High Symptom Burden Research Articles

Characteristics of Pediatric Concussion across Different Mechanisms of Injury in 5 through 12-Year-Olds

To investigate characteristics of sport-related concussion (SRC), recreation-related concussion (RRC), and nonsport or recreation-related concussion (non-SRRC) in patients 5 through 12years old, an understudied population in youth concussion. This observational study included patients aged 5 through 12years presenting to a specialty care concussion setting at ≤28days postinjury from 2018 through 2022. The following characteristics were assessed: demographics, injury mechanism (SRC, RRC, or SRRC), point of healthcare entry, and clinical signs and symptoms. Kruskal-Wallis and chi-square tests were used to assess group differences. Posthoc pairwise comparisons were employed for all analyses (α=0.017). One thousand one hundred forty-one patients reported at ≤28days of injury (female=42.9%, median age=11, interquartile range (IQR)=9-12) with the most common mechanism being RRC (37.3%), followed by non-SRRC (31.9%). More non-SRRCs (39.6%) and RRC (35.7%) were first seen in the emergency department (P<.001) compared with SRC (27.9%). Patients with RRC and non-SRRC were first evaluated at specialists 2 and 3days later than SRC (P<.001). Patients with non-SRRC reported with higher symptom burden, more frequent visio-vestibular abnormalities, and more changes to sleep and daily habits (P<.001) compared with RRC and SRC (P<.001). In concussion patients 5 through 12years, RRCs and non-SRRC were more prevalent than SRC, presenting first more commonly to the emergency department and taking longer to present to specialists. Non-SRRC had more severe clinical features. RRC and non-SRRC are distinct from SRC in potential for less supervision at time of injury and less direct access to established concussion health care following injury.

Likelihood of Post-COVID Condition in people with hybrid immunity; data from the German National Cohort (NAKO)

The risk of Post-COVID-19 condition (PCC) under hybrid immunity remains unclear. Using data from the German National Cohort (NAKO Gesundheitsstudie), we investigated risk factors for self-reported post-infection symptoms (any PCC is defined as having at least one symptom, and high symptom burden PCC as having nine or more symptoms). Sixty percent of 109,707 participants reported at least one previous SARS-CoV-2 infection; 35% reported having had any symptoms 4-12 months after infection; among them 23% reported nine or more symptoms. Individuals, who did not develop PCC after their first infection, had a strongly reduced risk for PCC after their second infection (50%) and a temporary risk reduction, which waned over 9 months after the preceding infection. The risk of developing PCC strongly depended on the virus variant. Within variants, there was no effect of the number of preceding vaccinations, apart from a strong protection by the fourth vaccination compared to three vaccinations for the Omicron variant (odds ratio = 0.52; 95% confidence interval 0.45-0.61). Previous infections without PCC and a fourth vaccination were associated with a lower risk of PCC after a new infection, indicating diminished risk under hybrid immunity. The two components of risk reduction after a preceding infection suggest different immunological mechanisms.

P-move: a randomized control trial of exercise in patients with advanced pancreatic or biliary tract cancer (aPBC) receiving beyond first-line chemotherapy

PurposePatients with advanced pancreatic and biliary tract cancer (aPBC) frequently suffer from high symptom burden. Exercise can reduce treatment side effects and improve patient-related outcomes (PROMs). However, evidence from prospective studies regarding feasibility and efficacy in advanced settings are sparse. The primary aim of this prospective, randomized-controlled study was to evaluate the feasibility and effects of exercise (ET) in patients with aPBC.MethodsPatients with aPBC beyond first-line therapy were randomized according to the minimization procedure with stratification by gender, age, and loss of body weight in the past six months. The intervention group (IG) completed 3 training units/week for 8 weeks (1x supervised strength sessions, 2x individualized home-based sessions). Control group (CG) received recommendations on physical activity during cancer.Results41 patients (stage IV pancreatic or biliary tract cancer) were included no adverse events related to exercise occurred during the trial. Physical function increased significantly in IG in 5 out of 7 physical domains. Comparison of IG and CG at 8 weeks (t2) showed significant differences in favour of IG in leg press (p=0.001), bench press (p=0.011), sit-to-stand (p=0.001) and crunch (0.006). Constipation revealed a significant difference in favour of IG at t2 (p=0.033). Quality of life stabilized/increased in IG during the study period compared to a decrease in CG. Throughout/Over the 8 weeks, fatigue notably reduced in the IG (p=0.028).ConclusionExercise is safe and feasible in patients with aPBC undergoing further line therapy. Significant improvements in physical functioning and increased quality of life were achieved.German Clinical Trials Register ID: DRKS00021179; Registration date 15.05.2020

Patient Perceptions of Specialist Palliative Care Intervention in Surgical Oncology Care.

