Electronic Patient-reported Outcomes Research Articles

Patient motivators of postoperative electronic patient-reported outcome symptom monitoring use in thoracic surgery patients: a qualitative study

BackgroundElectronic patient-reported outcome (ePRO) systems can be used to engage patients in remote symptom monitoring to support postoperative care. We interviewed thoracic surgery patients with ePRO experience to identify factors that influenced use of ePROs to report their symptoms post-discharge.MethodThis qualitative study used semi-structured telephone interviews with adults who underwent major thoracic surgery at an academic medical center in North Carolina. Individuals who enrolled in symptom monitoring, completed at least one ePRO survey, and were reachable by phone for the interview were included. The ePRO surveys assessed 10 symptoms, including validated Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures and thoracic surgery-specific questions. Surveys, offered via web-based and automated telephone options, were administered for four weeks post-discharge with alerts sent to clinicians for concerning symptoms. The interviews were guided by the Capability, Opportunity, Motivation model for behavior change (COM-B) and examined factors that influenced patients’ completion of ePRO surveys post-discharge. Team members independently coded interviews and identified themes, informed by COM-B. We report descriptive statistics (demographics, number of surveys completed) and themes organized by COM-B components.ResultsOf 28 patients invited, 25 (89%) completed interviews from July to October 2022. Participants were a median 58 years, 56% female, 80% White, and 56% had a history of malignancy. They completed 131/150 (87%) possible ePRO surveys. For capability, participants reported building ePROs into their routine and having the skills and knowledge, but lacking physical and emotional energy, to complete ePROs. For opportunity, participants identified the ease and convenience of accessing ePROs and providers’ validation of ePROs. Motivators were perceived benefits of a deepening connection to their clinical team, improved symptom management for themselves and others, and self-reflection about their recovery. Factors limiting motivation included lack of clarity about the purpose of ePROs and a disconnect between symptom items and individual recovery experience.ConclusionsPatients described being motivated to complete ePROs when reinforced by clinicians and considered ePROs as valuable to their post-discharge experience. Future work should enhance ePRO patient education, improve provider alerts and communications about ePROs, and integrate options to capture patients’ complex health journeys.

Electronic Patient-Reported Outcome-Driven Symptom Management by Oncology Pharmacists in a Majority-Minority Population: An Implementation Study.

There is a lack of systematic solutions to manage supportive care issues in racial/ethnic minorities (REM) receiving treatment for cancer. We developed and implemented an electronic patient-reported outcome (ePRO)-driven symptom management tool led by oncology pharmacists in a majority-minority cancer center located in Southern California. This study was designed to evaluate the implementation outcomes of our multilevel intervention. This was a prospective, pragmatic, implementation study conducted between July 2021 and June 2023. Newly diagnosed adult patients with cancer receiving intravenous anticancer therapies completed symptom screening using ePRO that consists of the Patient-Reported Outcomes Measurement Information System measures at each infusion visit during the study. ePRO results were presented to an oncologist pharmacist for personalized symptom management and treatment counseling. The RE-AIM framework was used to guide implementation outcomes. Differences in symptom trajectories and clinical outcomes between groups were tested using generalized estimating equations. We screened 388 patients of whom 250 were enrolled (acceptance rate: 64.4%), with 564 assessments being completed. The sample consisted of non-Hispanic White (NHW, 42.4%), Hispanic/Latinx (H/L, 30.8%), and non-Hispanic Asian (20.4%), with one (21.6%) of five participants preferring speaking Spanish. Compared with NHW, H/L participants had greater odds of reporting mild to severe pain interference (odds ratio [OR], 1.91 [95% CI, 1.18 to 3.08]; P = .008) and nausea and vomiting (OR, 2.08 [95% CI, 1.21 to 3.58]; P = .008), and higher rates of urgent care utilization (OR, 1.92 [95% CI, 1.04 to 3.61]; P = .04) within 30 days. Nausea and vomiting (n = 131, 23.2%), pain (n = 91, 16.1%), and fatigue (n = 72, 12.8%) were most likely to be intervened, with 90% of the participants expressing satisfaction across all visits. Our multilevel ePRO-driven intervention led by oncology pharmacists helps facilitate symptom assessments and management and potentially reduce health disparities among REM.

Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study.

Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC. This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed. Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%-71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%-76.4%). One adverse event not related to budesonide rectal foam occurred. The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.

Automation of ePROMs in radiation oncology and its impact on patient response and bias

PurposeThis study evaluates the impact of integrating a novel, in-house developed electronic Patient-Reported Outcome Measures (ePROMs) tool with a commercial Oncology Information System (OIS) on patient response rates and potential biases in real-world data science applications. Materials and MethodsWe designed an ePROMs tool using the NodeJS web application framework, automatically sending e-mail questionnaires to patients based on their treatment schedules in the OIS. The tool is used across various treatment sites to collect PROMs data in a real-world setting. This research examined the effects of increasing automation levels on both recruitment and response rates, as well as potential biases across different patient cohorts. Automation was implemented in three escalating levels, from telephone reminders for missing reports to minimal intervention from study nurses. ResultsFrom August 2020 to December 2023, 1,944 patients participated in the PROMs study. Our findings indicate that automating the workflows substantially reduced the patient management workload. However, higher levels of automation led to lower response rates, particularly in collecting late-phase symptoms in breast and head-and-neck cancer cohorts. Additionally, email-based PROMs introduced an age bias when recruiting new patients for the ePROMs study. Nevertheless, age was not a significant predictor of early dropout or missing symptom reports among patients participating. Notably, increased automation was significantly correlated with lower response rates in breast (p = 0.026) and head-and-neck cancer patients (p < 0.001). ConclusionIntegrating ePROMs within the OIS can significantly reduce workload and personnel resources. However, this efficiency may compromise patient responses in certain groups. A balance must be achieved between workload, resource allocation, and the sensitivity needed to detect clinically significant effects. This may necessitate customized automation levels tailored to specific cancer groups, highlighting a fundamental trade-off between operational efficiency and data quality.

