Global QOL Score Research Articles

Factors Associated with Health-related Quality of Life in Moroccan Adults with Asthma

Introduction: The assessment of asthmatics’ health-related quality of life (HRQOL) has become an important outcome measure of the disease’s effects from the patient’s perspective. This study aims to assess the asthmatics’ QOL and determine the factors affecting it. Methods: A cross-sectional study was conducted among 220 adult people with asthma attending the Pneumology Department of Hassan II University Hospital in Fez from March to May 2022. Patients were questioned by a face-to-face questionnaire, an asthma control test, an observance questionnaire, a knowledge questionnaire, and a specific asthma QOL questionnaire. The influence of the variables was evaluated by bivariate analysis and multiple linear regression. Results: The mean age was 48.4 ± 15.4. 71.8% were women, half were not attending school, and 77.7% lived in urban areas. 67.7% were nonsmokers, and 72.73% were passive workers. Only 42.27% complied well with treatment, and 41.82% have well-controlled asthma. The majority of people had insufficient knowledge. The QOL was considered good for 20% of the participants, poor for 11.8%, and average for 68.2% of the patients. The mean of the global QOL score was 5.1 ± 0.9. The most significant factors associated with a higher QOL were good asthma control (ß = 0.70; P ≤ 0.001), good knowledge score (ß = 0.125; P = 0.013), insurance coverage (ß = 0.144; P = 0.005), and work activity (ß = 0.133; P = 0.007). Conclusion: Our study found multiple factors affecting asthma patients’ QOL, including asthma control, knowledge, and socioeconomic status. We can take some measures to improve the situation through patient education.

Cut-off points to classify numeric values of quality of life into normal, mild, moderate, and severe categories: an update for EORTC-QLQ-H&N35

BackgroundQuality of life (QoL) is an important determinant of physical and mental health. QoL in head and neck cancer tends to deteriorate due to changes in the physical, functional, psychological aspects. EORTC-QLQ-H&N35 is an instrument that measure the QoL specifically in head and neck cancer patients. EORTC-QLQ-H&N35 give a numeric value to QoL of patients with high value correspond to better QoL.ObjectiveThe aim of present study was to find out the cut-off points of numeric values of EORTC-QLQ-H&N35 to categorize QoL impairment into different categories (normal, mild, moderate, and severe). Present study also aims analyze the QoL among head and neck cancer patients under these new categories.MethodologyTotal 205 patients of head and neck cancer visiting to the outpatient unit were enrolled in this study. Hindi version of EORTC-QLQ-H&N35 was used to evaluate the QoL. Total 9 classification schemes were created with different cut-off points to classify the global QoL score into normal, mild, moderate and severe categories. QoL data was then analyze using the scheme having highest F value in ANOVA test.ResultsClassification scheme having cut-off values 76–100 for normal QoL, 51–75 for mild QoL impairment, 26–50 for moderate and 0–25 for severe QoL impairment found to have highest F value (729.915) in ANOVA test. The mean QoL score among total 205 patients were 60.08 ± 19.06. Based on the new classification scheme, QoL was normal in 46 (22.4%) patients whereas QoL was impaired to mild level in 76 (37.1%) patients, to moderate level in 76 (37.1%) and to severe level in 7 (3.4%) patients. Role functioning, emotional functioning and social functioning was impaired to severe level in 4 (2.0%), 13 (6.3%) and 3 (1.5%) patients respectively.ConclusionEORTC-QLQ-H&N35 offer a comprehensive review of QoL in head and neck cancer patients. By designating the QoL score into different categories, it will become easier for clinician to have a better idea of QoL of head and neck cancer patients.

The Burden of symptoms and Quality of life of Filipino patients with Myeloproliferative neoplasm: A Multicenter Cross-sectional survey.

