Jansen, Jennifer

PURPOSE Remote symptom monitoring using patient-reported outcomes (PROs) has been shown to improve symptom control and physical function among patients with advanced cancer. However, it is unclear whether these benefits are similar across demographic groups. This exploratory analysis of the PRO-TECT trial examined whether the effects of electronic symptom monitoring varied by race, age, sex, and educational attainment. METHODS PRO-TECT was a cluster randomized trial conducted across 52 US community oncology practices comparing weekly electronic symptom monitoring with usual care (UC). Adult patients with metastatic solid tumors receiving systemic therapy were enrolled (N = 1,191). Participants in the PRO arm completed weekly symptom surveys including the PRO-CTCAE, triggering alerts to the care team for severe or worsening symptoms. Patients chose whether to complete weekly PROs online or via telephone-based interactive voice response not requiring Internet access. Outcomes were measured using the European Organisation for Research and Treatment of Cancer QLQ-C30 symptom control and physical function scales. Subgroup analyses were performed by race (Black v White), age (<65 v ≥65 years), sex (male v female), and educational attainment (≤high school v >high school). RESULTS From baseline to 3 months, PRO participants showed greater improvements in symptom control (+2.37 v −0.20, P = .002) and physical function (+1.54 v −0.93, P = .02) versus UC. Benefits were most pronounced among younger, female, Black, and less educated participants. Black participants in the PRO arm were more likely to report that symptom reporting made them feel more in control of their care compared with White participants. CONCLUSION Electronic symptom monitoring improved quality-of-life outcomes overall, including among groups who have historically experienced higher symptom burden or barriers to communication. Remote PRO systems may represent an equitable strategy to enhance cancer care delivery.

PURPOSE Many trials ask patients to complete patient-reported outcome measures (PROMs) via the web, excluding patients unable to use/access the Internet. The PRO-TECT trial (AFT-39, ClinicalTrials.gov identifier: NCT03249090 ) also offered a telephone interface option (interactive voice response [IVR]). We compared patients choosing IVR versus web on alert rates to nurses and clinical outcomes to determine if a telephone option can close disparities in symptom management. METHODS PRO-TECT randomized 26 community oncology practices to the PROM intervention arm where concerning symptoms generated automated alerts to nurses. IVR and web patients were compared for social determinants of health (SDOH) using analysis of variance and chi-square tests. After accounting for clustering and confounders, we used generalized estimating equations to compare alert rates, mixed models for quality of life (QOL) at 3 months, and Cox regression for emergency visits and survival at 12 months. RESULTS Among 593 patients, 215 (36%) chose IVR and 378 (64%) chose web. IVR patients were older (65.2 v 60.8 years) and were more often rural residents (32% v 23%), Black (27% v 11%), and with less education (54% v 27% ≤high school; all P < .01). Patients choosing IVR had more surveys with concerning symptoms (49% v 37%) and nurses felt clinical attention was warranted more often (4.8 surveys v 3.4 surveys; all P < .001) but ultimately experienced similar benefits as web in QOL, emergency visits, and survival. CONCLUSION One third of community patients choose a telephone option over the web for reporting PROMs during cancer care. These patients are disproportionately from SDOH backgrounds at risk of poor clinical outcomes and have higher symptom management needs but ultimately experience similar clinical benefits as patients choosing the web. PROM programs should offer web alternatives to close disparities in symptom management.

PURPOSE Monitoring with electronic patient-reported outcome (ePRO) systems can improve cancer outcomes and is increasingly recommended. Optimal implementations of ePROs in routine clinical care are not yet known. Perspectives from clinicians, clinic staff, and patients who used ePROs can provide real-world insights for optimizing the design, efficiency, and effectiveness of future implementations. METHODS Providers, clinic staff, and patients receiving treatment for metastatic cancer from community oncology practices that implemented ePROs as part of the national PRO-TECT trial (Alliance AFT-39) participated in semi-structured interviews related to ePROs. Perceptions from clinicians on perceived benefits, usefulness, acceptability, impact on quality of care, and required effort; from staff on clinical integration and effort; and from patients on ease of use, usefulness, and effort were collected. Themes, subthemes, and recommendations were identified via a standardized coding-based directed thematic analytic approach. RESULTS Ninety-eight clinic members and 67 patients participated from 25 intervention sites. Four themes were identified: (1) positive impact of ePROs on cancer care quality, communication, and relationship-building; (2) ePRO system usability; (3) challenges to ePRO integration with clinical workflow; and (4) recommendations for improving ePRO systems and implementation. Subthemes related to the impact of ePROs on cancer care included enhanced communication with care team, increased awareness of symptoms, and increased ability to self-manage symptoms. Actionable recommendations for future initiatives were to engage and train clinicians, staff, and organizational support for ePRO-related activities; tailor content of ePRO surveys to be clinically actionable; integrate ePRO alert notifications and reports with existing information systems; and optimize integration of ePROs with existing clinic workflow processes. CONCLUSION Experiences of care team members and patients were positive, with actionable recommendations identified to guide future ePRO implementations.