THE DEVELOPMENT AND FEASIBILITY OF A NOVEL ELECTRONIC PATIENT-REPORTED OUTCOME MEASURES (EPROMS) QUESTIONNAIRE IN PATIENTS WITH PENILE CANCER

BackgroundPenile cancer (PeCa) is a rare cancer with surgical options that affect patients’ quality-of-life. Patient-reported outcome measures (PROMs) are uncommonly utilised in this cohort despite their several patient-centred benefits and there are recommendations to further digitalise PROMs. This prospective, population-based study aimed to report the development and feasibility of a novel electronic patient-reported outcome measures (ePROMs) questionnaire for patients with PeCa. Materials and methodsA novel ePROMs questionnaire was developed and sent to patients three days before outpatient clinic appointments. The questionnaire included up to 30 items on patient symptomology and quality-of-life, including a self-reported quality-of-life score (rated 0 being worst and 100 being best). Data were collected for patients followed up between August 2021 and May 2022. The primary feasibility outcomes, adherence and engagement, were measured by response and drop-out rates. Differences in responders and non-responders were also ascertained. Secondary outcomes explored the clinical utility of the questionnaire. Responders were subcategorised into three groups: circumcision (Ci), partial penectomy (PP) or total penectomy (TP) and differences were analysed. This study was approved by the local Trust Governance Panel, including for ethical considerations. Results220 adult males were sent ePROMs questionnaires, and 141 (64%) responded initially. The mean dropout rate of subsequent questionnaires was 56%. The maximum number of questionnaires sent to and completed by a patient was eight (n=1). Non-responders were older (p<0.0001), with poorer performance status (p<0.0001) and lower body mass index (p=0.0288). TP patients reported the lowest median quality-of-life score 68.50 (8 – 99), followed by the Ci group (72.0, 37 – 94) and the PP group (76.0, 10 – 99). ConclusionsPatients initially engaged and adhered to the ePROMs questionnaire but struggled to maintain this over time. Clinical data gathered by the questionnaire may be utilised to inform patient care. The questionnaire requires additional validation, research, and education. MicroabstractThis study reports the development and feasibility of a novel electronic patient-reported outcome measures questionnaire for patients with penile cancer. 220 adult males were sent questionnaires, and 141 (64%) responded initially. The mean dropout rate of subsequent questionnaires was 56%, displaying that over time patients struggled to maintain adherence and engagement. The questionnaire requires additional validation, research, and education.

Health information and technology engagement for clinical research and healthcare purposes (HITECH) survey of patients with a history of cancer.

e13672 Background: Digital technology offers oncology clinicians and researchers the ability to more closely monitor patients on therapy, including with electronic patient-reported outcomes (ePROs) and real-time passively collected data (for example: heart rate, oxygen saturation, etc.), via smartphone and wearable devices. In order to realize the potential for these technologies to improve patient experience and outcomes, it is critical that we consider the perspectives of patients to design usable and useful digital monitoring programs. Methods: We conducted a cross-sectional survey of cancer patients from a large academic medical institution to study willingness to use digital devices to collect data and to share discrete types of data for the purposes of medical care or research. A survey including baseline characteristics and questions pertaining to digital technology use was sent to participants enrolled in the UCLA Mental Health and Health Technology Research Registry, from November 2023 to January 2024. Participants were included if they were patients at UCLA, age 18 years and older, owned a smartphone and/or wearable device, and self-reported a history of cancer. The primary outcomes of interest were willingness to collect and share digital device data. We report summary statistics for our population. Results: A total of 690 patients participated in our survey. The majority were female (58.5%), 76.7% non-Hispanic white, 8.8% Hispanic, 5.8% Asian, and 2.0% black. Median age was 69 years old. Nearly all participants reported experience using a patient portal (98.9%). Willingness to collect data using a digital device, for the purposes of clinical care was reported by 93.3% of patients. Similarly, 92.0% were willing to use a device to collect health data for research purposes. Sharing patterns were similar regardless of whether data was intended to be for clinical care or research purposes (Table). Conclusions: The overwhelming majority of patients who own a smartphone and/or wearable are willing to collect health data on their digital device for either clinical care or research. There is a preference for sharing more objective clinical information (vitals and physical activity measurements), and less inclination to share subjective information (daily activity, symptoms, and mood). This could be attributable to the greater effort required to input information as well as skepticism of the usefulness of the subjective data. Notably, we must recognize that some patients are not well-represented in this study population. Their perspectives should also be explored to prevent widening of the digital divide. [Table: see text]

The impact of self-reported social determinants of health (SDOH) on patient engagement and symptom burden across a remote patient monitoring (RPM) pathway in 42 European hospitals.

