Symptom clusters and their impact on quality of life in multiple myeloma survivors: Secondary analysis of BMT CTN 0702 trial.

Autologous haematopoietic cell transplantation (autoHCT) and continuous post-transplant maintenance therapy are the standard of care in transplant-eligible multiple myeloma (MM) patients. We sought to describe symptom burden and identify symptom clusters occurring in MM patients after autoHCT using data from the BMT CTN 0702 randomized controlled trial comparing the outcomes of three treatment interventions after an autoHCT in 758 MM patients. We analysed individual transplant-related symptoms assessed via the FACT-BMT questionnaire at enrolment and annually for 4-year post-autoHCT. We also described the effect the individual symptoms and symptom clusters have on quality of life (QoL). We identified three stable symptom clusters: malaise symptom cluster (lack of energy, feeling ill, having pain, experiencing nausea, loss of appetite), physical symptom cluster (having skin problems, tremors, worsening eyesight, change in taste, shortness of breath, frequent colds) and emotional symptom cluster (feeling sad, being nervous, experiencing sleep problems). Malaise and emotional symptom clusters have a greater impact on QoL than the physical symptoms cluster. Identifying these symptoms warrant additional support in terms of psychosocial support, in addition to treatment of the physical symptoms themselves.

Identification of patient subgroups who benefit from a behavioral intervention to improve adjuvant endocrine therapy adherence: a randomized-controlled trial.

PURPOSE: Adjuvant endocrine therapy (AET) reduces breast cancer morbidity and mortality; however, adherence is suboptimal. Interventions exist, yet few have improved adherence. Patient characteristics may alter uptake of an intervention to boost adherence. We examined moderators of the effect of a virtual intervention (STRIDE; #NCT03837496) on AET adherence after breast cancer. METHODS: At a large academic medical center, patients taking AET (N = 100; Mage = 56.1, 91% White) were randomized to receive STRIDE versus medication monitoring. All stored their medication in digital pill bottles (MEMS Caps) which captured objective adherence. Participants self-reported adherence (Medication Adherence Report Scale) at 12 weeks post-baseline. Moderators included age, anxiety, and depressive symptoms (Hospital Anxiety and Depression Scale), AET-related symptom distress (Breast Cancer Prevention Trial Symptom Scale), and AET-specific concerns (Beliefs about Medications Questionnaire). We used hierarchical linear modeling (time × condition × moderator) and multiple regression (condition × moderator) to test the interaction effects on adherence. RESULTS: Age (B = 0.05, SE = 0.02, p = 0.003) and AET-related symptom distress (B = -0.04, SE = 0.02, p = 0.02) moderated condition effect on self-reported adherence while anxiety (B = -1.20, SE = 0.53, p = 0.03) and depressive symptoms (B = -1.65, SE = 0.65, p = 0.01) moderated objective adherence effects. AET-specific concerns approached significance (B = 0.91, SE = 0.57, p = 0.12). Participants who received STRIDE and were older or presented with lower anxiety and depressive symptoms or AET-related symptom distress exhibited improved adherence. Post hoc analyses revealed high correlations among most moderators. CONCLUSIONS: A subgroup of patients who received STRIDE exhibited improvements in AET adherence. The interrelatedness of moderators suggests an underlying profile of patients with lower symptom burden who benefitted most from the intervention. STUDY REGISTRATION: NCT03837496.

An evaluation of sexual function and health-related quality of life following laparoscopic surgery in individuals living with endometriosis.

