two Southern academic medical centers from 2021 to 2026. This study will utilize a pragmatic approach, evaluating real-world data collected during routine care for quantitative implementation and patient outcomes. The Consolidated Framework for Implementation Research (CFIR) will be used to conduct a qualitative evaluation at key time points to assess barriers and facilitators, implementation strategies, fidelity to implementation strategies, and perceived utility of these strategies. We will use a mixed-methods approach for data interpretation to finalize a formal implementation blueprint. DISCUSSION: This pragmatic evaluation of real-world implementation of remote symptom monitoring will generate a blueprint for future efforts to scale interventions across health systems with diverse patient populations within value-based healthcare models. TRIAL REGISTRATION: NCT04809740 ; date of registration 3/22/2021.

Quantifying treatment preferences and their association with financial toxicity in women with breast cancer.

BACKGROUND: The objective of the current study was to understand treatment preferences and their association with financial toxicity in Patient Advocate Foundation clients with breast cancer. METHODS: This choice-based conjoint analysis used data from a nationwide sample of women with breast cancer who received assistance from the Patient Advocate Foundation. Choice sets created from 13 attributes of 3 levels each elicited patient preferences and trade-offs. Latent class analysis segmented respondents into distinct preference archetypes. The Comprehensive Score for Financial Toxicity (COST) tool captured financial toxicity. Adjusted generalized linear models estimated COST score differences by preference archetype. RESULTS: Of 220 respondents (for a response rate of 10%), the median age was 58 years (interquartile range, 49-66 years); 28% of respondents were Black, indigenous, or people of color; and approximately 60% had household incomes <$40,000. The majority of respondents were diagnosed with early-stage cancer (91%), 38% had recurrent disease, and 61% were receiving treatment. Treatment choice was most affected by preferences related to affordability and impact on activities of daily living. Two distinct treatment preference archetypes emerged. The "cost-prioritizing group" (75% of respondents) was most concerned about affordability, impact on activities of daily living, and burdening care partners. The "functional independence-prioritizing group" (25% of respondents) was most concerned about their ability to work, physical side effects, and interference with life events. COST scores were found to be similar between the archetypes in adjusted models (cost-prioritizing group COST score, 12 [95% confidence interval, 9-14]; and functional independence-prioritizing COST score, 11 [95% confidence interval, 9-13]). CONCLUSIONS: Patients with breast cancer prioritized affordability or maintaining functional independence when making treatment decisions. Because of this variability, preference evaluation during treatment decision making could optimize patients' treatment experiences.

"It's important to me": A qualitative analysis on shared decision-making and patient preferences in older adults with early-stage breast cancer.

OBJECTIVE: Shared decision-making (SDM) occurs when physicians and patients jointly select treatment that aligns with patient care goals. Incorporating patient preferences into the decision-making process is integral to successful decision-making. This study explores factors influencing treatment selection in older patients with early-stage breast cancer (EBC). METHODS: This qualitative study included women age ≥65 years with EBC. To understand role preferences, patients completed the Control Preferences Scale. Semi-structured interviews were conducted to explore patients' treatment selection rationale. Interview transcripts were analyzed using a constant comparative method identifying major themes related to treatment selection. RESULTS: Of 33 patients, the majority (48%) desired shared responsibility in treatment decision-making. Interviews revealed that EBC treatment incorporated three domains: Intrinsic and extrinsic influences, clinical characteristics, and patient values. Patients considered 19 treatment selection themes, the most prioritized including physician trust and physical side effects. CONCLUSIONS: Because preferences and approach to treatment selection varied widely in this sample of older, EBC patients, more research is needed to determine best practices for preference incorporation to optimize SDM at the time of treatment decisions.

Should we be talking about guidelines with patients? A qualitative analysis in metastatic breast cancer.