1506 Background: SDOH are a significant driver of cancer care disparities impacting access to care, adherence to treatment plans, treatment-related toxicities and quality of life (QoL) across the cancer care continuum. RPM based on electronic patient-reported outcomes (ePROs) is a powerful tool to facilitate communication between pts and providers, thereby improving symptom management, QoL and disease outcomes. Equitable participation in RPM pathways must be ensured to avoid increase existing disparities. In this study we report the prevalence of unfavorable SDOH and their impact on engagement with RPM and symptom burden in an RPM pathway deployed in routine care across 42 hospitals in FR and BE. Methods: Patient-level SDOH data provided by consented pts enrolled in the RPM pathway between 08-2023 and 12-2023 was used. Single-item questions were dichotomized from validated ePROs covering educational level, health literacy (3 subdomains health status, treatment and disease understanding), digital literacy, employment status, financial and food security, caregiver support, and access to care. SDOH profiles were defined as unfavorable (impairment at moderate/elevated level) vs. favorable (absence or impairment at a low level). RPM engagement and symptom burden were defined respectively as weekly ePRO reporting and number of alerts due to severe or worsening symptoms. Multivariable backward stepwise regression models (including age, gender, stage, health behaviors) assessed associations between SDOH profile and RPM engagement and symptom burden. Results: 896 (40%) pts provided SDOH data, of which 622 (69%) females with median age of 60 (P25-75 50-70). Most common primary tumor were breast (436, 49%) and gastrointestinal (171, 19%), 488 (55%) were non-metastatic. 653 (73%) pts reported at least 1 unfavorable SDOH, specifically: 199 (22.2%) on educational level, 134 (15.0%) on health status understanding, 27 (3.0%) on treatment understanding, 84 (9.4%) on disease understanding, 218 (24.3%) on digital literacy, 63 (7.0%) on employment status, 104 (11.6%) on financial security, 89 (9.9%) on food security, 348 (38.8%) on caregiver support and 56 (6.3%) on access to care. Lower RPM engagement was associated with unfavorable digital literacy (β -0.05, p&lt;0.001) and treatment understanding (β -0.1, p=0.004). Higher symptom burden was associated with unfavorable financial security (β 0.066, p=0.020) and disease understanding (β -0.1077, p=0.001), but favorable employment status (β 0.0497, p=0.025). Conclusions: RPM with ePROs offers an opportunity to screen for SDOH in routine care. The vast majority of pts enrolled had at least 1 unfavorable SDOH. Specific actionable unfavorable SDOH were associated with lower engagement and higher symptom burden. Personalizing RPM pathways according to SDOH may foster equitable care.

Evaluation of a complex survivorship intervention incorporating electronic patient-reported outcomes in early stage breast and gynecologic cancer: Results from the Linking You to Support and Advice (LYSA) randomized controlled trial.

1505 Background: Expert consensus supports a multidisciplinary strategy in cancer survivorship care to enhance patient outcomes and quality of life. We hypothesized that introducing a women’s survivorship clinic into routine follow up care would be feasible, and associated with improved symptom management and quality of life (QOL). Methods: LYSA was a multisite randomized controlled trial with parallel arms (experimental and active comparator), co-designed with public and patient involvement. Eligibility: early-stage hormone receptor-positive breast or gynaecologic cancer (GYN) within 12 months of completing primary therapy, and internet access (NCT05035173). Experimental arm attended a nurse-led clinic targeting symptom management, and dietetic consultation. Electronic patient-reported outcome (ePRO) assessments were undertaken at baseline, and bimonthly to 12 months. An online trigger alert system facilitated symptom management. Active comparator arm attended the nurse-led clinic at baseline and end of study. Primary endpoint (feasibility): Proportions of participants completing baseline and follow up ePRO surveys, and engaging in healthcare consultations after ePRO triggers. Pilot efficacy endpoints: changes in cancer-related symptom (PROMIS, PRO-CTCAE, Fear of Cancer Recurrence), health-related QOL Questionnaires (EORTC-QLQ, EQ5D5L) . Sample size target (n=200) facilitated feasibility outcomes. Between arm differences were estimated using generalized linear model, adjusted for baseline outcome. Results: 200 women were randomized, March 2021-August 2022 across two sites; 84% breast and 16% GYN. Consent was obtained in clinic (51%), video call (33%) or phone (16%). Median age was 54 (range 23-78). Of the 173 participants completing the study (n = 90 experimental, 83 comparator), all completed both baseline and end of study surveys. Following symptom triggers (experimental arm), there were 322 study nurse visits across 86 participants, and 243 dietician visits across 73 participants. Engagement with healthcare and other supportive resources was approximately twice more than comparator arm, due to referral. There were no notable between-arm differences with respect to EQ5D5L items at study end. However, experimental arm participants had better EORTC Total scores at study end relative to comparator (difference in means -3.87 95%CI -6.58 to -1.16, p=0.005). There were also significant (p &lt; 0.05) differences observed between the arms for 8/12 symptom items reflecting less fatigue, anxiety and depression in experimental arm at study end. Conclusions: The LYSA trial met its primary feasibility endpoint, with high rates of ePRO completion. Secondary endpoint analysis is ongoing including an economic analysis and future studies. Clinical trial information: NCT05035173 .

Efficacy of eSyM: Acute care utilization among patients with cancer who do versus do not report ePROs.

11001 Background: Patients (pts) receiving cancer treatment frequently experience burdensome symptoms that compromise outcomes and necessitate acute care. Prior clinical trials have demonstrated that electronic patient-reported outcome (ePRO)-based symptom management programs improve outcomes in controlled settings. Deploying these programs in routine care settings remains challenging. With funding from the Cancer Moonshot IMPACT Consortium, we created eSyM – an ePRO-based, EHR-integrated symptom management program – to facilitate the widespread adoption of active symptom management efforts. Methods: eSyM was deployed across six health systems from September 2019-August 2022 via a modified stepped-wedge cluster randomized pragmatic trial. Pts starting chemotherapy (CHEM) or undergoing surgery (SURG) for a suspected or confirmed thoracic, gastrointestinal, or gynecologic cancer were prompted to complete symptom questionnaires regularly; those reporting symptoms were offered additional supports. To assess eSyM efficacy, we studied pts who were eligible to use the program – comparing those who completed at least one symptom questionnaire to those who did not. Outcomes included emergency department (ED) visits and inpatient encounters (INPT) at 30 and 90-days. Odds ratios with 95% CIs were derived after adjusting to account for the propensity to report ePROs as a function of age, sex, race/ethnicity, employment, marital status, poverty, rurality, insurance, comorbidity, cancer, treatment goal, institution, and calendar time. Results: Among eSyM-eligible pts, 51% (N = 10,454/20,471) completed at least one symptom questionnaire (median 4 reports/patient) – 47% (3815/8187) for CHEM and 54% (6639/12,293) for SURG. Comparing symptom reporters to non-reporters, the proportion of CHEM+SURG pts experiencing an ED event was 5.3% vs. 7.1% at 30 days and 10.0% vs. 12.9% at 90 days; and the proportion experiencing an INPT event was 6.7% vs. 11.3% at 30 days and 14.0% vs. 19.5% at 90 days ( p&lt; 0.001 for all). Adjusted ORs appear in the. Conclusions: After accounting for propensity to report symptoms, completing at least one symptom questionnaire was associated with lower odds of experiencing an ED or INPT encounter among CHEM and SURG pts across six diverse health systems. eSyM engagement reduced acute care utilization. This EHR-integrated symptom management solution is broadly available to health systems that use Epic. Clinical trial information: NCT03850912 . [Table: see text]