STUDY QUESTION: What is the relationship between sexual function, health-related quality of life (HRQoL), and laparoscopic surgery in individuals living with endometriosis? SUMMARY ANSWER: A higher number of laparoscopic surgeries is significantly associated with poorer HRQoL and greater levels of sexual dysfunction in individuals with endometriosis. WHAT IS KNOWN ALREADY: Prior research indicates that endometriosis is associated with lowered HRQoL and sexual function and that these outcomes are influenced by endometriosis-related symptom profiles, medical, and surgical management. A limited number of studies have examined changes in sexual function in individuals with endometriosis following laparoscopic surgery or following repeated surgeries. STUDY DESIGN, SIZE, DURATION: A cross-sectional community-based online survey was used to examine the relationships between sexual function, HRQoL, and laparoscopic surgery (n = 210). PARTICIPANTS/MATERIALS, SETTING, METHODS: Individuals with a self-reported diagnosis of endometriosis were recruited via online advertising through social media and gynaecology clinics. Endometriosis-specific data (e.g. diagnostic delay, symptom experience) was collected in addition to engagement with laparoscopic surgery, level of HRQoL (EuroQol-5 Dimension: EQ-5D-5L), and sexual function (Female Sexual Function Index: FSFI). Bivariate correlational analyses and hierarchical multiple regression were used to determine the associations between the variables of interest. MAIN RESULTS AND THE ROLE OF CHANCE: Individuals with endometriosis have substantially poorer HRQoL in comparison to Australian normative samples, with greater levels of endometriosis-related symptom burden, distress, and pain significantly associated with lower levels of HRQoL. The mean FSFI score was suggestive of clinically significant female sexual dysfunction, with the lowest level of function noted in the domain of sexual pain and the highest level of function noted in the sexual satisfaction domain. A greater number of laparoscopic surgeries was significantly associated with poorer overall HRQoL and greater levels of sexual dysfunction. LIMITATIONS, REASONS FOR CAUTION: The cross-sectional nature of the data precludes direct findings of causality and further longitudinal research is recommended. The information pertaining to engagement in laparoscopic surgery was self-report in nature and was not medically verified. WIDER IMPLICATIONS OF THE FINDINGS: The study's findings highlight the pervasive impact of endometriosis on all domains of living, emphasizing the need to extend treatment planning beyond that of physical pain management alone. Early referral for assessment and management of sexual wellbeing is recommended prior to, and post-surgical intervention, with a focus on maintaining post-surgical changes, potentially reducing the need for multiple surgeries. STUDY FUNDING, COMPETING INTEREST(S): The study was not associated with research funding. Author CN reports grant funding from the Australian Government and Medical Research Future Fund (MRFF) and was a previous employee of CSL Vifor (formerly Vifor Pharma Pty Ltd). TRIAL REGISTRATION NUMBER: N/A.

Hypoglycaemia symptom frequency, severity, burden, and utility among adults with type 1 diabetes and impaired awareness of hypoglycaemia: Baseline and 24-week findings from the HypoCOMPaSS study.

AIMS: To determine the frequency, severity, burden, and utility of hypoglycaemia symptoms among adults with type 1 diabetes (T1D) and impaired awareness of hypoglycaemia (IAH) at baseline and week 24 following the HypoCOMPaSS awareness restoration intervention. METHODS: Adults (N = 96) with T1D (duration: 29 ± 12 years; 64% women) and IAH completed the Hypoglycaemia Burden Questionnaire (HypoB-Q), assessing experience of 20 pre-specified hypoglycaemia symptoms, at baseline and week 24. RESULTS: At baseline, 93 (97%) participants experienced at least one symptom (mean ± SD 10.6 ± 4.6 symptoms). The proportion recognising each specific symptom ranged from 15% to 83%. At 24 weeks, symptom severity and burden appear reduced, and utility increased. CONCLUSIONS: Adults with T1D and IAH experience a range of hypoglycaemia symptoms. Perceptions of symptom burden or utility are malleable. Although larger scale studies are needed to confirm, these findings suggest that changing the salience of the symptomatic response may be more important in recovering protection from hypoglycaemia through regained awareness than intensifying symptom frequency or severity.

A comprehensive systematic literature review of the burden of illness of Lennox-Gastaut syndrome on patients, caregivers, and society.