BACKGROUND: Little data exist on perceptions of guideline-based care in oncology. This qualitative analysis describes patients' and oncologists' views on the value of guideline-based care as well as discussing guidelines when making metastatic breast cancer (MBC) treatment decisions. PATIENTS AND METHODS: In-person interviews completed with MBC patients and community oncologists and focus groups with academic oncologists were audio-recorded and transcribed. Two coders utilized a content analysis approach to analyze transcripts independently using NVivo. Major themes and exemplary quotes were extracted. RESULTS: Participants included 20 MBC patients, 6 community oncologists, and 5 academic oncologists. Most patients were unfamiliar with the term "guidelines." All patients desired to know if they were receiving guideline-discordant treatment but were often willing to accept this treatment. Five themes emerged explaining this including trusting the oncologist, relying on the oncologist's experiences, being informed of rationale for deviation, personalized treatment, and openness to novel therapies. Physician discussions regarding the importance of guidelines revealed three themes: consistency with scientific evidence, insurance coverage, and limiting unusual practices. Oncologists identified three major limitations in using guidelines: lack of consensus, inability to "think outside the box" to personalize treatment, and lack of guideline timeliness. Although some oncologists discussed guidelines, it was often not considered a priority. CONCLUSIONS: Patients expressed a desire to know whether they were receiving guideline-based care but were amenable to guideline-discordant treatment if the rationale was made clear. Providers' preference to limit discussions of guidelines is discordant with patients' desire for this information and may limit shared decision-making.

Impact of Guideline-Discordant Treatment on Cost and Health Care Utilization in Older Adults with Early-Stage Breast Cancer.

BACKGROUND: National Comprehensive Cancer Network (NCCN) guideline-based treatment is a marker of high-quality care. The impact of guideline discordance on cost and health care utilization is unclear. MATERIALS AND METHODS: This retrospective cohort study of Medicare claims data from 2012 to 2015 included women age ≥65 with stage I-III breast cancer receiving care within the University of Alabama at Birmingham Cancer Community Network. Concordance with NCCN guidelines was assessed for treatment regimens. Costs to Medicare and health care utilization were identified from start of cancer treatment until death or available follow-up. Adjusted monthly cost and utilization rates were estimated using linear mixed effect and generalized linear models. RESULTS: Of 1,177 patients, 16% received guideline-discordant treatment, which was associated with nonwhite race, estrogen receptor/progesterone receptor negative, human epidermal growth receptor 2 (HER2) positive, and later-stage cancer. Discordant therapy was primarily related to reduced-intensity treatments (single-agent chemotherapy, HER2-targeted therapy without chemotherapy, bevacizumab without chemotherapy, platinum combinations without anthracyclines). In adjusted models, average monthly costs for guideline-discordant patients were $936 higher compared with concordant (95% confidence limits $611, $1,260). For guideline-discordant patients, adjusted rates of emergency department visits and hospitalizations per thousand observations were 25% higher (49.9 vs. 39.9) and 19% higher (24.0 vs. 20.1) per month than concordant patients, respectively. CONCLUSION: One in six patients with early-stage breast cancer received guideline-discordant care, predominantly related to undertreatment, which was associated with higher costs and rates of health care utilization. Additional randomized trials are needed to test lower-toxicity regimens and guide clinicians in treatment for older breast cancer patients. IMPLICATIONS FOR PRACTICE: Previous studies lack details about types of deviations from chemotherapy guidelines that occur in older early-stage breast cancer patients. Understanding the patterns of guideline discordance and its impact on patient outcomes will be particularly important for these patients. This study found 16% received guideline-discordant care, predominantly related to reduced intensity treatment and associated with higher costs and rates of health care utilization. Increasing older adult participation in clinical trials should be a priority in order to fill the knowledge gap about how to treat older, less fit patients with breast cancer.

What Is Important When Making Treatment Decisions in Metastatic Breast Cancer? A Qualitative Analysis of Decision-Making in Patients and Oncologists.

