Symptom Management Program Research Articles

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.

Symptom clusters and symptom network analysis during immunotherapy in lung cancer patients.

This study analyzes symptoms in lung cancer patients undergoing immunotherapy to identify core symptom clusters through network analysis and lay a foundation for effective symptom management programs. The sample comprised 240 lung cancer patients receiving immunotherapy. Participants were assessed using the Memorial Symptom Assessment Scale. Exploratory factor analysis was used to extract symptom clusters, and network analysis using JASP 0.17.3 was performed to explore the centrality indices and density of the symptom network. Five symptom clusters were identified, i.e., emotion-related, lung cancer-related, physical, skin, and neural symptom clusters, with a cumulative variance contribution rate of 55.819%. Network analysis revealed that sadness was the most intense symptom (rs = 2.189), dizziness was the most central symptom (rc = 1.388), and fatigue was the most significant bridging symptom (rb = 2.575). This study identified five symptom clusters and a symptom network among lung cancer patients during immunotherapy. The network analysis's centrality indices and network density results can assist healthcare professionals in devising more precise symptom management strategies.

Patient and care team experiences with an EHR-integrated symptom management program (eSyM) in routine oncology practice.

324 Background: Clinical trials have shown that collecting electronic patient-reported outcomes (ePROs) improves quality of life and survival in cancer patients. To bolster integration of ePROs into routine care, the SIMPRO Research Consortium developed an electronic symptom management (eSyM) program, deployed it at six cancer centers, and conducted a hybrid effectiveness-implementation study. eSyM, an ePRO toolkit integrated into the Epic EHR, enables patients to report and care teams to triage symptoms in real-time. To assess eSyM, we conducted structured qualitative interviews with patients and clinic staff, including doctors, nurses, advanced practice providers, and administrative staff. We sought to understand eSyM from the patient and staff perspectives. Methods: Using an iterative process, we developed semi-structured interview guides to query the experiences and perceptions of patients and staff exposed to eSyM. Questions were informed by the Consolidated Framework for Implementation Research. One year after eSyM was launched, sites identified and referred participants for interviews or focus groups. Participants must have either used eSyM to submit symptoms (patients) or had access to eSyM at their institution (staff). Patients provided written consent; a consent waiver was obtained for staff. Interviews were recorded and transcribed, and a common analytic codebook was developed. Transcripts were dual or triple-coded and underwent thematic analysis to identify key contexts and concepts within and across patient and staff groups. Results: From 9/28/20 to 4/14/23, 50 staff participated in individual interviews and 29 participated in focus groups (79 total). From 9/14/23 to 3/14/24, 14 patient interviews were conducted. Transcripts revealed that staff and patients held similar beliefs regarding eSyM compatibility, communication, and prioritization. 93% (13/14) of patients and 72% (57/79) of staff believed eSyM was easy to use and improved communication. Both cohorts (66% staff, 36% patients) noted that competing demands often needed to be prioritized over responding to symptom concerns. Discordance emerged in the domains of receptivity and technology; patients were more receptive and capable of using eSyM than staff perceived. Both groups believed eSyM was helpful but perceived that deeper engagement from patients and staff was necessary for sustainability. Conclusions: Most interviewees reported that eSyM added value and was easy to navigate. Competing clinical demands, however, frequently deprioritized use of eSyM. Staff tended to underestimate patients’ receptivity to use eSyM and were more likely to cite competing demands as a barrier to their own use of eSyM. Sites looking to adopt eSyM, or similar ePRO programs, will benefit from understanding the facilitators that need to be incorporated and the barriers that need to be surmounted to optimize success. Clinical trial information: NCT03850912 .

The relationship between patient-reported experience and patient-reported outcomes in patients with cancer.