Myeloproliferative neoplasms (MPN) are hematologic malignancies characterized by cellular proliferation of one or more hematopoietic cell lines. Management has been focused on blood count control but addressing relief from symptoms and providing a better quality of life (QOL) are equally important in the care of these patients. The MPN Symptom Assessment Form-Total Symptom Score (MPN-SAF TSS) is used to determine symptoms at baseline and during treatment. Understanding the symptom burden is important in developing a holistic management plan for MPN. Hence, this study aimed to determine the symptom burden and QOL of Filipino patients with MPN. Using a validated Filipino version of the MPN-SAF-TSS questionnaire and the University of the Philippines-Department of Health QOL (UP-DOH QOL) questionnaire, a cross-sectional survey of consecutive patients with MPN from two public and two private tertiary hospitals was conducted. We purposively sampled adults, newly diagnosed or previously diagnosed with polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF). The mean scores were compared with the type of MPN using analysis of variance. Linear regression was done to determine the association of patients' characteristics to the mean symptom burden and QOL scores, while logistic regression was used to determine the association of patient and disease characteristics with the level of symptom severity and QOL. A total of 167 (63 PV, 66 ET, and 38 MF) patients were surveyed from four centers. The mean overall symptom burden score was 24.41 (standard deviation [SD]=18.91) with MF having the highest score at 28.53, followed by PV at 23.75 and ET at 22.67. The majority (80.24%) had a high QOL with a mean global QoL score of 84.92 (SD=16.75). Comparison of individual scores showed bone pain and weight loss were significantly higher in patients with MF compared to PV (p=0.0002) and ET (p=0.032); while pruritus was significantly higher in PV compared to ET and MF (p=0.043). Logistic regression analysis showed female sex and being newly diagnosed (adjusted odds ratio [aOR] 11.22, 95% confidence interval [CI] 2.32-54.25) were associated with high symptom burden while having a controlled blood count (aOR 0.26, 95% CI 0.10-0.71) was associated with low symptom burden and high QOL. The majority of the participants were symptomatic with moderate to severe symptom burden. While no statistically significant difference was seen among the three types of MPN in terms of overall mean symptom score, patients with MF were more likely to have a severe symptom burden while patients with ET had the least symptoms. Despite having symptoms, QOL was regarded as high. QoL was significantly higher among those with PV or ET than those with MF. Our study highlighted the utility of a validated symptom scoring system in determining the symptom burden and who would benefit from pharmacologic/non-pharmacologic symptom management. Results emphasized incorporating symptom scoring in clinical practice and going beyond blood counts in caring for our patients with MPN.

NCOG-20. WEARABLE DEVICE DATA QUANTIFY DISEASE PROGRESSION IN HIGH GRADE GLIOMA AND MAY PROVIDE NOVEL OUTCOME MEASURES

Abstract BACKGROUND Functional status is a prognostic measure of survival in high grade glioma (HGG). Real-time monitoring between clinical encounters can extend the reach of care and provide actionable insights to drive more personalized and proactive care. We present data from the completed BrainWear Study, a highly novel study evaluating if data captured via a wrist-worn wearable device in patients with HGG can be used to explain, influence and/or predict cancer-related outcomes. Materials and METHODS All participants agreed to wear a wrist-worn Axivity AX3 triaxial accelerometer changed at 14-day intervals. Raw accelerometer data was processed using the UKBiobank Accelerometer analysis package v6.2.3 for Python and inclusion of high-quality wear time selected as ≥72 hours of data over 7-days. We analysed variation in activity by patient demographics and MRI result utilising the Response Assessment in Neuro-Oncology (RANO) criteria. Patient reported outcomes (PROs) were completed at planned study timepoints. Wilcoxin-signed rank test was used to compare participant activity at timepoints of stable or progressive disease (PD). Mixed-effects models were used to evaluate changes in activity. RESULTS 12512 days of accelerometer data were recorded from 56 patients (36 male; 20 female) with a median age of 60 years. 80% of the data were characterised as high-quality. Mean acceleration(mg) and time spent walking daily(h/day) correlated positively with the global health QOL and physical functioning scores and inversely with the fatigue score from PROs. In the 6-weeks surrounding an MRI scan, patients with PD walked on average 1856 steps less per day than those with stable disease, and spent 22 minutes less walking (p=0.0403). Several wearable data daily physical activity measures demonstrated statistically significant change at the time of PD. CONCLUSION Remote monitoring data can complement snapshots of health gathered during clinical visits. Collection of digital data hold promise for novel HGG trial outcome measure development.

Dexamethasone free antiemetic prophylaxis for highly emetogenic chemotherapy: A phase III, double-blind, randomized controlled trial.