Symptoms reported by patients using an ePRO compared with those reported to nurses via telephone triage.

1542 Background: It is unclear how symptoms reported by an electronic patient-reported outcomes (ePRO) tool compare to symptoms reported to triage nurses by patient-initiated telephone calls. This work describes symptoms reported using each of these methods, and the percent of patients requiring an acute office visit triggered by these symptom reports. Methods: Among patients diagnosed with breast, lung, or colon cancer at three community oncology practices from 2020 to 2023, we examined ePRO symptom reports and compared these with symptoms reported via telephone triage to nurses by patients not using the ePRO tool. Results: 3,509 patients reported symptoms by ePROs, and 9,071 patients only reported by phone. Among patients reporting by ePRO, 2,162 submitted both ePROs and used telephone triage services. The most common symptoms that patients reported by ePRO reports (47,284 reports) were weakness / fatigue (72.9% of patients), pain (62.0%), nausea (39.2%), and headache (33.1%). The most common symptoms that patients reported by phone reports (19,344 reports) were pain (32.9%), weakness / fatigue (13.4%), swelling (11.1%), cough (10.3%), and diarrhea (9.4%). The median number of reports in the ePRO group was 6.0 (mean 13.5, IQR: 2.0, 15.0) per patient and the median number of reports in the phone triage group was 1.0 (mean 2.1, IQR: 1.0, 2.0) per patient. The most common high-urgency symptoms in the ePRO group (defined by practice defined symptom threshold) were weakness / fatigue (67.2% of patients), pain (55.7%), headache (40.2%), nausea (32.0%), and difficulty breathing (29.2%), while the most common high-urgency symptoms (as determined by the triage nurse) in the phone triage group were pain (32.4%), weakness / fatigue (11.8%), swelling (11.4%), fever/chills (10.1%), and cough (9.7%). More patients reported high-urgency symptoms by ePRO (n = 1,873, 53.4%) compared to those reported by phone triage (n = 2,448, 27.0%). Of patients in the ePRO group with a severe symptom who visited a site with acute care visits data, 330 patients (45.4%) had an acute care visit within 72 hours of a symptom report compared to 745 patients (47.5%) in the telephone triage group. Conclusions: Patients using ePROs reported more symptoms than patients reporting by phone, possibly because electronic reporting allows patients to easily communicate symptoms to care providers and receive prompt attention. Pain and weakness/fatigue were the most common urgent symptoms in both groups. The need for an acute care visit was the same in both groups. Further refinement of the ePRO tool including standardization of symptom thresholds, more uniform implementation in practices, and patient education with respect to optimal use of the ePRO may enable practices to replace telephone triage with ePROs.

Implementation and preliminary efficacy of a risk stratification system +/- patient-reported outcomes monitoring for patients with hospital-diagnosed advanced lung cancer.

11095 Background: Risk stratification systems may improve quality of care for patients with advanced lung cancer (ALC) by identifying those at high risk of rehospitalization and directing them to supportive care. The purpose of this study was to evaluate the implementation and preliminary efficacy of a risk-based system, with/without electronic patient-reported outcome (ePRO) symptom monitoring, to trigger supportive care for patients with hospital-diagnosed ALC. Methods: In this single-site, non-randomized, pragmatic study, patients in an academic center with hospital-diagnosed ALC were stratified to low or high risk using an established tool. High-risk patients were referred to two-pronged supportive care: patient navigation and outpatient palliative care. Eligible patients were recruited for 3 months of ePRO symptom monitoring coupled with provider alerts. Healthcare utilization was assessed at 90 days post-discharge. Program feasibility and acceptability were assessed using percent of eligible supportive care referrals made and completed, enrollment rates in ePROs, ePRO completion, and notifications to providers of concerning symptoms. Preliminary efficacy was defined as percentage of concerning ePRO symptoms resulting in new clinical action and 90-day readmissions. Results: At the time of interim analysis, 49 patients had been assessed with 48/49 (98%) identified as high risk. Patients had a mean age of 66 years, and were non-Hispanic, 51% male, and 22% Black. Patient navigation referral (92%) and completion (88%) was high. Palliative care referral (89%) and completion (45%) was lower. 14/39 (36%) of eligible patients enrolled in ePRO symptom monitoring, with competing priorities or feeling overwhelmed as the primary reasons for non-participation. Patient-level ePRO completion ranged from 0-100% (mean 53%). Nearly all (97%) concerning symptoms were reported to the clinical team; 27% of these resulted in new clinical action. By 90 days, 16/37 (43%) had hospital readmissions. Conclusions: Patient navigation was feasible and acceptable in patients with hospital-diagnosed ALC. However, there are ongoing barriers to implementation of post-hospitalization ePRO symptom monitoring and palliative care. Additional evaluation is needed to understand the barriers and facilitators and to measure the impact of navigation on patient outcomes. Since nearly all patients met high-risk criteria, future programs will eliminate risk stratification and target all patients with hospital-diagnosed ALC. Clinical trial information: NCT05722847 . [Table: see text]

Feasibility and utilization of electronic patient-reported outcome measures for lung cancer in routine clinical care.