248 Background: Measures of patient experience (PEX) and patient-reported outcomes (PRO) are used by health systems across the US to improve care delivery and quality of life, respectively. Despite their widespread use, little is known regarding the relationship between these two types of patient-generated data. From 2018 to 2023, we conducted a pragmatic type-II hybrid effectiveness/implementation study of an electronic health record (EHR)-embedded symptom management program (eSyM) across six diverse cancer centers. This project focused on patients who started chemotherapy (CHEMO) or had surgery (SURG) for a suspected or confirmed gastrointestinal, gynecologic, or thoracic malignancy. Methods: We conducted a cross-sectional study of adults who were eligible for either the control or intervention arm of the eSyM study to determine if patients who reported having an inferior care-team experience were more likely to report having worse symptoms. Participants completed a one-time survey via REDCap that included elements from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) and the Patient-Reported Outcomes Measurement Information System (PROMIS). Analyses determined the extent to which PEX measures were associated with PRO measures by evaluating differences in mean PROMIS scores for those who rated their PEX highly vs. not highly. Results: In total, 1419 respondents reported having cancer for which they received care at a participating center: median age 66, 63% female, 5% black, 13% disabled, 66% married/partnered, 23% high school or less education, 22% somewhat-extreme difficulty paying bills. For both CHEMO and SURG patients, 82% rated their overall cancer care-team experience highly (top box score of 9-10). Compared to patients who did not rate their care-team experience highly, those who did reported better scores for depression, fatigue, anxiety, pain interference, physical function, and self-efficacy (Table). PROMIS values differed for other CAHPS measures too. Conclusions: Among patients receiving routine cancer care, there was a significant association between PEX and multiple PROs. Further investigation of the nature and strength of the association between PEX and PRO measures is warranted. If confirmed, this association could lead to the development of interventions that impact both patient satisfaction and quality of life. Clinical trial information: NCT03850912 . Mean difference in PROMIS scores for patients who rated their care-team experience highly versus not highly (P from two-sample T-test). CHEMO (N=889) SURG (N=530) Mean Diff 95%CI P value Mean Diff 95%CI P value Depression -2.7 -4.3, -1.1 0.001 -3.3 -5.3, -1.4 <0.001 Anxiety -3.7 -5.4, -1.9 <0.001 -3.6 -5.7, -1.5 <0.001 Fatigue -2.3 -4.0, -0.5 0.011 -4.5 -6.8, -2.2 <0.001 Pain interference -3.6 -5.3, -1.9 <0.001 -4.7 -6.7, -2.7 <0.001 Physical function 1.6 0.1, 3.1 0.042 3.5 1.4, 5.6 0.001 Self-efficacy 3.9 2.6, 5.2 <0.001 6.4 4.6, 8.1 <0.001

The Mediating Effects of Symptom Experiences on the Relationship between Body Image and Quality of Life among Hemodialysis Patients in a Single Center.

This study aimed to confirm the mediating effects of symptom experiences on the relationship between the body image and quality of life of hemodialysis patients. Data were collected from 153 patients who were diagnosed with ESRD at a tertiary general hospital and receiving regular hemodialysis in Korea. The data were collected between 20 July and 11 August 2023. The following statistical analyses were conducted: t-test, ANOVA, Scheffé test, Pearson's correlation coefficient analysis, and Hayes' Process Macro Model 4 (to test the mediating effect). The factors influencing quality of life were body image (β = 0.46, p < 0.001), monthly family income (over KRW 3 million) (β = 0.22, p = 0.002), and symptom experiences (β = -0.20, p = 0.001). The mediation analysis indicated that the symptom experiences mediated the relationship between body image and quality of life. Based on the results, education, counseling, and symptom management programs that can improve body image and reduce symptom experience should be developed, and customized programs that reflect the characteristics of a target population, such as economic level, should be developed and provided.

Nurse-led proactive mobile application in symptom management for children with medical complexity: Study protocol for a randomized controlled trial.

To investigate the effect of a nurse support using a proactive mobile app to enhance parental self-efficacy in symptom management for children with medical complexity. A single-blinded, randomized controlled trial with a two-armed repeated measures design. Eligible parents and the children will be recruited from the special schools and non-government offices. They will be randomly assigned either to the intervention or control groups. Subjects in the study group will receive nurse parental support using a symptom management mobile app for 3 months. The control group will receive the usual care that is available in the community. Data will be collected pre-intervention (T1), immediately after the intervention (T2), and three-month after intervention (T3). The primary outcome is parental self-efficacy. The secondary outcomes include child's symptom burden and their health service utilization. Primary outcome will be compared across two groups in T2 and T3 using with control for the pre-test value of parental self-efficacy. Generalized estimating equation (GEE) will be used to address secondary objectives from T1 to T3 with appropriate link function. As a result of the successful implementation of this nurse-led symptom management, parental self-efficacy will be enhanced. Both the symptoms reported by the children and their health service utilization will be reduced. Findings of this study will help in service delivery improvements because it maximizes the availability and accessibility of paediatric health service to parents and the children in local communities. The evidence produced in this study will enlarge the knowledge base that supports evidence-based paediatric home nursing service with the use of health technology in symptom management. This evidence will also contribute to the development of other symptom management programs for other paediatric patient groups. NCT05765643 (ClinicalTrials.gov identifier). Parents of children with medical complexity contributed in mobile application development by giving comments on the usability of mobile application. Improve health service delivery: Home nursing service may not be sustainable in a long run in Hong Kong, as the health care system has been facing a serious nursing workforce shortage in recent years. Besides, these services are affected or even suspended during the community outbreak of infectious disease, like recent coronavirus disease pandemic. Nurse parental support in symptom management for the CMC using a proactive mobile health application will help in service delivery improvements because it maximizes the availability and accessibility of paediatric health service to parents and their CMC in local communities. Improve physical and psychological health of parents and their CMC: The success of program implementation will help to increase parental self-efficacy in symptom management for their CMC, as a result of decrease of children's symptom burden. Improve knowledge base: The evidence produced in this study will (1) enlarge the knowledge base that supports evidence-based paediatric community nursing service related to symptom management for the CMC. This evidence will contribute to the development of other symptom management programs for other paediatric patient groups.