Fully elucidating the burden that Lennox-Gastaut syndrome (LGS) places on individuals with the disease and their caregivers is critical to improving outcomes and quality of life (QoL). This systematic literature review evaluated the global burden of illness of LGS, including clinical symptom burden, care requirements, QoL, comorbidities, caregiver burden, economic burden, and treatment burden (PROSPERO ID: CRD42022317413). MEDLINE, Embase, and the Cochrane Library were searched for articles that met predetermined criteria. After screening 1442 deduplicated articles and supplementary manual searches, 113 articles were included for review. A high clinical symptom burden of LGS was identified, with high seizure frequency and nonseizure symptoms (including developmental delay and intellectual disability) leading to low QoL and substantial care requirements for individuals with LGS, with the latter including daily function assistance for mobility, eating, and toileting. Multiple comorbidities were identified, with intellectual disorders having the highest prevalence. Although based on few studies, a high caregiver burden was also identified, which was associated with physical problems (including fatigue and sleep disturbances), social isolation, poor mental health, and financial difficulties. Most economic analyses focused on the high direct costs of LGS, which arose predominantly from medically treated seizure events, inpatient costs, and medication requirements. Pharmacoresistance was common, and many individuals required polytherapy and treatment changes over time. Few studies focused on the humanistic burden. Quality concerns were noted for sample representativeness, disease and outcome measures, and reporting clarity. In summary, a high burden of LGS on individuals, caregivers, and health care systems was identified, which may be alleviated by reducing the clinical symptom burden. These findings highlight the need for a greater understanding of and better definitions for the broad spectrum of LGS symptoms and development of treatments to alleviate nonseizure symptoms.

Disease and treatment burden of patients with haemophilia entering the explorer6 non-interventional study.

OBJECTIVES: We aimed to characterise baseline disease and treatment burden in a large population with haemophilia A/B, both with (HAwI/HBwI) and without (HA/HB) inhibitors. METHODS: The prospective, non-interventional explorer6 study included patients ≥12 years old with severe HA, severe/moderate HB or HAwI/HBwI of any severity, treated according to local standard of care (excluding previous/current exposure to concizumab or emicizumab). Baseline characteristics and historical clinical data were collected and patient-reported outcomes, including treatment burden, were assessed. RESULTS: The explorer6 study enrolled 231 patients with haemophilia (84 HAwI/HBwI) from 33 countries. At baseline, patients with HA/HB treated with prophylaxis had the lowest median annualised bleeding rates (ABRs; 2.0), irrespective of haemophilia type; of these patients, 27.5% (HA) and 31.4% (HB) had target joints. Patients with HAwI/HBwI treated episodically reported the highest treatment burden. Of these patients, 28.5% (HAwI) and 25.1% (HBwI) performed sports activities in the month before screening. CONCLUSION: Despite receiving routine clinical care, historical and baseline information from patients enrolled in explorer6 showed that patients with HA/HB treated episodically and patients with HAwI/HBwI had higher ABRs, higher treatment burden and participated in sports less than those with HA/HB treated with prophylaxis. Emerging treatments could be beneficial in addressing these unmet medical needs.

Characteristics and influencing factors of demoralization in patients with lung cancer: A latent class analysis.

OBJECTIVE: Demoralization has garnered increasing attention in recent years as a significant psychological distress. This study aims to identify latent classes of demoralization in lung cancer patients using Latent Class Analysis (LCA) from a person-centered perspective and to explore the factors influencing the latent classes of demoralization. METHODS: A cross-sectional study using convenience sampling was conducted among 567 lung cancer patients in three tertiary hospitals in China. LCA was employed to classify heterogeneous classes of demoralization. Multinomial logistic regression analyses were performed to explore the associations between demographic and clinical characteristics, as well as physical symptoms, resilience, family function, and coping strategies, with class membership in the identified heterogeneous subgroups of lung cancer patients. RESULTS: Three latent classes of demoralization were identified: the high demoralization group (Class 1, 14.8%), the moderate demoralization-distress and helplessness group (Class 2, 37.2%), and the low demoralization group (Class 3, 48.0%). In comparison to Class 3, lung cancer patients with hypertension, higher core symptom burden, poorer resilience, dysfunctional family dynamics, and resignation coping were more likely to belong to Class 1 and Class 2. CONCLUSIONS: The demoralization patterns in lung cancer patients were varied. Targeted intervention should be developed based on the characteristics of each class, and timely attention should be paid to high-risk patients.

High symptom burden in patients undergoing gastrectomy for cancer.