BACKGROUND: Metastatic breast cancer (MBC) is an ideal environment for shared decision-making because of the large number of guideline-based treatment options with similar efficacy but different toxicity profiles. This qualitative analysis describes patient and provider factors that influence decision-making in treatment of MBC. MATERIALS AND METHODS: Patients and community oncologists completed in-person interviews. Academic medical oncologists participated in focus groups. Interviews and focus groups were audio-recorded, transcribed, and analyzed using NVivo. Using an a priori model based on the Ottawa Framework, two independent coders analyzed transcripts using a constant comparative method. Major themes and exemplary quotes were extracted. RESULTS: Participants included 20 patients with MBC, 6 community oncologists, and 5 academic oncologists. Analysis of patient interviews revealed a decision-making process characterized by the following themes: decision-making style, contextual factors, and preferences. Patient preference subthemes include treatment efficacy, physical side effects of treatment, emotional side effects of treatment, cognitive side effects of treatment, cost and financial toxicity, salience of cutting-edge treatment options (clinical trial or newly approved medication), treatment logistics and convenience, personal and family responsibilities, treatment impact on daily activities, participation in self-defining endeavors, attending important events, and pursuing important goals. Physician decisions emphasized drug-specific characteristics (treatment efficacy, side effects, cost) rather than patient preferences, which might impact treatment choice. CONCLUSION: Although both patients with MBC and oncologists considered treatment characteristics when making decisions, patients' considerations were broader than oncologists', incorporating contextual factors such as the innovative value of the treatment and life responsibilities. Differences in perspectives between patients and oncologists suggests the value of tools to facilitate systematic communication of preferences in the setting of MBC. IMPLICATIONS FOR PRACTICE: Both patients with metastatic breast cancer (MBC) and oncologists emphasized importance of efficacy and physical side effects when making treatment decisions. However, other patient considerations for making treatment decisions were broader, incorporating contextual factors such as the logistics of treatments, personal and family responsibilities, and ability to attend important events. Furthermore, individual patients varied substantially in priorities that they want considered in treatment decisions. Differences in perspectives between patients and oncologists suggest the value of tools to facilitate systematic elicitation of preferences and communication of those preferences to oncologists for integration into decision-making in MBC.

Concordance with NCCN treatment guidelines: Relations with health care utilization, cost, and mortality in breast cancer patients with secondary metastasis.

BACKGROUND: The impact of National Comprehensive Cancer Network (NCCN) treatment guideline concordance on costs, health care utilization, and mortality for patients with breast cancer and secondary metastases is unknown. METHODS: From 2007 to 2013, women with early-stage breast cancer who received treatment for secondary metastases (n = 5651) were evaluated for first recorded systemic therapy concordance with NCCN guidelines within the Surveillance, Epidemiology, and End Results Program-Medicare linked database. Generalized linear and mixed effects models evaluated factors associated with nonconcordance and the relation between concordance status and health care utilization and costs. Mortality risk was estimated with Cox regression. RESULTS: Eighteen percent of the patients received nonconcordant therapy, with the most common being single-agent, human epidermal growth factor receptor 2 (HER2)-targeted therapy (36%), therapy mismatched with the estrogen receptor/HER2 status (11%), unapproved bevacizumab regimens (10%), and adjuvant regimens in a metastatic setting (6%). A younger age, a hormone receptor-negative status, and a HER2-positive status were associated with nonconcordance (P < .05). Nonconcordance was associated with 22% and 21% increased rates of emergency department visits and hospitalizations, respectively, and $1765 higher average monthly Medicare costs. Differences in adjusted mortality risk were noted by the category of nonconcordance; single-agent, HER2-targeted therapy was associated with decreased mortality risk (hazard ratio [HR], 0.66; 95% confidence limit [CL], 0.57-0.76), and increased mortality risk was observed with unapproved bevacizumab use (HR, 1.40; 95% CL, 1.13-1.74). CONCLUSIONS: Most patients (82%) received treatment consistent with NCCN guidelines. Nonconcordant treatment was associated with higher health care utilization and costs, with mortality differences observed by the type of guideline deviation. Consideration of both patient and financial outcomes will be important as health systems increase the emphasis on guideline-based care.

Impact of Nonconcordance With NCCN Guidelines on Resource Utilization, Cost, and Mortality in De Novo Metastatic Breast Cancer.