The effects of a symptom management program on symptom experience and physical function in Thai adults with chronic obstructive pulmonary disease: A single-blind randomized controlled trial study.

Adults with Chronic Obstructive Pulmonary Disease (COPD) experience a range of unpleasant symptoms, including fatigue, dyspnea, sleep disturbances, anxiety, and depression, that are interrelated and impact one another. Developing a program to handle simultaneous symptoms poses challenges but offers advantages for adults with COPD in efficiently managing symptoms. This study aimed to determine the effects of a symptom management program on symptom experience and physical function in Thai adults with COPD. A randomized controlled trial (RCT) with a Repeated Measures design was performed. One hundred and two participants were allocated randomly to either the control group (n = 51) or the experimental group (n = 51). The experimental group received eight weeks of the symptom management program and usual care, while the control care group received only usual care. Data were collected from January 2023 to August 2023 at baseline, 4th weeks, and 8th weeks using the demographic data, the modified Medical Research Council (mMRC), the Pittsburgh Sleep Quality Index (PSQI), the Multidimensional Assessment of Fatigue (MAF), the Hospital Anxiety and Depression Assessment Scale (HADS), the COPD Assessment Test (CAT), and 6-Minute Walk Distance (6-MWD). The hypotheses were analyzed using Repeated Measures Multivariate Analysis of Variance (MANOVA). The symptom management program significantly impacted the experimental group's symptom experience and physical function at Weeks 4 and 8 (F = 5.257, p <0.001). There were significantly improved mean scores for the mMRC, MAF, 6MWD, and CAT (p <0.001, p <0.05). No statistically significant differences were observed in the PSQI, HADS-Anxiety, and HADS-Depression over time. Implementing a symptom management program can help patients with COPD efficiently manage their symptoms. In clinical settings, nurses should integrate this program into routine nursing care to enhance the quality of life for patients suffering from COPD. The program can help patients preserve physical functionality while reducing dependence on family and society. Thai Clinical Trials Registry (TCTR20230111006).

Early postoperative core symptoms and their relationship with resilience in oesophageal cancer patients-A multicentre cross-sectional study.

To assess early postoperative core symptoms in oesophageal cancer patients and their relationship with resilience. Patients with oesophageal cancer face a high number of severe symptoms in the early post-operative period and require the development of an effective symptom management programme. Identifying core symptoms through network analysis helps in accurate patient care. A multicentre cross-sectional study. A cross-sectional survey was conducted from August 2022 to August 2023 at three hospitals in Anhui Province, China. A total of 469 patients were recruited for this study and 418 (89.1%) patients completed this investigation. Using network analysis to find early post-operative core symptoms in oesophageal cancer patients. Multiple linear regression was used to analyse resilience factors affecting core symptoms. Sadness was the most core symptom in oesophageal cancer patients in the early post-operative period (rs = 1.41), followed by incision pain and difficulty breathing while resting (rs = 1.20, rs = 1.08). Resilience was significantly associated with patients' feelings of sadness, with optimism having the greatest impact on sadness (p < .01). Sadness is the most core symptom in patients in the early post-operative period and special attention should be paid to improving their level of resilience. Local symptoms and dysfunction in the early post-operative period should be treated in a synergistic manner. This study identifies core symptoms and their relationship to resilience in patients with oesophageal cancer in the early post-operative period. Symptoms as the main core symptom in patients in the early post-operative period, which was sadness and was significantly associated with resilience. Precise interventions can be made to target patients' core post-operative symptoms, which can help improve the effectiveness of symptom management. We have complied with the relevant EQUATOR research reporting checklist. No patient or public contribution in the study.

