Cancer Quality Of Life Questionnaire Core Research Articles

Trait emotional intelligence and its impact on quality of life, anxiety, and depression in patients with gastric cancer

Aims/Background Trait emotional intelligence is associated with anxiety and depression symptoms and quality of life in cancer patients. However, studies on the relationship of trait emotional intelligence with anxiety, depression, and quality of life in gastric cancer patients are limited. This study investigates the relationship of trait emotional intelligence with depression and quality of life in gastric cancer patients to provide a theoretical basis for clinical management. Methods A total of 270 patients with gastric cancer treated in our hospital from July 2020 to July 2023 were selected, of which 31 patients with missing questionnaire entries and missed visits were screened out, resulting in the enrolment of 239 gastric cancer patients in this study. In this survey, self-administered general information questionnaires, namely Trait Emotional Intelligence Short Form (TEIQue-SF), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), and Hospital Anxiety and Depression Scale (HADS) were used. Results TEIQue-SF total scores were positively correlated with QLQ-C30 scores (p < ..001) and negatively correlated with HADS-A and HADS-D scores (p < ..001). TEIQue-SF total score was a superior positive predictor of the QLQ-C30 score (β = 0.412, p < ..001) and a superior negative predictor of the HADS score (β = –0.740, p < ..001). TEIQue-SF total score (β = 0.141, p = 0.006) and HADS score (β = –0.665, p < ..001) were good predictors of QLQ-C30 score. The direct effect of TEIQue-SF total score on QLQ-C30 score was 0.141, while HADS score between TEIQue-SF total score and QLQ-C30 score had a mediated effect value of 0.492. Conclusion Trait emotional intelligence not only directly affects the quality of life, but also indirectly affects the quality of life through anxiety and depression. Clinicians should pay attention to the anxiety, depression, and emotional intelligence of patients with gastric cancer to help them improve their quality of life.

Quality of Life and Nutritional Outcomes of Stomach-Preserving Surgery for Early Gastric Cancer

The Sentinel Node Oriented Tailored Approach (SENORITA) randomized clinical trial evaluated quality of life (QoL) and nutritional outcomes between the laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG). However, there has been no report on the QoL and nutritional outcomes of patients who underwent stomach-preserving surgery among the LSNNS group. To compare long-term QoL and nutritional outcomes between patients who underwent stomach-preserving surgery and those who underwent standard gastrectomy and to identify factors associated with poor QoL outcomes in patients who underwent stomach-preserving surgery. This study is a secondary analysis of the SENORITA trial, a randomized clinical trial comparing LSNNS with LSG. Patients from 7 tertiary or general hospitals across the Republic of Korea were enrolled from March 2013 to December 2016, with follow-up through 5 years. Data were analyzed between August and September 2022. Among trial participants, patients who underwent actual laparoscopic standard gastrectomy in the LSG group and those who underwent stomach-preserving surgery in the LSNNS group were included. Patients who did not complete the baseline or any follow-up questionnaire were excluded. Stomach-preserving surgery vs standard gastrectomy. Overall European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30) and stomach module (STO22) scores, body mass index, hemoglobin, protein, and albumin levels. A total of 194 and 257 patients who underwent stomach-preserving surgery and standard gastrectomy, respectively, were included in this study (mean [SD] age, 55.6 [10.6] years; 249 [55.2%] male). The stomach-preserving group had better QoL scores at 3 months postoperatively in terms of physical function (87.2 vs 83.9), dyspnea (5.9 vs 11.2), appetite loss (13.1 vs 19.4), dysphagia (8.0 vs 12.7), eating restriction (10.9 vs 18.2), anxiety (29.0 vs 35.2), taste change (7.4 vs 13.0), and body image (19.5 vs 27.2). At 1 year postoperatively, the stomach-preserving group had significantly higher body mass index (23.9 vs 22.1, calculated as weight in kilograms divided by height in meters squared) and hemoglobin (14.3 vs 13.3 g/dL), albumin (4.3 vs 4.25 g/dL), and protein (7.3 vs 7.1 g/dL) levels compared to the standard group. Multivariable analyses showed that tumor location (greater curvature, lower third) was favorably associated with global health status (β, 10.5; 95% CI, 3.2 to 17.8), reflux (β, -8.4; 95% CI, -14.7 to -2.1), and eating restriction (β, -5.7; 95% CI, -10.3 to -1.0) at 3 months postoperatively in the stomach-preserving group. Segmental resection was associated with risk of diarrhea (β, 40.6; 95% CI, 3.1 to 78.1) and eating restriction (β, 15.1; 95% CI, 1.1 to 29.1) at 3 years postoperatively. Stomach-preserving surgery after sentinel node evaluation was associated with better long-term QoL and nutritional outcomes than standard gastrectomy. These findings may help facilitate decision-making regarding treatment for patients with early-stage gastric cancer. ClinicalTrials.gov Identifier: NCT01804998.

Establishment and evaluation of the impact of a supervisory group for chemotherapy safety management in an oncology department.