Background: The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) have directed the care of patients with cancer for >20 years. Payers are implementing guideline-based pathway programs that restrict reimbursement for non-guideline-based care to control costs, yet evidence regarding impact of guidelines on outcomes, including mortality, Medicare costs, and healthcare utilization, is limited. Patients and Methods: This analysis evaluated concordance of first treatment with NCCN Guidelines for women with de novo stage IV metastatic breast cancer (MBC) included within the SEER-Medicare linked database and diagnosed between 2007 and 2013. Cox proportional hazards models were used to evaluate the association between mortality and guideline concordance. Linear mixed-effects and generalized linear models were used to evaluate total cost to Medicare and rates of healthcare utilization by concordance status. Results: We found that 19% of patients (188/988) with de novo MBC received nonconcordant treatment. Patients receiving nonconcordant treatment were more likely to be younger and have hormone receptor-negative and HER2-positive MBC. The most common category of nonconcordant treatment was use of adjuvant regimens in the metastatic setting (40%). Adjusted mortality risk was similar for patients receiving concordant and nonconcordant treatments (hazard ratio [HR], 0.85; 95% confidence limit [CL], 0.69, 1.05). When considering category of nonconcordance, patients receiving adjuvant regimens in the metastatic setting had a decreased risk of mortality (HR, 0.60; 95% CL, 0.43, 0.84). Nonconcordant treatments were associated with $1,867 higher average Medicare costs per month compared with concordant treatments (95% CL, $918, $2,817). Single-agent HER2-targeted therapy was the highest costing category of nonconcordance at $3,008 (95% CL, $1,014, $5,001). Healthcare utilization rates were similar for patients receiving concordant and nonconcordant treatments. Conclusions: Despite a lack of survival benefit, concordant care was associated with lower costs, suggesting potential benefit to increasing standardization of care. These findings may influence policy decisions regarding implementation of pathway programs as health systems transition to value-based models.

Engagement Among Diverse Patient Backgrounds in a Remote Symptom Monitoring Program.

PURPOSE: Previous randomized controlled trials have demonstrated benefit from remote symptom monitoring (RSM) with electronic patient-reported outcomes. However, the racial diversity of enrolled patients was low and did not reflect the real-world racial proportions for individuals with cancer. METHODS: This secondary, cross-sectional analysis evaluated engagement of patients with cancer in a RSM program. Patient-reported race was grouped as Black, Other, or White. Patient address was used to map patient residence to determine rurality using Rural-Urban Commuting Area Codes and neighborhood disadvantage using Area Deprivation Index. Key outcomes included (1) being approached for RSM enrollment, (2) declining enrollment, (3) adherence with RSM via continuous completion of symptom surveys, and (4) withdrawal from RSM participation. Risk ratios (RR) and 95% CI were estimated from modified Poisson models with robust SEs. RESULTS: Between May 2021 and May 2023, 883 patients were approached to participate, of which 56 (6%) declined RSM. Of those who enrolled in RSM, a total of 27% of patients were Black or African American and 67% were White. In adjusted models, all patient population subgroups of interest had similar likelihoods of being approached for RSM participation; however, Black or African American patients were more than 3× more likely to decline participation than White participants (RR, 3.09 [95% CI, 1.73 to 5.53]). Patients living in more disadvantaged neighborhoods were less likely to decline (RR, 0.49 [95% CI, 0.24 to 1.02]), but less likely to adhere to surveys (RR, 0.81 [95% CI, 0.68 to 0.97]). All patient populations had a similar likelihood of withdrawing. CONCLUSION: Black patients and individuals living in more disadvantaged neighborhoods are at risk for lower engagement in RSM. Further work is needed to identify and overcome barriers to equitable participation.

Integrating electronic geriatric assessment and frailty screening for adults with acute myeloid leukemia to drive personalized treatment decisions.

PURPOSE: Evidenced based guidelines for patients with Acute Myeloid Leukemia (AML) acknowledge increasing importance of frailty assessment when deciding on treatment, yet comprehensive geriatric assessment (GA) results are not easily incorporated into clinic workflows and the electronic health record. This study assessed the feasibility of electronic GA use in a real-world environment. METHODS: Patients with AML, ≥ 60 years and at a treatment decision-making point were recruited at three academic institutions. An electronic GA (eGA) was completed by patients prior to starting treatment. Results were immediately available on a dashboard. Data on feasibility, useability and acceptability of the intervention were collected immediately after the clinical visit. Patients completed follow up surveys at 3 months and chart reviews were done to capture treatment and toxicities. RESULTS: 77 patients were enrolled with a median age of 71 years (range=61-88). The eGA results were 25 fit (31.0 %), 22 (32.0 %) intermediate, and 23 (31.0 %) frail. There was 62.7 % (n = 47) provider concordance with the eGA result and 27 (36.0 %) post visit reports indicated that the eGA results influenced the treatment decision. On average, patients completed the surveys unassisted in 16.24 min and providers reviewed the dashboard in 3.5 min. CONCLUSION: Patients easily completed an eGA prior to starting treatment. Results were reviewed by the physician and considered in the decision for optimal treatment. One third of physician reports indicated the results were used to inform the treatment decision. Feasibility of completing the eGA in the clinic without workflow disruption and utility of the results was demonstrated.

