Electronic Patient-reported Outcomes Research Articles

Application of Intelligent Management Model Based on Electronic Patient-Reported Outcome During Immunotherapy in Patients with Gastric Cancer: A Single-Center Retrospective Study

Aims/Background Gastric cancer is the third leading cause of cancer-related death worldwide, which seriously affects the health of patients. Immunotherapy is a commonly used clinical treatment for gastric cancer, but the adverse events caused by it seriously affect the prognosis of patients. Therefore, it is necessary to control and manage the disease risk of patients during immunotherapy. To explore the effect of applying an intelligent management model based on electronic patient-reported outcome (ePRO) in patients with gastric cancer during immunotherapy. Methods The clinical data of 184 gastric cancer patients receiving immunotherapy in The Fourth Hospital of Hebei Medical University from September 2021 to September 2023 were retrospectively analyzed. Ninety patients receiving ePRO-based intelligent management were selected, and 85 patients were included in the observation group after excluding 5 patients. For the reference group, 94 patients receiving common case management were selected, with 90 patients being included after excluding 4 patients. After 6 months of follow-up, the nutritional status score, quality of life, treatment compliance and adverse events were compared between the two groups. Results No significant difference was detected in nutritional status and World Health Organization Quality of Life-BREF (WHOQOL-BREF) scores of the patients before discharge (p > 0.05). After 2 months of follow-up, compared with the reference group, the observation group had a higher proportion of patients in grade A and grade B, which was not statistically significant (p > 0.05), and significantly higher physiological and psychological scores (p < 0.001), but showed no meaningful differences in other fields (p > 0.05). After 4 months of follow-up, the nutritional status in the observation group was significantly improved (p < 0.05), and the subjects displayed higher WHOQOL-BREF scores (p < 0.05) than those in the reference group. No significant difference in the incidence of adverse events was detected (p > 0.05). After 6 months of follow-up, the treatment compliance of the observation group was 83.53%, which was significantly higher than that of the reference group (70.00%; p < 0.05). Conclusion The intelligent management model based on ePRO is conducive to improving the nutritional status of patients with gastric cancer during immunotherapy, as well as enhancing their quality of life and treatment compliance, making it worthy of clinical application.

Electronic patient-reported outcomes as digital therapeutics for patients with cancer: a narrative review of current practices and future directions.

Improved cancer treatment outcomes have increased the demand for medical care that considers the quality of life of patients with cancer. Patient-reported outcomes (PROs) help assess the quality of life because they involve direct evaluation of the patients. Recently, electronic PROs (ePROs) have been used in clinical cancer care settings in Europe and the United States. Electronic PROs positively affected communication between patients with cancer and healthcare providers, enhanced education, optimized self-management, contributed to healthcare economics, assisted in monitoring adverse events, and improved prognosis. However, challenges such as adherence, burden on healthcare providers, lack of personalized formats, low digital literacy, and implementation costs remain. Therefore, carefully selecting the items to be recorded by ePROs in alignment with specific objectives is essential. Additionally, developing systems using lifelogs-digital records of daily activities-and creating mechanisms that automatically encourage patient behavioral changes based on the reported data are crucial. This review delineates the advantages and challenges of ePROs according to their history and proposes the prospects of ePRO.

Strategies for implementing an electronic patient-reported outcomes-based symptom management program across six cancer centers.

Electronic patient-reported outcome (ePRO)-based symptom management improves cancer patients' outcomes. However, implementation of ePROs is challenging, requiring technical resources for integration into clinical systems, substantial buy-in from clinicians and patients, novel workflows to support between-visit symptom management, and institutional investment. The SIMPRO Research Consortium developed eSyM, an electronic health record-integrated, ePRO-based symptom management program for medical oncology and surgery patients and deployed it at six cancer centers between August 2019 and April 2022 in a type II hybrid effectiveness-implementation cluster randomized stepped-wedge study. Sites documented implementation strategies monthly using REDCap, itemized them using the Expert Recommendations for Implementation Change (ERIC) list and mapped their target barriers using the Consolidated Framework for Implementation Research (CFIR) to inform eSyM program enhancement, facilitate inter-consortium knowledge sharing and guide future deployment efforts. We documented 226 implementation strategies: 35 'foundational' strategies were applied consortium-wide by the coordinating center and 191 other strategies were developed by individual sites. We consolidated these 191 site-developed strategies into 64 unique strategies (i.e., removed duplicates) and classified the remainder as either 'universal', consistently used by multiple sites (N = 29), or 'adaptive', used only by individual sites (N = 35). Universal strategies were perceived as having the highest impact; they addressed eSyM clinical preparation, training, engagement of patients/clinicians, and program evaluation. Across all documented SIMPRO strategies, 44 of the 73 ERIC strategies were addressed and all 5 CFIR barriers were addressed. Methodical collection of theory-based implementation strategies fostered the identification of universal, high-impact strategies that facilitated adoption of a novel care-delivery intervention by patients, clinicians, and institutions. Attention to the high-impact strategies identified in this project could support implementation of ePROs as a component of routine cancer care at other institutions. ClinicalTrials.gov. NCT03850912. February 22, 2019. https://clinicaltrials.gov/ct2/show/NCT03850912?term=hassett&draw=2&rank=1.

