Health-related quality of life (HRQoL) in patients with advanced melanoma receiving immunotherapies across real-world clinical practice settings.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e21004-e21004
Author(s):  
Richard Wayne Joseph ◽  
Frank Xiaoqing Liu ◽  
Alicia C. Shillington ◽  
Cynthia Macahilig ◽  
Scott J. Diede ◽  
...  

e21004 Background: Pembrolizumab (PEMBRO) and combination ipilimumab + nivolumab (IPI+NIVO) are FDA-approved immunotherapies for advanced melanoma (AM). HRQoL was better maintained with PEMBRO vs IPI in KEYNOTE-006. CheckMate-067 reported no clinically meaningful HRQoL differences with IPI+NIVO vs IPI. As randomized trial data are lacking, we compared HRQoL outcomes in AM between PEMBRO and IPI+NIVO in real-world clinical settings. Methods: A prospective, observational study was conducted with sponsor blinded to sites, and sites blinded to sponsor; nine oncologists from 9 US academic centers and affiliated satellite clinics enrolled AM patients (pts) age ≥18 years initiating first-line PEMBRO or IPI+NIVO between June 2017 – March 2018. The European Organization for the Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ C30) and EQ-5D-5L were administered at baseline and weeks 6, 12, 18, and 24 following therapy. Least squared (LS) mean changes in HRQoL scores from baseline were compared using mixed-effects models for repeated measures, adjusting for baseline covariates. Results: A total of 225 PEMBRO and 187 IPI+NIVO pts were enrolled, with > 95% questionnaire completion rates through week 24. At baseline, PEMBRO pts were more likely > age 65 (49% vs 37%, p = .011), stage IV disease (92% vs 85%; p = .002), and higher comorbidity index (1.0 vs 0.6; p < .001) compared with IPI+NIVO pts. Adjusted EORTC global health status/quality of life (GHS) LS mean changes from baseline showed greater improvement with PEMBRO vs. IPI+NIVO at 12, 18 and 24 weeks. At week 24, PEMBRO pts achieved a 3.3-point improvement (95% CI = 0.8, 5.7) and IPI+NIVO pts had no significant change (1.0, 95% CI = -1.6, 3.5), with a LS mean difference of 2.3 points (p = .037; 95% CI = 0.14, 4.51). At week 24, the EQ-5D visual analogue scale increased 1.0 (95% CI, -1.2, 3.2) for PEMBRO vs IPI+NIVO which decreased 0.9 (95% CI = -3.2, 1.3), with a statistically significant LS mean difference of 2.0 (95% CI = 0.4, 3.9; p = .045). Conclusions: Results from 2 measures suggest HRQoL was maintained vs. baseline in both PEMBRO and IPI+NIVO pts, with a significant between-group difference favoring PEMBRO in GHS over 24 weeks.

2022 ◽  
Vol 29 (1) ◽  
Author(s):  
Adryansyah Can ◽  
Ginanda Putra Siregar ◽  
Bungaran Sihombing

Objective: This study aims to evaluate five years of survival rate, and quality of life of the patient after radical nephrectomy in our center. Material & Methods: This descriptive longitudinal study included thirty patients who were diagnosed as having renal mass in the Urology division H. Adam Malik General Hospital between January 2014 and December 2015. All patients were completely followed-up for 5 years or the patient died during the observation. We used a translated and validated Indonesian written European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) questionnaire to assess the patient’s quality of life. Results: Overall 5-years survival of kidney tumor patients was 100%, 66.67%, 50%, 8.33%, respectively for stage 1 to 4. We found a sharp decrease in the cumulative survival rate of stage IV group in the first 24 months compared to the first 12 months, from 66.67% to 25%. This pattern of decrease was not found in the other group of stage. Overall, the quality of life of patients has increased in the first three years postoperatively and decreased in the two years afterward. These fluctuations consistently occur in all groups. All of the groups had reached the maximum quality of life at the third year postoperatively. Conclusion: Stage I renal cell carcinoma patient shown the best five-years survival rate and quality of life among others. The quality of life for all groups inclined for the first three years after surgery and decline consistently afterward. These findings are in accordance with many studies that have been published previously.  