Surgical oncology patients have a high symptom burden and increased risk of morbidity. The aim of palliative care is to evaluate and treat the patient in a holistic manner focusing on the unique attributes of each patient. This goal-concordant approach could help surgical patients cope with the stress and uncertainty that often accompany serious illness and surgery, improving overall outcomes. This qualitative analysis sought to explore whether unmet specialist palliative care or end-of-life needs exist in this population. Qualitative interviews were completed with a subset of participants in a randomized, controlled trial of a specialist palliative care intervention for patients undergoing abdominal oncologic surgery. The interview guide sought to elicit respondents' perceptions of palliative care and end-of-life needs perioperatively and postoperatively. Recurring themes were identified by two independent coders. Analysis of 47 interview transcripts revealed few serious concerns about end-of-life issues, however appreciation for the supportive presence offered by palliative care was present. Among participants who received specialist palliative care, many found the intervention helpful, but few were able to articulate issues that the intervention improved. These findings suggest low levels of unmet palliative care needs among this population, which is consistent with the results of the parent trial. Targeting patients with a higher symptom burden perioperatively may allow for improved symptom management and better adherence to the treatment plan postoperatively, as well as be a more focused use of specialist palliative care clinicians' efforts.

APPaRENT 3: Asthma Patients' and Physicians' Perspectives on the Burden and Management of Asthma in Seven Countries.

Asthma management is strongly dependent on physician and patient beliefs and perceptions about the disease and its long-term treatment. The APPaRENT 3 study was conducted to explore factors influencing treatment choice and to understand patients' and physicians' attitudes and perspectives on the use of controller inhalers in regular versus flexible dosing for asthma management. This cross-sectional survey of patients with asthma and treating physicians was conducted in seven countries: Indonesia, Malaysia, Philippines, Thailand, Vietnam (patient survey only), Saudi Arabia, and the United Arab Emirates. Assessment was carried out through an online/face-to-face questionnaire, where patients' viewpoints were focused on their attitudes and beliefs about asthma and treatment adherence, whereas physicians' viewpoints were gathered on their attitudes and beliefs about asthma management, knowledge of and adherence to asthma treatment guidelines, and asthma treatment regimens. Overall, 1400 patients (mean age, 34years) and 599 physicians (mean age, 43years) were included in the survey. Physicians similarly prioritised symptom control (39%) and exacerbation reduction (40%) in moderate asthma, whereas patients prioritised symptom control (41%) over exacerbation reduction (22%). Although both groups (physicians, 86%; patients, 84%) perceived asthma as well-controlled, poor management was evident based on Asthma Control Test (ACT) scores (mean, 15.7; standard deviation, 4.14; 82% had an ACT score<20) and high symptom burden (39% reported nighttime awakenings or early mornings≥2 nights/week). Most patients (76%) with moderate asthma were prescribed regular dosing, with the most common treatment being inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) with as-needed inhaled short-acting β2-agonist (SABA; 20%). Among patients on maintenance and reliever therapy, 93% of patients received a separate inhaled reliever. Despite high symptom burden, patients overestimated their level of asthma control. Physicians prioritised controlling symptoms and reducing exacerbations as treatment goals for moderate asthma, often prescribing regular dosing with ICS/LABA with as-needed inhaled SABA.

Validation of Patient-Reported Outcome Measure in Pediatric CKD (PRO-Kid).

Measuring the burden of symptoms that matter most to children and adolescents with chronic kidney disease (CKD) is essential for optimizing patient-centered care. We developed a novel CKD-specific Patient-Reported Outcome measure (PRO-Kid) to assess both frequency and impact of symptoms in children. In the current study, we further assessed the validity and internal consistency of PRO-Kid. In this multicenter study, children age 8 to 18 years with stages 3-5 CKD, including those on dialysis, were recruited from five pediatric centers. Children completed the 14-item PRO-Kid questionnaire and the validated Pediatric Quality of Life Inventory (PedsQL™ 4.0). We explored the dimensionality of the PRO-kid scale using exploratory and confirmatory factor analysis, to either establish that it is a unidimensional construct or identify evidence of subfactors. We then assessed internal consistency (Cronbach's alpha [Cα]) and construct validity (Pearson correlations). In total, 100 children were included. The median eGFR was 27.4 ml/min/1.73m2 [7.43, 63.4], and 26 children (26%) were on dialysis. Both the PRO-Kid frequency and the impact scales were unidimensional. Cα was high for both the PRO-Kid frequency and impact scales, 0.83 (95% CI = 0.78 to 0.88) and 0.84 (95% CI = 0.80 to 0.89) respectively, showing strong internal consistency. Pearson correlations between PRO-Kid and PedsQL™ scores were also strong: -0.78 (95% confidence interval [CI] = -0.85 to -0.70) for the frequency score and -0.69 (95% CI = -0.78 to -0.56) for the impact score, reflecting the association between poorer quality of life and higher symptom burden. PRO-Kid is a novel patient-reported symptom burden tool for children 8-18 years of age with CKD that correlates strongly in the expected direction with PedsQL™, supporting its validity. Future work will evaluate changes in PRO-Kid score with progression of CKD, and implementation of the tool into clinical care.