11107 Background: Prior studies have shown the value of Patient-Reported Outcomes (PRO) in cost burden, quality of life (QoL), and survival in cancer care. To facilitate focus on patient-centricity and value-based care, the International Consortium for Health Outcomes Measurements (ICHOM) and European Health Outcomes Observatory (H2O) developed a Core Outcomes Set (COS) in lung cancer. We explored the feasibility of deploying standardized PRO measures among patients with lung cancer in US clinical practice. Methods: A retrospective database study was conducted, with IRB waiver, using Carevive PROmPT, an electronic PRO (ePRO) remote symptom monitoring platform with weekly surveys comparable in scope to ICHOM/H2O COS, of symptomatic adverse events (PRO-CTCAE), physical function (PROMIS 4A Physical Function), and QoL items (EORTC QLQ-C30 items #29,30). Severe PRO-CTCAE symptom scores triggered care team alerts. From 9/2020 to 5/2023, 207 patients enrolled across 9 US cancer centers. Patients were ≥18 years, with lung cancer, and in current treatment. Patient engagement was measured by survey compliance, follow-up time, and completeness; clinician engagement was measured by platform utilization time, time to alert response, and clinical action taken. Results: Participants were 50% female, 86% White, 12% African American, median age 68, 81% NSCLC, and 26% with metastatic disease. Median survey persistence: 8 weeks, with 85% compliance over that time. Of domains assessed, 37 (58%) from Carevive data overlapped with ICHOM/H2O COS, with 19 measured over time. Overlapping domains included 15 clinical outcomes with 60% median completion rate and 22 PRO domains with 98% median completion. Of 19 domains assessed longitudinally, median compliance was 76%. Of patients triggering ≥1 ePRO symptom alert, 87% were within 4 weeks, with 46% requesting call-backs. Median clinician follow-up to alerts was 20 hours, with 69.3% addressed within 48 hours. Clinicians accessed the platform 2-3 times weekly, for median 2 minutes (range: 1-14 minutes) per login for nurses and Advanced Practitioners (AP). 89% of alerts were addressed by nurses and AP. Of alert responses, 66% indicated continuation of treatment, 12% were escalated to the clinical team, and 1% were escalated to hospitalization or ER visit. Conclusions: Results support the feasibility of integrating a standard set of multi-domain ePRO measures, comparable to the ICHOM/H2O COS, into routine cancer care, across multiple sites, with consistent patient engagement and provider utilization. One limitation is that clinical and financial impact were not directly assessed. Future research should explore direct clinician feedback, systematic implementation of PRO measures, and impacts on patient outcomes, resource utilization, and health systems.

Navigating cancer care through digital dialogue: Analyzing key phrases shared by patients in real-time exchange messages using an electronic patient-reported outcome measure (ePROM).

e13661 Background: Cancer is a complex ailment, giving rise to a myriad of symptoms, side effects, and questions that may arise unexpectedly. There is a growing interest in adopting more efficient approaches for the continuous monitoring of patients, particularly through virtual platforms. This study focuses on analyzing the word frequency in the context of cancer assistance using an ePROM. Methods: We conducted an analysis of an ePROM embedded in a mobile app designed for monitoring patients undergoing cancer treatment. Developed collaboratively by medical oncologists and software engineers, this app empowers patients to document their symptoms, quality of life, emotions, emergency room visits, and hospitalizations. Upon app registration, patients willingly share their data with their medical team, along with essential demographic information. A standout feature is the online chat facilitating real-time communication with the medical team, consolidating all information securely in one place. This patient-centric app is provided free of charge. Our study involved a retrospective and descriptive analysis focusing solely on data related to exchanged messages in the online chat between cancer patients and the medical team. These conversations spanned from February 2022 to January 2024 and included patients referred by physicians recommending our platform. The analysis centered on the frequency of non-technical words used in real-time conversations, clustered into semantic groups. Results: Our findings revealed a total exchange of 470,597 words across 684 conversations over a two-year period. In the healthcare context, the most frequent words were categorized as follows: 1) Seeking in-person assistance (568; 0.12%): hospital (424 mentions), emergency (82), urgent/urgency (51), and primary care (UBS, Portuguese acronym) (11); 2) Doubts regarding anything (979; 0.20%): doubt (694 mentions) and question (285); 3) Non-technical one-word symptoms (5213; 1.10%): pain (1821 mentions), nausea (961), tiredness (514), diarrhea (428), vomit (364), fever (304), cough (221), numbness (197), dizziness (162), insomnia (130), constipation (101), and wheezing (10). Conclusions: Our analysis showed two key insights: first, doubts persist throughout treatment, intertwined with the management of side effects; and second, the burden on patients is substantial, whether stemming from uncertainty about the next steps or the necessity for in-person assistance. Cancer's mental and physical toll underscores the importance of having a readily available team to provide guidance, even on simple instructions. In this light, virtual platforms may represent the future of care delivery. Continuous patient monitoring emerges as pivotal for enhancing healthcare assistance, treatment, and outcomes across various cancer types.

A randomized study comparing electronic patient-reported outcome (ePRO) monitoring with routine follow-up during trastuzumab deruxtecan treatment in patients with metastatic breast cancer (PRO-DUCE study).