PRO-P: evaluating the effect of electronic patient-reported outcome measures monitoring compared with standard care in prostate cancer patients undergoing surgery-study protocol for a randomized controlled trial.

With over 65,000 new cases per year in Germany, prostate cancer (PC) is the most common cancer in men in Germany. Localized PC is often treated by radical prostatectomy and has a very good prognosis. Postoperative quality of life (QoL) is significantly influenced by the side effects of surgery. One possible approach to improve QoL is postoperative symptom monitoring using ePROMs (electronic patient-reported outcome measures) to accurately identify any need for support. The PRO-P ("Influence of ePROMS in surgical therapy of PC on the postoperative course") study is a randomized controlled trial employing 1:1 randomization at 6weeks postoperatively, involving 260 patients with incontinence (≥ 1 pad/day) at six participating centers. Recruitment is planned for 1year with subsequent 1-year follow-up. PRO-monitoring using domains of EPIC-26, psychological burden, and QoL are assessed 6, 12, 18, 24, 36, and 52weeks postoperatively. Exceeding predefined PRO-score cutoffs triggers an alert at the center, prompting patient contact, medical consultation, and potential interventions. The primary endpoint is urinary continence. Secondary endpoints refer to EPIC-26 domains, psychological distress, and QoL. Aspects of feasibility, effect, and implementation of the intervention will be investigated within the framework of a qualitative process evaluation. PRO-P investigates the effect on postoperative symptom monitoring of a structured follow-up using ePROMs in the first year after prostatectomy. It is one of the first studies in cancer surgery investigating PRO-monitoring and its putative applicability to routine care. Patient experiences with intensified monitoring of postoperative symptoms and reflective counseling will be examined in order to improve primarily urinary continence, and secondly other burdens of physical and psychological symptoms, quality-of-life, and patient competence. The potential applicability of the intervention in clinical practice is facilitated by IT adaption to the certification standards of the German Cancer Society and the integration of the ePROMs survey via a joint patient portal. Positive outcomes could readily translate this complex intervention into routine clinical care. PRO-P might improve urinary incontinence and QoL in patients with radical prostatectomy through the structured use of ePROMs. ClinicalTrials.gov NCT05644821. Registered on 09 December 2022.

Electronic patient-reported outcomes improve postoperative gynecologic oncology care in a rural academic center

Electronic patient-reported outcomes improve postoperative gynecologic oncology care in a rural academic center

Implementation of ePROs Into Multidisciplinary Tumor Board Discussions for Patients With Pancreatic Cancer: The INSPIRE Intervention.