The nursing model of establishing a chemotherapy safety management supervisory group has guaranteed the safety and effectiveness of intravenous chemotherapy while reducing the adverse effects of chemotherapy and improving patient satisfaction and quality of life. To explore the impact of establishing a nursing supervision group on improving the safety management of patients receiving chemotherapy in the oncology department. We selected a total of 60 patients who underwent chemotherapy at the oncology department between January and June 2021 and assigned them to the control group. They received conventional chemotherapy safety management nursing care. We selected another 60 patients undergoing chemotherapy in the oncology department between July and December 2021 and assigned them to the observation group. They received a nursing intervention model facilitated by the chemotherapy safety supervision team. We compared the intervention effects in the two groups. Patient satisfaction was significantly higher in the observation group than in the control group (P< 0.05); the incidence of post-chemotherapy nausea and vomiting was significantly lower in the observation group than in the control group (P< 0.05); and the self-rating depression scale (SDS) and self-rating anxiety scale (SAS) scores of patients in the observation group were reduced (P< 0.05) and significantly lower than in the control group (P< 0.05). We used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core 30 (EORTC-QLQ-C30) and found a statistically significant difference in the quality of life of patients before the nursing intervention and on the day of discharge (P< 0.05). The establishment of a chemotherapy safety management supervisory group was effective in reducing the incidence of post-chemotherapy nausea and vomiting as well as the patient's psychological burden; it could also improve the quality of life of patients and their satisfaction with nursing care.

Quality-of-lifeoutcomes in metastatic spinal cord compression: findings from the SCORAD trial.

This article reports detailed quality-of-life data including preferred and actual place of care from SCORAD, the only large prospective randomized trial in metastatic spinal cord compression (MSCC). SCORAD compared 2 doses of radiotherapy in patients with MSCC: 8 Gy single fraction and 20 Gy in 5 fractions. In total, 686 patients were randomized, of whom 590 had Health-Related Quality of Life (HRQoL) data collected at baseline and at least 1 later time point. HRQoL was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 supplemented with the QLU-C10D and data on place of care at weeks 1, 4, 8, and 12 postrandomization. Quality-of-Life Adjusted Survival was computed by multiplying Kaplan-Meier survival probabilities with the UK utility weights obtained from the QLU-C10D. Patients with a baseline physical functioning score of above 50 demonstrated a 28% reduction in the risk of death (hazard ratio [HR] = 0.72, 99% confidence interval [CI] = 0.54 to 0.95; P = .003). An increased risk of death was associated with fatigue (HR = 1.35, 99% CI = 1.03 to 1.76; P = .0040), dyspnea (HR = 1.61, 99% CI = 1.24 to 2.08; P < .001), and appetite loss (HR = 1.25, 99% CI = 0.99 to 1.59; P = .014). The preferred place of care for the majority was at home or with relatives (61%-74% across the 12 weeks) but achieved by only 53% at 8 weeks. Prolonged survival in patients with MSCC was associated with better HRQoL. More than 60% of patients preferred to be cared for at home or with relatives, but only half were able to achieve this. There was no difference in HRQoL between the multifraction and single-fraction groups. ISRCTN97555949 and ISRCTN97108008.

Efficacy of ferric carboxymaltose on haemoglobin response among older patients with gastrointestinal bleeding: a randomised clinical trial.

Acute gastrointestinal bleeding (AGIB) is common in older patients but the use of iron in this context remains understudied. This study aimed to evaluate prospectively the efficacy of ferric carboxymaltose to treat anaemia in older patients after AGIB. This randomised double-blinded placebo-controlled clinical trial was conducted in 10 French centres. Eligible patients were 65years or more, had controlled upper or lower gastrointestinal bleeding and a haemoglobin level of 9-11g/dl. Patients were randomly assigned, in a 1:1 ratio, to receive either one intravenous iron injection of ferric carboxymaltose or one injection of saline solution. The primary endpoint was the difference in haemoglobin level between day 0 and day 42. Secondary endpoints were treatment-emergent adverse events, serious adverse events, rehospitalisation and improvement of quality of life (QOL) at day 180. From January 2013 to January 2017, 59 patients were included. The median age of patients was 81.9 [75.8, 87.3] years. At day 42, a significant difference in haemoglobin level increase was observed (2.49g/dl in the ferric carboxymaltose group vs. 1.56g/dl in the placebo group, P = 0.02). At day 180, QOL, measured on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, improved by 10.5 points in the ferric carboxymaltose group and by 8.2 points in the placebo group (P = 0.56). Rates of adverse events and rehospitalisation were similar in the two groups. Intravenous iron seems safe and effective to treat anaemia in older patients after AGIB and should be considered as a standard-of-care treatment. ClinicalTrials.gov (NCT01690585).

Comparing the efficacy of a multi-dimensional breast cancer rehabilitation programme versus a home-based exercise programme during adjuvant cancer treatment