1504 Background: Trastuzumab deruxtecan (T-DXd) is a highly effective agent for HER2-positive metastatic breast cancer (MBC), but is associated with adverse events such as nausea, fatigue, and interstitial lung disease. Based on recent studies showing that symptom monitoring and alert notifications via ePROs could improve patient quality of life (QoL) and prognosis, we hypothesized that employing this method may diminish the treatment burden for patients receiving T-DXd. Methods: In this multicenter, randomized controlled exploratory study (jRCTs031200387), we randomized patients with HER2-positive MBC eligible for T-DXd to either the ePRO monitoring (ePROm) group or the usual care (UC) group. ePROm involved weekly symptom and daily body temperature/SpO2 reports via a smartphone or computer at home. If any symptoms exceeded the predetermined thresholds, an email alert was sent to the medical staff, the ePRO was evaluated, and, if necessary, a phone consultation was provided. The primary endpoint was the change in the Global QoL score of EORTC QLQ-C30 from baseline at week 24. Secondary endpoints included score changes in the functional and symptom scales of EORTC QLQ-C30, and the time to deterioration of Global QoL (defined as a 10-point decrease from baseline). For a score difference between groups of 10 points and a standard deviation of 24, the required number of patients was 55 in each group, with a two-sided alpha error of 10% and a power of 87%. We analyzed the primary endpoint using a mixed-effects model for repeated measures. Results: Between March 2021 and January 2023, 111 patients were enrolled at 38 hospitals in Japan, with 56 assigned to ePROm and 55 to UC; the full-analysis set for QoL assessment included 54 and 52 patients, respectively. During the 24-week period, there were 1223 ePRO reports (95% compliance rate) in the ePROm group, including 427 alert notifications (7.9 per patient) to healthcare providers. Overall compliance with the questionnaire for QoL was 97%. Mean changes from baseline scores in Global QoL at week 24 showed that ePROm was significantly better than UC (mean difference 8.0 [90% CI 0.2, 15.8]; p=0.091). Role, cognitive, and social functioning were better in ePROm, with mean differences of 10.0 (95% CI 1.1, 18.9; p=0.028), 6.3 (1.1, 11.5; p=0.017), and 10.9 (3.9, 18.0; p=0.003), respectively. There was no difference in nausea/vomiting (0.5 [- 6.2, 7.1]; p=0.889), while fatigue was significantly better in ePROm (-8.4 [-16.1, -0.6]; p=0.034). Median time to first deterioration in Global QoL score was 3.9 months (95% CI 2.5, 13.9) in ePROm and 3.0 months (95% CI 1.6, 6.7) in UC (hazard ratio 0.73 [95% CI 0.45, 1.17]; p=0.159). Conclusions: ePROm systems, especially for symptom and SpO2 tracking in HER2-positive MBC patients treated with T-DXd, are promising to enhance patient QoL. Clinical trial information: jRCTs031200387 .

Electronic patient-reported outcome measures (E-Proms): Results of the H2020 CAPABLE project for patients with metastatic renal cell cancer (mRCC).

11045 Background: E-Proms were shown to benefit both survival and quality of life (QoL) of cancer patients. So far, E-Proms have been mostly implemented as the electronic version of validated, paper-based questionnaires typically administered at follow-up visits. Benefits of telemedicine systems that put symptom reporting within a wider framework embracing a holistic view of a patient's wellbeing are still under-investigated. Methods: Thirty mRCC patients were enrolled in the CAPABLE project intervention cohort during 2023. They were provided with the CAPABLE smartphone app, and with a smartwatch able to monitor vital parameters, physical activity, and sleep. The app acts as a virtual coach, allowing patients to enter any symptom they experience through an interface inspired by both CTACE and proCTCAE. Immediate feedback on whether to contact or not a doctor is generated according to the symptom severity. Patient’s data are matched with the ESMO guidelines for toxicity management, a selection of which was computerized within CAPABLE, and any generated recommendation is shown to the patient. The app manages the symptom follow up, periodically prompting the patient to report any change, and it also promotes activities aimed at improving patients’ education, mental wellbeing and lifestyle. All the entered data may be visualized by doctors at the hospital. The CAPABLE cohort was compared with a control cohort of 77 mRCC patients, enrolled in 2021/2022, who underwent standard care. All patients filled in a set of questionnaires measuring QoL, satisfaction, nutritional and psychological status at enrollment (T0), after 3 months (T1) and after 6 months (T2). A focus group with the CAPABLE cohort was held close to the end of the study. In this report the primary outcome, i.e. EORTC QLQ-C30 score for QoL, is discussed, together with qualitative results from the focus group. Results: The analysis shows an increase in the average QoL for the CAPABLE cohort (80.7 vs 84.9), and a slight decrease in the controls (80 vs 77), with a statistically significant interaction between time and cohort (p &lt; 0.05). Considering QLQ-C30 subscales, CAPABLE patients showed less fatigue and improved social and role functioning. As from the focus group, the app was perceived as effective and useful. More connection with the patient’s clinical pathway and more personalization according to specific treatments were highlighted as needed improvements. Conclusions: This study shows that E-Proms may be effectively included in a comprehensive and engaging system for remote management of mRCC patients. Clinical trial information: NCT06161233 .

Patient-reported experience with an immunotherapy telehealth platform.