The incorporation of electronic patient-reported outcomes (ePROs), such as the Geriatric Assessment (GA) and treatment preferences, into decision-making for pancreatic cancer has been limited by clinician- and system-level barriers concerning workflow. We hypothesized that ePRO inclusion within multidisciplinary tumor boards (MDTBs) would circumvent barriers and provide a venue for systematic consideration of critical patient-provided information. The INtegrating Systematic PatIent-Reported Evaluations (INSPIRE) intervention consists of (1) patient survey completion, including GA and patient preferences, and (2) screensharing patient ePROs during MDTBs. Proctor et al's implementation outcomes were assessed, with penetration (the proportion of consented patients who were presented at MDTBs) acting as the primary outcome (considered successful at 70%). Secondary outcomes included adoption, feasibility, acceptability, appropriateness, cost, and sustainability, assessed by clinician post-MDTB exit surveys, clinician postintervention surveys, clinician postintervention semistructured interviews, and time-coding analysis of recorded and transcribed historical (November 2021-February 2022) and intervention (September 2022-June 2023) MDTBs. A total of 50 patients completed surveys and all were presented at MDTBs (penetration=100%). All eligible clinicians (n=9) enrolled patients (adoption=100%) and reported that ePROs were useful in 90% and led to a change in treatment plan in 30% of cases. In postintervention surveys and interviews, clinicians primarily responded positively to feasibility, acceptability, and appropriateness questions. Time-coding analysis found a modest time cost of an additional 51.1 seconds in mean discussion time-per-patient between preintervention (mean [SD], 172.7 [111.4] seconds) and intervention patients (mean [SD], 223.8 [107.1] seconds); 86% of clinicians reported the intervention did not take too much time. All surveyed clinicians reported interest in continuing the intervention and suggested adaptations to further promote sustainability. The integration of ePROs into pancreatic MDTBs was feasible and acceptable, providing a potential approach to increase the utilization of ePROs by clinical teams in their management of patients with pancreatic cancer.

Rheumatology in the digital health era: status quo and quo vadis?

Rheumatology faces a critical shortage of health-care professionals, exacerbated by an ageing patient population and escalating costs, resulting in widening gaps in care. Exponential advances in digital health technologies (DHTs) in the past 5 years offer new opportunities to address these challenges and could contribute to overall improved health care. However, keeping pace with innovations and integrating them into clinical practice can be challenging. This Review explores the transformative potential of DHTs for rheumatology in reshaping the entire patient pathway and redefining the roles of patients and providers, and discusses the potential barriers to DHT integration. Key technologies, such as large language models, clinical decision-support systems, digital therapeutics, electronic patient-reported outcomes, digital biomarkers, robots, self-sampling devices and artificial intelligence-based scribes, can be implemented along the patient pathway. A digital-first hybrid stepped-care patient pathway could combine in-person and remote care, enabling personalized and continuous monitoring through a digital safety net. The potential benefits and risks of transforming the traditional patient-provider relationship into a digital health triad with technology are discussed. Collaborative efforts are needed to navigate the evolving digital health landscape and harness the potential of DHTs to improve rheumatology care.

Developing an implementation blueprint: Lessons learned from integrating electronic patient-reported outcomes in HIV clinics in Alabama.

People living with HIV are disproportionately affected by depression, anxiety, and substance use which impede engagement with HIV treatment services and can increase risks of HIV-related morbidity and mortality. Capturing timely, accurate patient data at point of care is recommended to inform clinical decision-making and retain patients on the HIV care continuum. Currently, there is limited use of validated screening tools for substance use and mental health at the point of care in HIV clinics, even though people with HIV (PWH) have a high prevalence of these comorbidities. Even fewer clinics screen in a manner that encourages disclosure of stigmatized substance use, depression, and anxiety. Electronic patient-reported outcomes (ePROs) are an evidence-based modality to overcome such limitations by eliciting responses directly from patients via tablet, smartphone, or computer. To date, there is limited consensus on how to implement ePROs into non-academic settings and enhance uptake. Our team sought to address this gap by examining the implementation of ePROs, previously implemented in an academic clinic, to enhance screening and treatment of mental health (MH) and substance use at five Ryan White HIV/AIDS Program-funded clinics in Alabama. The ePROs were delivered through a multi-component intervention titled HIV + Service delivery and Telemedicine through Effective Patient Reported Outcomes (+STEP), which also provides targeted training to frontline clinicians, and resources for MH and substance use treatment for PWH without access to care. The objective of this study is to provide an implementation blueprint that can be tested and utilized in other HIV clinics to integrate ePROs and increase evidence-based screening for depression, anxiety, and substance use among PWH, as well as outline lessons learned from implementation to date. The findings from this study provide practical steps and advice based on our experience in implementing electronic patient-reported outcomes in HIV clinics in the US Deep South.

