Home Time Among Older Adults With Acute Myeloid Leukemia Following Chemotherapy.

Importance: Patients with acute myeloid leukemia (AML) recognize days spent at home (home time) vs in a hospital or nursing facility as an important factor in treatment decision making. No study has adequately described home time among older adults with AML. Objective: To describe home time among older adults with AML (aged ≥66 years) and compare home time between 2 common treatments: anthracycline-based chemotherapy and hypomethylating agents (HMAs). Design, Setting, and Participants: A cohort of adults aged 66 years or older with a new diagnosis of AML from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database in 2004 to 2016 was identified. Individuals were stratified into anthracycline-based therapy, HMAs, or chemotherapy, not otherwise specified (NOS) using claims. Main Outcomes and Measures: The primary outcome was home time, quantified by subtracting the total number of person-days spent in hospitals and nursing facilities from the number of person-days survived and dividing by total person-days. A weighted multinomial regression model with stabilized inverse probability of treatment weighting to estimate adjusted home time was used. Results: The cohort included 7946 patients with AML: 2824 (35.5%) received anthracyclines, 2542 (32.0%) HMAs, and 2580 (32.5%) were classified as chemotherapy, NOS. Median (IQR) survival was 11.0 (5.0-27.0) months for those receiving anthracyclines and 8.0 (3.0-17.0) months for those receiving HMAs. Adjusted home time for all patients in the first year was 52.4%. Home time was highest among patients receiving HMAs (60.8%) followed by those receiving anthracyclines (51.9%). Despite having a shorter median survival, patients receiving HMAs had more total days at home and 33 more days at home in the first year on average than patients receiving anthracyclines (222 vs 189). Conclusions and Relevance: This retrospective study of older adults with AML using SEER-Medicare data and propensity score weighting suggests that the additional survival afforded by receiving anthracycline-based therapy was entirely offset by admission to the hospital or to nursing facilities.

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.

Longitudinal patient-reported outcomes on genotype-guided irinotecan dosing: feasibility and clinical relevance.

INTRODUCTION: Standard investigator-based adverse events (AE) assessment is via CTCAE for clinical trials. However, including the patient perspective through PRO (patient-reported outcomes) enhances clinicians' understanding of patient toxicity and fosters early detection of AEs. We assessed longitudinal integration of PRO-CTCAE within clinical workflow in a phase II trial. MATERIALS AND METHODS: As a sub-study in a phase II trial of genotype-directed irinotecan dosing evaluating efficacy in patients with metastatic colorectal cancer receiving FOLFIRI and bevacizumab, patients reported on 13 AEs generating a PRO-CTCAE form. The primary objective was to estimate forms completed by patients and clinicians at least 80% of time. Secondary objectives were estimating concordance and time to first score of specific symptoms between patient and clinician pairs. RESULTS: Feasibility of longitudinal PRO-CTCAE integration was met as 96% of patients and clinician-patient pairs completed at least 80% of PRO-CTCAE forms available to them with 79% achieving 100% completion. Concordance between patient and clinician reporting a severe symptom was 73% with 24 disconcordant pairs, 21 involved patients who reported a severe symptom that the clinician did not. Although protocol-mandated dose reductions were guided by CTCAE not PRO-CTCAE responses, the median time to dose reduction of 2.53 months, and the time-to-event curve closely approximated time to patient-reported toxicity. CONCLUSION: Longitudinal integration of PRO-CTCAE paired CTCAE proved feasible. Compared to clinicians, patients reported severe symptoms more frequently and earlier. Patient-reported toxicity more closely aligned with dose decreases indicating incorporation into routine clinical practice may enhance early detection of toxicity improving patient safety and quality of life.

National Implementation of an Artificial Intelligence-Based Virtual Dietitian for Patients With Cancer.