133 Background: Chemotherapy-induced nausea and vomiting (CINV) is a common side effect of highly emetogenic chemotherapy (HEC). Current guidelines recommend the use of dexamethasone (DEX) for prophylaxis, but the effectiveness and safety of a DEX-free regimen for CINV prophylaxis in HEC is not known. Methods: This was an investigator-initiated, double-blind, phase 3 RCT designed to show the non-inferiority of a DEX-free regimen (olanzapine, palonosetron, and fosaprepitant; OPF) compared to the NCCN recommended DEX-containing regimen (olanzapine, palonosetron, and dexamethasone; OPD). Chemotherapy-naive patients aged 18-80 years receiving single-day HEC were randomized 1:1 to receive either the OPD regimen (olanzapine 5 mg once a day on days 1-4, palonosetron 0.25 mg on day 1, and DEX 12 mg on day 1) or the OPF regimen (olanzapine and palonosetron as above, and fosaprepitant 150 mg on day 1).The primary endpoint was to compare complete response (CR) rates for vomiting (no vomiting and no rescue medication) during the overall phase (start of chemotherapy to 120 h). The secondary endpoints were CR for nausea (ESAS), toxicities (CTCAE), and patient reported outcome measures (PROM) using MDASI. 175 patients in each arm were required show non-inferiority (NI) of OPF regimen compared to OPD regiment with power of 90%, 2-sided alpha of 5%, and NI margin of 15%. Results: Between May 2022-Dec 2022, 350 patients were randomized and 346 received the study interventions (OPD arm n = 174 and OPF arm n = 172). The most common chemotherapy used was adriamycin/cyclophosphamide (66%) followed by cisplatin (27%). CR rates for vomiting for the overall phase were 48.8% in the OPD arm and 79.6% in the OPF arm (P < 0.001), with an absolute difference of -30.8% and 2-sided 95% CI = (-40.31, -21.24) which was within the pre-defined NI margin of 15% and also showed superiority. The DEX-free arm also had significantly higher CR rates for nausea and total control (vomiting and nausea combined) (Table). PROM for fatigue (P = 0.009) and drowsiness (P = 0.002) were more in the OPF arm in the acute phase, and insomnia (P < 0.001) in the OPD arm in the delayed phase. Global Health Status QOL score on day 6 in the OPD arm was 55.36 ± 16.15 and in the OPF arm was 57.84 ± 12.76, P = 0.11. Conclusions: This study shows that a DEX-free OPF regimen is superior to the DEX-based OPD regimen and should be considered a standard option for CINV prophylaxis for HEC. Clinical trial information: CTRI/2022/03/040906 . [Table: see text]

SABR for Early Non-Small Cell Lung Cancer: Changes in Pulmonary Function, Dyspnea, and Quality of Life

The aim of this study is to report pulmonary function tests (PFTs), clinician-reported and patient-reported QoL outcomes on a cohort of NSCLC patients treated with SABR. 119 patients with NSCLC were treated with SABR in the prospective cohort SSBROC study of patients with T1-T2N0M0 NSCLC. PFTs and quality of life measures were obtained at baseline pre-treatment and 6 monthly. Here we report on the 6- to 18-month time points. ANCOVA methods adjusting for baseline analysed potential predictors on outcomes of PFT and patient-reported dyspnoea at 18 months. The only statistically significant decline in PFTs was seen in FEV1 at 18 months post-SABR with a decline of -0.11L (p = 0.0087, 95% CI -0.18 to -0.02). Of potential predictors of decline, only a 1 unit increase in smoking pack years resulted in a -0.12 change in DLCO (p = 0.026, 95% CI -0.02 to -0.23) and a 0.003 decrease in FEV1 (p = 0.026, 95% CI -0.006 to -0.0004). For patient reported outcomes, statistically significant worsening in both QLQC30 and QLQLC13 dyspnoea scores occurred at the 18-month time point, but not earlier. No potential predictors of worsening dyspnoea were statistically significant. There was no statistically significant decline in clinician-reported outcomes or global QoL scores. We found a statistically significant decline in FEV1 at 18 months post-treatment. Smoking pack years was a predictor for decline in DLCO and FEV1 at 18 months. Worsening of patient-reported dyspnoea scores was observed, consistent with the expected progression of lung co-morbid disease.

Association of smoking history on health-related quality of life in patients undergoing radical cystecomy.

Radical cystectomy (RC) has the potential to impact health-related quality of life (HRQOL). Many patients who undergo RC are current or former smokers. To better inform preoperative patient counseling, we examined the association between smoking status and HRQOL after RC. A secondary analysis was performed on a prospective, longitudinal study (2008-2014) examining HRQOL in patients undergoing RC for bladder cancer. We analyzed 12 validated patient-reported outcome measures that focused on functional, symptomatic, psychosocial, and global HRQOL domains. Measures were collected pre-operatively and 3-, 6-, 12-, 18-, and 24-months postoperatively. For each HRQOL domain, we estimated the mean domain scores using a generalized estimation equation linear regression model. Each model included survey time, smoking status, and time-smoking interaction as covariates. Pairwise comparisons of current, former, and never smokers were estimated from the models. Of the 411 patients available for analysis, 29% (n = 119) never smoked, 59% (n = 244) were former smokers, and 12% (n = 48) were current smokers. Over the follow-up period, never smokers compared to current smokers had better global QOL scores (mean difference = +8.9; 95% CI 1.3-16; p = 0.023) and lower pain levels (mean difference = -10; 95% CI -19 to -0.54; p = 0.036). Compared to current smokers, former smokers had marginal improvements in global QOL (+6.9 points) and pain (-7.5 points) during the follow-up period. Current smokers reported worse HRQOL recovery in the 24-months after RC. These findings can be used to counsel patients who smoke on recovery expectations.