2004 ◽  
Vol 2 (2) ◽  
pp. 115-124 ◽  
Author(s):  
JÖRG DIRMAIER ◽  
SILKE ZAUN ◽  
UWE KOCH ◽  
TIMO HARFST ◽  
HOLGER SCHULZ

Objective: Recent years have shown an increase in the use of questionnaires measuring health-related quality of life to verify the quality of treatment in the field of oncology. An often used cancer-specific questionnaire is the “Quality of Life Core Questionnaire of the European Organization for the Research and Treatment of Cancer” (EORTC QLQ-C30). The purpose of this study is to analyze the psychometric properties of the EORTC QLQ-C30 (version 1) in order to determine the feasibility and appropriateness for its use in inpatient cancer rehabilitation in Germany with heterogeneous diagnoses.Methods: The questionnaire was administrated to a sample of 972 cancer patients at the beginning of treatment and to 892 patients after treatment. Besides descriptive analysis, the statistical analyses include confirmatory analysis and the multitrait/multimethod approach to test the questionnaire's postulated scale structure (factorial validity) and its reliability (internal consistencies). The analysis also includes a comparison of responsiveness indices (effect size, reliable change index) to test the sensitivity of the instrument.Results: The EORTC QLQ-C30 showed satisfactory levels of reliability and sensitivity, but the postulated scale structure could not be confirmed. The results illustrate that the varimax-rotated solution of a principal component analysis does not confirm the scale structure postulated by the authors. Correspondingly, the selected fit indices within the scope of the confirmatory factor analysis do not show satisfactory results either.Significance of results: We therefore consider version 1 of the EORTC QLQ-C30 to be only limitedly useful for the routine assessment of changes in the quality of life of cancer patients in inpatient rehabilitation in Germany, especially because of the instrument's length and possible redundancies. For this reason, a scoring procedure limited to a subset of items is suggested, revealing satisfactory to good psychometric indices. However, further psychometric tests are necessary, especially with regard to validity and sensitivity.


2020 ◽  
Vol 66 (1) ◽  
Author(s):  
Antonio Augusto Claudio Pereira ◽  
Nayara De Paula Passarin ◽  
Jordana Henriques Coimbra ◽  
Gabriela Grasso Pacheco ◽  
Marcel Pereira Rangel

Introdução: A qualidade de vida de pacientes oncológicos tem sido objeto de estudo em muitos trabalhos brasileiros. Contudo, apesar da alta prevalência de indivíduos submetidos a radioterapia, poucos estudos com ênfase nesse grupo de pacientes foram identificados. Objetivo: Avaliar a qualidade de vida e a prevalência de sintomas depressivos em pacientes com neoplasias malignas durante o tratamento radioterápico. Método: Estudo transversal quantitativo realizado com 153 pacientes oncológicos em vigência de tratamento radioterápico em um centro especializado em oncologia e radioterapia, localizado no Noroeste do Estado do Parana. Os dados foram coletados entre marco e setembro de 2018. O European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) e o Inventario de Depressão de Beck foram utilizados para avaliar a qualidade de vida e os sintomas depressivos, respectivamente. Resultados: Os domínios “qualidade de vida”, “função cognitiva” e “função social” foram os que menos se mostraram prejudicados na amostra estudada, enquanto “insônia”, “perda de apetite” e “dificuldades financeiras” destacaram-se entre os maiores preditores de baixa qualidade de vida. Ademais, contatou-se que 22% dos indivíduos avaliados apresentaram algum grau de transtorno de humor, sendo 11% diagnosticados com depressão. Conclusão: O declínio na qualidade de vida e a prevalência de sintomas depressivos em pacientes oncológicos, mesmo os em vigência de radioterapia, enaltecem a importância de intervenções precoces que visem a restabelecer a funcionalidade e o bem-estar.


2019 ◽  
Vol 76 (6) ◽  
pp. 598-606
Author(s):  
Jovica Milovanovic ◽  
Dragoslava Andrejic ◽  
Ana Jotic ◽  
Vojko Djukic ◽  
Oliver Toskovic ◽  
...  

Backround/Aim. Considering the distinct increase in the incidence of oropharyngeal cancer over oral cavity cancers and changing epidemiology with human papilloma virus (HPV) infection emerging as an important risk factor, there is a need to establish better treatment choices in specific groups of patients with oropharyngeal cancer. The aim of this study was to assess the quality of life (QOL) and functional performance and the impact of different demographical data, stage of disease, and treatment type on these parameters in patients with oropharyngeal cancer with successfully achieved locoregional control a year after the treatment. Methods. Study included 87 patients who underwent QOL and functional impairment assessment 12 to 14 months after finished oncological treatment with the following questionnaires: the European Organization for Research and Treatment of Cancer Quality-of Life-Questionnaire-C30 (EORTC QLQ-C30), European Organization for Research and Treatment of Cancer Quality of- Life Questionnaire-Head and Neck 35 (EORTC QLQ-H&N35) and The Karnofsky Performance Scale (KPS). Results. Specific groups of patients had significantly different post-treatment QOL scores. The factors associated with the worse QOL scores were female gender, not being in a partnership, level of education and HPV status. Conclusion. Clinicians should consider socioeconomic factors and HPV status in planning the recovery after treatment of patients with oropharyngeal carcinoma. Gender, education level and employment are the variables that form a certain risk profiles associated with the lower QOL.