“Life…Gets Turned Upside-Down…” Opportunities to Improve Palliative Care for High-Grade Glioma

ContextEarly palliative care referral is recommended broadly in oncology. Yet, few patients with high-grade gliomas (HGG) – highly aggressive brain tumors – receive specialty palliative care consultation. ObjectivesTo delineate unique needs of HGG patients relative to other oncology patients according to perceptions of a diverse sample of US palliative medicine physicians and neuro-oncologists in each of the eight domains of palliative care; and to describe contrasts between physician specialties on indications for and timing of specialty palliative care referrals in HGG. MethodsBetween September 2021 and May 2023, we conducted semi-structured, 40-minute interviews with ten palliative medicine physicians and ten neuro-oncologists. Participants were recruited via purposive sampling for diversity in geographic setting, years in practice, and practice structure. Interviews were audio-recorded, professionally transcribed, and coded by two investigators. Data were analyzed thematically using a qualitative, phenomenological approach. ResultsThe palliative care needs of HGG relative to other cancers across palliative care domains are distinguished by poor prognosis, physical and cognitive deficits, and neuropsychiatric symptoms. Themes on indications for palliative care referral differed between neuro-oncologists and palliative physicians. Neuro-oncologists favored selective referral for clinical indications such as high non-neurologic symptom burden requiring time-intensive management. Palliative physicians favored early referral of most HGG patients, to allow for maximal benefit across HGG trajectory. ConclusionPatients with HGG have unique palliative care needs that affect palliative care delivery across care domains. Bidirectional education, enhanced collaboration, and consensus guidelines may help overcome barriers to specialty palliative care referral.

The Gut Microbiome and Symptom Burden After Kidney Transplantation: An Overview and Research Opportunities.

Many kidney transplant recipients continue to experience high symptom burden despite restoration of kidney function. High symptom burden is a significant driver of quality of life. In the post-transplant setting, high symptom burden has been linked to negative outcomes including medication non-adherence, allograft rejection, graft loss, and even mortality. Symbiotic bacteria (microbiota) in the human gastrointestinal tract critically interact with the immune, endocrine, and neurological systems to maintain homeostasis of the host. The gut microbiome has been proposed as an underlying mechanism mediating symptoms in several chronic medical conditions including irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, and psychoneurological disorders via the gut-brain-microbiota axis, a bidirectional signaling pathway between the enteric and central nervous system. Post-transplant exposure to antibiotics, antivirals, and immunosuppressant medications results in significant alterations in gut microbiota community composition and function, which in turn alter these commensal microorganisms' protective effects. This overview will discuss the current state of the science on the effects of the gut microbiome on symptom burden in kidney transplantation and future directions to guide this field of study.

Lung function and quality of life one year after severe COVID-19 in Brazil.

To evaluate symptoms, lung function, and quality of life of a cohort of patients hospitalized for severe COVID-19 12 months after hospital admission. This was a cross-sectional study. We included severe COVID-19 survivors hospitalized in one of three tertiary referral hospitals for COVID-19 in the city of Belo Horizonte, Brazil. Participants were submitted to lung function and six-minute walk tests and completed the EQ-5D-3L questionnaire. The whole sample comprised 189 COVID-19 survivors (mean age = 59.6 ± 13.4 years) who had been admitted to a ward only (n = 96; 50.8%) or to an ICU (n = 93; 49.2%). At 12 months of follow-up, 43% of patients presented with dyspnea, 27% of whom had a restrictive ventilatory disorder and 18% of whom presented with impaired DLCO. There were no significant differences in FVC, FEV1, and TLC between the survivors with or without dyspnea. However, those who still had dyspnea had significantly more impaired DLCO (14.9% vs. 22.4%; p < 0.020) and poorer quality of life. After one year, survivors of severe COVID-19 in a middle-income country still present with high symptom burden, restrictive ventilatory changes, and loss of quality of life. Ongoing follow-up is needed to characterize long COVID-19 and identify strategies to mitigate its consequences.