Quality of life assessment on non-small cell lung cancer patients treated by molecular targeted therapy

Introduction: Lung cancer is the leading cause of cancer death worldwide and in Vietnam. Among lung cancer cases, non-small cell lung cancer (NSCLC) accounts for approximately 85%. Most patients are diagnosed at the advanced stage, hence systemic therapy plays a crucial role to increase survival time. Targeted therapy is now the standard of care for NSCLC with TKIs sensitive mutations because of its efficacy and tolerability. The study of QoL in these groups of patients remains limited in Vietnam. Objectives: To evaluate the quality of life in patients with non-small cell lung cancer (NSCLC) being treated by targeted therapy and to determine the factors that affect the quality of life (QOL). Methodology: A descriptive study was conducted on 55 non-small cell lung cancer patients being treated at the Hue Central Hospital and the Hue University of Medicine and Pharmacy Hospital from 6/2021 to 8/2022. The EORTC QLQ-C30 was used to assess the quality of life. Evaluation of the quality of life by descriptive statistics. The linear regression test was used to determine the correlated factor. Results: The mean age of the group of patients was 66.6 ± 9.9. The global health scale was 55.8 ± 12.6 which was found to be related to the level of depression DASS21 (p < 0.01). In the functional scale, the cognitive function had the highest score (84.2 ± 14.8), and the lowest was social function items (42.4 ± 18.9). The function score was found to be correlated to the disease duration (p < 0.05) and DASS21 (p < 0.01) Less common symptoms were constipation and nausea. The most prominent symptoms were loss of appetite and fatigue. The symptom score was related to the disease duration (p = 0.02) and DASS21 (p < 0.01). In terms of financial impact, the mean score was 41.2 (± 38.5), related to the residence (p = 0.04), occupation (p = 0.04), and economic condition (p = 0.01). Conclusion: The global health QoL score was quite high in NSCLC patients treated with molecular targeted therapy. The residence, occupation, economic conditions, duration of illness, and DASS21 were associated with the QoL of patients. Key words: non-small cell lung cancer, quality of life, molecular targeted therapy, EORTC QLQ_C30, advanced stage.

Prospective Study of Whole Lung Irradiation with Intensity Modulated Radiotherapy/Volumetric Modulated ARC Therapy (IMRT/VMAT) in Patients of Bone and Soft Tissue Ewing Sarcoma with Pulmonary Metastasis

<h3>Purpose/Objective(s)</h3> To evaluate the progression free survival and pulmonary failure free survival post Whole Lung Irradiation in patients of bone and soft tissue Ewing sarcoma with pulmonary metastasis and to evaluate the efficacy and early toxicities associated with Cardiac Sparing Whole Lung Irradiation in these patients. <h3>Materials/Methods</h3> In this prospective, interventional, single arm study, we recruited a total of 18 patients with bone and soft tissue Ewing sarcoma with pulmonary metastasis between January 2020 to December 2021. All the patients, after the treatment of primary disease, received Whole Lung Irradiation (WLI) - 18Gy/10#/2 weeks in patients above 18 years of age and 15Gy/10#/2 weeks in those below 18 years of age. All the patients were treated using Image guided IMRT/VMAT technique. Evaluation of pulmonary response was done with NCCT chest at 3 months and 6 months post WLI. Toxicities during and after RT was graded using the CTCAE v.5 criteria. 2-D Echo and PFT values were assessed at 3 months and at 6 months. The quality of life scores were obtained using EORTC QLQ C-30 (version 3) at 4 time points. <h3>Results</h3> Majority of the patients were adults and majority had progression during the study. Only 4 patients had pulmonary relapse as the first site of progression. The 6-month PFS and Pulmonary FFS was 50.8% and 71.4%, respectively. There was statistically significant decrease in FEV1 and FVC values post RT and most patients showed restrictive pattern in PFTs after 6 months of WLI. There was no statistically significant decrease in LVEF or any other cardiac toxicities post RT. The global health QoL scores were significantly reduced at 6 months post RT when compared to pre-RT values. Dmean of heart was 13.1Gy (12.2Gy with a total dose of 15Gy and 14.0Gy with a total dose of 18Gy), which was significantly less compared to conventional planning. No patients had acute or chronic Grade 3 or more toxicities of RT. Only few patients developed Grade 2 toxicities following RT and the proportion of patients showing Grade 2 or more toxicities was significantly less compared to 2-D conventional planning. <h3>Conclusion</h3> This prospective single arm study demonstrated the feasibility and dosimetric advantages (superior cardiac sparing and superior dose coverage of lung volumes) of cardiac sparing whole lung irradiation using VMAT technique. There were no significant severe RT related toxicities and the survival rates were similar to those seen in previous studies. Further studies with greater sample size and longer follow-up will be required to establish the long-term efficacy and safety of this irradiation technique.