An electronic patient-reported outcome symptom monitor: the Chinese experience with rapid development of a ready-to-go symptom monitor

BackgroundMonitoring symptoms is crucial for the early detection of disease progression and timely intervention, which is essential for reducing severe cases and mortality rates in rapidly spreading pandemics, such as COVID-19. Therefore, during infectious disease pandemics, the rapid development of real-time symptom monitoring platforms is essential. This study aimed to explore the urgent development process of an electronic system for patient-reported outcome monitoring in emergency situations.MethodsThe development of the electronic patient-reported outcome COVID-19 symptom monitoring platform (ePRO-CoV-SM) included the following steps: (1) modifying an electronic patient-reported outcome symptom-reporting platform to assess patients with COVID-19 and validating its feasibility and sensitivity for longitudinal symptom measurement; (2) updating the system to accommodate the newly emerged severe acute respiratory syndrome coronavirus 2 BA.2.2 variant; and (3) applying it in real-world settings. Literature review, expert consultation, and subject-group discussions were used to develop symptom items. Response rate and missing item rate were used as validation indicators for ePRO-CoV-SM.ResultsThe ePRO-CoV-SM (2.0) consists of a core set of symptom items, a WeChat mini program, an online project design backend, a management and communication front, and a database. During the 2020 verification, the response rate of ePRO symptom monitoring reached 89.47% and the item missing rate was 0.33%, the monitoring revealed that a considerable number of asymptomatic patients were experiencing undesirable symptoms during the isolation period. In its real-world application in 2022, the response rate was 85.93% and the item missing rate was 4.84%, the monitoring found the symptom burden was higher in the younger group (18–40 years old) than in the older group (40–67 years old), and over 30% of patients reported symptoms such as cough (36.08%), dry mouth (35.67%), sleep disorders (32.27%), appetite loss (32.17%), and sputum (30.79%) during the isolation period.ConclusionsElectronic patient-reported outcome measurement was demonstrated to be sensitive and feasible for monitoring symptoms in patients with COVID-19. By integrating smartphone-based data collection with real-time online data transmission and secure data storage using Secure Sockets Layer encryption, an electronic platform for monitoring critical symptoms can be rapidly established in emergency situations.

Patient-reported outcomes (PROs) programs for monitoring symptoms among patients treated with immunotherapy: A scoping review.

Monitoring toxicities among patients receiving immune checkpoint inhibitors (ICIs) using patient-reported outcome (PRO) measures (PROMs) is relatively recent. This scoping review aims to guide decision-making in the development of PROMs ICI programs. Four electronic databases were searched from inception to January 2024. Data on PROMs ICI programs (eg, PROMs used, frequency) were extracted. Two authors with established inter-rater reliability screened titles, abstracts, and full texts. A narrative synthesis identified patterns in the data. 22 articles described 16 unique multicomponent, electronic PRO programs, mainly developed for remote monitoring of toxicities between appointments. Patients typically completed 18-26 items from the PRO-CTCAE or CTCAE weekly, with high adherence/satisfaction. Commonly monitored symptoms were diarrhea, fatigue, shortness of breath, cough, nausea, decreased appetite, rash, joint pain, pain, and mood. Other features of PROM programs included clinician alerts, with some program only flagging symptoms that had an impact on treatment. Some program also or only sent alerts to patients to contact their clinicians and gave access to symptom management information. In terms of efficacy, the only consistent finding was an increase in QOL. The findings of this scoping review provide some indication as to which components of a PROM program are promising. However, as the evidence-based for PROMs among patients receiving ICIs is growing, many questions remain, including which symptoms to monitor, using which PROM, and at what frequency. More trials are needed to answer these questions and to determine how best to implement PROM ICI programs in clinical practice.

Enhancing Clinicians' Use of Electronic Patient-Reported Outcome Measures in Outpatient Care: Mixed Methods Study.