BACKGROUND: There is little data describing symptom burden before or after gastrectomy for patients with cancer. We aimed to examine the perioperative patterns of symptom severity in patients undergoing gastrectomy. METHODS: In this single-institution prospective cohort study, patients scheduled to undergo gastrectomy for cancer completed serial symptom measurement questionnaires preoperatively, at postoperative day (POD) 1-3, and POD 4-7. The percent of patients with moderate to severe scores was calculated at each time point. RESULTS: Thirty-nine patients completed 94 surveys. Preoperatively, 46% reported at least one moderate/severe symptom. This increased to 88% during POD 1-3 and 79% during POD 4-7. During the preoperative period, 25% of patients reported moderate to severe interference in at least one aspect of daily life. This increased to 73% of patients at both POD 1-3 and POD 4-7. CONCLUSIONS: Patients undergoing gastrectomy for cancer frequently experience symptoms that interfere with daily life. A better understanding of these symptoms may improve patients' experiences with, and recovery from, gastrectomy.

Patient-reported outcome measures in surgical patients with upper gastrointestinal cancers: A qualitative interview study.

BACKGROUND AND OBJECTIVES: Patients with pancreatic and gastroesophageal (PGE) cancers experience high symptom burden, but patient experience throughout multimodality treatment remains unclear. We aimed to delineate the experience and symptom burden of patients throughout their perioperative course. METHODS: Qualitative interviews were performed with 17 surgical patients with PGE cancer. Interview transcripts were analyzed and symptoms were ranked by frequency. An expert panel assessed the relevance of these symptom inventory items. RESULTS: Of the 17 patients included, 35% (n = 6) underwent gastrectomy, 30% (n = 5) underwent esophagectomy, and 35% (n = 6) underwent pancreatectomy; 76% (n = 13) received neoadjuvant systemic chemotherapy and/or chemoradiation. Overall, 32 symptoms were reported, and 19 were reported by over 20% of patients. An expert panel rated nine symptoms to be relevant or very relevant to PGE surgical patients. These symptoms (difficulty swallowing, heartburn/reflux, diarrhea, constipation, flushing/sweating, stomach feeling full, malaise, dizziness, or feeling cold) were added to the core MD Anderson Symptom Inventory (MDASI) if they were commonly reported or reached a threshold relevancy score. CONCLUSIONS: In this qualitative study, we developed a provisional symptom inventory for patients undergoing surgery for PGE cancer. This symptom inventory module of the MDASI for PGE surgical patients will be psychometrically tested for validity and reliability.

Gender differences in symptom burden among people living with HIV/AIDS receiving antiretroviral therapy in Yunnan, China.

ABSTRACTLittle is known about gender differences in the symptom burden of people living with HIV/AIDS (PLWHA) on antiretroviral therapy in China. This study was conducted based on a biopsychosocial-medical model to describe gender differences in symptom burden among 1035 PLWHA in Yunnan Province, China. After propensity score matching, 798 PLWHA were included in this analysis. Feeling stressed, poor sleep, and memory loss were the most burdensome symptoms among men, while feeling stressed, memory loss, and dizziness were the most burdensome symptoms among women. Among men PLWHA, factors associated with symptom burden were being of the ethnic minority, CD4 count ≥ 500 cells/mm3, physical functioning, and social support. Among women PLWHA, factors associated with symptom burden were being an inpatient, physical functioning, psychological functioning, and social support. Our findings suggest that healthcare providers need to take into account gender differences when developing optimal prevention, treatment, and care programs that provide individualized care to reduce patients' symptom burden.

Optimizing Care: Integrative Oncology in Myeloproliferative Neoplasm.

PURPOSE OF REVIEW: Myeloproliferative neoplasm (MPN) burdens the lives of those affected. MPN patients endure significant impacts on their physical, psychological, and social well-being. While pharmacological interventions offer some disease and symptom control, they often have unfavorable side effects. This review explores the potential of Integrative Oncology (IO) therapies in managing MPNs and their associated symptoms. RECENT FINDINGS: IO is dedicated to augmenting conventional treatments through integrating interventions targeting the mind, body, nutrition, supplements, and other supportive care therapies. Several small studies suggest the benefit of an IO approach in MPN patients. These benefits are postulated to be modulated through enhanced physical capacity, reduced disease-related inflammation, subconscious mind training, and gut microbiome modulation. By combining IO with evidence-based pharmacological treatments, the potential exists to enhance the quality of life and clinical outcomes for individuals with MPNs. Future research should prioritize well-powered studies, including diverse demographics and symptom profiles, with appropriate study duration, to draw definite conclusions regarding the observed effects.