Quality of Life in Men With Prostate Cancer Randomly Allocated to Receive Docetaxel or Abiraterone in the STAMPEDE Trial.

Docetaxel and abiraterone acetate plus prednisone or prednisolone (AAP) both improve survival when commenced alongside standard of care (SOC) androgen deprivation therapy in locally advanced or metastatic hormone-sensitive prostate cancer. Thus, patient-reported quality of life (QOL) data may guide treatment choices. A group of patients within the STAMPEDE trial were contemporaneously enrolled with the possibility of being randomly allocated to receive either docetaxel + SOC or AAP + SOC. A mixed-model assessed QOL in those who had completed at least one QLQ-C30 + PR25 questionnaire. The primary outcome measure was difference in global-QOL (QLQ-C30 Q29&30) between patients allocated to docetaxel + SOC or AAP + SOC over the 2 years after random assignment, with a predefined criterion for clinically meaningful difference of > 4.0 points. Secondary outcome measures included longitudinal comparison of functional domains, pain, and fatigue, plus global-QOL at defined timepoints. Five hundred fifteen patients (173 docetaxel + SOC and 342 AAP + SOC) were included. Baseline characteristics, proportion of missing data, and mean baseline global-QOL scores (docetaxel + SOC 77.8 and AAP + SOC 78.0) were similar. Over the 2 years following random assignment, the mean modeled global-QOL score was +3.9 points (95% CI, +0.5 to +7.2; P = .022) higher in patients allocated to AAP + SOC. Global-QOL was higher for patients allocated to AAP + SOC over the first year (+5.7 points, 95% CI, +3.0 to +8.5; P < .001), particularly at 12 (+7.0 points, 95% CI, +3.0 to +11.0; P = .001) and 24 weeks (+8.3 points, 95% CI, +4.0 to +12.6; P < .001). Patient-reported QOL was superior for patients allocated to receive AAP + SOC, compared with docetaxel + SOC over a 2-year period, narrowly missing the predefined value for clinical significance. Patients receiving AAP + SOC reported clinically meaningful higher global-QOL scores throughout the first year following random assignment.

Quality of Life Outcomes Following Stereotactic Body Radiotherapy in Patients with Oligo-Metastatic Disease: A Systematic Review and Meta-Analysis

<h3>Purpose/Objective(s)</h3> The management of oligo-metastatic disease (OMD) is evolving, with increasing data supporting the use of stereotactic body radiotherapy. The aim of this systematic review and meta-analysis is to analyses health related quality of life (HRQOL) outcomes and the side-effects of SBRT in patients with OMD. <h3>Materials/Methods</h3> We searched MEDLINE, Epub Ahead of Print, EMBASE, Cochrane CT, Cochrane SR, Emcare, and PsycInfo databases (from inception to March 2020). Randomized clinical trials (RCTs) or observational studies were included if HRQOL outcomes were reported from patients with defined OMD (£5 metastases) who received SBRT as metastasis-directed therapy, and who completed validated HRQOL questionnaires at baseline and 12-months. Meta-analysis using weighted mean difference was performed to estimate a difference between baseline and 12-month scores. Secondary outcome, calculated by the pooled incidence rate approach using the inverse variance method, was the estimated event rate of clinically significant Common Terminology Criteria for Adverse Events (CTCAE) grade 2-4 and grade 5 toxicity, expressed per person-time of follow-up. Authors of studies included were contacted to obtain additional information. Methods adhered to PRISMA guidelines. <h3>Results</h3> Four of 7,545 studies screened were eligible for inclusion. Two studies were phase II RCTs and two were prospective single arm studies. Among 277 patients who received SBRT, median follow-up was 31 months (range 24–41 months). Two studies included only prostate cancer patients and two studies included mixed histologies. Two studies measured European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and two measured Functional Assessment of Cancer Therapy – General (FACT-G) scores. Using a fixed effects model, the mean change in 12-month EORTC QLQ-C30 global health QOL score from baseline demonstrated a statistically significant decline (pooled weighted mean difference -5.2, 95% CI -9.3 to -1.2, both prostate cancer studies, 57 patients total). Meta-analysis of total FACT-G scores in the other two studies was not possible as mean difference results for one study were unavailable. For the available multi-histology study, no statistically significant difference was seen in baseline to 12-month mean FACT-G total scores in the SBRT arm. We estimated an event rate of 0.06 (95% CI: 0.024, 0.15) CTCAE grade 2-4 toxicities per person-year and 0.008 (95% CI: 0.002, 0.031) grade 5 toxicities per person-year. <h3>Conclusion</h3> Although a statistically significant decline in the EORTC QLQ C30 global health/QOL measure was seen, it was small and unlikely to be of clinical importance. Rates of SBRT-related clinical toxicities are low. There is limited QOL data published for patients with OMD, with varying HRQOL tools used.