Translation, Cultural Adaptation, and Validation into Romanian of the Myeloproliferative Neoplasm Symptom Assessment Form-Total Symptom Score (MPN-SAF TSS or MPN-10) Questionnaire.

Background: Patients with myeloproliferative neoplasms (MPNs) experience a high disease-related symptom burden. A specific instrument to evaluate quality of life (QoL), i.e., the MPN Symptom Assessment Form Total Symptom Score (MPN-SAF TSS; MPN-10), was developed. We conducted the translation, cultural adaptation, and validation into Romanian of the MPN-10. Methods: We translated the MPN-10 and tested its psychometric properties. Results: We recruited 180 MPN patients: 66 polycythemia vera (36.67%), 61 essential thrombocythemia (33.89%), 51 primary and secondary myelofibrosis (SMF) (28.33%), and 2 MPN-unclassifiable (1.11%). The mean TSS was 19.51 ± 16.51 points. Fatigue, inactivity, and concentration problems were the most cumbersome symptoms. We detected scoring differences between MPN subtypes regarding weight loss (p < 0.001), fatigue (p = 0.006), early satiety (p = 0.007), night sweats (p = 0.047), pruritus (p = 0.05), and TSS (p = 0.021). There were strong positive associations between TSS and inactivity, fatigue, and concentration problems, and moderate negative correlations between QoL scores and all MPN-10 items. Cronbach's α internal consistency coefficient was 0.855. The Kaiser-Meyer-Olkin construct validity test result was 0.870 and the Bartlett Sphericity Test was significant (p < 0.001). Symptom scores were loaded into one single factor according to the exploratory factor analysis. Conclusions: The Romanian MPN-10 version displayed excellent psychometric properties and is a reliable instrument for assessing symptom burden and QoL in Romanian MPN patients.

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.

Patient-reported and clinical outcomes among patients with pancreatic cancer.

e23200 Background: Pancreatic cancer is associated with poor survival, high symptom burden, and psychological distress. Conventional assessments such as performance status (PS) have relied on provider-generated data to evaluate the selection of treatment and prognosis. Patient-reported outcome measures (PROMs) represent a patient-centric representation of the patient experience and are increasingly applied as tools to help improve outcomes and quality of life. However, little is known about the correlation of PROMs with ECOG PS and clinical outcomes in pancreatic cancer. Methods: We performed a retrospective analysis of patients with pancreatic cancer seen at the Henry Ford Health System between 09/2020 and7/2023, using ICD codes. The NIH’s validated and standardized Patient-Reported Outcomes Measurement Information System was used to capture 4 core domains: fatigue, pain interference, physical function, and depression. Patient-level variables and disease-specific variables were obtained by chart review from EHR. Kruskal-Wallis tests for continuous variables and or Fisher’s exact tests for categorial variables were used to compare the different ECOG scores and PROM scores and patient-level and disease-specific variables. Results: 176 patients were analyzed, with a median age of 65, 58% were male. Most patients had Stage 1 32.9% followed by Stage 4 25.9%, stage 3 22.9%, 1 32.9%. The majority had an ECOG score of 1, followed by, 0, 2, and only 10 had an ECOG PS of 3. There was no statistically significant difference in PS scores according to smoking status, race, or AJCC Stage but differed by age (P = 0.0007). PS score was not significantly associated with PROMscores on depression, fatigue, or pain interference. However, increasing PS scores were associated with a significant increase in low physical function PROM scores (P &lt; 0.0001). Conclusions: Clinician-assessed PS is a single assessment of the patient’s tolerance to therapies subject to physician bias; our study provides encouraging data on the association between PS and patients’ reported physical function. The other PROM domains did not provide additional meaningful information on the patient’s function although are part of clinical decision-making. [Table: see text]

A fast transition: A case study of patients' experiences during the diagnostic and surgical treatment phase of an accelerated brain cancer pathway.