Quality of life and symptom burden in hematological cancer patients receiving hematopoietic stem cell transplantation: an observational study at Regional Cancer Centre, India.

PURPOSE: Hematopoietic stem cell transplant (HSCT) is an intense form of treatment, resulting in major symptom burden but can prove curative. The quality of life (QOL) is a major endpoint for these patients as the survival rate in them has improved over time. The aim of the study is to assess the QOL and symptom burden of hematological malignancy patients at admission to hospital for HSCT, at 1 month and at 3 months following HSCT. METHODS: This prospective observational study was done on hematological malignancy patients who were admitted for HSCT in a regional cancer center. The study subjects were assessed by the Functional Assessment of Cancer Therapy-Bone Marrow Transplant Scale (FACT-BMT Scale), Edmonton Symptom Assessment Scale-revised (r-ESAS), and Depression, Anxiety and Stress Scale-21 Items (DASS-21) at the time of hospital admission for transplantation, on day 30 (~ 1 month) and day100 (~ 3 months) of transplantation. RESULTS: A total of 68 patients were included in this study. FACT-BMT scores have decreased from baseline (F0) to the first follow-up (F1) and then increased in the third follow-up (F2). The maximum r-ESAS mean score was for tiredness among all other symptoms at F0 as well as at F1 and at F2. The DASS 21 scores for depression, anxiety, and stress were maximum during F1 and minimum during F2. CONCLUSION: Symptom burden is maximum during the first month of BMT, which improves later and QOL becomes improved with time.

Patterns and predictors of symptom burden and posttraumatic growth among patients with cancer: a latent profile analysis.

PURPOSE: The study identified different patterns of symptom burden and posttraumatic growth (PTG) among patients with cancer and to explored the effects of sociodemographic, disease-related, and family resilience factors, which could provide reference for the development of personalized nursing measures. METHODS: A questionnaire survey was conducted with 329 patients with cancer who were undergoing treatment. Latent profile analysis (LPA) was used to explore the patterns of symptom burden and PTG among patients with cancer, and multiple logistic regression analysis was used to explore the influencing factors of different patterns. RESULTS: Based on the fit indicators of LPA, a three-class pattern model of posttraumatic responses was shown to be optimal, including resisting, struggling, and growth groups. In the resisting group (34.34%), patients reported low symptom burden and low PTG; in the struggling group (19.15%), patients showed a high symptom burden and moderate PTG; in the growth group (46.51%), patients showed low symptom burden and high PTG. Moreover, patients with cancer with high levels of family resilience were more likely to fall into the struggling and growth groups. Specifically, those with lower scores in the optimistic attitude and higher scores in the family and social support dimension of family resilience were more likely to fall into the struggling group, whereas those with lower scores in the transcendence and spiritual belief dimensions of family resilience were more likely to fall into the resisting group. Additionally, patients with at least three children were more likely to fall into the struggling group. CONCLUSIONS: This study showed heterogeneity in symptom burden and PTG patterns among patients with cancer. Patients' growth must include both psychological growth and the mitigated symptom burden. Family factors may be intervention targets to improve the growth patterns.

Predictors of persistence of post-chemotherapy symptoms among survivors of solid tumor cancers.