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.

180 Background: Financial toxicity affects 20% of cancer survivors and is associated with decreased treatment adherence and poor clinical outcomes. No large-scale programs have been implemented to mitigate financial toxicity among patients undergoing cancer treatment. We evaluated the effect of monthly patient-reported financial toxicity screening as part of a larger digital monitoring intervention. Methods: PRO-TECT (AFT-39) is a cluster-randomized trial of patients undergoing systemic therapy for metastatic cancer. Practices were randomized 1:1 to digital symptom monitoring with patient-reported outcomes (“PRO practices”) or usual care (“control practices”). Digital monitoring consisted of between-visit online or automated telephone patient surveys containing symptom, functioning, and financial toxicity screening questions for up to one 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 analysis was development or worsening of financial difficulties, assessed via the EORTC QLQ-C30 (“Has your physical condition or medical treatment caused you financial difficulties?”), at any time compared to baseline. A randomly selected subset of patients and nurses were interviewed about their experiences with the intervention. Results: 1,191 patients were enrolled (593 PRO; 598 control) at 52 US community oncology practices. Overall, 30.2% of patients treated at practices that received the intervention developed, or experienced worsening of, financial difficulties, compared to 39.0% of patients treated at control practices (p = 0.01). Patients and nurses interviewed stated that financial toxicity screening identified patients for financial counseling who otherwise would be reluctant to seek, or unaware of the availability of, assistance. Conclusions: Screening for financial toxicity as part of routine digital patient monitoring with PROs reduces the development, or worsening, of financial difficulties among patients undergoing systemic cancer therapy. Clinical trial information: NCT03249090.

349527 Background: Symptoms are common during cancer care but often go undetected. Digital systems that elicit patient-reported outcomes (PRO) surveys may detect symptoms early and prompt clinicians to intervene, thereby alleviating suffering and averting complications. Methods: In a cluster-randomized trial, U.S.-based community oncology practices were randomized 1:1 to digital symptom monitoring with PRO surveys, or to usual care control. Patients receiving systemic treatment for metastatic cancer were eligible. At PRO practices, participants were invited to complete a weekly survey via web or automated telephone system for up to one year, including questions about nine common symptoms, performance status, and falls. Severe or worsening symptoms triggered electronic alerts to care team nurses, and reports showing longitudinal symptom data were available to oncologists at visits. Pre-specified secondary outcomes included impact on physical function, symptom control, and health-related quality of life (HRQL). The primary outcome of survival is not yet mature. Results: At 52 practices, 1,191 patients were eligible and enrolled (593 PRO; 598 control). Clinically meaningful benefits were experienced in physical function by 13.8% more patients with PRO versus control (P=0.009); symptom control by 16.1% (P=0.003); and HRQL by 13.4% (P=0.006). Mean changes from baseline were superior with PRO versus control for physical function (mean difference 2.47, 95% CI 0.41-4.53; P=0.02), symptom control (2.56, 0.95-4.17; P=0.002), and HRQL (2.43, 0.90-3.96; P=0.002). Patients completed 20,565/22,486 (91.5%) of expected weekly PRO surveys. Conclusions: Digital symptom monitoring during cancer treatment confers clinical benefits. Clinical trial information: NCT03249090.

Abstract Background Racial disparities in patient-reported outcomes (PROs; e.g., symptoms, financial burden) among patients with cancer are well documented. Prior studies have attributed such disparities to patient- and provider-level factors, but less is known about the contribution of practice-level factors. Hospital racial composition of patients has been linked to disparities in care quality and outcomes, but questions remain regarding whether oncology practice racial composition mediates racial disparities. Using 2017-2020 data from the Patient-Reported Outcomes to Enhance Cancer Treatment (PRO-TECT) trial (ClinicalTrials.gov NCT03249090), we examined racial disparities in PROs among patients with metastatic cancer, and whether oncology practice racial composition accounted for observed disparities. Methods Our sample included 1099 patients (n=198 Black; n=901 White) from 51 community oncology practices across the US. Predictors of interest were patient race (Black vs. White) and practice-reported racial composition (Black patient population &gt;20% vs. ≤20%). Patient-reported outcome metrics included pain, appetite loss, fatigue, nausea, dyspnea, insomnia, constipation, diarrhea, and financial burden, measured at baseline and at 1- and 3-month follow-up using the EORTC Quality of Life Core Questionnaire (QLQ-C30). Raw EORTC QLQ-C30 scores were standardized to range from 0 (best) to 100 (worst). We estimated multilevel linear mixed models predicting each PRO as a function of patient race, adjusting for clinical and sociodemographic factors, followed by further adjustment for practice racial composition. Results Twelve out of fifty-one (23.5%) practices reported a Black racial composition of &gt;20%, with 41.6% of Blacks and 14.5% Whites receiving care at these practices. Across all practices, Blacks reported worse pain (β=5.5, p=0.02), nausea (β=2.5, p=0.04) and financial burden (β=7.6, p&lt;0.01), but less fatigue (β=-4.1, p=0.05) when compared with Whites. Regardless of race, patients receiving care at practices with a Black racial composition of &gt;20% reported more pain (β=5.5, p=0.01), appetite loss (β=8.1, p&lt;0.01), fatigue (β=5.1, p=0.01), nausea (β=2.3, p=0.05), dyspnea (β=4.3, p=0.04), and insomnia (β=4.8, p=0.03) than patients receiving care at practices comprised of ⇐20% Blacks. Practice racial composition did not mediate racial disparities in PROs. Conclusion Racial disparities in PROs were observed among patients treated at US community oncology practices. Practice racial composition was associated with multiple PROs, regardless of patient race, but racial disparities in PROs were not explained by practice racial composition. These findings suggest that identifying and addressing the needs of practices serving a disproportionate share of Black patents may be one effective strategy to mitigate practice-level disparities in cancer outcomes. Citation Format: Cleo A. Samuel, Olive Mbah, Wendi Elkins, Marjory Charlot, Amylou Dueck, Brenda F. Ginos, Jennifer Jansen, Deborah Schrag, Patty Spears, Angela Stover, Ethan Basch. Separate and unequal: Examining the role of race and site of care on patient-reported outcomes among patients with metastatic cancer (AFT-39) [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-119.

