Abstract PD12-12: Floor and ceiling effects in the EORTC QLQ-C30 physical functioning subscale among patients with breast cancer enrolled in commercial clinical trials vs. a community trial

2021 ◽  
Author(s):  
Meena N Murugappan ◽  
Bellinda King-Kallimanis ◽  
Christina Mangir ◽  
Lynn Howie ◽  
Vishal Bhatnagar ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Physical Functioning ◽  
Ceiling Effects ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Functioning Subscale ◽  
Physical Functioning Subscale ◽  
Community Trial

scholarly journals Quality of Life of Breast Cancer Women During Chemotherapy with Fluorouracil, Doxorubicin and Cyclophosphamide (FAC) Regimen

2017 ◽  
Vol 35 (4) ◽  
pp. 373
Author(s):  
Sophit Korpunsilp ◽  
Tipaporn Pongmesa
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Side Effects ◽  
Physical Functioning ◽  
P Value ◽  
Life Questionnaire ◽  
Appetite Loss ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Objective: To assess quality of life (QoL) of female breast cancer patients undergoing chemotherapy with a fluorouracil, doxorubicin, and cyclophosphamide (FAC) regimen.Material and Method: This prospective analytical study was performed among 40 Thai female patients receiving the FAC regimen at Pranangklao Hospital, Nonthaburi province. Their QoL was assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Breast Cancer Module (EORTC QLQ-BR23).Results: Most patients were aged 50 years or over (77.5%) and had been diagnosed with stage 2 breast cancer (47.5%). According to the EORTC QLQ-C30, the patients’ QoL significantly decreased compared to the baseline after cycle 3 for global health status (p-value=0.002) and QoL (p-value=0.001), as well as physical functioning (p-value=0.015) and role functioning (p-value=0.001), while symptoms of fatigue, nausea/vomiting, and appetite loss increased (p-value<0.001). After cycle 5, the patients’ QoL was still significantly lower than at baseline, for physical functioning (p-value=0.009) and symptoms of fatigue, nausea/vomiting, appetite loss (p-value<0.001) and dyspnea (p-value=0.005). The EORTC QLQ-BR23 reported significantly worse systemic therapy side effects for both cycles 3 and 5 (p-value<0.001), and distress due to hair loss also appeared after cycle 5 (p-value=0.016). No significant differences were revealed on any scales between cycles 3 and 5.Conclusion: The patients’ QoL significantly decreased after chemotherapy with the FAC regimen, with some side effects from treatment and reduction in some functioning.

Primary surgery versus no surgery in synchronous metastastic breast cancer: Patient-reported outcomes of the ABCSG 28 Posytive trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 1074-1074
Author(s):  
Vesna Bjelic-Radisic ◽  
Florian Fitzal ◽  
Guenther G. Steger ◽  
Christian Marth ◽  
Marija Balic ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Physical Functioning ◽  
Systemic Therapy ◽  
Metastatic Breast ◽  
Primary Systemic Therapy ◽  
Primary Surgery ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

1074 Background: The ABCSG 28 Posytive trial compared primary surgery versus primary systemic therapy without surgery in synchronous metastatic breast cancer. The primary aim of the study was to investigate whether immediate resection of the primary tumor followed by standard systemic therapy improves median survival compared with no surgical resection (NCT01015625). This report describes quality-of-life (QoL) results. Methods: Patients were randomized between 2011 and 2015. Patients completed the EORTC QLQ-C30 and EORTC QLQ-BR 23 before treatment and every 6 months during follow-up. Results: 90 patients (45 with surgery, 45 with primary systemic therapy without surgery) from 15 centers were included in the QoL analysis. At 6 months patients after surgery reported more insomnia, breast symptoms and arm symptoms than patients without surgery, but these differences were no longer present at later follow-up visits. In the univariate and multivariate analysis the global health status and physical functioning scales of EORTC QLQ C30 were statistically significant predictors for OS and TTP (p < 0.05). Over a 24-month follow-up, patients > 60 years showed more QoL impairments than those < 60 years, independent of treatment. Patients < 60 years had better physical functioning and less fatigue, appetite loss, constipation and breast symptoms than older patients. There were no differences in QoL between patients with bone metastases vs those with visceral ± bone metastases. Conclusions: In patients with primary metastatic breast cancer primary surgery does not appear to improve QoL. Global health status and physical functioning scales of EORTC QLQ-C30 appears to be a predictive factor for OS and TTP. Clinical trial information: NCT01015625.