BackgroundBreast cancer is the most common female malignancy worldwide and a major cause of morbidity and mortality. Exercise during adjuvant treatment improves function and relieves symptoms in breast cancer survivors. However, it is unclear if an unsupervised exercise programme may be as effective as a supervised multimodal group. We investigated the feasibility and efficacy of a centre-based multidimensional rehabilitation (MDR) programme for breast cancer survivors undergoing adjuvant treatment and compared it to an unsupervised home-based exercise (HE) programme.MethodsParticipants were self-allocated to either MDR or HE group. MDR participants underwent 24 supervised exercise classes and 10 education classes over 12 weeks. HE participants were instructed on a home exercise regime. Outcome measures, including the 6-min walk test (6MWT) and Frenchay Activities Index (FAI), FACT-Cognitive Function scale, and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, were conducted at baseline (W0), post-intervention (W12) and 6-months post-intervention (M6). Variance between time points and the 2 groups were analysed using a linear mixed model (unstructured covariance matrix) and adjusted with Bonferroni.ResultTwenty-five participants attended at least half of the MDR interventions, while 21 completed the HE interventions. The former showed significant improvement in 6MWT, from 406.88 m (W0) to 443.34 m (W12) to 452.81 m (M6), while the improvement in the HE group was not significant (407.67 m (W0) to 433.14 m (W12) to 430.96 m (M6)). Both groups showed a significant improvement in FAI, with earlier significant improvement noted at W12 in the MDR group (22.71 (W0) to 27.65 (W12) to 28.81 (M6)) compared to the HE group (23.16 (W0) to 26.47 (W12) to 29.85 (M6)). Dropout rate was 16% in the MDR group and 34% in HE group. Overall satisfaction with the MDR programme was high.ConclusionBoth MDR and HE programmes were feasible. MDR was superior in improving endurance and earlier return to instrumental activities for those who completed at least half of the sessions. Future studies could explore use of technology to improve adherence to exercise.Trial registrationThe study was registered with ClinicalTrial.gov on 01/04/2022 with the registration number NCT05306808.

Efficacy of a digital lifestyle intervention on health-related QUAlity of life in non-small cell LUng CAncer survivors following inpatient rehabilitation: protocol of the QUALUCA Swiss multicentre randomised controlled trial

IntroductionNon-small cell lung cancer (NSCLC) survivors suffer from impaired physical and psychological functioning and reduced health-related quality of life (HRQoL) that persist after active treatment ends. Sustaining rehabilitation benefits, promoting...

Quality of life and associated factors among patients with cancer receiving chemotherapy at Dessie Comprehensive Specialized Hospital, North-East Ethiopia: a cross-sectional study.

Cancer is a major public health problem around the world. Cancer by itself and its treatment modalities affect the quality of life (QoL) of patients with it. However, there were a paucity of studies about the QoL of patients receiving chemotherapeutic treatment in Ethiopia. This study was aimed at addressing such a gap. Accordingly, we investigated QoL and associated factors among cancer patients receiving chemotherapy at Dessie Comprehensive Specialized Hospital (DCSH), North East Ethiopia, in 2023. We employed a cross-sectional study from April 1 to May 30, 2023. The data was collected using the European Organization for Research and Treatment of Cancer Core QoL Questionnaire, version 3.0 (EORTC QLQ-C30). The data was entered and cleaned using EpiData version 4.6 and exported to Statistical Package for Social Sciences (SPSS) version 27 for analysis. The association between the dependent and independent variables was determined using Odds Ratios (ORs) at a p value < 0.05 with a 95% CI. Data was collected from 394 patients. Their mean summary QoL score was 36.3 ± 9.0. About 39.3% demonstrated a good QoL summary score, whereas 60.7% were impacted by symptoms. A good functional QoL score was observed in 42.6% of the participants. About 54.8% and 31.7% reported good overall health status and good overall QoL, respectively. The most impacted functional domain was social functioning, affecting 64.5% of participants. The most common symptom was diarrhea, affecting 65.5% of the participants. Secondary school education level (Adjusted Odds Ratio-AOR = 3.16, 95% CI: 1.14-8.81), diploma and above education level (AOR = 4.90, 95% CI: 1.29-18.62), and urban residency (AOR = 1.74, 95% CI: 1.07-2.82) had a significant positive association with QoL, while being a civil servant (AOR = 0.13, 95% CI: 0.04-0.49), having stage III cancer (AOR = 0.14, 95% CI: 0.05-0.39), and stage IV cancer (AOR = 0.16, 95% 0.06-0.44) had a significant negative association with it. The QoL for cancer patients undergoing chemotherapy was significantly low and associated with their level of education, occupational status, area of residence, and stage of cancer. Incorporating psychosocial support is thus crucial in their treatment plans.

Tislelizumab versus chemotherapy as second-line treatment for European and North American patients with advanced or metastatic esophageal squamous cell carcinoma: a subgroup analysis of the randomized phase III RATIONALE-302 study

The phase III RATIONALE-302 study evaluated tislelizumab, an anti-programmed cell death protein 1 antibody, as second-line (2L) treatment for advanced/metastatic esophageal squamous cell carcinoma (ESCC). This prespecified exploratory analysis investigated outcomes in patients from Europe and North America (Europe/North America subgroup). Patients with tumor progression during/after first-line systemic treatment were randomized 1:1 to open-label tislelizumab or investigator's choice of chemotherapy (paclitaxel, docetaxel, or irinotecan). The Europe/North America subgroup comprised 108 patients (tislelizumab: n= 55; chemotherapy: n= 53). Overall survival (OS) was prolonged with tislelizumab versus chemotherapy (median: 11.2 versus 6.3 months), with a hazard ratio (HR) of 0.55 [95% confidence interval (CI) 0.35-0.87]; HR was similar irrespective of programmed death-ligand 1 score [≥10%: 0.47 (95% CI 0.18-1.21); <10%: 0.55 (95% CI 0.30-1.01)]. Median progression-free survival was 2.3 versus 2.7 months with tislelizumab versus chemotherapy [HR: 0.97 (95% CI 0.64-1.47)]. Overall response rate was greater with tislelizumab (20.0%) versus chemotherapy (11.3%), with more durable response (median duration of response: 5.1 versus 2.1 months). Tislelizumab had a favorable safety profile versus chemotherapy, with fewer patients experiencing ≥grade 3 treatment-related adverse events (13.0% versus 51.0%). Those on tislelizumab experienced less deterioration in health-related quality of life, physical functioning, and/or disease- and treatment-related symptoms (i.e. fatigue, pain, and eating problems) as compared to those on chemotherapy, per the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and QLQ-OES18 scores. As a 2L therapy for advanced/metastatic ESCC, tislelizumab improved OS and had a favorable safety profile as compared to chemotherapy in European/North American ESCC patients in the randomized phase III RATIONALE-302 study.