"Clinical trials are space travel": Factors of psychological response to recurrence among oncologists enrolling patients in treatment optimization trials.

BACKGROUND: Cancer recurrence after treatment is a concern for patients and oncologists alike. The movement towards treatment optimization, with trials testing less than the current standard of care (SoC), complicates this experience. Our objective was to assess oncologists' psychological response to patient recurrence on optimization-focused trials and identify factors that influence those experiences. METHODS: Clinical oncologists participated in a semi-structured interview regarding patient enrollment in treatment optimization trials. We identified factors that influence the degree of psychological response that the oncologist may feel after patient recurrence. Residual agreement analysis was used to identify whether differences in reported psychological response was associated with alternative emphases on identified factors. RESULTS: Thirty-six oncologists identified 20 factors spanning five major themes that affected their psychological response to patient recurrence. All oncologists expressed willingness to enroll patients in treatment optimization clinical trials; however, half indicated that they were more likely to experience a negative psychological response after a treatment optimization trial than after a traditional intensification trial, and a quarter reported that patient recurrence on an optimization trial would impact their recommendations for future trial enrollment. Oncologists who reported more negative psychological responses to patient recurrence after participation in an optimization trial were more likely to emphasize introspective factors, while those who reported no difference in response emphasized patient- and process-focused factors. CONCLUSIONS: Although most oncologists recognize the importance of treatment optimization trials, a significant proportion indicated a greater potential for psychological distress following patient recurrence in such trials and offered insight into how trial design and the process of patient enrollment can be improved to minimize those negative psychological responses.

Oncologist-Reported Barriers and Facilitators to Enrolling Patients in Optimization Trials That Test Less Intense Cancer Treatment.

PURPOSE: As outcomes improve in early-stage breast cancer, clinical trials are undergoing a paradigm shift from intensification trials (more therapy) to improve survival to optimization trials, which assess the potential for using less toxic therapy while preserving survival outcomes. However, little is known about physician perspectives in community and academic settings about possible barriers and facilitators that could affect accrual to optimization clinical trials and the generalizability of future findings. METHODS: We conducted a qualitative study with semistructured interviews of medical oncologists from different academic and community practices to assess their perspectives on optimization trials. Interviews were audio-recorded and transcribed. Three independent coders used a content analysis approach to analyze transcripts using NVivo. Major themes and exemplary quotes were extracted. RESULTS: All 39 physicians reported that they would enroll patients in optimization clinical trials. Oncologists highlighted specific reasons to consider optimization trials. These included quality-of-life improvement by reducing toxicity, reduction in financial toxicity, fertility preservation, ability to avoid chemotherapy, minimization of overtreatment in patients with comorbid conditions, personalized treatment, opportunities to test novel therapies, and leveraging the availability of targeted therapies. Oncologists also identified accrual barriers, such as tumor-specific biology, individual (host) factors, prognostic markers of risk, access to therapies, provider experience, and system constraints. They voiced recommendations regarding preliminary data, trial design, and tools to support enrollment in optimization trials. CONCLUSION: Although oncologists are generally willing to enroll patients on optimization clinical trials, barriers affect their acceptance. A scientific focus on overcoming these barriers is needed to support future enrollment on trials tailoring therapy on the basis of risk and potential benefit to allow true personalization of treatment.

Enhancing Efficiency and Reach Using Facebook to Recruit Breast Cancer Survivors for a Telephone-Based Supportive Care Randomized Trial During the COVID-19 Pandemic.