Despite the increasing use of patient-reported outcome measures (PROMs) for collecting self-reported data among hospital outpatients, clinicians' use of these data remains suboptimal. Insight into this issue and strategies to enhance the use of PROMs are critical but limited. This study aimed to examine clinicians' use of PROM data for value-based outpatient consultations and identify efforts to enhance their use of PROMs in a Dutch university hospital. First, we aimed to investigate clinicians' use of outpatients' PROM data in 2023, focusing on adoption, implementation, and maintenance. Second, we aimed to develop insights into the organizational-level strategies implemented to enhance clinicians' use of PROM data from 2020 to 2023. This included understanding the underlying rationales for these strategies and identifying strategies that appeared to be missing to address barriers or leverage facilitators. Third, we aimed to explore the key factors driving and constraining clinicians' use of PROMs in 2023. We integrated data from 4 sources: 1-year performance data on clinicians' use of PROMs (n=70 subdepartments), internal hospital documents from a central support team (n=56), a survey among clinicians (n=47), and interviews with individuals contributing to the organizational-level implementation of PROMs (n=20). The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework was used to analyze clinicians' adoption, implementation, and maintenance of PROMs. Strategies were analyzed using the Expert Recommendations for Implementing Change taxonomy, and results were structured around the constructs of capability, opportunity, and motivation. On average, around 2023, clinicians accessed PROM data for approximately 3 of 20 (14%) patients during their outpatient consultation, despite numerous strategies to improve this practice. We identified issues in adoption, implementation, and maintenance. The hospital's strategies, shaped organically and pragmatically, were related to 27 (37%) out of 73 Expert Recommendations for Implementing Change strategies. These strategies focused on enhancing clinicians' capability, opportunity, and motivation. We found shortcomings in the quality of execution and completeness of strategies in relation to addressing all barriers and leveraging facilitators. We identified variations in the factors influencing the use of PROMs among frequent PROM users, occasional users, and nonusers. Challenges to effective facilitation were apparent, with certain desired strategies being unfeasible or impeded. Enhancing clinicians' use of PROMs has remained challenging despite various strategies aimed at improving their capability, opportunity, and motivation. The use of PROMs may require more substantial changes than initially expected, necessitating a shift in clinicians' professional attitudes and practices. Hospitals can facilitate rather than manage clinicians' genuine use of PROMs. They must prioritize efforts to engage clinicians with PROMs for value-based outpatient care. Specific attention to their professionalization may be warranted. Tailored strategies, designed to address within-group differences in clinicians' needs and motivation, hold promise for future efforts.

Quality of life in women with early-stage and metastatic hormone receptor-positive, HER2-negative breast cancer receiving endocrine therapy.

Early discontinuation of endocrine therapy (ET) is higher among patients with early breast cancer (EBC) compared to patients with metastatic hormone receptor-positive (HR+) breast cancer (MBC). In our clinical experience the reasons for this may include a significant burden of ET side effects impacting quality of life (QOL) in patients with EBC. We hypothesized that QOL is lower in patients with HR + EBC compared to patients with HR + MBC on ET. We conducted a cross-sectional observational study to assess QOL utilizing FACT-ES & EORTC QLQ C30 tools among patients with EBC and MBC receiving ET across 5 Irish hospitals. A total of 417 patients were enrolled-EBC (79% n = 331) and MBC 21% (n = 86). Using the FACT-ES, we found no difference in overall QOL by stage (139.2 vs 141, P = .33). Patients with HR + MBC had a lower symptom burden from ET compared to HR + EBC (61.4 vs 54, P < .01). In adjusted multivariate linear regression models, there was no difference in QOL for patients with EBC and MBC receiving ET. There was no significant difference in overall QOL for patients with EBC and MBC. However, patients with EBC experienced more endocrine symptoms. In adjusted multivariate linear regression models, the stage did not predict QOL. Our results suggest that endocrine symptoms are significant contributors to impaired QOL for patients with EBC but the role of other determinants of QOL (eg, stage) is less clear. Future work could include the development of stage-specific QOL tools and utilization of electronic patient-reported outcomes (ePROs) to identify and manage emergent toxicities.

Pain severity among Black and White patients with cancer within a remote symptom monitoring program using electronic patient-reported outcomes.