Health-related quality of life with pembrolizumab plus chemotherapy vs placebo plus chemotherapy for advanced triple-negative breast cancer: KEYNOTE-355.

In KEYNOTE-355 (NCT02819518), the addition of pembrolizumab to chemotherapy led to statistically significant improvements in progression-free survival and overall survival in patients with advanced triple-negative breast cancer with tumor programmed cell death ligand 1 (PD-L1) combined positive score of at least 10. We report patient-reported outcomes from KEYNOTE-355. Patients were randomly assigned 2:1 to pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles plus investigator's choice chemotherapy (nab-paclitaxel, paclitaxel, or gemcitabine plus carboplatin). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30), Breast Cancer-Specific Quality of Life Questionnaire, and EuroQol 5-Dimension questionnaire visual analog scale were prespecified. Patient-reported outcomes were analyzed for patients who received at least 1 dose of study treatment and completed at least 1 patient-reported outcome assessment. Changes in patient-reported outcome scores from baseline were assessed at week 15 (latest time point at which completion and compliance rates were at least 60% and at least 80%, respectively). Time to deterioration in patient-reported outcomes was defined as time to first onset of at least a 10-point worsening in score from baseline. Patient-reported outcome analyses included 317 patients with tumor PD-L1 combined positive score of at least 10 (pembrolizumab plus chemotherapy: n = 217; placebo plus chemotherapy: n = 100). There were no between-group differences in change from baseline to week 15 in QLQ-C30 global health status/quality of life (QOL; least-squares mean difference = -1.81, 95% confidence interval [CI] = -6.92 to 3.30), emotional functioning (least-squares mean difference = -1.43, 95% CI = -7.03 to 4.16), physical functioning (least-squares mean difference = -1.05, 95% CI = -6.59 to 4.50), or EuroQol 5-Dimension questionnaire visual analog scale (least-squares mean difference = 0.18, 95% CI = -5.04 to 5.39) and no between-group difference in time to deterioration in QLQ-C30 global health status/QOL, emotional functioning, or physical functioning. Together with the efficacy and safety findings, patient-reported outcome results from KEYNOTE-355 support pembrolizumab plus chemotherapy as a standard of care for patients with advanced triple-negative breast cancer with tumor PD-L1 expression (combined positive score ≥10).

Paradoxical Findings in Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with C5 Inhibitors: Suboptimal Disease Control Perceived As Satisfactory

Introduction: The introduction of C5 inhibitors (C5i) for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) has resulted in lower morbidity and mortality rates. However up to 86% of patients still experience anemia and fatigue in 63% of them which may impact their quality of life (QoL). The SATURNO study aimed to assess PNH patient and physician satisfaction with C5i treatment, along with the impact of the disease and clinical outcomes. Methods: A multicenter, observational, cross-sectional study conducted in PNH patients receiving C5i treatment for at least 3 months in Spain. Key clinical and laboratory data were collected, including red blood cells (RBC) transfusions, hemolytic crisis, hemoglobin (Hb), haptoglobin (Hp), lactate dehydrogenase (LDH), absolute reticulocyte count (ARC) and bilirubin. Patient satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM) and Visual Analog Scale (VAS). Physician satisfaction was measured using the TSQM general item and VAS. Fatigue and QoL were evaluated using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), respectively. The Work Productivity and Activity Impairment questionnaire (WPAI) was also used. Results: A total of 56 patients and 13 physicians participated in the study. Median (IQR) age of patients was 54.0 (44.5; 63.5) years, 35.7% were female and median (IQR) duration of treatment with C5i was 6.6 (3.3; 11.6) years. Overall, 94.6% of patients and 90.6% of physicians reported to be satisfied, very satisfied, or extremely satisfied with the treatment. Mean (SD) VAS score for patient satisfaction was 9.0 (1.2) and for physicians 7.9 (1.7) out of 10. Mean (SD) EORTC QLQ-C30 score was 71.7 (21.7) out of 100. Mean (SD) FACIT-F score was 39.7 (10.6) out of 52 and fatigue was reported by 55.2% of patients. Clinical and laboratory parameters showed a significant proportion of patients exhibiting abnormal values. Hb and Hp were below the normal ranges in 67.9% and 65.1% of patients, respectively, whereas elevated LDH, ARC and indirect bilirubin were observed in 50.0%, 83.0% and 75.9% of them, respectively. In the last 12 months, 30.9% of patients had received at least one RBC transfusion, with a mean (SD) number of 8.6 (8.4) RBC transfusions, and 33.9% experienced at least one hemolytic crisis with a mean (SD) of 4.9 (9.4). Work productivity assessment revealed that 60.7% of patients were currently unemployed, a mean (SD) percentage of absenteeism of 5.7% (12.4) and presenteeism of 23.8% (26.0). Overall mean (SD) percentage of work productivity impairment was 25.6% (27.3). Activity impairment was reported by 36.4% (28.3) of patients. Conclusions: The SATURNO study showed that although patients and physicians reported satisfaction with C5i treatment, this might be challenged. A substantial number of PNH patients treated with C5i still experience anemia, fatigue and abnormal laboratory values, indicative of ongoing hemolysis and suboptimal control. Moreover, patients with PNH had affected work productivity and a proportion of them were experiencing activity impairment. These findings highlight the need for comprehensive management strategies to address the impact of the disease on patients with PNH receiving C5i treatment.