1637 Background: The Making Telehealth Delivery of Cancer Care at Home Effective and Safe for Immunotherapy (MATCHES-IO) intervention seeks to improve the efficiency and patient experience for those treated with single agent pembrolizumab. Because pembrolizumab is administered as an outpatient infusion every 3-weeks, patients require up to 18 clinic visits per year to receive treatment, which is arduous. During the COVID-19 pandemic, the FDA granted accelerated approval for an extended interval dosing administered every 6 weeks, but despite this approval every 3-week dosing remains the standard (65% of prescriptions) as clinicians perceive this schedule enables them to identify and manage toxicity early. Telehealth may be the impetus to change the standard to the more convenient 6-week in person schedule, but evidence is needed. Methods: We conducted a single arm pragmatic trial to evaluate the efficiency and patient experience of a telehealth immunotherapy platform (MATCHES-IO) in patients with non-small cell lung, genitourinary, or melanoma cancers receiving single agent pembrolizumab. MATCHES-IO evaluates whether in-person visits for pembrolizumab therapy q6wk (rather than q3wk), with interim telehealth toxicity checks between in-person treatments, is more efficient and enhances patient experience relative to the standard q3wk infusion visits. The components of the platform include clinician-patient virtual visits, labs at home, biometric devices at home for vital sign monitoring, and electronic patient-reported outcomes to monitor for common IO-related toxicities. Patient experience was assessed after each MATCHES-IO televisit for up to two televisits. We measured experience with a patient experience survey that included the net promoter score, of how likely are they to recommend this intervention to similar patients (scale 0-10, higher score is desirable). A score of 9 or greater is considered excellent. Results: Between July 2023 and February 2024, 27 patients were enrolled, median age 68 (range 45–85), 74% white, 11% black, 11% Asian, and 41% female. Cancer types included thoracic (59% of patients), genitourinary (33%), and melanoma (7%). 19 patients (70.4%) have completed a MATCHES-IO televisit and completed the patient experience survey. The median net promoter score was 9 (range 2-10). 94% patients perceived a benefit to the MATCH-IO televisit including saved time (83% of respondents), patient convenience (83%), convenience for caregiver/family (44%), saved money (44%), and better monitoring of cancer and treatment (39%). 78% of patients found the at home visit less stressful than the in-person visit. Conclusions: Patients endorsed an enhanced experience with an immunotherapy telehealth platform for extended dosing of pembrolizumab. Further follow-up is needed to confirm these experience findings and determine whether this platform improved efficiency through fewer in-person visits.

Usability and feasibility of the open-source GeRI platform for remote assessments in older adults with prostate cancer.

e13664 Background: The Geriatric Remote Initiative (GeRI) is an open-source tool to collect patient-generated health data for older adults with cancer. It comprises a WiFi-enabled Raspberry Pi tablet, a Bangle.js 2 wrist accelerometer, and Mi Body Composition Scale 2 for data collection. Following the initial phase where feedback from older cancer survivors and caregivers refined a demonstration GeRI platform, this study deployed a live version of GeRI in advanced prostate cancer patients to evaluate its feasibility and usability. Methods: In this single-arm pilot feasibility and usability study, we evaluated GeRI among ten advanced prostate cancer patients aged ≥65 years undergoing androgen deprivation (ADT) across varied frailty risk categories. Participants interacted with GeRI for ≥12 weeks. Data collection comprised demographics, clinical information, and vulnerability assessment (Cancer and Aging Research Group [CARG] score) from in-clinic surveys. Biometric (wearable/scale) and electronic patient-reported outcomes data from the tablet were securely transmitted to the institution’s HIPAA-compliant cloud. Usability was evaluated using the System Usability Scale (SUS), aiming for an average score of 68 or higher. Feasibility was achieved if ≥6 participants completed at least 50% of all prompted interactions with the system components (surveys, wearable, and weight/bioimpedance) throughout a 12-week study period. Results: Ten men with metastatic hormone-sensitive prostate cancer [median age: 73 years; 40% minority; median of 3 months of ADT exposure (IQR: 2-4.5); 80% had intensified ADT with 60% getting concurrent prostate-directed radiation] engaged with GeRI for a median of 104 days (IQR: 93-131). 40% were vulnerable with a CARG&gt;5. System usability, evaluated by SUS, yielded a mean score of 84 (SD: 12.5). All participants met the feasibility criterion. Deficiencies in obtaining complete 48-hour accelerometry data from 7 participants were noted with only 1 being due to persistent non-wear of the wearable and the remainder due to transmission failure. Conclusions: The GeRI platform exhibited exceptional usability and met all feasibility benchmarks in a geriatric oncology setting, highlighting its potential despite technical hurdles in accelerometry data collection. Further deployment of GeRI is underway [or planned] through an expanded program focusing on other cancer types, including head and neck, and more robust biometric data collection.

With eyes on the future: Prospective evaluation of immune-related adverse events in patients with lung cancer.

e23177 Background: Immune checkpoint inhibitors (ICIs) bear unique, time-dependent immune-related adverse events (irAEs). However, limited data exist regarding tolerability in real-world populations. We report interim, non-sex stratified results of the first study prospectively evaluating ICI tolerability in patients with lung cancer (LC) in a real-world setting. Methods: Recruitment began in July 2023 and is ongoing. The electronic Patient-Reported Outcomes version of the Common Terminology Criteria (PRO-CTCAE) was utilized to assess patients’ irAEs. Patients (pts) complete up to 6 questionnaires throughout their treatment plus an end of treatment evaluation. Inclusion criteria includes pts ≥18 years, with LC stage I to IV, receiving single-agent ICI at Dana-Farber Cancer Institute. Descriptive statistics summarized patients' demographics, clinical characteristics, and symptoms. Results: 36 pts were enrolled in the study as of January 23, 2024. 35 pts have completed their first PRO-CTCAE questionnaire; the median number of completed questionnaires was 2 (range: 1-6). Due to the current sample size, results reported reference pts’ first PRO-CTCAE assessment. 53% of pts identified as female, 92% identified as White, and 6% as Black (Table 1). 56% of pts (19/34) reported having shortness of breath (SOB), most of whom (63%; 12/19) reported having moderate to severe SOB that often (somewhat to very much; 42%; 8/19) interfered with daily activities; 21% of them (4/19) stated that the SOB had worsened since starting ICIs. Similarly, of the 54% (19/35) with a cough, 42% (8/19) reported a moderate to very severe cough and 16% (3/19) reported its worsening since ICI initiation. 14 pts reported anorexia secondary to treatment, with most of them (57%; 8/14) reporting that it interfered with daily activities. Most pts (79%; 27/34) noted some degree of lack of energy. Rates of skin toxicity were low, with only 6% (2/35) experiencing a rash after beginning ICIs. Many pts did not experience nausea, abdominal pain, or unexpected sweating (80%; 28/35, 83%; 29/35, 77%; 27/35). However, of the pts reporting nausea and abdominal pain, high severity of these symptoms was noted (43%; 3/7, 50%; 3/6). Other low frequency irAEs included diarrhea, dry mouth, and dysgeusia. Conclusions: SOB and cough were the most common symptoms experienced with high severity in this ongoing prospective evaluation of irAEs in pts with LC. Though nausea and abdominal pain were less common, when present, these symptoms were reported with high severity. Future data from this study will elucidate patient experiences with irAEs throughout their treatment course. [Table: see text]