Statistical analysis plan for the NU IMPACT stepped-wedge cluster randomized trial

BackgroundAs part of the IMPACT Consortium of three effectiveness-implementation trials, the NU IMPACT trial was designed to evaluate implementation and effectiveness outcomes for an electronic health record (EHR)-embedded symptom monitoring and management program for outpatient cancer care. NU IMPACT uses a unique stepped-wedge cluster randomized design, involving six clusters of 26 clinics, for evaluation of implementation outcomes with an embedded patient-level randomized trial to evaluate effectiveness outcomes. Collaborative, consortium-wide efforts to ensure use of the most robust and recent analytic methodologies for stepped-wedge trials motivated updates to the statistical analysis plan for implementation outcomes in the NU IMPACT trial. MethodsIn the updated statistical analysis plan for NU IMPACT, the primary implementation outcome patient adoption, as measured by clinic-level monthly proportions of patient engagement with the EHR-based cancer symptom monitoring system, will be analyzed using generalized least squares linear regression with auto-regressive errors and adjustment for cluster and time effects (underlying secular trends). A similar strategy will be used for secondary patient and provider implementation outcomes. DiscussionThe analytic updates described here resulted from highly iterative, collaborative efforts among statisticians, implementation scientists, and trial leads in the IMPACT Consortium. This updated statistical analysis plan will serve as the a priori specified approach for analyzing implementation outcomes for the NU IMPACT trial.

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]

The effect of nurse-led remote telephone triage on symptom management of patients with cancer: A systematic review and meta-analysis.

Cancer patients experience many symptoms. Nurse-led remote telephone triage can improve their quality of life by contributing to the management of these symptoms. This study aimed to investigate the effects of nurse-led remote telephone triage on symptom management of patients with cancer. The searches were conducted in 10 databases and gray literature from May 2023 to July 2023 without any year limitations. A fixed-effects model was used in the meta-analysis. Cochran's Q chi-squared test and I2 statistics were used for heterogeneity. The PRISMA checklist was used. Data obtained from the included studies were analyzed using CMA 3 software. Six relevant studies (1671 patients) were included. Nurse-led remote telephone triage was found to have a positive and moderate effect on parameters such as pain (Hedge's g = 0.21, p < .001), fatigue (Hedge's g = 0.28, p < .001), and depression (Hedge's g = 0.24, p < .001) in patients with cancer. Also, the remote telephone triage had a positive and low effect on outcomes such as anxiety (Hedge's g = 0.17, p = .001), nausea (Hedge's g = 0.17, p = .004), and vomiting (Hedge's g = 0.16, p = .007) but did not affect diarrhea results. This study showed that nurse-led remote telephone triage considerably improved the symptoms of patients with cancer. This study will increase oncology nurses' awareness that nurse-led remote telephone triage of patients with cancer can improve their symptoms. Remote symptom triage developed using evidence-based guidelines and protocols can significantly contribute to the regular follow-up of patients' symptoms, providing quality care, and establishing appropriate symptom management programs and systems with high levels of evidence.

Effects of a change in recall period on reporting severe symptoms: an analysis of a pragmatic multisite trial.

Optimal methods for deploying electronic patient-reported outcomes to manage symptoms in routine oncologic practice remain uncertain. The electronic symptom management (eSyM) program asks chemotherapy and surgery patients to self-report 12 common symptoms regularly. Feedback from nurses and patients led to changing the recall period from the past 7 days to the past 24 hours. Using questionnaires submitted during the 16 weeks surrounding the recall period change, we assessed the likelihood of reporting severe or moderate and severe symptoms across 12 common symptoms and separately for the 5 most prevalent symptoms. Interrupted time-series analyses modeled the effects of the change using generalized linear mixed-effects models. Surgery and chemotherapy cohorts were analyzed separately. Study-wide effects were estimated using a meta-analysis method. In total, 1692 patients from 6 institutions submitted 7823 eSyM assessments during the 16 weeks surrounding the recall period change. Shortening the recall period was associated with lower odds of severe symptom reporting in the surgery cohort (odds ratio = 0.65, 95% confidence interval = 0.46 to 0.93; P = .02) and lower odds of moderate and severe symptom reporting in the chemotherapy cohort (odds ratio = 0.83, 95% confidence interval = 0.71 to 0.97; P = .02). Among the most prevalent symptoms, 24-hour recall was associated with a lower rate of reporting postoperative constipation but no differences in reporting rates for other symptoms. A shorter recall period was associated with a reduction in the proportion of patients reporting moderate-severe symptoms. The optimal recall period may vary depending on whether electronic patient-reported outcomes are collected for active symptom management, as a clinical trial endpoint, or another purpose. ClinicalTrials.gov ID NCT03850912.