Patients receiving a brain cancer diagnosis may face cognitive decline and a poor prognosis. In addition, they suffer from a high symptom burden in a complex cancer pathway. The aim of this study was to investigate the early hospital experiences of brain tumour patients during the diagnostic and surgical treatment phase. A descriptive longitudinal single-case study design was used, and data were analysed via systematic text condensation. The patients' experiences of being diagnosed with and treated for brain cancer were interpreted in terms of the central theme: a fast transition into an unknown journey. This theme consisted of the following subthemes: emotionally overwhelmed, putting life on hold and an unfamiliar dependency. Patients diagnosed with brain cancer struggle with overwhelming emotions due to this sudden life-threatening diagnosis, their fear of brain surgery and their progressing dependence. Patients did not voice their feelings, fears or needs, so these may easily be overlooked and unmet. A proactive and continuous care approach throughout the diagnostic phase is needed to support these patients.

National implementation of an AI-based virtual dietitian for patients with cancer.

1500 Background: Nutritional status is an established key driver of cancer outcomes and patient experience. However, the workforce of oncology dietitians is unable to meet the needs of the population, and 80% of patients seek but do not receive nutrition support. Advances in artificial intelligence (AI) and machine learning (ML) capabilities afford the opportunity to expand reach and rapidly hone in on clinical and contextual needs to deliver evidence-based nutritional guidance. Methods: To address this unmet need, an AI-based nutrition expert-platform was developed. Interventions were curated by oncology-nutrition experts based on peer-reviewed literature and clinical guidelines to facilitate self-management of cancer side effects and optimize nutrition. A growing database of over 114,000 evidence-based interventions powers Ina, a text-message based virtual nutrition assistant. Interventions are continually enhanced and refined using AI and ML applied to an extensive learning dataset. The tool was implemented nationally in partnership with 25 cancer advocacy organizations. Data on demographics, patient-reported outcomes, and utilization were systematically collected. Results: Between July 2019 and August 2023, 3,310 users from all 50 states registered for the virtual nutrition platform. Based on self-report, users were 73% female; mean age 57 years (18-91); most common cancer types were GU (22%), Breast (21%), Gyn (19%), GI (14%), and Lung (12%), representing nearly 90% of users. Users were medically complex, with 50% reporting Stage 3-4 disease, 64% with metastases, and 50% with 2+ chronic conditions. Nutritional challenges were highly prevalent: 58% were overweight/obese by BMI, 83% reported barriers to good nutrition, and 42% had food allergies/intolerances. Levels of engagement were high: 68% of users texted queries to Ina, 79% completed surveys, and median user retention duration was 8.8 months. Overall, 94% of users reported being satisfied with the platform and 98% found the guidance to be helpful. In an evaluation of outcomes, 84% reported actively using the nutrition advice to guide their diets, 47% used the recommended recipes, and 82% felt the program improved their quality of life. In this cohort with high symptom burden, 88% reported Ina helped them manage their symptoms and 34% noted improved symptom control during participation. Conclusions: Implementation of an evidence-based AI virtual dietitian is feasible, and is reported by patients to be beneficial on diet, quality of life, and symptom control. Ongoing evaluations are assessing impact on other outcomes.

A descriptive patient-reported outcomes (PROs) analysis of KEYNOTE-412 to understand head and neck symptom burden.

11116 Background: The randomized, double-blind, phase 3 KEYNOTE-412 study (NCT03040999) investigated pembrolizumab (pembro) + chemoradiation therapy (CRT) versus placebo + CRT for locally advanced head and neck squamous cell carcinoma (LA HNSCC). Descriptive PRO analysis may provide important insight to better understand patient (pt) experiences. This analysis evaluated pt experience by examining item-level PRO scores. Methods: Adults with LA HNSCC were randomly assigned 1:1 to pembro 200 mg IV Q3W or placebo + CRT. PROs included the EORTC QLQ-C30 and EORTC QLQ-H&amp;N35. Responses to each item of the QLQ-C30 and H&amp;N35 were analyzed descriptively based on treatment group combined data. Each item was evaluated overall, and then for the H&amp;N35 by tumor location and by clinical event (death, distant progressive disease [PD], local regional PD, local PD, and distant metastasis or histologically persistent/residual disease). Symptom burden was defined as responses of “a little,” “quite a bit,” “very much,” or “yes.” Items associated with high symptom burden (≥30% of responses “quite a bit,” “very much,” or “yes”) at baseline were analyzed over time. Results: Of 756 pts with PRO data, highly endorsed items (≥50% experiencing the symptom) on the QLQ-C30 at baseline were pain, trouble sleeping, needing rest, tiredness, and worry; highly endorsed (≥50%) items from the H&amp;N35 were pain in mouth, painful throat, problems swallowing solid food, coughing, hoarseness, and use of pain killers. Pts with an event, compared to pts who were event-free at the time of data cut-off, experienced greater symptom burden at baseline; for example, pain in mouth (56% vs 50%), pain in jaw (47% vs 37%), use of pain killers (71% vs 58%), weight loss (53% vs 30%), trouble eating (63% vs 46%), and problems swallowing solid food (69% vs 56%). Symptoms at baseline also differed by primary tumor location, demonstrating the heterogeneity of symptom burden across this population. Based on the threshold of ≥30% reporting worse responses at baseline, 20 items on the H&amp;N35 were analyzed over time. Of pts who experienced an event (n = 345, 46%), 6 items met this threshold: pain in mouth (32%), problems swallowing solid food (41%), trouble eating (32%), use of pain killers (71%), use of nutritional supplements (34%), and weight loss (53%). For these items, a similar or greater percentage of pts with symptoms were observed over time in those who had events compared to those with no events. Conclusions: Observations of pts enrolled in KEYNOTE-412 study who had events, appearing to have greater symptom burden at baseline, suggests there may be a relationship between baseline item scores and clinical outcomes. Heterogeneity of populations may lead to variability of baseline PRO scores and should be considered in PRO analysis. Further research is needed to explore the relationship between baseline PROs and event outcomes as well as additional subgroup analysis. Clinical trial information: NCT03040999 .