CONTEXT: Late or residual symptoms diminish quality of life for many cancer survivors after completion of treatment. OBJECTIVES: Examine risk factors associated with persisting symptom burden after chemotherapy and the lack of symptom improvement over time. METHODS: Survivors who completed curative-intent chemotherapy within two years for solid tumors were enrolled into a symptom management trial. There were 375 survivors with two or more comorbid conditions or one comorbid condition and elevated depressive symptoms (pre-defined risk factors in the trial design) who received interventions and 71 survivors without these risk factors who did not receive interventions. For all survivors, symptoms were assessed at intake, 4, and 13 weeks and categorized as mild, moderate, or severe based on the interference with daily life. The probabilities of moderate or severe symptoms and symptom improvement were analyzed using generalized mixed-effects models in relation to comorbidity, depressive symptoms, age, sex, race/ethnicity, employment, time since chemotherapy completion, and physical function. Multiple symptoms were treated as nested within the survivor. RESULTS: Moderate or severe symptoms at baseline and the lack of improvement over time were associated with younger age and lower physical function over and above a greater number of comorbidities and elevated severity of depressive symptoms. CONCLUSION: Risk factors identified in this research (younger age, lower physical function, greater comorbidity, and higher depressive symptoms) can be used to allocate resources for post-treatment symptom management for cancer survivors in order to relieve symptoms that do not necessarily resolve with time.

The faces of Long-COVID: interplay of symptom burden with socioeconomic, behavioral and healthcare factors.

AIMS: The long-term effects of COVID-19 (Long COVID) include 19 symptoms ranging from mild to debilitating. We examined multidimensional correlates of Long COVID symptom burden. METHODS: This study focused on participants who reported having had COVID in Spring 2023 (n = 656; 85% female, mean age = 55, 59% college). Participants were categorized into symptom-burden groups using Latent Profile Analysis of 19 Long-COVID symptoms. Measures included demographics; quality of life and well-being (QOL); and COVID-specific stressors. Bivariate and multivariate associations of symptom burden were examined. RESULTS: A three-profile solution reflected low, medium, and high symptom burden, aligning with diagnosis confirmation and treatment by a healthcare provider. Higher symptom burden was associated with reporting more comorbidities; being unmarried, difficulty paying bills, being disabled from work, not having a college degree, younger age, higher body mass index, having had COVID multiple times, worse reported QOL, greater reported financial hardship and worry; maladaptive coping, and worse healthcare disruption, health/healthcare stress, racial-inequity stress, family-relationship problems, and social support. Multivariate modeling revealed that financial hardship, worry, risk-taking, comorbidities, health/healthcare stress, and younger age were risk factors for higher symptom burden, whereas social support and reducing substance use were protective factors. CONCLUSIONS: Long-COVID symptom burden is associated with substantial, modifiable social and behavioral factors. Most notably, financial hardship was associated with more than three times the risk of high versus low Long-COVID symptom burden. These findings suggest the need for multi-pronged support in the absence of a cure, such as symptom palliation, telehealth, social services, and psychosocial support.

Real-world clinical evaluation of natural and induced vasomotor symptoms in the USA and Europe.

OBJECTIVE: This study aimed to examine physicians' and patients' perceptions regarding symptom burden and impact in women experiencing natural vasomotor symptoms (nVMS) or vasomotor symptoms induced by endocrine therapy for breast cancer (iVMS). METHODS: The cross-sectional survey based on real-world clinical consultations was conducted in the USA and five European countries. Obstetrician-gynecologists, primary-care physicians and oncologists provided demographic and symptom data for patients experiencing VMS; patients optionally self-reported their experiences via questionnaires, including their symptom profile and work/activity burden through the Menopause Quality of Life (MENQOL) and Work Productivity and Activity Impairment (WPAI) tools. RESULTS: Physicians completed survey forms on 2451 consulting patients; patients completed 1029 questionnaires. nVMS and iVMS severity was significantly associated with the severity of mood symptoms and sleep disturbances (p < 0.0001). However, around half of the patients with mild nVMS/iVMS also experienced moderate-severe mood changes (55.4%/43.7%) or sleep disturbances (42.4%/40.4%). Presence of mood/sleep disturbances alongside nVMS increased MENQOL vasomotor scores (p = 0.004/p < 0.001). Presence of sleep disturbances increased WPAI activity impairment (p < 0.001) but mood changes did not. Similar findings were reported for iVMS patients. CONCLUSION: Significant burden from the triad of natural or induced menopausal symptoms, sleep disturbances and mood changes affected women's daily activities, work and quality of life more than vasomotor symptoms alone.

Inter-reporter differences in symptom burdens in Japanese children with cancer.