Influence of Whole-Process Nutrition Management on Nutritional Status of Patients with Esophageal Cancer Undergoing Radiotherapy

To probe the effect of whole-process nutrition management on the nutritional status of patients with esophageal cancer undergoing radiotherapy, 100 patients were allocated to the control group (n = 50) and observation group (n = 50). Patients in both groups underwent routine treatment after admission. The control group adopted conventional nutrition management, while the observation group was given whole-process nutrition management. Compared to the control group, the patient-generated subjective global assessment score in the observation group declined after intervention (P &lt; 0.05). Levels of prealbumin, albumin, transferrin, immunoglobulin A, immunoglobulin G, immunoglobulin M, CD3+, and CD4+ in the observation group were elevated compared to the control group after intervention (P &lt; 0.05). According to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, the observation group exhibited higher scores in the aspects of family understanding and cooperation, mental condition, appetite, daily life, and sleep quality than the control group after intervention (P &lt; 0.05). Furthermore, the incidence of adverse reactions in the observation group was lessened compared to the control group (P &lt; 0.05). Hence, implementing whole-process nutrition management in patients undergoing radiotherapy can promote their nutritional status and quality of life.

Application of sintilimab combined with anlotinib hydrochloride in the clinical treatment of microsatellite stable colorectal cancer

BACKGROUND Microsatellite stable (MSS) colorectal cancer (CRC) is a common type of tumor with limited treatment options. Sintilimab and anlotinib hydrochloride are two extensively studied anticancer drugs. AIM To probe the clinical value of combining sintilimab with anlotinib hydrochloride in MSS CRC treatment. METHODS During the period spanning from April 2019 to April 2022, Zhejiang Provincial People’s Hospital accommodated a cohort of 92 patients diagnosed with MSS CRC who were classified into two distinct groups in our study, the observation group and the control group. The control group was administered anlotinib hydrochloride as their designated therapy, whereas the observation group received the additional treatment of sintilimab in conjunction with the therapy assigned to the control group. The administration of treatment occurred in cycles consisting of a duration of 3 wk, and the evaluation of effectiveness took place subsequent to the completion of two consecutive cycles of treatment within both groups. A comparative analysis between the two groups was conducted to assess the short-term efficacy and ascertain the incidence of adverse events transpiring throughout the duration of the treatment period. Changes in the levels of carcinoembryonic antigen, carbohydrate antigen 199 (CA199), CA125, and T cell subsets (CD4+, CD8+, CD4+/CD8+) as well as the assessment of the quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 were compared between the two groups prior to and subsequent to therapy. Finally, a 1-year follow-up was conducted for both groups of patients, and the survival status was recorded and analyzed. RESULTS The short-term effectiveness displayed by the observation group surpassed that exhibited by the control group, with a statistically significant discrepancy (76.09% vs 50.00%), reaching a significance level denoted as P &lt; 0.05. Following the administration of treatment, the observation group manifested a considerable reduction in numerous serum indicators, which were found to be lower than the corresponding pretreatment levels within the same group as well as the post-treatment levels observed in the control group (P &lt; 0.05). Post-treatment, the T lymphocyte subset levels within the observation group demonstrated a remarkable amelioration, surpassing the corresponding pre-treatment levels observed within the same group as well as the post-treatment levels observed in the control group (P &lt; 0.05). Subsequent to the therapeutic intervention, the observation group showcased a notable amelioration in the scores associated with multiple dimensions of life quality. These scores outperformed the pretreatment scores within the same group as well as the post-treatment scores observed in the control group (P &lt; 0.05). The safety levels of drug use in the two group were comparable (19.57% vs 13.04%), and no distinct difference was observed upon comparison (P &gt; 0.05). After the completion of treatment, both groups of patients underwent a 1-year follow-up outside the hospital. Throughout this period, 1 patient within the observation group and 2 patients within the control group became untraceable and were lost to follow-up. During the follow-up period of the observation group, 12 patients died, resulting in a survival rate of 73.33% (33/45), while in the control group, 21 patients died, resulting in a survival rate of 52.27% (23/44). The implementation of Kaplan-Meier survival analysis revealed a conspicuous contrast in survival rates exhibited by the two groups (log-rank = 4.710, P = 0.030). CONCLUSION The combination of sintilimab and anlotinib hydrochloride demonstrated favorable efficacy in the treatment of MSS CRC patients, leading to improvements in patient immunity and prognosis. Additionally, it exerted inhibitory effects on the expression of carcinoembryonic antigen, CA199, and CA125.