A Structural Equation Model of the Relationship Between Symptom Burden, Psychological Resilience, Coping Styles, Social Support, and Psychological Distress in Elderly Patients With Acute Exacerbation Chronic Obstructive Pulmonary Disease in China

PurposeThe prevalence of psychological distress is frequently observed among old adults with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). However, current researches are insufficient to clarify the correlation among these relevant factors. This study examined the effects of symptom burden, psychological resilience, coping styles and socialsupporton psychological distress Methods255 elderly patients with AECOPD were conveniently selected in Taian, Shandong Province. The General Information Questionnaire, Distress Thermometer, The Revised Memorial Symptom Assessment Scale, Connor-Davidson Resilience Scale, Simplified Coping Style Questionnaire, Perceived Social Support Scale were used to investigate. The relationship among factors was estimated by using a structural equation model ResultsPsychological distress score of elderly patients with AECOPD was (5.25±1.01); coping styles, psychological resilience, symptom burden, social support directly affected psychological distress (the direct effects were -0.934, 0.174, 0.169 and -0.086); coping styles had the largest total effect on psychological distress (the total effect was -0.934); psychological resilience indirectly affected psychological distress through coping styles (the indirect effect was -0.743); symptom burden indirectly affected psychological distress through psychological resilience (the indirect effect was 0.254); social support indirectly affected psychological distress through symptom burden, psychological resilience, and coping styles (the indirect effect was -0.799) ConclusionThe psychological distress of elderly patients with AECOPD is at a moderate level; coping styles, psychological resilience and social support have positive effects on alleviating the psychological distress of elderly patients with AECOPD; symptom burden is negatively correlated with psychological distress. Healthcare professionals should pay more attention to elderly patients with AECOPD who are particularly prone to experiencing higher levels of psychological distress, especially in the presence of low coping style, limited psychological resilience, inadequate levels of social support, and high symptom burden.

Predictors of symptom scores in myeloproliferative neoplasms: A real-world retrospective cohort study.