PURPOSE: Nutritional status is an established driver of cancer outcomes, but there is an insufficient workforce of registered dietitians to meet patient needs for nutritional counseling. Artificial intelligence (AI) and machine learning (ML) afford the opportunity to expand access to guideline-based nutritional support. METHODS: An AI-based nutrition assistant called Ina was developed on the basis of a learning data set of >100,000 expert-curated interventions, peer-reviewed literature, and clinical guidelines, and provides a conversational text message-based patient interface to guide dietary habits and answer questions. Ina was implemented nationally in partnership with 25 advocacy organizations. Data on demographics, patient-reported outcomes, and utilization were systematically collected. RESULTS: Between July 2019 and August 2023, 3,310 users from all 50 states registered to use Ina. Users were 73% female; median age was 57 (range, 18-91) years; most common cancer types were genitourinary (22%), breast (21%), gynecologic (19%), GI (14%), and lung (12%). Users were medically complex, with 50% reporting Stage III to IV disease, 37% with metastases, and 50% with 2+ chronic conditions. Nutritional challenges were highly prevalent: 58% had overweight/obese BMIs, 83% reported barriers to good nutrition, and 42% had food allergies/intolerances. Levels of engagement were high: 68% texted questions to Ina; 79% completed surveys; median user retention was 8.8 months; 94% were satisfied with the platform; and 98% found the guidance helpful. In an evaluation of outcomes, 84% used the advice to guide diet; 47% used recommended recipes, 82% felt the program improved quality of life (QoL), and 88% reported improved symptom management. CONCLUSION: Implementation of an evidence-based AI virtual dietitian is feasible and is reported by patients to be beneficial on diet, QoL, and symptom management. Ongoing evaluations are assessing impact on other outcomes.

A phase II trial of UGT1A1 genotype-guided FOLFIRI plus bevacizumab as first-line therapy for advanced, unresectable colorectal cancer.

BACKGROUND: FOLFIRI is a standard regimen for metastatic colorectal cancer (mCRC). We hypothesized that a pharmacogenomic-directed strategy where more efficient irinotecan metabolizers (UGT1A1 *1/*1 homozygotes and *1/*28 heterozygotes) receive higher-than-standard irinotecan doses would improve progression-free survival (PFS) compared to non-genotype selected historical controls with acceptable toxicity. METHODS: In this phase II multicenter study irinotecan dosing in first-line FOLFIRI and bevacizumab for mCRC was based on UGT1A1 genotype with *1/*1, *1/*28, and *28/*28 patients receiving 310 mg/m2, 260 mg/m2, and 180 mg/m2, respectively. Primary endpoint was PFS. Secondary endpoints were investigator and patient-reported adverse events, and estimation of overall survival (OS). RESULTS: One-hundred patients were enrolled with 91 evaluable for PFS and 83 evaluable for best response. Median PFS was 12.5 months (90% CI 10.9, 15.4), shorter than the anticipated alternative hypothesis of 14 months. PFS by genotype was 12.5 months (90% CI 10.9, 17.4) for *1/*1, 14.6 months (90% CI 11.8, 17.5) for *1/*28, and 6 months (90% CI 2.3, 7.7) for *28/28, respectively. OS was 24.5 months (90% CI 19.1, 30.7) and by genotype was 26.5 (90% CI 19.1, 32.9), 25.9 (90% CI 17.6, 37.7), and 13.4 (90% CI 2.3, 20.5) months for *1/*1, *1/*28, and *28/*28, respectively. G3/4 toxicity was similar between all subgroups, including diarrhea and neutropenia. CONCLUSIONS: A pharmacogenomic-directed irinotecan strategy improved PFS in the *1/*1 and *1/*28 genotypes with higher rates of neutropenia and similar rates of diarrhea compared to expected with standard FOLFIRI dosing. However, improvements in response rate and PFS were modest. This strategy should not change standard practice for mCRC patients in the first-line setting.

Optimization of alert notifications in electronic patient-reported outcome (ePRO) remote symptom monitoring systems (AFT-39).

PURPOSE: Clinical benefits result from electronic patient-reported outcome (ePRO) systems that enable remote symptom monitoring. Although clinically useful, real-time alert notifications for severe or worsening symptoms can overburden nurses. Thus, we aimed to algorithmically identify likely non-urgent alerts that could be suppressed. METHODS: We evaluated alerts from the PRO-TECT trial (Alliance AFT-39) in which oncology practices implemented remote symptom monitoring. Patients completed weekly at-home ePRO symptom surveys, and nurses received real-time alert notifications for severe or worsening symptoms. During parts of the trial, patients and nurses each indicated whether alerts were urgent or could wait until the next visit. We developed an algorithm for suppressing alerts based on patient assessment of urgency and model-based predictions of nurse assessment of urgency. RESULTS: 593 patients participated (median age = 64 years, 61% female, 80% white, 10% reported never using computers/tablets/smartphones). Patients completed 91% of expected weekly surveys. 34% of surveys generated an alert, and 59% of alerts prompted immediate nurse actions. Patients considered 10% of alerts urgent. Of the remaining cases, nurses considered alerts urgent more often when patients reported any worsening symptom compared to the prior week (33% of alerts with versus 26% without any worsening symptom, p = 0.009). The algorithm identified 38% of alerts as likely non-urgent that could be suppressed with acceptable discrimination (sensitivity = 80%, 95% CI [76%, 84%]; specificity = 52%, 95% CI [49%, 55%]). CONCLUSION: An algorithm can identify remote symptom monitoring alerts likely to be considered non-urgent by nurses, and may assist in fostering nurse acceptance and implementation feasibility of ePRO systems.