Patient-Reported Outcomes: Danicopan As Add-on Therapy to Ravulizumab or Eculizumab Versus Placebo in Patients with Paroxysmal Nocturnal Hemoglobinuria and Clinically Significant Extravascular Hemolysis

Background Treatment with complement C5 inhibitors eculizumab (Ecu) and ravulizumab (Rav) inhibits terminal complement activity, improving hemoglobin (Hgb) levels and clinical outcomes for patients (pts) with paroxysmal nocturnal hemoglobinuria (PNH), including reduced morbidity and mortality by preventing intravascular hemolysis (IVH), thrombotic events, hospitalizations, and death. In an analysis using data from the International PNH Registry (NCT01374360), Ecu improved pt survival through 20 y of real-world follow-up. Rav demonstrated a 98.4% survival rate up to 6 y in an open-label study (NCT03056040). Approximately 10-20% of pts experienced ongoing anemia caused by clinically significant extravascular hemolysis (cs-EVH). The phase 3, international, randomized, double-blind, placebo (Pbo)-controlled ALPHA (NCT04469465) superiority clinical trial assessed the effectiveness and safety of danicopan (Dan) add-on therapy to Rav or Ecu in pts with PNH and cs-EVH. This current analysis examined patient-reported outcomes (PROs) through wk 24. Methods Pts (≥18 y) with PNH and cs-EVH (Hgb ≤9.5 g/dL; absolute reticulocyte count ≥120×10 9/L) on Rav/Ecu &amp;gt;6 mo were randomized 2:1 to Dan or Pbo add-on therapy to Rav/Ecu for 12 wks (treatment period [TP] 1). At wk 12, Pbo arm pts switched to Dan (Pbo-Dan) and Dan arm pts continued treatment (Dan-Dan) for another 12 wks (TP2). The initial Dan dose of 150 mg TID could be escalated to 200 mg TID based on clinical response at investigator's discretion. Endpoints included change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score to wks 12 and 24 (key secondary) and changes in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Scale (EORTC-QLQ-C30) global health status/QoL and physical functioning subscales and fatigue, nausea/vomiting, appetite loss, constipation, and diarrhea symptom subscales, and EuroQoL-5-Dimensions, 3-level version (EQ-5D-3L) to wk 24 (exploratory). Results As of 20 September 2022, 86 pts were randomized; 60 had completed (n=60) TP2 (Dan n=40; Pbo n=20). Baseline characteristics were similar between arms. The study met its primary endpoint of significant improvement in Hgb and all key secondary endpoints, including FACIT-Fatigue at wk 12 (data previously presented). Clinically meaningful (&amp;gt;5 point) and statistically significant increases from baseline in FACIT-Fatigue score were observed for Dan vs Pbo at wk 12 (least square mean difference [SEM] 7.97 [1.13] vs 1.85 [1.58]; P=0.0021). At wk 24 ( Fig 1), outcomes were maintained in the Dan-Dan arm (40.32) and improved in Pbo-Dan arm (40.55) to levels similar to the general public score of 43.6. Significant improvements from baseline with Dan vs Pbo were demonstrated for EORTC-QLQ-C30 scores (physical function and social function within functional subscales, and fatigue within symptom subscales) at wk 12, maintained at wk 24 for the Dan-Dan arm, and demonstrated at wk 24 in Pbo-Dan arm ( Fig 2). Trends in changes from baseline in other EORTC-QLQ-C30 function subscale scores paralleled that of the physical function subscale. EQ-5D-3L scores (US Health State Index) were similar between arms at baseline (Dan, 0.83; Pbo, 0.80), wk 12 (Dan, 0.90; Pbo, 0.86), and wk 24 (Dan-Dan, 0.90; Pbo-Dan, 0.87); scores at all timepoints are comparable to the general public (0.855-0.958). Dan demonstrated favorable benefit-risk profile with no deaths, meningococcal infections, or discontinuations due to hemolysis; additional safety analyses including adverse events were previously presented. No new safety signals were demonstrated. Conclusions These data suggest that Dan plus Rav or Ecu improves QoL compared to Rav or Ecu alone for pts with PNH and cs-EVH. In this phase 3, randomized, controlled superiority trial, improvements in clinically relevant PROs were observed in the Dan vs Pbo arm in the first double-blind 12 wks of treatment, and FACIT-Fatigue and EORTC-QLQ-C30 scores were maintained during the open-label period to wk 24 in the Dan-Dan arm and improved at wk 24 in Pbo-Dan arm to levels similar to those of the general public. Comparable EQ-5D-3L scores were maintained between arms across the study.

Psychometric Properties and Factorial Analysis of the Arabic McGill-QoL Questionnaire in Breast Cancer.