scholarly journals Impact of Oncological Therapy and Viscum album L Treatment on Cancer-Related Fatigue and Internal Coherence in Nonmetastasized Breast Cancer Patients

2020 ◽  
Vol 19 ◽  
pp. 153473542091721 ◽  
Author(s):  
Shiao Li Oei ◽  
Anja Thronicke ◽  
Matthias Kröz ◽  
Philipp von Trott ◽  
Friedemann Schad ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Physical Functioning ◽  
Real World ◽  
Viscum Album ◽  
Breast Cancer Patients ◽  
Cancer Related Fatigue ◽  
Eortc Qlq C30 ◽  
Internal Coherence ◽  
Eortc Qlq

Introduction: Viscum album L extracts (VA) are frequently used in integrative oncology. Aim of this study was to evaluate the impact of add-on VA applications on various patient-reported outcome measures. Methods: A longitudinal real-world study was conducted, using data from the Network Oncology clinical registry. Primary, nonmetastasized breast cancer patients treated with oncological standard therapy partly combined with VA applications were included. Internal Coherence Cancer-related Fatigue, and EORTC QLQ-C30 questionnaires were assessed at baseline and 6, 12, and 24 months later. Results: A total of 319 patients received standard oncological therapy and 40% of them additionally VA applications. After 6 and 12 months for patients treated with chemotherapy (Ctx) only a significant decline of the thermo-coherence, and worsening of fatigue was observed. For patients receiving VA applications but no Ctx, significant beneficial effects on thermo-coherence, fatigue, and seven EORTC QLQ-C30 scales were observed 24 months later. Adjusted multivariable long-term subgroup ( n = 106) regression analysis revealed that Ctx, immuno-, and endocrine therapies had a worsening of 17, 17, and 6 point changes, respectively, for EORTC QLQ-C30 fatigue ( P = .0004), while VA applications showed an improvement of 12 point change. A similar impact of improvement (add-on VA) and worsening (standard oncological treatment regimens) on EORTC QLQ-C30 insomnia ( P = .009) and physical functioning ( P = .005) were observed. Conclusions: In the present real-world study, add-on VA applications had a supportive effect on cancer-related fatigue, insomnia, physical functioning, and thermo-coherence. Thus, VA applications might be suited to alleviate symptom burden during anticancer therapy in breast cancer patients.

scholarly journals POS0291 THE IMPACT OF DRUG INDUCED AND OTHER RHEUMATIC MUSCULOSKELETAL DISORDERS (MD) ON THE QUALITY OF LIFE (QOL) OF CANCER PATIENTS RECEIVED ANTICANCER DRUG TREATMENT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 371.1-371
Author(s):  
A. Koltakova ◽  
A. Lila ◽  
L. P. Ananyeva ◽  
A. Fedenko
Keyword(s):  
Drug Treatment ◽  
Cancer Patients ◽  
Anticancer Drug ◽  
Physical Functioning ◽  
Role Functioning ◽  
Drug Induced ◽  
Significant Difference ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
The Impact