Clinical Decision Support for Surgery: A Mixed Methods Study on Design and Implementation Perspectives From Urologists.

OBJECTIVE: To assess urologist attitudes toward clinical decision support (CDS) embedded into the electronic health record (EHR) and define design needs to facilitate implementation and impact. With recent advances in big data and artificial intelligence (AI), enthusiasm for personalized, data-driven tools to improve surgical decision-making has grown, but the impact of current tools remains limited. METHODS: A sequential explanatory mixed methods study from 2019 to 2020 was performed. First, survey responses from the 2019 American Urological Association Annual Census evaluated attitudes toward an automatic CDS tool that would display risk/benefit data. This was followed by the purposeful sampling of 25 urologists and qualitative interviews assessing perspectives on CDS impact and design needs. Bivariable, multivariable, and coding-based thematic analysis were applied and integrated. RESULTS: Among a weighted sample of 12,366 practicing urologists, the majority agreed CDS would help decision-making (70.9%, 95% CI 68.7%-73.2%), aid patient counseling (78.5%, 95% CI 76.5%-80.5%), save time (58.1%, 95% CI 55.7%-60.5%), and improve patient outcomes (42.9%, 95% CI 40.5%-45.4%). More years in practice was negatively associated with agreement (P <.001). Urologists described how CDS could bolster evidence-based care, personalized medicine, resource utilization, and patient experience. They also identified multiple implementation barriers and provided suggestions on form, functionality, and visual design to improve usefulness and ease of use. CONCLUSION: Urologists have favorable attitudes toward the potential for clinical decision support in the EHR. Smart design will be critical to ensure effective implementation and impact.

Learning to Overcome Barriers to Electronic Patient-Reported Outcome Implementation: Lessons From the Field.

#Implementation of #ePROs in real world settings, lessons learned.

Scoping review of values elicitation tools for treatment decisions in hepatocellular carcinoma.

BACKGROUND: Treatment choices in hepatocellular carcinoma (HCC) involve consideration of tradeoffs between the benefits, toxicities, inconvenience, and costs. Stated preference elicitation methods have been used in the medical field to help evaluate complex treatment decision-making. The aim of this study was to conduct a scoping review to assess the evidence base for the use of preference elicitation tools or willingness to pay/willingness to accept methods for HCC treatment decision-making from both the patient and provider perspective. METHODS: We performed a scoping review to identify abstracts or manuscripts focused on the role preference elicitation tools or willingness to pay/willingness to accept methods for HCC treatment options among patients, caregivers, and/or providers. Two researchers independently screened full-text references and resolved conflicts through discussion. We summarized key findings, including the type and setting of preference-elicitation tools used for HCC treatment decisions. RESULTS: Ten published abstracts or manuscripts evaluated the role of preference elicitation tools for HCC treatments. The studies revealed several attributes that are considered by patients and providers making HCC treatment decisions. Many of the studies reviewed suggested that while patients place the most value on extending their overall survival, they are willing to forgo overall survival to avoid risks of treatments and maintain quality of life. Studies of physicians and surgeons found that provider preferences are dependent on patient characteristics, provider specialty, and surgeon or hospital-related factors. CONCLUSION: This scoping review explored both patient and physician preferences towards treatment modalities in all stages of HCC. The studies revealed a large scope of potential attributes that may be important to patients and that many patients are willing to forgo survival to maintain quality of life. Further research should explore both preference elicitation of currently available and emerging therapies for HCC as well as the use of this data to develop patient-facing tools to assist in navigating treatment options.

[Special issue PRO] Considering endpoints for comparative tolerability of cancer treatments using patient report given the estimand framework.