This study aimed to assess the psychometric properties of the Arabic McGill Quality of Life Questionnaire-Revised (MQOL-R) in breast cancer survivors. One-hundred-forty breast cancer survivors were recruited and completed the questionnaire. The construct validity was assessed using confirmatory factor analysis (CFA). MQOL-R scores were correlated with Global Health Status/QoL and functional subscales of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) for convergent validity. Reliability was estimated using Cronbach's alpha and intraclass correlation coefficients (ICC). CFA reproduced a four-factor model (ie, physical, psychological, existential, and social) with good fit indices (comparative fitting index = 0.980; root mean square error of approximation = 0.091), with all items significantly loading on their respective subscales. The total MQOL-R scores were correlated with the global health status/QoL and functional subscales of the EORTC QLQ-C30 (r = -0.172, P < 0.01). Known-group validity was proven by different MQOL-R scores according to functional status (50.62 ± 6.35 vs 45.98 ± 7.19, P < 0.01). Reliability was supported by good internal consistency and high test-retest correlation coefficients for the Arabic MQOL-R and its subscales (ICC range, 0.83-0.95). The Arabic MQOL-R demonstrated adequate construct validity, factor structure, excellent test-retest reliability, and good internal consistency. This tool is valuable for assessing the quality of life in research and physical therapy rehabilitation settings among Arabic-speaking breast cancer survivors.

Meme Kanseri Tanısı Almış Kadınlarda Beslenme Durumu, Yaşam Kalitesi ve Akdeniz Diyetine Bağlılığın Değerlendirilmesine İlişkin Bir Araştırma

Aim: The aim of this study is to assess the quality of life and adherence to the Mediterranean diet (MD) among female breast cancer patients.&#x0D; Material and Method: The study included a cohort of 120 women who received a breast cancer diagnosis within the last year. Anthropometric measurements were conducted, and body composition analysis was carried out to determine body fat percentage. The Mediterranean Diet Adherence Scale (MEDAS) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) were employed for data collection.&#x0D; Results: A total of 120 breast cancer patients, with an average age of 49.8±10.56 years, were enrolled in the study. Among these participants, 42.5% were categorized as having a normal weight. The mean waist circumference and waist/hip ratio were 94.6±12.20 cm and 0.87±0.10, respectively. Body fat percentages were determined to be 36.8±8.61%. The average total energy intake was 1944.9±385.24 kcal, with the percentage of total fat intake from energy averaging at 35.6±4.81%. Patients had a mean body mass index (BMI) of 29.0±5.80 kg/m², with 40.8% of them classified as obese. The mean MEDAS score was 7.3±2.65, and the EORTC QLQ-C30 score averaged at 69.7±11.94. There is a negative correlation was found between BMI, waist circumference and MEDAS score; A positive correlation was found between MEDAS scores and EORTC scores.&#x0D; Conclusion: Breast cancer patients with high compliance with the Mediterranean diet have a higher quality of physical, emotional and social life. Therefore, evaluation of modifiable risk factors in breast cancer patients is essential for the prognosis of the disease.

Change in Quality of Life after Stereotactic Body Radiation Therapy (SBRT) on a Prospective Trial of Peripheral Stage I or II Non-Small Cell Lung Cancer Predicts Survival

We previously reported the results of a randomized, multi-institutional phase II clinical trial evaluating one versus three fractions of SBRT for peripheral Stage I to II non-small cell lung cancer (NSCLC). A secondary objective to compare quality of life (QOL) data and its association with survival outcomes is reported. Medically inoperable patients with biopsy-proven peripheral T1-2N0M0 NSCLC were enrolled. Patients were randomized to 30 Gy in 1 fraction (arm 1) or 60 Gy in 3 fractions (arm 2) and stratified by performance status. QOL scores from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and EORTC QLQ Lung Cancer-Specific Module (EORTC QLQ-LC13) questionnaires were required at baseline and each follow-up visit. Univariate models were generated to evaluate associations between QOL scores and survival with 95% confidence intervals (CI) calculated at each time point. Among 98 patients enrolled (49 in each arm), 88 patients had data available for QOL analysis. At 6 month follow up, patients with stable or decreased (n = 49) versus those with increased global QOL scores (n = 27) had worse progression-free survival (HR [Hazards' Ratio] 2.32 [CI, 1.14-4.73], p = 0.021) and overall survival (HR 2.13 [CI, 1.01-4.51], p = 0.048). Similar results persisted at the 12 month follow up for progression-free survival (HR 3.90 [CI, 1.52-10.04], p = 0.016) and overall survival (HR 3.25 [CI, 1.25-8.43], p = 0.016). Median overall survival for patients with stable or decreased global QOL versus increased global QOL at 6 month follow up was 39.0 vs 60.3 months (p = 0.032). Change in QOL is an early predictor of survival following SBRT for patients with peripheral early-stage NSCLC.

Improved Quality of Life in Metastatic Castration-Resistant Prostate Cancer Patients Receiving Consecutive Cycles of 177Lu-PSMA I&T.