Effects of symptom management program on selected health outcomes among older people with chronic obstructive pulmonary disease: a quasi-experimental study

Older adults have limitations from their aging process and chronic disease, so developed interventions must pay attention and concern to their aging degeneration and needs. This study aims to study the effects of a symptom management program on selected health outcomes among older people with chronic obstructive pulmonary disease. The quasi-experimental research included the 15 older patients in the control group receiving routine nursing care, while the other 15 in the experimental group received a 4-week symptom management program. First, the general information was analyzed using descriptive statistics. Next, the average health outcomes were analyzed using independent and dependent t-tests, Mann–Whitney U Test, and Wilcoxon Signed Ranks Test. In addition, the readmission rate was compared using Fisher’s Exact Test. Results revealed that most of the older patients were men (96.7%), aged 60–88 years (Mean = 71.57, SD = 7.75), with a smoking history (93.3%). The improvements were found in dyspnea (p < .01), its severity during activities (p < .01), and the quality of life (p = .04) among patients who attended the program. However, both groups did not have a different pulmonary function (p = .25) and the proportion of readmission within 28 days (p = .50). This study shows that the symptom management program can reduce dyspnea and severity during activities and improve the quality of life. Older people suffer from chronic obstructive pulmonary disease, especially when experiencing dyspnea. Therefore, it is crucial to have a symptom management program for older patients, especially a program developed to respond to changes in the aging process and the limitations of older people. This developed program was age-friendly to deal with symptoms and improve quality of life. However, this program should be explored in typical situations without the effects of the coronavirus disease (COVID-19) pandemic. In addition, more extensive population-based studies and randomized controlled trials should be adopted to increase credibility and ensure generalization.Clinical Trial Registration Number: https://osf.io/6sj7y (October 4, 2021).

Implementing a nurse-led screening clinic for symptom distress with community-based referral for cancer survivors: A feasibility study.

This prospective, single-arm, pragmatic implementation study evaluated the feasibility of a nurse-led symptom-screening program embedded in routine oncology post-treatment outpatient clinics by assessing (1) the acceptance rate for symptom distress screening (SDS), (2) the prevalence of SDS cases, (3) the acceptance rate for community-based psychosocial support services, and (4) the effect of referred psychosocial support services on reducing symptom distress. Using the modified Edmonton Symptom Assessment System (ESAS-r), we screened patients who recently completed cancer treatment. Patients screening positive for moderate-to-severe symptom distress were referred to a nurse-led community-based symptom-management program involving stepped-care symptom/psychosocial management interventions using a pre-defined triage system. Reassessments were conducted at 3-months and 9-months thereafter. The primary outcomes included SDS acceptance rate, SDS case prevalence, intervention acceptance rate, and ESAS-r score change over time. Overall, 2988/3742(80%) eligible patients consented to SDS, with 970(32%) reporting ≥1 ESAS-r symptom as moderate-to-severe (caseness). All cases received psychoeducational material, 673/970(69%) accepted psychosocial support service referrals. Among 328 patients completing both reassessments, ESAS-r scores improved significantly over time (p<0.0001); 101(30.8%) of patients remained ESAS cases throughout the study, 112(34.1%) recovered at 3-month post-baseline, an additional 72(22%) recovered at 9-month post-baseline, while 43(12.2%) had resumed ESAS caseness at 9-month post-baseline. Nurse-led SDS programs with well-structured referral pathways to community-based services and continued monitoring are feasible and acceptable in cancer patients and may help in reducing symptom distress. We intend next to develop optimal strategies for SDS implementation and referral within routine cancer care services.

Patient engagement with a portal-based symptom management program across six health systems.