Regulatory agencies are advancing the use of systematic approaches to collect patient experience data, including patient-reported outcomes (PROs), in cancer clinical trials to inform regulatory decision-making. Due in part to clinician under-reporting of symptomatic adverse events, there is a growing recognition that evaluation of cancer treatment tolerability should include the patient experience, both in terms of the overall side effect impact and symptomatic adverse events. Methodologies around implementation, analysis, and interpretation of "patient" reported tolerability are under development, and current approaches are largely descriptive. There is robust guidance for use of PROs as efficacy endpoints to compare cancer treatments, but it is unclear to what extent this can be relied-upon to develop tolerability endpoints. An important consideration when developing endpoints to compare tolerability between treatments is the linkage of trial design, objectives, and statistical analysis. Despite interest in and frequent collection of PRO data in oncology trials, heterogeneity in analyses and unclear PRO objectives mean that design, objectives, and analysis may not be aligned, posing substantial challenges for the interpretation of results. The recent ICH E9 (R1) estimand framework represents an opportunity to help address these challenges. Efforts to apply the estimand framework in the context of PROs have primarily focused on efficacy outcomes. In this paper, we discuss considerations for comparing the patient-reported tolerability of different treatments in an oncology trial context.

Understanding health-related quality of life measures used in early-stage non-small cell lung cancer clinical trials: A review.

Health-related quality of life (HRQoL) is an important consideration in cancer clinical research, which can be substantially influenced by cancer treatment procedures and medications. The treatment landscape for early-stage (stage I-III) non-small cell lung cancer (NSCLC) is rapidly evolving. In this light, it is important to evaluate the most suitable instruments for HRQoL assessment and timing. Given there is often a requirement for patients with early-stage disease to receive long-term treatment to reduce the risk of disease recurrence after surgery, maintenance or improvement in HRQoL is an important goal of both neoadjuvant and adjuvant treatments. Key challenges with assessing HRQoL relate to the suitability of existing instruments to measure relevant treatment-related adverse effects, consistency in HRQoL assessment approach between similar studies, gaps in data collection and reporting, and interpretation of longitudinal data. Frequent assessments during and after treatment are warranted to capture the true impact of treatment and disease progression on HRQoL, and changes in the relative importance of these factors over time. There is scope for improving existing HRQoL approaches, including ease of use and integration of digital tools to facilitate analysis and interpretation, to enhance the experience of both patients and healthcare professionals. In this narrative review, we discuss key considerations for HRQoL assessment and evaluate the tools currently available to measure HRQoL in NSCLC, many of which were designed with advanced disease in mind. We focus on the key challenges of measuring HRQoL for the specific needs of patients with early-stage disease, and consider future perspectives, to determine the most appropriate HRQoL instruments and analysis methods to use in early-stage NSCLC clinical trials.1.

Feasibility, Acceptability, and Outcomes of a Mobile Health Tool for Radical Cystectomy Recovery.

PURPOSE: Postoperative education and symptom tracking are essential following cystectomy to reduce readmission rates and information overload. To address these issues, an internet-based tool was developed to provide education, alerts, and symptom tracking. We aimed to evaluate the tool's feasibility, acceptability, and impact on complication and readmission rates. MATERIALS AND METHODS: Thirty-three eligible patients over 18 years old scheduled for cystectomy were enrolled. Patients were asked to use the mobile health (mHealth) tool daily for the first 2 weeks, then less frequently up to 90 days after discharge. Descriptive statistics were used to summarize study variables. Feasibility was defined as at least 50% of patients using the tool once a week, and acceptability as patient satisfaction of > 75%. RESULTS: Use of the mHealth tool was feasible, with 90% of patients using it 1 week after discharge, but engagement declined over time to 50%, with technological difficulties being the main reason for nonengagement. Patient and provider acceptability was high, with satisfaction > 90%. Within 90 days, 36% experienced complications after discharge and 30% were readmitted. Engagement with the mHealth application varied but was not statistically associated with readmission (P = .21). CONCLUSIONS: The study showed that the electronic mobile health intervention for patients undergoing cystectomy was feasible, acceptable, and provided valuable educational content and symptom management. Future larger studies are needed to determine the tool's effectiveness in improving patient outcomes and its potential implementation into routine clinical care.

Impact of Remote Symptom Monitoring With Electronic Patient-Reported Outcomes on Hospitalization, Survival, and Cost in Community Oncology Practice: The Texas Two-Step Study.