Characterization of remote symptom alerts generated from patient-reported outcome (PRO) symptom monitoring in a real-world breast cancer population.

e23193 Background: Women with breast cancer experience debilitating symptoms, yet the patient-reported symptom burden among patients on treatment remains largely uncharacterized. This study characterized electronic PRO (ePRO) symptom monitoring data of patients with breast cancer in real-world settings to assess differences in remote symptom alerts by clinical characteristics. Methods: We conducted a retrospective descriptive study of complete case ePRO data reported by patients at twelve US sites using Carevive PROmPT, a remote symptom monitoring platform. Participants consent to share de-identified, aggregate ePRO symptom data and sociodemographic and clinical characteristics from the electronic health record. We characterized PRO-CTCAE symptom data reported by breast cancer patients on active cancer treatment enrolled between 9/2020 and 11/2023. The PRO platform generates an algorithm-based alert if the combination of symptom severity, frequency, and interference is moderate or severe. We used descriptive statistics to characterize symptom severity and number of alerts by baseline patient-report ECOG status, age, cancer stage (Stage I-III vs. IV), and breast cancer subtype. Results: Of 646 patients, 519 (80%) generated alerts during treatment. Population characteristics were: median age 56 years-old (range 26-84), 72% White, 20% Black/African American, 62% Stage I-III, 15% HER2 positive, 47% ER and/or PR positive, HER2 negative,18% triple negative. Patients reported a total of 19,425 symptoms over a median of 12 weeks with 80% compliance rate, of which 39% resulted in alerts. Participants generated a median of 1 alert per week. About 50% of alerts occurred in the first 12 weeks of ePRO completion, with a higher proportion in Week 1-4 across all subgroups (range, 15-38%). On average, ECOG 2 or greater patients generated more alerts per week than ECOG 0-1, (mean 2.1, (SD 1.3) vs. 1.7 (SD 1.0). Younger patients ( &lt; 50 years) generated more alerts compared to those older than 50 years (87% vs. 77%). Patients with early-stage disease reported more alerts than the Stage IV group (81% vs. 78%). In the metastatic setting, triple negative patients reported a median of 3 (range 1-8) moderate/severe symptoms per week; the other subtypes reported a median of 1 (range 1-8). Conclusions: Women on breast cancer treatment reported their symptom experience with high compliance rates in the real-world setting. Nearly 40% of symptom reports generated an alert, with a higher proportion in the first month of treatment. Younger, early-stage, and metastatic triple negative patients with breast cancer reported a higher symptom burden compared to other groups. Future work will investigate symptom experience by sociodemographic and clinical characteristics to further identify patients who may benefit from more intensive symptom reporting and management.

Financial toxicity (FT), quality of life (QoL), and medication adherence patient-reported outcomes (PROs) in CLL on first-line (1L) oral oncolytics.

e23157 Background: While oral oncolytics have transformed CLL treatment, high costs may cause significant FT adversely impacting patients beyond direct out-of-pocket (OOP) costs. The association of FT with QoL and medication adherence has not been characterized with oral oncolytics in CLL. Methods: Electronic PRO surveys were longitudinally administered to patients initiating any 1L oral oncolytic therapy for CLL within the last 6 months at two academic centers. PROs included FACIT-COST (significant FT: score &lt; 26), FACT-LEU QoL, MARS-5 (suboptimal adherence: score &lt; 25) and PROMIS PMAS to assess medication adherence. PROs were administered at baseline, 3 months, and 6 months after enrollment. Pearson’s correlation ( r) was calculated between PRO domains. Semi-structured, qualitative interviews were conducted after 3-month timepoints and analyzed. Results: 34 patients were enrolled: median age 65 yrs (range 33-80), 59% male, 6% Black, 9% Hispanic. Majority received BTK inhibitors (56%, acalabrutinib/zanubrutinib) followed by venetoclax (44%); 50% received concurrent obinutuzumab. Most had private insurance (50%) followed by Medicare (44%). Median time from 1L initiation to study enrollment: 1.5 months. PRO completion rates: 100% (baseline), 85% (3 mo) and 74% (6 mo). Summarized PRO and interview outcomes are displayed below. Conclusions: Patients with CLL on 1L oral oncolytics experienced worsening FT associated with poor medication adherence and worse QoL over time. PROs were discordant with qualitative interviews and suggested that FT may be driven by factors other than OOP costs. Although funding and patient assistance programs were beneficial, uncertainty over losing funding may be a long-term driver of FT and merits further study. [Table: see text]