PURPOSE There is increasing interest in implementing digital systems for remote monitoring of patients’ symptoms during routine oncology practice. Information is limited about the clinical utility and user perceptions of these systems. METHODS PRO-TECT is a multicenter trial evaluating implementation of electronic patient-reported outcomes (ePROs) among adults with advanced and metastatic cancers receiving treatment at US community oncology practices (ClinicalTrials.gov identifier: NCT03249090 ). Questions derived from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) are administered weekly by web or automated telephone system, with alerts to nurses for severe or worsening symptoms. To elicit user feedback, surveys were administered to participating patients and clinicians. RESULTS Among 496 patients across 26 practices, the majority found the system and questions easy to understand (95%), easy to use (93%), and relevant to their care (91%). Most patients reported that PRO information was used by their clinicians for care (70%), improved discussions with clinicians (73%), made them feel more in control of their own care (77%), and would recommend the system to other patients (89%). Scores for most patient feedback questions were significantly positively correlated with weekly PRO completion rates in both univariate and multivariable analyses. Among 57 nurses, most reported that PRO information was helpful for clinical documentation (79%), increased efficiency of patient discussions (84%), and was useful for patient care (75%). Among 39 oncologists, most found PRO information useful (91%), with 65% using PROs to guide patient discussions sometimes or often and 65% using PROs to make treatment decisions sometimes or often. CONCLUSION These findings support the clinical utility and value of implementing digital systems for monitoring PROs, including the PRO-CTCAE, in routine cancer care.

7044 Background: There is growing interest to implement electronic patient-reported outcomes in oncology practices for symptom monitoring. It is not well known what nurse, physician, and patient impressions of benefits, acceptability, and challenges are in routine care use. Methods: PRO-TECT is an ongoing U.S. national trial including 26 community oncology practices across 15 states that implemented PRO symptom monitoring [NCT03249090]. Patients complete weekly PROs between visits, nurses receive alerts for severe/worsening symptoms, and oncologists review PROs at office visits. Interviews were conducted with 147 stakeholders including nurses (N = 46), oncologists (N = 27), data managers (N = 15), and patients (N = 59). Each stakeholder group had different interview guides with overlapping topics to explore experiences with the PRO system. Interviews lasted 15-60 minutes, were digitally recorded, transcribed, and entered into a qualitative analysis software program. A codebook was developed from the research questions, interview guides, and discussions with the project team. Standardized coding methods were applied, with transcripts double coded for thematic analysis. Feedback surveys were also completed by nurses (N = 57), oncologists (N = 38), and patients (N = 435). Results: Key benefits perceived across stakeholder groups included increased patient self-awareness of symptoms; improved direct communication of patients with care teams; more open and honest conveying of symptom experiences; ability to track symptoms over time; and increased involvement of patients in their own care. Most stakeholders felt PRO symptom monitoring had a positive impact on quality of care delivery, and believed benefits of PROs outweighed necessary staff efforts. Challenges included additional work by nurses to review and respond to alerts, staff turnover requiring retraining, and limited time of oncologists. In the survey, 39/56 (70%) nurses felt the PRO system improved quality of care; 27/33 (82%) oncologists noted PROs were useful for team discussions and care delivery; and 320/434 (74%) patients agreed that weekly PRO reporting improved discussions with their care team. Conclusions: Clinicians and patients perceived weekly PRO symptom monitoring between visits to be valuable despite added staff effort. Results of additional analyses are forthcoming. Clinical trial information: NCT03249090 .