PURPOSE: There is raising interest to implement electronic patient-reported outcomes (ePROs) for symptom monitoring to enhance the quality of cancer care. Step 1 of the Texas Two-Step Study demonstrated successful implementation of an ePRO system in >200 sites of service of a large community oncology practice. We now report step 2 of this study which evaluates the impact of ePROs on outcomes among patients enrolled in the Centers for Medicare & Medicaid Services' Oncology Care Model (OCM) program. METHODS: This observational study focused on patients with metastatic cancer enrolled in OCM at large community oncology practice located in Texas between July 2020 and December 2020. Patients who completed ≥1 survey via the ePRO tool were included in the study group and were propensity score matched with patients in a control group. Adverse events (AEs; hospitalizations, emergency department visits, deaths) and total cost of care were a priori study outcomes. Mann-Whitney U and chi-square tests compared continuous and categorical variables, respectively, with multivariable logistic regression for adjustment of covariates. RESULTS: Of 831 patients with metastatic cancer, 458 matched patients (229/group) were identified, with 52% male and a mean age of 74 years. Mean total AEs were lower in the study group compared with control (0.98 v 1.41; P = .007), with decreased hospitalizations (20% v 32.5%; P = .002), emergency visits (38.4% v 42.3%; P > .05), and deaths (11.8% v 16.6%; P > .05). Average number of hospitalizations was lower (0.28 v 0.52; P = .003) with reduced mean duration of hospitalizations (1.9 vs 3.2 d; P = .03). The total cost of care was reduced by an average of $1,146 per member per month. CONCLUSION: Symptom monitoring with ePROs improved quality and value of cancer care delivery by reducing hospitalizations, emergency visits, and deaths while lowering cost of care in a large oncology practice.

Feasibility of Weekly Electronic Health Record-Embedded Patient-Reported Outcomes for Patients Starting Oral Cancer-Directed Therapy.

PURPOSE: To examine the feasibility of integrating a symptom management platform into the electronic health record (EHR) using electronic patient-reported outcomes (ePROs) during oral cancer-directed therapy (OCDT) and explore the impact of prompting oncology nurse navigators (ONNs) to respond to severe symptomatic adverse events (SAEs). MATERIALS AND METHODS: Adults prescribed OCDT at Dana-Farber Cancer Institute were consecutively invited to participate. Participants received weekly messages to complete ePROs. The first half enrolled in a passive (P) group where ePROs responses could be viewed anytime, but outreach was not expected. The second half enrolled in an active (A) group where severe SAEs prompted emails to ONNs for outreach within 1 business day. Feasibility was the proportion of participants completing ≥2 ePROs during the first 30 days. Participants were followed for up to 90 days. RESULTS: From June 25, 2019, to August 18, 2021, 100 participants enrolled, and 96 remained enrolled for at least 30 days. Overall, average age was 59 years, 80% female, and 9% used the platform in Spanish. Twenty-two A (45%) and 27 P (57%) participants met the feasibility threshold (P = .26). ePROs returned at 30 days were similar (P = .50): 0 ePROs 17 A, 13 P; 1 ePRO 10 A, 7 P; 2 ePROs 3 A, 5 P; 3 ePROs 1 A, 4 P; 4 ePROs 7 A, 8 P; and 5 ePROs 11 A, 10 P. Documented telephone encounters at 30 days were similar (109 A, 101 P; P = .86). CONCLUSION: EHR-embedded ePROs administered weekly for people on OCDT was feasible, although many went incomplete. ePRO completion was not clearly affected by nursing calls for severe SAEs. Future efforts will investigate improving engagement and addressing symptoms proactively.

Real-World Use of Electronic Patient-Reported Outcome (ePRO) Tools Integrated in the Electronic Medical Record During Radiation Therapy for Head and Neck Cancer: Feasibility Study.

Purpose Use of electronic patient-reported outcome (ePRO) tools in routine oncology practice can be challenging despite evidence showing they can improve survival, improve patient and practitioner satisfaction, and reduce medical resource utilization. Head and neck cancer (HNC) patients receiving radiation therapy (RT) may be a group that would particularly benefit from interventions focused on early symptom management. Methods Patients undergoing definitive RT for HNC were enrolled in a feasibility study and received ePRO surveys integrated within the electronic medical record (EMR) on a weekly basis during RT. After completion of each ePRO survey, a radiation oncology registered nurse documented the findings and subsequent interventions within the EMR. Results Thirty-four patients with HNC who received curative RT at a single center were enrolled. The total number of surveys completed was 194 with a median of 7 surveys per patient (range 1-8). There was a total of 887 individual abnormal findings reported on the ePROs, and the authors found that all 887 had a corresponding documented intervention. Post-treatment practitioner questionnaires highlighted that ePROs were felt to be helpful for the care team in providing care to HNC patients. Conclusion For patients with HNC receiving RT, ePROs can be effectively utilized to address patient symptoms within an integrated health care system. Creating an infrastructure for the use of ePROs integrated within the EMR in routine care requires an approach that accounts for local workflows and buy-in from patients and the entire care team.