Background:Pts with cancer may have MD that can be caused by neoplastic/paraneoplastic disease, rheumatic diseases or be induced by anticancer drug treatment. There is no data about MD influence on the QoL of cancer patients. The EORTC QoL questionnaire (QLQ)-C30 is a valid questionnaire designed to assess different aspects (Global health (GH), Functional (FS) and symptoms (SS) scales) that define the QoL of cancer patients [1].Objectives:The objective of the study was to assess the impact of drug induced and other types of MD on the QoL of cancer patients that received anticancer drug treatment by using of EORTC QLQ-C30 v3.0.Methods:The sampling of 123 pts (M/F – 40/83; mean age 54.4±12.8) with breast (32,5%), gastrointestinal (17%), ovary (8%), lung (7%) and other cancer was observed by rheumatologist in the oncology outpatient clinic. All pts received anticancer drug treatment: chemotherapy (104 pts), target therapy (16 pts) checkpoint-inhibitors (14 pts), hormone therapy (13 pts) in different combinations. 102(82.9%) of 123pts had MD include arthritis (12 pts), synovitis (5 pts), arthralgia (66 pts), periarthritis (34 pts), osteodynia (13 pts). There were 58 pts (group 1; M/F – 14/44; mean age 52.5±12.2) with anticancer drug treatment induced MD and 44 pts (group 2; M/F – 16/27; mean age 57.6±13.5) with other type of MD include 26 pts with skeletal metastasis. The were 21 pts (group 3; M/F – 10/11; mean age 52.9±11.1) without MD. All pts fulfilled EORTC QLQ-C30 v3.0 (tab.1).Table 1.The median [Q1;Q3] of results of GH, SS and SS of EORTC QLQ-C30ScaleSubscaleGroup1Group2Group3GH58.3[50;58]58.3[41.7;83.3]50[50;66.7]FS*Physical functioning73.3[60;86.7]73.3[66.7;86.7]86.7[80;93]Role functioning66.7[66.7;100]83.3[50;100]100[83;100]Emotional functioning83.3[66.7;100]75[66.7;91.7]91.6[83.3;100]Social functioning83.3[66.7;100]83.3[50;100]100[83.3;100]SS*Pain33.3[0;50]16.7[0;33.3]0[0;16.7]*There are only the scores that had got a statistical difference between the groups.Kruskal-Wallis H and post-hoc (Dwass-Steel-Critchlow-Fligner (DSCF) pairwise comparisons) tests for data analysis were performed.Results:A Kruskal-Wallis H test has shown a statistically significant difference in physical (χ2(2)=7.54; p=0.023), role (χ2(2)=9.87; p=0.007), emotion (χ2(2)=7.69; p=0.021) functioning and pain (χ2(2)=8.44; p=0.015) scores between the different groups. A post-hoc test with DSCF pairwise comparisons of median has shown a statistically significant difference between 1 and 3 groups (W=3.904; p=0.016) for physical functioning, between 2 and 3 groups (W=3.35; p=0.004) for role functioning, between 2 and 3 groups (W=4.03; p=0.012) for emotional functioning, between 1 and 3 groups (W=-3.97; p=0.014) for pain scale.Conclusion:The study has shown that MD associated with anticancer drug treatment adversely affected the QoL of cancer patients received anticancer drug treatment by reducing a physical functioning and by increasing pain scores. Presence of other types of MD adversely affect the QoL by reducing emotional and role functioning.References:[1]Aaronson NK,et al.The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst.1993;85(5):365-376. doi:10.1093/jnci/85.5.365Disclosure of Interests:None declared

Dynamics of quality of life of patients as a method of evaluating surgical treatment outcome in oral and oropharyngeal cancer

2021 ◽  
Vol 59 (1) ◽  
pp. 31-35
Author(s):  
N. Trizna ◽  
Z. Kaliadich ◽  
E. Zhaleika ◽  
A. Evmenenko
Keyword(s):  
Quality Of Life ◽  
Treatment Outcome ◽  
Physical Functioning ◽  
Oropharyngeal Cancer ◽  
Individual Therapy ◽  
Quality Of Life Indicators ◽  
Eortc Qlq C30 ◽  
Oral And Oropharyngeal Cancer ◽  
Eortc Qlq