A Prospective Study on Health-Related Quality of Life and Patient-Reported Outcomes in Adult Brain Tumor Patients Treated with Pencil Beam Scanning Proton Therapy.

Simple SummaryPatients with complex brain tumors are regularly treated with proton therapy (PT) to obtain an optimal curative treatment with limited toxicity. Value-based oncological medicine is increasingly important, particularly when long-term survival is to be expected. The aim of our prospective study was to evaluate health-related quality of life (HRQOL) and patient reported outcomes (PROs) in patients treated with PT for brain tumors. PT only temporarily influences PROs and QoL directly following PT and lower QoL and PROs were mostly reported by patients who were already in a worse condition with symptoms related to the tumor and previous treatment, before the start of PT. This study assists in improving patient support in patients with brain tumors receiving PT.Proton therapy (PT) is delivered to complex brain tumors to obtain an optimal curative treatment with limited toxicity. Value-based oncological medicine is increasingly important, particularly when long-term survival is to be expected. This study aims to evaluate health-related quality of life (HRQOL) and patient reported outcomes (PROs) in patients treated with PT for brain tumors. Adult patients with brain tumors treated with PT filled out the EORTC-QLQ-C30 and BN20 questionnaires up to three years following PT. Toxicity was scored using the CTCAE v4.03. QoL and PRO were correlated to clinical factors. Three-year overall survival, distant brain control and local control rates were 98%, 97% and 84%, respectively. No ≥G3 acute toxicity was observed. Late PT-related ≥G3 severe toxicity occurred in seven patients (5.7%). Lower global QoL scores after PT were significantly correlated to low Karnofsky performance status (KPS) before PT (p = 0.001), surgical complications before PT (p = 0.04) and progressive disease (p = 0.017). A low QLQ-30 summary score at one year follow-up was correlated to sex (p = 0.015), low KPS before PT (p < 0.001), and central nervous system symptoms before PT (p = 0.018). Reported QLQ-BN20 neurological symptoms were correlated to lower KPS at baseline (p < 0.001) and surgical complications before PT (p = 0.03). PT-related toxicity only influenced reported symptoms directly following PT, but not QoL. Although global QoL temporarily decreased after treatment, it improved again from one year onwards. Global QoL and reported symptoms over time were not correlated with the proton therapy and were more related to preexisting symptoms and progressive disease. This study assists in improving patient support in patients with brain tumors receiving PT.

Quality of life in urologic cancer patients: importance of and satisfaction with specific quality of life domains

PurposeQuality of life (QoL) has been the subject of increasing interest in oncology. Most examinations of QoL have focused on health-related QoL, while other factors often remain unconsidered. Moreover, QoL questionnaires implicitly assume that the subjective importance of the various QoL domains is identical from one patient to the next. The aim of this study was to analyze QoL in a broader sense, considering the subjective importance of the QoL components.MethodsA sample of 173 male urologic patients was surveyed twice: once while hospitalized (t1) and once again 3 months later (t2). Patients completed the Questions on Life Satisfaction questionnaire (FLZ-M), which includes satisfaction and importance ratings for eight dimensions of QoL. A control group was taken from the general population (n = 477).ResultsHealth was the most important QoL dimension for both the patient and the general population groups. While satisfaction with health was low in the patient group, the satisfaction ratings of the other seven domains were higher in the patient group than in the general population. The satisfaction with the domain partnership/sexuality showed a significant decline from t1 to t2. Multiple regression analyses showed that the domains health and income contributed most strongly to the global QoL score at t2 in the patient group.ConclusionHealth is not the only relevant category when assessing QoL in cancer patients; social relationships and finances are pertinent as well. Importance ratings contribute to a better understanding of the relevance of the QoL dimensions for the patients.

Health-Related Quality of Life in Patients with Relapsed/Refractory Multiple Myeloma during Treatment with Ixazomib-Thalidomide-Dexamethasone Followed By Ixazomib Maintenance

Health-Related Quality of Life in Patients with Relapsed/Refractory Multiple Myeloma during Treatment with Ixazomib-Thalidomide-Dexamethasone Followed By Ixazomib Maintenance