The aim of this retrospective analysis was to evaluate health-related quality of life (HRQoL) for patients with metastatic castration-resistant prostate cancer (mCRPC) receiving consecutive cycles of 177Lu-prostate-specific membrane antigen (PSMA) radioligand therapy (RLT) using the reliable and validated European Organisation for Research and Treatment of Cancer core quality-of-life (QoL) questionnaire. In addition, differences in HRQoL between patients with early discontinuation of treatment because of disease progression and patients who were defined as eligible for treatment continuation were analyzed. Methods: In total, 60 mCRPC patients were included in this analysis. The European Organisation for Research and Treatment of Cancer core QoL questionnaire was completed at baseline, before each treatment cycle up to the sixth treatment cycle, and at the time of PSMA-ligand PET/CT scans after the second and fourth treatment cycles. QoL assessment included global health status, functional scales, and symptom burden during treatment. Results: Global health was significantly improved at the second and fourth cycles of 177Lu-PSMA RLT (P = 0.014 and P = 0.039, respectively). In line with this, role and emotional functioning showed significant improvements at the second and fourth treatment cycles (role functioning, P = 0.045 and P = 0.048, respectively, and emotional functioning, P = 0.035 and P = 0.007, respectively). In addition, compared with baseline, fatigue and pain were significantly alleviated at the second and fourth treatment cycles (pain, P = 0.035 and P = 0.034, respectively, and fatigue, P = 0.042 and P = 0.041, respectively). Other aspects of HRQoL, even if not significantly improved, remained stable over time, except for deterioration of fatigue at the study's end (P = 0.014) and reduction of dyspnea at the second treatment cycle (P = 0.012). Patients with early discontinuation of treatment showed a concordant decline in HRQoL. Conclusion: mCRPC patients showed significant improvement in HRQoL in the course of treatment with 177Lu-PSMA RLT. Furthermore, patients with early discontinuation of treatment showed an analogous decline in HRQoL.

Prediction Model for Postoperative Quality of Life Among Breast Cancer Survivors Along the Survivorship Trajectory From Pretreatment to 5 Years: Machine Learning-Based Analysis.

Breast cancer is the most common cancer and the most common cause of cancer death in women. Although survival rates have improved, unmet psychosocial needs remain challenging because the quality of life (QoL) and QoL-related factors change over time. In addition, traditional statistical models have limitations in identifying factors associated with QoL over time, particularly concerning the physical, psychological, economic, spiritual, and social dimensions. This study aimed to identify patient-centered factors associated with QoL among patients with breast cancer using a machine learning (ML) algorithm to analyze data collected along different survivorship trajectories. The study used 2 data sets. The first data set was the cross-sectional survey data from the Breast Cancer Information Grand Round for Survivorship (BIG-S) study, which recruited consecutive breast cancer survivors who visited the outpatient breast cancer clinic at the Samsung Medical Center in Seoul, Korea, between 2018 and 2019. The second data set was the longitudinal cohort data from the Beauty Education for Distressed Breast Cancer (BEST) cohort study, which was conducted at 2 university-based cancer hospitals in Seoul, Korea, between 2011 and 2016. QoL was measured using European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 questionnaire. Feature importance was interpreted using Shapley Additive Explanations (SHAP). The final model was selected based on the highest mean area under the receiver operating characteristic curve (AUC). The analyses were performed using the Python 3.7 programming environment (Python Software Foundation). The study included 6265 breast cancer survivors in the training data set and 432 patients in the validation set. The mean age was 50.6 (SD 8.66) years and 46.8% (n=2004) had stage 1 cancer. In the training data set, 48.3% (n=3026) of survivors had poor QoL. The study developed ML models for QoL prediction based on 6 algorithms. Performance was good for all survival trajectories: overall (AUC 0.823), baseline (AUC 0.835), within 1 year (AUC 0.860), between 2 and 3 years (AUC 0.808), between 3 and 4 years (AUC 0.820), and between 4 and 5 years (AUC 0.826). Emotional and physical functions were the most important features before surgery and within 1 year after surgery, respectively. Fatigue was the most important feature between 1 and 4 years. Despite the survival period, hopefulness was the most influential feature on QoL. External validation of the models showed good performance with AUCs between 0.770 and 0.862. The study identified important factors associated with QoL among breast cancer survivors across different survival trajectories. Understanding the changing trends of these factors could help to intervene more precisely and timely, and potentially prevent or alleviate QoL-related issues for patients. The good performance of our ML models in both training and external validation sets suggests the potential use of this approach in identifying patient-centered factors and improving survivorship care.

Utilization of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 scale for evaluation of quality of life among cancer patients treated with chemotherapy: A hospital-based observational study.

In this new era of cancer management, the quality of life (QOL) is given more importance than the quantity of life. QOL evaluation studies are widely used in oncology to assess the patient's performance in different cancer types and treatment modalities. To evaluate cancer patients' QOL after various chemotherapy cycles. An observational study was performed on cancer patients receiving chemotherapy in the daycare setting of a South Indian Tertiary Care Hospital for 6 months. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) questionnaire was employed to study the QOL. Precisely, 102 patients participated in the study, out of which the majority were in the 51 to 60 age group (24%). Female participants (65%) were more. Functional scale domains especially physical ability (P = 0.004), role (P = 0.033), and emotional functioning (P = 0.01) were significantly decreased in patients treated with 4 to 6 chemotherapy cycles. Cognitive ability (P = 0.043) significantly improved in patients treated with more than 6 chemotherapy cycles. Dyspnea (P = 0.036) was significantly increased in patients treated with 4 to 6 chemotherapy cycles and decreased significantly with the further addition of chemotherapy cycles. Dyspnea is a commonly observed symptom among cancer patients and is often neglected by physicians. Chronic dyspnea can negatively impact a patient's functional ability. Cancer symptoms such as dyspnea should also be given priority and need appropriate treatment. Based on the findings, further interventions can be made to improve the functional ability of cancer patients. Also, studies can be conducted to correlate with cancer rehabilitation programs to improve functional ability and complete the entire chemotherapy cycle.