138 Background: Black patients with cancer report higher pain intensity for both consistent and breakthrough pain. Remote symptom monitoring (RSM) using electronic patient-reported outcomes (ePROs) allows patients with cancer to communicate symptoms between visits. This study evaluated whether there were racial disparities in pain severity reporting among Black and White patients with cancer utilizing RSM with ePROs. Methods: This retrospective study analyzed data from 1453 patients with cancer undergoing treatment who utilized an RSM platform for the completion of weekly PRO-CTCAEs surveys to report pain intensity. Survey data from patients during the initial 6 months following RSM enrollment at the University of Alabama at Birmingham (UAB) and the Mitchell Cancer Institute (MCI) were included. Descriptive statistics were compared using frequencies, percentages, and Cramer’s V for categorical variables. Regression models were adjusted for age, sex, cancer type, and rurality. Results: Data from 1453 patients and 17,722 surveys were analyzed. 454 (31.2%) patients were Black and 999 (68.8%) patients were White. Among 454 baseline surveys completed by Black patients, no pain was reported in 68%, mild pain in 4%, moderate in 12%, and severe in 16%. In comparison, among 999 baseline surveys completed by White patients, no pain was reported in 71%, mild pain in 3%, moderate in 12% and severe in 14% (V=0.03). Among all post-baseline surveys completed by Black patients, no pain was reported in 69% (n=5081), mild pain in 5%, moderate in 13% and severe in 13%. In comparison, among all post-baseline surveys completed by White patients, no pain was reported in 72% (n=11188), mild pain in 4%, moderate in 14% and severe in 10% (V=0.05). In adjusted analysis, severe pain at follow-up was higher amongst Black patients than White patients (OR 1.17; 95% CI 0.87-1.56). Conclusions: Although modestly increased prevalence (3%) in any pain at baseline and severe pain during their 6 months after enrollment in RSM was observed for Black participants compared to Whites, this finding was not significant in adjusted models. This analysis suggests similar pain levels for Black and White patients within RSM programs. RSM can promote proactive reporting and early intervention for pain, which may help to mitigate previously reported disparities in long-term pain for Black individuals.

Enhancing pediatric oncology clinical trials through patient reported outcomes (PROs)

Survival rates of children with cancer have significantly increased over the last decades in high income countries. However, cancer survivors often face significant long-term adverse effects on physical, psychosocial, and neurocognitive health. The use of Patient-Reported Outcomes (PROs) in clinical trials may help to further optimize treatment regimens to minimize acute and late adverse events. Despite clear recommendations of regulatory agencies, the use of PROs in pediatric clinical trials remains limited. In this article, we discuss the rationale to assess PROs in pediatric clinical trials with a specific highlight on electronic PRO (ePRO) assessment. In addition, we underscore the importance of recent international guideline developments such as the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL-IMI) and the CONsolidated Standards of Reporting Trials – Patient-Reported Outcomes (CONSORT-PRO) to improve the robustness of PRO data assessment in pediatric oncology, thus facilitating better patient care and more accurate assessments of treatment effects. Best practice examples for the use of modern technologies in ePRO assessments are presented and potential barriers and challenges are discussed. We conclude that – despite some challenges and barriers – the routine assessment of (e)PROs in pediatric clinical trials has the potential to substantially improve the quality of the trials and facilitate the usability of outcome data. We call for a joint effort to take proactive steps to incorporate PROs into clinical trials in pediatric oncology, thus giving children a voice.

Impact of real-world remote symptom monitoring program on hospitalizations and ICU admissions.

377 Background: Previous randomized controlled trials have demonstrated benefits to patients from remote symptom monitoring (RSM) with electronic patient-reported outcomes (ePROs) including healthcare utilization. However, less is known about the impact of RSM in diverse, real-world populations. Methods: This cross-sectional analysis from a hybrid, type 2 implementation-effectiveness trial evaluated the impact of RSM on healthcare utilization amongst patients with cancer receiving chemotherapy, immunotherapy, monoclonal antibody, or targeted therapy at two academiccancer centers in the Southeastern United States. Modified Poisson regression models with robust standard error and 95% confidence interval (CI) was used to calculate the relative risk (RR) of any hospital or ICU utilization between patients receiving RSM and controls for 3 and 6 months after index date. Models were controlled for age at index, race, sex, cancer type, cancer stage, insurance, prior treatment, comorbidities, RUCA, and follow-up during COVID-19 pandemic. Additional logistic regression models were used to estimate odds ratios (OR) for subset analysis stratified by race (Black or African American, Other, or White), rurality using Rural-Urban Commuting Area Codes, and neighborhood disadvantage using Area Deprivation Index (ADI). Results: From 5/2021-2/2024, 1215 patients were enrolled in RSM; 27% were Black, 16% lived in a rural area, and 25% lived in an area with high neighborhood disadvantage. The populations receiving RSM were similar to the control population (n = 4559); 26% were Black, 22% lived in a rural area, and 28% lived in area with high neighborhood disadvantage. The unadjusted relative risk of hospitalization for patients receiving RSM and control patients were 0.70 (95% CI, 0.63-0.70) and 0.77 (95% CI, 0.71-0.85), respectively. In adjusted analyses, hospitalizations were lower amongst patients receiving RSM compared to control patients with a RR of 0.82 (95% CI 0.73-0.92). Similar patterns were observed for ICU admissions (RR 0.59; 95% CI,0.40-0.88). Analysis by patient subgroup was similar to the overall analysis. A lower odd of hospitalizations and ICU admissions at 6 months was observed across all subset analyses: Black vs. White patients (OR 0.80; OR 0.48); rural vs. urban patients (OR 0.78; OR 0.68); and patients living in areas of high vs. lower neighborhood disadvantage (OR 0.59; OR 0.33). Conclusions: The use of RSM amongst patients receiving treatment for cancer is associated with reductions in hospitalizations and ICU admissions in real-world, diverse settings. Further work to expand this intervention nationally is needed. Clinical trial information: NCT04809740 .