PURPOSE: Evidence supporting social media-based recruitment of cancer survivors is limited. This paper describes how we used Facebook during the COVID-19 pandemic to augment our recruitment of breast cancer survivors for our two-site telephone-based randomized clinical trial (RCT) at Dartmouth-Hitchcock Medical Center and the University of Alabama at Birmingham. METHODS: Originally a two-site RCT of a telephone-delivered breast cancer survivorship intervention, we extended our clinic-based recruitment to Facebook. Participant characteristics, geographic reach, and baseline outcomes were compared across recruitment sources (ie, two clinics and Facebook) using descriptive statistics and effect sizes. RESULTS: Enrollment rates (20%-29%) were comparable across recruitment sources. The 21-month Facebook marketing campaign accounted for 59% (n = 179/303) of our total sample and had the greatest geographic reach, recruiting women from 24 states. The Facebook campaign reached a total of 51,787 unique individuals and cost $88.44 in US dollars (USD) per enrolled participant. Clinic samples had a greater proportion of women who were widowed (8% v 1%; P = .03) and Facebook had a higher proportion of women with a household income over $40,000 USD (83% v 71%; P = .02). There were no statistically significant differences between Facebook and the two clinics on baseline survey scores. CONCLUSION: Augmenting traditional recruitment with Facebook increased our RCT's geographic and sociodemographic reach and supported meeting recruitment goals in a timely way. In the wake of the COVID-19 pandemic, cancer survivorship researchers should consider using social media as a recruitment strategy while weighing the advantages and potential biases introduced through such strategies.

Adaptation of Remote Symptom Monitoring Using Electronic Patient-Reported Outcomes for Implementation in Real-World Settings.

PURPOSE: Despite evidence of clinical benefits, widespread implementation of remote symptom monitoring has been limited. We describe a process of adapting a remote symptom monitoring intervention developed in a research setting to a real-world clinical setting at two cancer centers. METHODS: This formative evaluation assessed core components and adaptations to improve acceptability and fit of remote symptom monitoring using Stirman's Framework for Modifications and Adaptations. Implementation outcomes were evaluated in pilot studies at the two cancer centers testing technology (phase I) and workflow (phase II and III) using electronic health data; qualitative evaluation with semistructured interviews of clinical team members; and capture of field notes from clinical teams and administrators regarding barriers and recommended adaptations for future implementation. RESULTS: Core components of remote symptom monitoring included electronic delivery of surveys with actionable symptoms, patient education on the intervention, a system to monitor survey compliance in real time, the capacity to generate alerts, training nurses to manage alerts, and identification of personnel responsible for managing symptoms. In the pilot studies, while most patients completed > 50% of expected surveys, adaptations were identified to address barriers related to workflow challenges, patient and clinician access to technology, digital health literacy, survey fatigue, alert fatigue, and data visibility. CONCLUSION: Using an implementation science approach, we facilitated adaptation of remote symptom monitoring interventions from the research setting to clinical practice and identified key areas to promote effective uptake and sustainability.

Treatment Decision Making and Financial Toxicity in Women With Metastatic Breast Cancer.

INTRODUCTION: Oncologists have increasingly been proponents of shared decision making (SDM) to enhance patient outcomes and reduce unnecessary health care spending. However, its effect on patient out-of-pocket costs is unknown. This study investigated the relationship between patient preferences for SDM and financial toxicity (FT) in patients with metastatic breast cancer (MBC). PATIENTS AND METHODS: This cross-sectional study utilized surveys of women aged ≥ 18 with MBC who received care at two academic hospitals in Alabama from 2017 to 2019. Patients self-reported their SDM preference (Control Preferences Scale) and FT (Comprehensive Score for Financial Toxicity [COST] tool; 11-item scale, with lower scores indicating worse FT). Effect sizes were calculated using the proportion of variance explained (R2) or Cramer's V. Differences in FT by SDM preference were estimated using mixed models clustered by site and treating medical oncologist. RESULTS: In 95 women with MBC, 44% preferred SDM, 29% preferred provider-driven decision making, and 27% preferred patient-driven decision making. Patients preferring SDM were more often college educated (53% vs. 39%; V = 0.12) with an income greater than $40,000/y (55% vs. 43%; V = 0.18). Overall median COST was 22 (interquartile range, 16-29). After adjusting for patient demographic and clinical characteristics, patients preferring patient-driven decision making trended toward worse FT (COST 17: 95% confidence interval, 12-22) compared to those preferring SDM (COST 19: 95% confidence interval, 15-23) and those preferring provider-driven decision making (COST 22: 95% confidence interval, 17-27). CONCLUSION: Patients preferring more patient-driven decision making reported worse FT, although differences did not reach statistical significance. Further research is needed to understand this relationship.