Financial Toxicity Monitoring in a Randomized Controlled Trial of Patient-Reported Outcomes During Cancer Treatment (Alliance AFT-39).

PURPOSE: Financial toxicity (FT) affects 20% of cancer survivors and is associated with poor clinical outcomes. No large-scale programs have been implemented to mitigate FT. We evaluated the effect of monthly FT screening as part of a larger patient-reported outcomes (PROs) digital monitoring intervention. METHODS: PRO-TECT (AFT-39) is a cluster-randomized trial of patients undergoing systemic therapy for metastatic cancer. Practices were randomly assigned 1:1 to digital symptom monitoring (PRO practices) or usual care (control practices). Digital monitoring consisted of between-visit online or automated telephone patient surveys about symptoms, functioning, and FT (single-item screening question from Functional Assessment of Chronic Illness Therapy-COmprehensive Score for financial Toxicity) for up to 1 year, with automated alerts sent to practice nurses for concerning survey scores. Clinical team actions in response to alerts were not mandated. The primary outcome of this planned secondary analysis was development or worsening of financial difficulties, assessed via the European Organisation for Research and Treatment of Cancer QLQ-C30 financial difficulties measure, at any time compared with baseline. A randomly selected subset of patients and nurses were interviewed about their experiences with the intervention. RESULTS: One thousand one hundred ninety-one patients were enrolled (593 PRO; 598 control) at 52 US community oncology practices. Overall, 30.2% of patients treated at practices that received the FT screening intervention developed, or experienced worsening of, financial difficulties, compared with 39.0% treated at control practices (P = .004). Patients and nurses interviewed stated that FT screening identified patients for financial counseling who otherwise would be reluctant to seek, or unaware of the availability of, assistance. CONCLUSION: In this report of a secondary outcome from a randomized clinical trial, FT screening as part of routine digital patient monitoring with PROs reduced the development, or worsening, of financial difficulties among patients undergoing systemic cancer therapy.

Preoperative Treatment of Locally Advanced Rectal Cancer.

BACKGROUND: Pelvic radiation plus sensitizing chemotherapy with a fluoropyrimidine (chemoradiotherapy) before surgery is standard care for locally advanced rectal cancer in North America. Whether neoadjuvant chemotherapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) can be used in lieu of chemoradiotherapy is uncertain. METHODS: We conducted a multicenter, unblinded, noninferiority, randomized trial of neoadjuvant FOLFOX (with chemoradiotherapy given only if the primary tumor decreased in size by <20% or if FOLFOX was discontinued because of side effects) as compared with chemoradiotherapy. Adults with rectal cancer that had been clinically staged as T2 node-positive, T3 node-negative, or T3 node-positive who were candidates for sphincter-sparing surgery were eligible to participate. The primary end point was disease-free survival. Noninferiority would be claimed if the upper limit of the two-sided 90.2% confidence interval of the hazard ratio for disease recurrence or death did not exceed 1.29. Secondary end points included overall survival, local recurrence (in a time-to-event analysis), complete pathological resection, complete response, and toxic effects. RESULTS: From June 2012 through December 2018, a total of 1194 patients underwent randomization and 1128 started treatment; among those who started treatment, 585 were in the FOLFOX group and 543 in the chemoradiotherapy group. At a median follow-up of 58 months, FOLFOX was noninferior to chemoradiotherapy for disease-free survival (hazard ratio for disease recurrence or death, 0.92; 90.2% confidence interval [CI], 0.74 to 1.14; P = 0.005 for noninferiority). Five-year disease-free survival was 80.8% (95% CI, 77.9 to 83.7) in the FOLFOX group and 78.6% (95% CI, 75.4 to 81.8) in the chemoradiotherapy group. The groups were similar with respect to overall survival (hazard ratio for death, 1.04; 95% CI, 0.74 to 1.44) and local recurrence (hazard ratio, 1.18; 95% CI, 0.44 to 3.16). In the FOLFOX group, 53 patients (9.1%) received preoperative chemoradiotherapy and 8 (1.4%) received postoperative chemoradiotherapy. CONCLUSIONS: In patients with locally advanced rectal cancer who were eligible for sphincter-sparing surgery, preoperative FOLFOX was noninferior to preoperative chemoradiotherapy with respect to disease-free survival. (Funded by the National Cancer Institute; PROSPECT ClinicalTrials.gov number, NCT01515787.).