Ear Acupressure for Allergic Rhinitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Background The treatment effects and safety of ear acupressure (EAP) for patients with allergic rhinitis (AR) have yet to be clarified. Objective To evaluate the effects and safety of EAP in AR patients. Design Systematic review of published studies. Methods A total of 24 English and Chinese databases (PubMed, EMBASE (Excerpta Medical Database), Cochrane Central Register of Controlled Trials, CINAHL, Informit, ScienceDirect, LILACS (Latin American and Caribbean Health Sciences), ProQuest, AMED, Blackwell Synergy, PsycINFO, Panteleimon, AcuBriefs, KoreaMed, IndMed, Ingenta, mRCT, ISI Web of Knowledge, ERIC, VIP Information (http://www.cqvip.com), China National Knowledge Infrastructure (http://www.cnki.net), Cochrane Library, Chinese Cochrane Centre Controlled Trials Register Platform, and Wanfang Chinese Digital Periodical and Conference Database) were searched from their respective inceptions to August 2020 to collect randomized controlled trials of ear acupressure for allergic rhinitis. We performed literature inclusion, data extraction, and trial quality evaluations. Methodological quality was assessed according to the Cochrane Handbook. Revman5.3 was used for all analyses. Results A total of 203 trials were identified and eleven studies involved 1094 participants aged 3–70 years. EAP was better than control group interventions in terms of effectiveness (risk ratio (RR): 0.51; 95% confidence interval (CI): 0.36–0.70; P < 0.0001). EAP was superior to sham EAP in terms of improvement of the total nasal symptom score (RR: −0.50; 95% CI: −0.96–0.05; P = 0.03), sneezing score (RR: −0.36; 95% CI: −0.59–0.12; P = 0.003), global QoL score (RR: 0.42; 95% CI: 0.04–0.08; P = 0.03), and eye symptom score (RR: −0.36; 95% CI: −0.67–0.05; P = 0.02). Conclusions Despite the positive results, it is premature to confirm the efficacy of EAP for treating AR. More high-quality studies are needed to confirm safety and efficacy.

Relationship between Pain Scores and EORTC QLQ-C15-PAL Scores in Outpatients with Cancer Pain Receiving Opioid Therapy.

Cancer pain is one of the most frequent and distressing symptoms associated with cancer and has a serious impact on the QOL of patients. However, inadequate pain treatment has also been reported in outpatients with cancer pain. The aims of this study were (1) to evaluate the relationship between pain intensity using the Numerical Rating Scale (NRS) and QOL scores using the Japanese version of the European Organization for Research and Treatment of Cancer (QOL Questionnaire Core 15 for Palliative Care (QLQ-C15-PAL)), and (2) to investigate their association with various pain patterns, especially with baseline and breakthrough pain. Forty outpatients who were receiving opioid therapy and obtained informed consent participated. We collected a total of 222 pharmacist consultations during the study period. Global QOL scores and pain scores (PA) in the QLQ-C15-PAL (PA score, 0-100) at the first visit were significantly correlated with worst pain intensity. In addition, the scores for the worst pain were significantly correlated with not only physical functioning scores but also with emotional functioning scores. The correlations between the worst pain NRS and PA scores were positive. Specifically, patients tended to report large variability of NRS scores when the PA score was less than 40 and also when they exhibited pain patterns with "baseline and breakthrough cancer pain in the same day" or "baseline pain throughout the day." Reducing the worst pain NRS and relieving breakthrough pain appear to be important measures to improve the QOL of outpatients receiving opioid therapy for cancer pain.

Effects of epigallocatechin gallate-enriched green tea extract capsules in uterine myomas: results of an observational study.

The daily ingestion of green tea extract (GTE) capsules in women with oligo- or asymptomatic uterine myomas was monitored over 6months with regard to their quality of life, myoma-associated complaints and side effects. The participants were interviewed and examined at the beginning of the study (T1) and then again after 6months (T3). Quality of life was assessed using a SF-12 questionnaire while their myoma-associated complaints were ascertained by using a self-developed myoma symptom questionnaire. Changes in the size of the myomas were evaluated by vaginal sonography. Side effects after 3months (T2) and 6months were documented by systematic interviews. Overall; 25 participants (median 45years) have been enrolled. The analysis of the SF-12 questionnaire showed a significant improvement of the physical cumulative score of the SF-12 during the 6month GTE capsule ingestion (T1: mean value (M) = 52.731; 95% confidence interval (KI95%): 49.791-55.671; T3: M = 55.862; KI95%%: 55.038-56.685; p = 0.019). However, the mental cumulative score of the SF-12 did not change significantly (p = 0.674). No significant correlation could be established between the capsule ingestion and changes in the symptom questionnaire, the laboratory parameters nor the myoma size. No relevant adverse side effects were reported. Women who took GTE capsules showed a significant improvement in their physical cumulative score on the SF-12, but not in the global QoL score. Myoma size or other objective parameters did not change.