BACKGROUND: Recent studies about inter-reporter differences and patient-reported outcomes (PROs) in childhood cancer from Western countries showed that caregiver proxy reports tend to overestimate symptom burdens in comparison with children's self-reports. However, the results from Western countries may not be generalizable to Asian countries. METHODS: This paper is a secondary analysis of a validation study of the Japanese pediatric version of the Memorial Symptom Assessment Scale including 88 dyads of children aged 7-12 years and 74 dyads of children aged 13-18 years and their caregivers. The study assessed the inter-reporter differences of eight and 31 symptom burdens calculated as symptom scores in children aged 7-12 years and 13-18 years, respectively, and the association between inter-reporter differences and the characteristics of children and caregivers. RESULTS: The majority of children and caregivers scored equally at the dyadic level for almost all symptoms. However, 37.5% of symptoms in children aged 7-12 years and 10.0% of symptoms in children aged 13-18 years showed significant inter-reporter differences, suggesting a general tendency of caregivers to underestimate their children's symptom burden. The caregiver's age was the characteristic most frequently associated with magnitude of inter-reporter differences. CONCLUSIONS: Caregiver proxy reports may be a reliable source of PROs in Japanese children with cancer, as self-reported and caregiver proxy-reported symptom burdens were generally concordant. However, as some significant inter-reporter differences were observed, an effort should be made within the medical community to evaluate the parent-child relationship to minimize inter-reporter differences and achieve better symptom management.

Primary data on symptom burden and quality of life among elderly patients at risk of dying during unplanned admissions to an NHS hospital: a cohort study using EuroQoL and the integrated palliative care outcome scale.

BACKGROUND: Older people account heavily for palliative care needs at the population level and are growing in number as the population ages. There is relatively little high-quality data on symptom burden and quality of life, since these data are not routinely collected, and this group are under-recruited in primary research. It is unclear which measurement tools are best suited to capture burdens and experience. METHODS: We recruited a cohort of 221 patients aged 75 + years with poor prognosis who had an unplanned admission via the emergency department in a large urban hospital in England between 2019 and 2020. Risk of dying was assessed using the CriSTAL tool. We collected primary data and combined these with routine health records. Baseline clinical data and patient reported quality of life outcomes were collected on admission and reassessed within the first 72 h of presentation using two established tools: EQ-5D-5 L, EQ-VAS and the Integrated Palliative Outcomes Scale (IPOS). RESULTS: Completion rate was 68% (n = 151) and 33.1% were known to have died during admission or within 6 months post-discharge. The vast majority (84.8%) reported severe difficulties with at least one dimension of EQ-5D-5 L at baseline and improvements in EQ-VAS observed at reassessment in 51.7%. The baseline IPOS revealed 78.2% of patients rating seven or more items as moderate, severe or overwhelming, but a significant reduction (-3.6, p < 0.001) in overall physical symptom severity and prevalence was also apparent. No significant differences were noted in emotional symptoms or changes in communication/practical issues. IPOS total score at follow up was positively associated with age, having comorbidities (Charlson index score > = 1) and negatively associated with baseline IPOS and CriSTAL scores. CONCLUSION: Older people with poor prognosis admitted to hospital have very high symptom burden compared to population norms, though some improvement following assessment was observed on all measures. These data provide valuable descriptive information on quality of life among a priority population in practice and policy and can be used in future research to identify suitable interventions and model their effects.

Symptoms and quality of life among men starting treatment for metastatic castration-resistant prostate cancer - a prospective multicenter study.