A randomized phase III study evaluating dexamethasone-based mouthwash to prevent chemotherapy-induced stomatitis in patients with breast cancer.

Stomatitis, which is a common side effect of chemotherapy, currently lacks a standardized approach for its prevention. Therefore, this multicenter, randomized, open-label, controlled phase III trial aims to assess the efficacy and safety of a dexamethasone-based mouthwash for preventing chemotherapy-induced stomatitis in patients with early breast cancer. We will randomly assign 230 patients with early breast cancer scheduled to receive chemotherapy in a 1:1 ratio to either the dexamethasone-based mouthwash group (10ml, 0.1mg/ml; swish for 2min and spit 4 times daily for 8weeks) or the mouthwash-with-tap-water group. The incidence of stomatitis, measured using electronic patient-reported outcomes, is the primary endpoint.

A comparative analysis of supportive care service needs in patients with pancreas versus other gastrointestinal cancers.

272 Background: Pancreatic ductal adenocarcinoma (PDAC) is the third leading cause of cancer death and presents with advanced incurable disease approximately 75% of the time, contributing to the lowest survival rate and worst multidimensional quality of life (QOL) compared to other adult solid tumors. Standardized screening for early integration of interdisciplinary care (IDC) services, advance care planning, and utilization of electronic patient-reported outcomes (ePROs) for improved QOL and symptom management are recommended, yet the literature is lacking in rigorously-conducted PDAC needs assessments, an important prerequisite to care model design. Methods: Between September 12, 2023 and May 7, 2024, 525 patients with gastrointestinal (GI) malignancies were sent a Supportive Care Questionnaire (SCQ), an ePRO survey assessing multi-dimensional IDC needs prior to first visit at an NCI-designated comprehensive cancer center in the Pacific Northwest. The SCQ includes validated surveys and a total of 12 domains chosen by the IDC service responsible for management of the given need(s), who also set trigger thresholds for referral to the IDC service. Rates of positive screens for each service were compared by cancer type (PDAC, Colorectal [CRC], gastroesophageal [GE]). Results: 340 (65%) SCQs were completed (57% via MyChart, 43% in person) similarly across disease groups; with an average of 10 mins to complete. Respondents were 49% female/59% male (Race: White (76.5%), Asian (10%), Black/African-American (4.5%), Other/Unknown (9%)/Ethnicity Non-Hispanic (90%, Hispanic 7.6%), Other/Declined/Unknown 2.4%), with primary language spoken being English (92%), Spanish (3.5%), simplified Chinese (1.5%) and Other (2.5%). Table 1 shows – by GI cancer type –the total number of responses and the proportion of patients who screened positive for one or more IDC services. Conclusions: Patients with PDAC had the greatest need for IDC services with most frequent positive screens indicating need for nutrition, social work, palliative care and patient navigation services when surveyed in our institution-wide program of SC screening for all new GI cancer patients. Results will inform further development of IDC services in PDAC and other GI cancers, including via staff prediction modeling. The SCQ is also being considered for SC screening and management across the Canopy Cancer Collective, a nationwide learning health network of pancreas cancer programs. PDAC CRC GE Surveyed 187 237 101 Completed 122 (65%) 153 (65%) 65 (64%) Positive Screen 68 (56%) 70 (46%) 26 (40%)

Empowered or challenged? The dual impact of condition-specific electronic Patient-Reported Outcome Measures in the person-centred care of women with breast cancer: A qualitative study

Empowered or challenged? The dual impact of condition-specific electronic Patient-Reported Outcome Measures in the person-centred care of women with breast cancer: A qualitative study

Patient and provider perceptions of the benefits and limitations of implementing ePRO-driven remote symptom monitoring into real-world cancer care settings.