Study of the quality of life indicators is an important part of a comprehensive analysis of new diagnosis, treatment, and prevention methods. It can serve as an additional criterion for selecting individual therapy or rehabilitation, examining the ability to work, and identifying psychological problems. Purpose of the study: The authors took a clinical case to demonstrate the use of внтфьшс monitoring of the quality of life indicators for the assessment of surgical and reconstructive treatment outcome for oral and oropharyngeal cancer. Results: The anticancer treatment effects were reflected in the physical functioning score according to the EORTC QLQ-C30 questionnaire (reduced to 80 points) and some symptomatic scores according to the EORTC QLQ-C30 and EORTC QLQ-H & N35 questionnaires. Medical rehabilitation measures resulted in positive dynamics of physical functioning scores according to the EORTC QLQ-C30 questionnaire (increase to 93.3 points) and symptomatic scores according to the EORTC QLQ-H & N35 questionnaire related to nutrition. At that, the patient has stopped having difficulty eating in public places; his body weight increased. The absence of pain and refusal to take analgesics also testified to successful treatment and improved quality of life. Conclusion: A subjective assessment of the various quality of life aspects in a particular patient provides valuable information about the individual response to the conducted treatment.

scholarly journals Qualidade de Vida Relacionada à Saúde de Pacientes com Câncer de Mama: Revisão Integrativa da Literatura

2020 ◽  
Vol 66 (1) ◽  
Author(s):  
Monique Binotto ◽  
Gilberto Schwartsmann
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cáncer De Mama ◽  
Life Questionnaire ◽  
European Organization ◽  
Quality Of Life Questionnaire ◽  
Cancer Breast ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Introdução: O câncer de mama pode alterar a qualidade de vida relacionada à saúde das pacientes. Objetivo: Compreender o impacto da quimioterapia para câncer de mama na qualidade de vida relacionada à saúde de pacientes. Método: Trata-se de uma revisão integrativa da literatura, compreendendo artigos publicados entre 2007 e 2019, disponíveis nas bases de dados PubMed, LILACS e SciELO. Analisaram-se 25 artigos na íntegra. Resultados: Os questionários mais frequentemente utilizados nos estudos foram o European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) e o módulo complementar European Organization for Research and Treatment of Cancer Breast Cancer-specific Quality of Life Questionnaire (EORTC QLQ-BR23). Em relação às alterações da qualidade de vida, a saúde global diminui durante a quimioterapia, mas pode melhorar após o término do tratamento. O aumento dos sintomas é relatado em diversos estudos e prejudicou a qualidade de vida relacionada à saúde das pacientes. Entretanto, os sintomas diminuem após o término da quimioterapia, exceto para algumas escalas. As escalas de imagem corporal, função sexual e funcionamento físico pioram ao longo do tratamento. A qualidade de vida mental/psicológica tem oscilações durante o tratamento, assim como a escala sobre as relações sociais. Conclusão: A qualidade de vida relacionada à saúde de mulheres com câncer de mama é afetada negativamente pelo tratamento quimioterápico, expressando maior impacto nas escalas de sintomas.

Patient-reported outcomes (PRO) from the phase 2 CodeBreaK 100 trial evaluating sotorasib in KRAS p.G12C mutated non-small cell lung cancer (NSCLC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9057-9057
Author(s):  
Alexander I. Spira ◽  
Frederick Hugh Wilson ◽  
Geoffrey Shapiro ◽  
Christophe Dooms ◽  
Alessandra Curioni-Fontecedro ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Health Status ◽  
Chest Pain ◽  
Global Health ◽  
Physical Functioning ◽  
Global Health Status ◽  
Phase 2 ◽  
Cancer Symptoms ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