6582 Background: Although high symptom burden indicates poor survival and informs treatment decisions, little is known about the impact of demographic, clinical, and laboratory features on total symptom score (TSS) in patients with myeloproliferative neoplasms (MPN). Methods: Patients with MPN (polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF)) were identified from the retrospective chart review. TSS, individual symptom scores (fatigue, early satiety, abdominal discomfort, inactivity, concentration problems, fever, night sweats, itching, bone pain, weight loss), demographic characteristics (race, ethnicity, age, gender), clinical features (time since diagnosis, depression status, obesity status, spleen size), laboratory results and season at the time of visit were recorded from the clinical encounter when index assessment of TSS was performed for each patient. Normality was assessed using visual inspection of data distribution, whereas multicollinearity was assessed using various inflation factors. A univariable regression followed by a multivariable regression analysis was conducted using a backward selection approach. A p-value &lt;0.05 indicated a statistically significant association of a given feature with TSS. Results: The chart review identified 252 patients (PV: 78; ET: 81; MF: 93). Mean age was 59 (SD: 17.7), 67 (SD: 13.0), and 68 (SD: 10.9) years for ET, PV, and MF respectively. Most patients were white (PV, MF: 92%; ET: 83%) and females (ET: 75%; PV: 60%; MF: 53%). The TSS of patients was highest with PV (mean: 18.5; SD: 16.9) followed by MF (mean: 18.1; SD: 15.4) and ET (mean: 14.3; SD: 15.9). Fatigue was the most reported symptom whereas the least reported symptoms were fever and weight loss. Univariable regression analyses showed depression (B: 17.7; p=0.02), female gender (B: 10.6; p=0.01), platelet count (B: 0.03; p=0.03), and hemoglobin (Hb) (B: -2.6; p=0.01) in PV patients, depression (B: 19.8, p=2x10-5) in ET patients and depression (B: 11.0, p=0.03), white blood cell (WBC) count (B: 0.2; p=0.01), neutrophil count (B: 0.3, p=0.01), and non-neutrophil WBC count (B: 0.6; p=0.02) in MF patients to have significant association with TSS. Multivariable regression analyses ( Table) showed Hb (B: -2.5; p=0.01) and platelet count (B: 0.02; p=0.03) in PV patients, depression (B: 19.7; p=2x10-5) in ET patients and depression (B: 12.3, p=0.01) and WBC count (B: 0.3; p=0.002) in MF patients to have a significant association with TSS. Conclusions: Depression in ET and MF and low Hb in PV were identified as significant drivers of symptom burden. Identifying and managing patients with these comorbidities could improve their quality of life with a potential survival benefit. [Table: see text]

Acupuncture for cancer symptoms: Clinical application and longitudinal impact.

e23191 Background: Evidence for acupuncture (ACUP) in cancer care is inconsistent. ACUP is variously used for multiple symptoms, e.g. anxiety, chemotherapy-related peripheral neuropathy, dyspnea, hot flashes, insomnia, and pain. Approximately 500 unique patients are treated for ACUP annually in our Section of Integrative Oncology. Our objective was to evaluate ACUP’s clinical application and longitudinal impact on symptoms severity. Methods: This was a retrospective analysis of those treated in a group ACUP session. Symptoms were rated before each session on a severity numeric rating scale (0-10). Clinical improvement was defined as a 2-point decrease from baseline (T1). We report symptoms from baseline to the fourth sessions (T1-T4). Counts are presented as percentages and numbers summarized by mean (standard deviation; SD) or median (interquartile range; IQR). Groups were compared statistically as appropriate. Results: 2239 consecutive patients were treated between 2015-2022. Mean (SD) age was 57 (±12); 83% were female; 57% breast primary site, 9% hematologic, 9% gastrointestinal, 8% gynecologic, 4% lung, 3% prostate, and 9% other malignancies. Symptoms treated were pain (61%), insomnia (48%), fatigue (44%), neuropathy (41%), anxiety (37%), hot flashes (37%), and other symptoms (17%). 68% presented with multiple symptoms. They received a median (IQR) of 4 (2-6) sessions and 7 (7-14) days apart. At T1 symptom severity scores, median (IQR), were anxiety 5(2-7), fatigue 5(3-7), hot flashes 6(4-8), insomnia 6(4-8), neuropathy 5(3-8), and pain 5(3-7); Table1. By T2, improvement was observed in patients, N (%), with hot flashes 476 (66%), anxiety 434 (62%), fatigue 464 (56%), insomnia 407 (55%), neuropathy 441 (55%), and pain 563 (50%). Symptom severity improvement was statistically significant by T2 and by T3 clinically relevant; Table 1. By T4, about 60% were still on ACUP treatment. Multiple ACUP sessions ( &gt; 1) were associated with older age and higher symptom burden, and fewer sessions with more severe T1 anxiety and fatigue. Fewer males were treated, yet symptoms improved like in females. Conclusions: Symptoms were of moderate severity at referral. In this large consecutive sample (N = 2239) of mostly younger breast cancer women, group ACUP was associated with broad based symptom benefit. Repeated ACUP treatments were important for clinical improvement. Males and females benefited equally however fewer males were referred. Several confounders need to be considered interpreting these results. [Table: see text]

Patient (pt) experience with and perceptions of transfusion-dependent (TD) and transfusion-independent (TI) myelofibrosis (MF): A qualitative interview study.