325 Background: Remote symptom monitoring (RSM) utilizes electronic patient-reported outcomes (ePROs) to facilitate the monitoring and management of treatment-related symptoms outside of traditional healthcare appointment settings. Research suggests benefits surrounding the implementation of RSM; however, there is a literature gap regarding patient and provider perceptions of its implemented use. Methods: This qualitative study included patients and providers from the University of Alabama at Birmingham (UAB) and the Mitchell Cancer Institute (MCI) in Mobile, Alabama, who participated in semi-structured interviews aimed at gaining insight into the experiences of and perceptions surrounding RSM utilization. Interviews occurred over the phone, via digital videoconference, or in person, and were transcribed and inductively coded using NVivo software alongside a constant comparative method to establish a grounded coding schema. Results: Forty patients (20 UAB; 20 MCI) and 30 oncology providers (16 UAB; 14 MCI) identified 25 benefits across 3 overarching themes. Patients and providers found RSM Facilitated Proactive Management enabling early symptom identification and intervention, which helped to reduce symptom burden. Both groups also noticed RSM Improved Therapeutic Alliance, by fostering the relationship between the patient and their care team and enhancing the patient’s sense of safety and security through continued and sincere communication. Patients and providers also discussed how RSM Promoted Self-Efficacy and Management among Patients by allowing patients to feel involved and in control of their care, while giving them an inclination to be active members in their care. Providers felt that more active patient involvement in care contributed to a more accurate and thorough reporting of symptoms. Patients and providers also noted drawbacks regarding RSM, including lack of need in cases of no or mild symptoms. Conclusions: Patients and providers recognized the impact RSM had on patient care during cancer treatment. However, given some of the perceived limitations, patient and provider evaluations should continue to ensure successful implementation in future clinical trials. Clinical trial information: NCT04809740 .

Assessing Correlations and Demographic Interactions Between PROMIS25 and SRS30 in Pediatric Patients With Spinal Deformity.

Historically, patient-reported outcome measures (PROMs) have been measured using anatomy-specific instruments. However, these instruments may be influenced by the presence of concomitant illnesses not associated with the orthopaedic condition. As such, standardized PROM tool, such as PROMIS25, have been developed to assess patient outcomes. In this study, we aim to compare the correlation and association between 2 common PROMs used for pediatric patients with spinal deformity. This study included patients younger than 21 years who were indicated for spinal deformity surgery at our institution. All patients were invited to complete SRS-30 and PROMIS-25 instruments through an automated, electronic patient-reported outcome platform before surgery. Patient demographics were recorded and Spearman correlations were calculated between the various PROMIS and SRS domains. Correlations were compared between different baseline characteristics and demographics using a rho-to-z transformation method. Ceiling and floor effects were also investigated. A total of 207 patients were enrolled in this study. The majority of PROMIS and SRS domains had moderate to strong correlations, with higher correlations observed when each instrument tried to capture the same construct. For example, there was strong correlation between PROMIS raw pain and SRS pain (ρ=-0.86, P <0.01), and PROMIS Depression and SRS Mental Health (ρ=-0.76, P <0.01). Ceiling effects ranged from 1.0 to 16.9% in SRS and 0.5 to 28.5% is PROMIS. Floor effects ranged from 0.5 to 1.5% in SRS and 0.5 to 29.0% in PROMIS. There were significant differences in the correlation between SRS Mental Health and PROMIS Depression when comparing between different sexes (male: ρ=-0.74, female: ρ=-0.59, P =0.04). In addition, there were significant differences in the correlation between SRS Mental Health and PROMIS Anxiety when comparing between different insurance payors (commercial: ρ=-0.86, female: ρ=-0.75, P =0.03). There is strong correlation between SRS and PROMIS domains in pediatric patients with spinal deformity. These correlations can differ by baseline characteristics and demographics. Providers should consider these differences when interpreting PROMs in diverse patient populations. Level III; Retrospective comparative study.