351 Background: Collecting patient-reported outcomes (PROs) improves quality of life and self-efficacy, reduces acute care needs, and extends survival for cancer patients. Prior studies evaluating the efficacy of PROs have often relied on unrepresentative populations seen at well-resourced health systems and treated in controlled settings. As a result, widespread PRO implementation has not been achieved. We sought to study the reach of an electronic PRO-based, EHR-integrated symptom management system (eSyM) that was deployed in routine clinical practice across six diverse health systems. Methods: All patients receiving medical oncology (MO) or surgical (SURG) care for a confirmed or suspected gastrointestinal, gynecologic, or thoracic malignancy were invited to use eSyM – a patient portal-based tool that asks patients to respond to symptom questionnaires, provides symptom management resources, and fosters patient-clinician communication. Study outcomes included any portal use, sending a message via the portal, and completing an eSyM symptom questionnaire via the portal. Spearman coefficients were used to assess the correlation between portal message use and eSyM questionnaire completion. Multivariable logistic regression models were used to identify factors associated with completing at least one eSyM questionnaire. Results: From September 2019 to March 2023, 9589 MO and 13,297 SURG patients had access to eSyM. Patient characteristics and usage rates were analyzed [Table]. Among portal users, most patients accessed it via the web app only, with 39.2% of MO and 42.6% of SURG patients accessing it via both the web and mobile apps. Correlations between message use and questionnaire use were moderate (0.48 for MO, 0.43 for SURG). Notably, 17.9% of MO and 21.7% of SURG patients sent a portal message but did not submit an eSyM questionnaire. Factors associated with lower odds of eSyM questionnaire completion for both the MO and SURG cohorts included: older age, male sex, Black race, Medicaid insurance, and being single, widowed, or disabled. Conclusions: In a diverse patient population from six community-based cancer centers, over 80% used the portal for any reason, over 58% sent a message, and over 46% submitted at least one eSyM questionnaire. Strategies that improve patient engagement and ameliorate disparities with ePRO-based programs are needed. Some eSyM non-responders never used the portal, whereas others used the portal for different reasons, suggesting that technical and non-technical barriers to ePRO programs exist.[Table: see text]

Leveraging electronic patient-reported outcomes collected at six cancer centers to identify symptom clusters across the first four weeks of chemotherapy.

366 Background: Symptom clusters are groups of two or more related concurrent symptoms. Interventions that target symptom clusters may be more efficient than those which address individual symptoms, yet few studies have identified symptom clusters using patient-reported outcomes collected in routine practice. The purpose of this study was to identify symptom clusters de novo using data reported in eSyM, an electronic health record-integrated cancer symptom management program deployed across six large and diverse health systems. Methods: Adults starting chemotherapy to treat thoracic, gastrointestinal, and gynecologic cancers used eSyM to report symptoms twice weekly for up to six months. We analyzed patient-reported symptom data from cycle 1, day 2 (T0), one week (T1), and two (T2), three (T3), and four (T4) weeks later. Patients reported attributes (i.e., frequency, severity, and interference) of 12 symptoms using items derived from the PRO-CTCAE. We calculated a composite grade (0, 1, 2, or 3) for each symptom and conducted an exploratory factor analysis using polychoric correlations and unweighted least squares estimation to identify symptom clusters at each time point. We considered rotated factor loadings ≥|0.30| meaningful and assessed the Eigenvalues, structure, and clinical relevance of two- through four-factor (i.e., cluster) models. Finally, we labeled each cluster according to its predominant symptoms using labels adopted from prior studies of symptom clusters in patients undergoing chemotherapy. Results: Our analytic sample at each time point included 730 (T0), 1605 (T1), 1571 (T2), 1617 (T3), and 1456 (T4) symptom reports. Of the two-, three-, and four-factor models, the two-factor model had the least cross-loading and was the most clinically relevant across time points. The two-factor model accounted for 100% of the total variance in symptoms. In this model, a gastrointestinal symptom cluster was comprised of vomiting, nausea, decreased appetite, trouble drinking, and diarrhea at all time points, while a psychoneurological symptom cluster was comprised of fatigue, pain, anxiety, shortness of breath, and constipation at all time points. Rash was present in the psychoneurological cluster at T0 but was not present in any cluster at T1-T4. Conclusions: Patients experience gastrointestinal and psychoneurological symptom clusters in the first four weeks of chemotherapy. Our findings suggest it is feasible to use routinely collected data to identify symptom clusters using composite PRO-CTCAE grades. Future research will investigate the prevalence of symptom clusters, clinical and demographic characteristics of patients at high risk for severe symptoms, and how to better manage symptom clusters.