9057 Background: In the registrational phase 2 CodeBreaK 100 trial, sotorasib demonstrated a response rate of 37.1% with median duration of 10.0 months, a median progression-free survival of 6.8 months, and a tolerable safety profile in patients with pretreated KRAS p.G12C mutated NSCLC. Patients received a median of 2 prior lines of therapy. Here, we report PRO measures of health-related quality of life (QoL), physical functioning, and key lung cancer symptoms from this trial. Methods: Eligible patients had KRAS p.G12C mutated advanced NSCLC and received prior standard therapies. Sotorasib was given at an oral daily dose of 960 mg with 21-day treatment cycles until disease progression. Disease-related symptoms and health-related QoL were evaluated as exploratory endpoints on day 1 of each cycle from baseline to discontinuation, using the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and its lung cancer module, EORTC QLQ-LC13. The single item, 5-point scale GP5, of the Functional Assessment of Cancer Therapy-General version was used to evaluate the impact of side effects. Predefined analyses included change from baseline using descriptive statistics and mixed model for repeated measures for global health status/QoL, physical functioning, and key lung cancer symptoms of cough, dyspnea and chest pain. Results: Of 126 patients enrolled, compliance rates for each of the questionnaires were high throughout the study ( > 70%). Data up to cycle 11 (where n > 20) are presented. EORTC QLQ-C30 global health status/QoL and physical functioning were maintained over time (least-square mean changes ranged from -3.5 to 0.2 and 0.1 to 3.9, respectively). EORTC QLQ-C30 symptoms of fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, and constipation were stable or improved. Similarly, key lung cancer-related symptoms, as measured by EORTC QLQ-LC13, remained stable or improved from baseline, with the greatest least-square mean change of -11.2 (95% Cl: -16.2, -6.1) for cough, -4.9 (95% Cl: -10.3, 0.4) for chest pain, and -3.4 (95% Cl: -7.8, 1.0) for dyspnea. Most patients reported on the GP5 that they were “not at all” (54.2%-79.2%) or “a little bit” (8.3%-33.3%) bothered by side effects from sotorasib, with 0%-7.4% reporting being bothered as “quite a bit” and 0% as “very much”. Conclusions: In patients from the single-arm phase 2 trial of sotorasib, PRO measures suggested maintenance or improvement of global health status/QoL, physical functioning, and the severity of key lung cancer-related symptoms, including cough, dyspnea, and chest pain. Self-reported side effect bother was minimal. These data, together with the encouraging efficacy and safety profiles, strongly support the use of sotorasib in this population. Clinical trial information: NCT03600883.

scholarly journals Assessing functioning in adolescents with chronic fatigue syndrome: psychometric properties and factor structure of the School and Social Adjustment Scale and the Physical Functioning Subscale of the SF36

2020 ◽  
Vol 48 (5) ◽  
pp. 546-556 ◽  
Author(s):  
M.E. Loades ◽  
S. Vitoratou ◽  
K.A. Rimes ◽  
T. Chalder
Keyword(s):  
Chronic Fatigue Syndrome ◽  
Psychometric Properties ◽  
Social Adjustment ◽  
Physical Functioning ◽  
Chronic Fatigue ◽  
Factor Solution ◽  
Fatigue Syndrome ◽  
Functioning Subscale ◽  
Physical Functioning Subscale ◽  
Social Adjustment Scale

AbstractBackground:Chronic fatigue syndrome (CFS) has a major impact on functioning. However, no validated measures of functioning for this population exist.Aims:We aimed to establish the psychometric properties of the 5-item School and Social Adjustment Scale (SSAS) and the 10-item Physical Functioning Subscale of the SF-36 in adolescents with CFS.Method:Measures were completed by adolescents with CFS (n = 121).Results:For the Physical Functioning Subscale, a 2-factor solution provided a close fit to the data. Internal consistency was satisfactory. For the SSAS, a 1-factor solution provided an adequate fit to the data. The internal consistency was satisfactory. Inter-item and item-total correlations did not indicate any problematic items and functioning scores were moderately correlated with other measures of disability, providing evidence of construct validity.Conclusion:Both measures were found to be reliable and valid and provide brief measures for assessing these important outcomes. The Physical Functioning Subscale can be used as two subscales in adolescents with CFS.

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