Good health-related quality-of-life and high patient-reported satisfaction after delayed breast reconstruction with pedicled flaps from the back

This paper presents the results of a randomized controlled trial (RCT) that focus on health-related quality-of-life (QoL) and patient-reported satisfaction following breast reconstruction with pedicled flaps from the back. We included women for unilateral delayed breast reconstruction. Patients were randomized to reconstruction by either a latissimus dorsi (LD) flap or a thoracodorsal artery perforator (TAP) flap. Assessment of QoL and patient satisfaction was made using two different patient-reported outcome measures (PROMs): The EORTC QLQ-30 and the Breast-Q questionnaire for post-mastectomy breast reconstruction. A total of 50 women were enrolled over a two-year period and allocated to reconstruction. Forty patients completed both surgery and follow-up and were included in the analysis - 18 in the LD group and 22 in the TAP group. The EORTC QLQ-30 was administered at the baseline and at one-year follow-up. There was no significant effect of introducing the TAP flap on either the summary score, the global QoL-score or the financial impact-score when compared to the LD flap. The Breast-Q questionnaire was administered only at one-year follow-up. There was no significant difference between the two groups for the scores for satisfaction with the reconstructed breast, the overall outcome and QoL related to psycho-social, sexual and physical well-being. Women from both groups report high satisfaction and QoL following the reconstruction. The quality of the dataset and the study design are, however, insufficient to rule out any existing difference. A larger cohort, longer follow-up and different design are warranted to assess the true clinical significance these reconstructions might have on satisfaction and QoL.

Association between the baseline frailty and quality of life in patients with prostate cancer (FRAQ-PC study).

The association between baseline frailty and health-related quality of life (HRQOL) in patients with prostate cancer (PC) remains unknown. We retrospectively evaluated the association of pretreatment frailty with HRQOL in 409 patients with PC from February 2017 to April 2020. Frailty and HRQOL were evaluated using the geriatric 8 (G8) screening tool and QLQ-C30 questionnaire, respectively. The primary objective was comparison of G8 and QOL scores between the localized diseases (M0 group) and metastatic castration-sensitive PC (mCSPC group). Secondary objectives were to study the association of G8 and QOL scores in each group and effect of frailty (G8 ≤ 14) on worse QOL. The median age of patients was 70years. There were 369 (surgery: 196, radiotherapy: 156, androgen deprivation therapy alone: 17) patients in the M0 and 40 patients in the mCSPC groups. There was a significant difference between the M0 and mCSPC groups in the G8 score (14.5 vs. 12.5), functioning QOL (94 vs. 87), global QOL (75 vs. 58), and 100-symptom QOL (94 vs. 85) scores. G8 scores were significantly associated with functioning, global, and 100-symptom QOL scores in both M0 and mCSPC groups. The multivariable logistic regression analyses showed that frailty (G8 ≤ 14) was significantly associated with worse global QOL, functioning QOL, and 100-symptom QOL scores. The baseline frailty and HRQOL were significantly different between the localized and metastatic disease. The baseline frailty was significantly associated with worse HRQOL in patients with PC.

Reliability and validity of the Japanese translation of the Eating Disorders Quality of Life (ED-QOL) scale for Japanese healthy female university undergraduate students and patients with eating disorders

BackgroundThe Eating Disorder Quality of Life (ED-QOL) scale is a 25-item self-report measure that assesses health-related quality of life (HRQoL) of eating-disorder patients. Although the ED-QOL is one of the most widely used questionnaires in many countries, no prior research has addressed the psychometric properties of the Japanese translation of the ED-QOL. Therefore, the aim of the present study was to assess its reliability and validity.MethodsA total of 99 Japanese female eating disorder patients and 469 female healthy university undergraduate students completed the Japanese translation of the ED-QOL in addition to the Eating Attitudes Test-26 (EAT-26) and Eating Disorder Inventory-2 (EDI-2). The patient group consisted of 37 patients with anorexia nervosa restricting type (AN-R), 35 patients with binge-eating/purge type (AN-BP), and 27 patients with bulimia nervosa (BN). We performed confirmatory factor analyses on the ED-QOL subscales both for Japanese eating disorder patients and for healthy university undergraduate students. Reliability was assessed using internal consistency indicated by Cronbach alpha coefficients and convergent validity was assessed using Pearson’s correlation coefficients. To assess group differences between the eating disorder patients and healthy university undergraduate students, Student’s t-tests were conducted.ResultsThe CFA showed that the CFI was .90 and RMSEA was .084 (90% confidence interval = .079–.088). The internal consistency of the ED-QOL varied from good to excellent. The EAT-26 total score and three subscales and the EDI-2 subscales had significant correlations with the ED-QOL global QOL score and four subscales. There were no significant correlations between the EDI-2 subscale “Body Dissatisfaction” and the ED-QOL subscales “Physical/Cognitive” and “Work/School”. Eating disorder patients scored significantly higher than healthy university undergraduate students on all ED-QOL subscales and the global QOL score.ConclusionsBased on this study, the Japanese translation of the ED-QOL can be regarded as reliable, valid, and functional for female eating-disorder patients and female healthy university undergraduate students.