An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial

BackgroundCancer patients with newly created ostomies face complications that reduce quality of life (QOL) and increase morbidity and mortality. This proof-of-concept study examined the feasibility, usability, acceptability, and initial efficacy of an eHealth program titled the “Patient Reported Outcomes-Informed Symptom Management System” (PRISMS) during post-ostomy creation care transition.MethodsWe conducted a 2-arm pilot randomized controlled trial among 23 patients who received surgical treatment with curative intent for bladder and colorectal cancer and their caregivers. After assessing QOL, general symptoms, and caregiver burden at baseline, participants were randomly assigned to PRISMS (n = 16 dyads) or usual care (UC) (n = 7 dyads). After a 60-day intervention period, participants completed a follow-up survey and post-exit interview. We used descriptive statistics and t-tests to analyze the data.ResultsWe achieved an 86.21% recruitment rate and a 73.91% retention rate. Among the PRISMS participants who used the system and biometric devices (n = 14, 87.50%), 46.43% used the devices for ≥ 50 days during the study period. Participants reported PRISMS as useful and acceptable. Compared to their UC counterparts, PRISMS patient social well-being scores decreased over time and had an increased trend of physical and emotional well-being; PRISMS caregivers experienced a greater decrease in caregiver burden.ConclusionsPRISMS recruitment and retention rates were comparable to existing family-based intervention studies. PRISMS is a useful and acceptable multilevel intervention with the potential to improve the health outcomes of cancer patients needing ostomy care and their caregivers during post-surgery care transition. A sufficiently powered RCT is needed to test its effects.Trial registrationClinicalTrial.gov ID: NCT04492007. Registration date: 30/07/2020.

Reduced symptom burden after implementation of an electronic symptom management program.

12006 Background: The SIMPRO consortium implemented an electronic patient reported outcomes (ePRO) symptom management program as part of routine clinical care for patients (pts) receiving systemic cancer therapy or surgery across six health systems including rural and community cancer centers. To evaluate impact of the Epic-integrated electronic symptom management (eSyM) program on quality of life, pre- and post-implementation surveys were sent to a subset of gastrointestinal, thoracic, and gynecologic medical oncology (MO) and surgical (Surg) patients at all sites. Methods: A survey assessing symptom burden, health literacy, and self-efficacy was administered to separate groups of MO and Surg pts before (Pre-Implementation) and after (Post-Implementation) eSyM deployment. A waiver of documentation of consent was obtained for participation. Questions were derived from validated instruments including PROMIS, a standardized measurement tool for patient-reported symptoms. Surveys were completed 30-90 days after surgery or start of systemic therapy. PROMIS item responses were scored individually then translated into standardized T-scores with a mean of 50 based on an established reference population. Mean T-scores for PROMIS depression, anxiety, fatigue, and pain interference were calculated. Higher T-score correlated with greater symptom burden. Comparison between groups utilized non-parametric Kruskal-Wallis testing. Results: The number of survey responses were 498 MO Pre-Implementation, 518 MO Post-Implementation, 566 Surg Pre-Implementation, and 507 Surg Post-Implementation. MO pts reported significantly lower PROMIS mean T-scores for depression, anxiety, fatigue, and pain interference after eSyM compared to a similar group of MO pts prior to eSyM. Surg pts reported lower T-scores for depression, anxiety, fatigue, and pain interference after eSyM compared to a similar group of Surg pts prior to eSyM, although reduction in pain interference was not statistically significant. Conclusions: eSyM deployment in MO was associated with a significant reduction in patient reported depression, anxiety, fatigue, and pain interference. Surgical pts after eSyM deployment reported significantly lower rates of depression, anxiety, and fatigue. External validation with PROMIS based surveys demonstrated small but meaningful benefits of ePRO symptom monitoring as part of routine clinical care across six diverse health systems. Clinical trial information: NCT03850912 . [Table: see text]

Self-reported overall wellbeing and physical function among chemotherapy and surgery patients completing symptom questionnaires across six health systems.