e23110 Background: MF is a rare myeloproliferative neoplasm for which Janus kinase inhibitors are the standard of care. Some Janus kinase inhibitors can exacerbate anemia, a hallmark feature of MF that increases in severity with disease progression. Red blood cell transfusions are an important component of anemia management, but transfusion dependence is an independent predictor of poor survival outcomes and is inversely correlated with quality of life (QOL). The current study aimed to elicit the perceived direct and indirect burden of transfusion dependence and its impact on pts with MF. Methods: Concept elicitation interviews were conducted remotely with Janus kinase inhibitor–experienced and symptomatic (MF Symptom Assessment Form v4.0 Total Symptom Score [TSS] ≥10) pts with MF across the US, UK, Germany, Italy, Spain, and Poland (N = 20). Five TD pts (≥2 blood transfusions in any 1 mo over the last 3 mo) and 15 TI pts (≤1 blood transfusion in any 1 mo over the last 3 mo) participated in 60-minute interviews, which followed a semistructured guide including open-ended questions and completion of ranking exercises and sociodemographic and clinical forms. Results: Of 20 pts, mean age was 59 years, 50% were male, and85% received a diagnosis of anemia after their MF diagnosis. Pts with anemia experienced a range of related symptoms, including fatigue (94%), weakness (53%), and night sweats (29%). These symptoms impacted several QOL domains, including emotional (88%) and physical (71%) health and social life (71%). Most pts (18 of 20) had received a transfusion in the past, of whom 5 were TD. In addition to higher transfusion burden, TD pts had higher symptom burden than TI pts (mean TSS, 30.8 vs 27.9).TD pts endorsed challenges with frequent transfusions relating to clinical concerns/safety (100%), convenience (100%), and travel (80%), all of which remained concerns when thinking about being TD in the future (40% each). These challenges resulted in emotional (80%) and physical (60%) impacts and impacts to activities of daily living (60%). Four of 5 (80%) reported that going ≥12 weeks without a transfusion would be helpful and positively impact their QOL. Similarly, TI pts felt it was important to remain TI, with 73% expressing concerns about becoming TD in the future. Regarding the most important MF treatment outcomes, MF symptom reduction and overall survival were the most common (40% each) among TD pts, and reduction/avoidance of transfusion was the most common (40%) among TI pts. Conclusions: These interviews characterize the substantial negative experiences with and perceptions of anemia and transfusions in pts with MF who are TD and those who are TI but concerned about becoming TD in the future. These findings highlight the value of treatment options that reduce/eliminate transfusion burden and prevent future transfusions in improving the experiences of pts with MF.

Evidence to support ePRO-based patient care in survivorship for outpatient with advanced upper gastrointestinal cancer.

e13789 Background: The patients with advanced upper gastrointestinal (UGI) cancer reported multiple symptom burdens at diagnosis and after failing multiple chemotherapy lines. Assessing the readiness of patient-reported outcome (PRO) parameters to support evidence-based pathways for monitoring and managing outpatients is an unmet clinical need to integrate PRO into routine outpatient care for UGI cancer patients. This study aims to identify the most relevant PRO parameters that represent the high symptom burden and functioning impairment overtime during chemotherapy for advanced UGI cancer. Methods: Eligible UGI adult cancer patients (N=111) for a new line of chemotherapy were enrolled. Multiple symptoms were assessed electronically for 36 weeks, using The M.D. Anderson Symptom Inventory GI module (MDASI-GI). Longitudinal symptoms burden was analyzed using mixed-effect models adjusted for age, sex, performance status (PS) (good vs. poor PS ( ECOG 0-1 vs. 2-4). Results: Patients who contributed with more than baseline PROs were included in the analysis (n=92). Of those patients, 43 were treatment-naïve, and 49 had received prior therapy. The primary tumor sites include esophageal (32%), gastroesophageal junction (GEJ) (25%), or gastric (40%). All patients at baseline reported the following symptoms at a severe level (score ≥7 on a 0-10 MDASI-GI scale): fatigue, lack of appetite, pain, disturbed sleep, drowsy, and inability to eat. There was no significant difference in the composite score of these symptoms overtime, regardless of disease groups or treatment status at baseline. Patients with poor PS reported a statistically significant severe composite score baseline ( P=.04). Patients who stayed longer in the study during their survivorship reported a decreased prevalence of moderate to severe symptoms (score of ≥ 4) from 51% at baseline to 40% at 12 weeks, 34% at 24 weeks, and to 28% at 36 weeks. Over time, treatment naïve patients had more severe numbness/tingling, while previously treated group had more severe distress. Conclusions: This longitudinal prospective study during survivorship in patients undergoing chemotherapy for advanced UGI cancer provides a set of most distressing symptom burdens that need to be monitored as part of outpatient care. These data support establishing symptom management pathways for routine use of ePRO for screening and triage of, and linking those symptoms to toxicities after chemotherapy for UGI cancer patients.