BACKGROUND: Men with metastatic castration-resistant prostate cancer (mCRPC) have an incurable disease. Along with prolonging life, symptom management is one of the main goals with treatment. This is also important from a palliative care perspective where the life prolonging outcomes should be balanced with quality of life (QoL) in this late phase. It is also essential in symptom management to view different dimensions of symptoms, for example how severe or distressing symptoms are, to support best QoL. Therefore, more knowledge is needed about the symptom experience when these treatments are initiated and thus the aim of this study was to describe different dimensions of symptoms in men with mCRPC starting their first-line of life-prolonging treatment, and to describe the association between symptom burden and QoL. METHODS: Baseline data from a prospective longitudinal study of 143 men with mCRPC starting their first-line life-prolonging treatment were used. Symptoms were measured using the Memorial Symptom Assessment Scale (MSAS) and global QoL was measured by the EORTC QLQ C-30. Data was analyzed using descriptive- and multivariable linear regression analyses. RESULTS: On average, the men had more than 10 symptoms (range 0-31 of 33). 50% or more reported sweats, lack of energy, pain, problems with sexual activity and sexual desire. The symptoms they reported as most severe, or most distressing were not always the ones that were reported as most frequent. There was an association between QoL and physical symptoms, and also between QoL, and analgesic use and prostate-specific antigen (PSA) values. CONCLUSION: Even if some men with mCRPC report many symptoms, the dimensions of severity and distress levels vary, and the most frequent symptoms was not always the most burdensome or distressing. There was an association between high physical symptom burden and QoL, suggesting that it is not the number of symptoms that affects QoL but rather the subjective perceived impact of the physical symptoms experienced. The knowledge of how men with mCRPC experience and perceive their symptoms may help health care professionals in symptom management aiming to improve QoL, which is a cornerstone in integrating early palliative care.

Association of Remote Patient-Reported Outcomes and Step Counts With Hospitalization or Death Among Patients With Advanced Cancer Undergoing Chemotherapy: Secondary Analysis of the PROStep Randomized Trial.

BACKGROUND: Patients with advanced cancer undergoing chemotherapy experience significant symptoms and declines in functional status, which are associated with poor outcomes. Remote monitoring of patient-reported outcomes (PROs; symptoms) and step counts (functional status) may proactively identify patients at risk of hospitalization or death. OBJECTIVE: The aim of this study is to evaluate the association of (1) longitudinal PROs with step counts and (2) PROs and step counts with hospitalization or death. METHODS: The PROStep randomized trial enrolled 108 patients with advanced gastrointestinal or lung cancers undergoing cytotoxic chemotherapy at a large academic cancer center. Patients were randomized to weekly text-based monitoring of 8 PROs plus continuous step count monitoring via Fitbit (Google) versus usual care. This preplanned secondary analysis included 57 of 75 patients randomized to the intervention who had PRO and step count data. We analyzed the associations between PROs and mean daily step counts and the associations of PROs and step counts with the composite outcome of hospitalization or death using bootstrapped generalized linear models to account for longitudinal data. RESULTS: Among 57 patients, the mean age was 57 (SD 10.9) years, 24 (42%) were female, 43 (75%) had advanced gastrointestinal cancer, 14 (25%) had advanced lung cancer, and 25 (44%) were hospitalized or died during follow-up. A 1-point weekly increase (on a 32-point scale) in aggregate PRO score was associated with 247 fewer mean daily steps (95% CI -277 to -213; P<.001). PROs most strongly associated with step count decline were patient-reported activity (daily step change -892), nausea score (-677), and constipation score (524). A 1-point weekly increase in aggregate PRO score was associated with 20% greater odds of hospitalization or death (adjusted odds ratio [aOR] 1.2, 95% CI 1.1-1.4; P=.01). PROs most strongly associated with hospitalization or death were pain (aOR 3.2, 95% CI 1.6-6.5; P<.001), decreased activity (aOR 3.2, 95% CI 1.4-7.1; P=.01), dyspnea (aOR 2.6, 95% CI 1.2-5.5; P=.02), and sadness (aOR 2.1, 95% CI 1.1-4.3; P=.03). A decrease in 1000 steps was associated with 16% greater odds of hospitalization or death (aOR 1.2, 95% CI 1.0-1.3; P=.03). Compared with baseline, mean daily step count decreased 7% (n=274 steps), 9% (n=351 steps), and 16% (n=667 steps) in the 3, 2, and 1 weeks before hospitalization or death, respectively. CONCLUSIONS: In this secondary analysis of a randomized trial among patients with advanced cancer, higher symptom burden and decreased step count were independently associated with and predictably worsened close to hospitalization or death. Future interventions should leverage longitudinal PRO and step count data to target interventions toward patients at risk for poor outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04616768; https://clinicaltrials.gov/study/NCT04616768. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2021-054675.