12110 Background: Health systems have begun using electronic patient reported outcomes (ePROs) to evaluate and ideally mitigate patients’ symptom burden following treatment for cancer and other conditions. However, the optimal number of symptoms and approach to capturing this information is unknown. We hypothesized that self-reported overall wellbeing (OWB) and physical function (PFN) would provide distinctive information, beyond that described by a multi-item symptom questionnaire, and augment the clinical utility of an ePRO system. Methods: eSyM, an EHR-integrated symptom management program, was deployed across six health systems for patients receiving chemotherapy or surgery for a suspected or confirmed thoracic, gastrointestinal, or gynecologic malignancy. eSyM prompts patients to complete a 12-item symptom questionnaire 2-3 times per week. This questionnaire also includes two pictogram questions that assess OWB and PFN – each scored using a four-point scale from 0 (best) to 3 (worst). We sought to identify patient characteristics associated with the lowest OWB and PFN (i.e., score = 3), to describe Spearman correlations between OWB and PFN, and to elucidate the relationships between symptom scores and OWB/PFN. Ordinal logistic regression models were used to adjust for potential confounding. Results: From September 2019-December 2022, 9753 patients submitted 75,166 questionnaires. There were 3846 chemotherapy patients (median age 66, 58% female, 17% non-white) and 5907 surgery patients (median age 61, 73% female, 7% non-white). The plurality of responses indicated mild impairment for OWB and PFN (Table). OWB and PFN scores were moderately correlated with each other (chemotherapy 0.62; surgery 0.59); with the sum of all symptom scores for chemotherapy (OWB 0.48, PFN 0.45) and surgery (OWB 0.51, PFN 0.45) patients; and with pain, fatigue, and anorexia (correlation coefficients 0.40-0.61). No individual symptoms were strongly correlated (coefficient &gt; 0.7) with OWB or PFN. After controlling for other factors, OWB and PFN scores varied significantly by health system. Patients with disability were more likely to report low OWB and PFN (ORs 1.99-3.26; p &lt; 0.05) versus other employment statuses. Conclusions: In a large cohort of chemotherapy and surgery patients from six community-based cancer centers, self-reported OWB and PFN scores were moderately correlated with common symptoms. These items offer discriminant and face validity and provide distinctive information that supplements a multi-item symptom questionnaire. Routine use of OWB and PFN can guide management strategies for symptomatic cancer patients. Clinical trial information: NCT03850912 . [Table: see text]

Use of statistical process control charts to identify impactful implementation strategies for an ePRO-based symptom management program across the SIMPRO Consortium.

6579 Background: Collecting electronic patient reported outcomes (ePROs) reduces the burden of cancer and prevents acute care hospitalizations. However, broad implementation in the routine care setting remains challenging, partly because the optimal implementation strategies – actions that are most likely to encourage adoption and use – are not known. Since 2019, the SIMPRO Consortium has deployed an ePRO-based symptom management program (eSyM) across 6 community-based cancer centers. Methods: We used statistical process control (SPC) charts to identify variation due to special versus common causes (random variation) for one key performance indicator (KPI) – the weekly ePROs response rate. All 6 SIMPRO sites contributed data for this analysis: 3 for chemotherapy patients and 3 for surgery patients. Sites had to have at least 18 months of KPI data; information from the first 4 months after eSyM rollout were excluded to account for program ramp-up. The KPI was calculated as the number of patients who submitted an ePRO questionnaire divided by the number eligible to submit a questionnaire each week. The upper and lower confidence limits were set at +/- 2 sigma to allow for 95% of observations to fall within the limits. Three rules were applied to identify special cause variation: 1) astronomical points (outside sigma limits), 2) shifts (8 or more points above or below a center line), and 3) trends (6 or more points consecutively ascending or descending). Implementation strategies that mapped to special cause variations were selected as those most likely to impact the KPI. Results: Across the 6 sites that deployed eSyM, the mean KPI performance ranged from 19.7%-35.7%. SPC charts detected multiple special cause variations in the KPI at all 6 sites, though the patterns varied by site. All sites demonstrated positive and negative astronomical variations as well as positive and negative shifts. Three sites demonstrated negative trends; no sites demonstrated positive trends. Direct patient outreach was the implementation strategy most frequently associated with special cause variation, followed by changes in promoting the ePRO program to clinical staff. Positive changes were associated with strategy initiation; negative changes were associated with strategy discontinuation. Conclusions: Applying SPC charts to a KPI from the eSyM deployment highlighted the effect of personal communication with patients and providers, suggesting that these implementation strategies could offer value to other sites deploying eSyM. The absence of positive trends early in eSyM program deployment underscores the need to identify better implementation strategies and allocate more resources to foster program adoption and sustainability. Applying SPCs to other KPIs, such as symptom severity and healthcare utilization, could improve eSyM deployment and impact.