2020 ◽  
Vol 66 (1) ◽  
Author(s):  
Monique Binotto ◽  
Gilberto Schwartsmann

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.


1995 ◽  
Vol 13 (5) ◽  
pp. 1249-1254 ◽  
Author(s):  
M J Hjermstad ◽  
S D Fossa ◽  
K Bjordal ◽  
S Kaasa

PURPOSE The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a well-validated instrument that assesses health-related quality of life (HRQOL) in cancer patients. It is used in cancer clinical trials in Europe, Canada, and the United States, and has demonstrated high reliability and validity in different groups of cancer patients. Despite thorough testing of reliability and validity, we have not identified any reports on its test/retest reliability; thus, a test/retest study was performed at the Norwegian Radium Hospital (NRH). MATERIALS AND METHODS Cancer patients from the outpatient clinic who were off treatment for > or = 3 months were eligible for the study. The EORTC QLQ-C30 was given to the patients when they presented for their visit. The second questionnaire was received by the patients 4 days later. Of 291 eligible patients, 270 (93%) agreed to participate and 190 (73%) completed both questionnaires. RESULTS The test/retest reliability measured by Pearson's correlation coefficient was high for all functional scales, with a range from .82 for cognitive and role function to .91 for physical function. The r value for global HRQOL was .85. For the symptom scales--nausea/vomiting, fatigue, and pain--the coefficients were .63, .83, and .86, respectively. The single-item coefficients ranged from .72 for diarrhea to .84 for financial impact. The Spearman rank correlation was in the same range for all dimensions. CONCLUSION The EORTC QLQ-C30 seems to yield high test/retest reliability in patients with various cancer diagnoses whose condition is not expected to change during the time of measurement.


Thorax ◽  
2019 ◽  
Vol 74 (4) ◽  
pp. 354-361 ◽  
Author(s):  
Fraser Brims ◽  
Samal Gunatilake ◽  
Iain Lawrie ◽  
Laura Marshall ◽  
Carole Fogg ◽  
...  

PurposeMalignant pleural mesothelioma (MPM) has a high symptom burden and poor survival. Evidence from other cancer types suggests some benefit in health-related quality of life (HRQoL) with early specialist palliative care (SPC) integrated with oncological services, but the certainty of evidence is low.MethodsWe performed a multicentre, randomised, parallel group controlled trial comparing early referral to SPC versus standard care across 19 hospital sites in the UK and one large site in Western Australia. Participants had newly diagnosed MPM; main carers were additionally recruited. Intervention: review by SPC within 3 weeks of allocation and every 4 weeks throughout the study. HRQoL was assessed at baseline and every 4 weeks with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30. Primary outcome: change in EORTC C30 Global Health Status 12 weeks after randomisation.ResultsBetween April 2014 and October 2016, 174 participants were randomised. There was no significant between group difference in HRQoL score at 12 weeks (mean difference 1.8 (95% CI −4.9 to 8.5; p=0.59)). HRQoL did not differ at 24 weeks (mean difference −2.0 (95% CI −8.6 to 4.6; p=0.54)). There was no difference in depression/anxiety scores at 12 weeks or 24 weeks. In carers, there was no difference in HRQoL or mood at 12 weeks or 24 weeks, although there was a consistent preference for care, favouring the intervention arm.ConclusionThere is no role for routine referral to SPC soon after diagnosis of MPM for patients who are cared for in centres with good access to SPC when required.Trial registration numberISRCTN18955704.


2020 ◽  
Vol 29 (10) ◽  
pp. 2651-2660
Author(s):  
Richard W. Joseph ◽  
Frank Xiaoqing Liu ◽  
Alicia C. Shillington ◽  
Cynthia P. Macahilig ◽  
Scott J. Diede ◽  
...  

Abstract Background Pembrolizumab (PEMBRO) and ipilimumab + nivolumab (IPI + NIVO) are approved advanced melanoma (AM) immunotherapies. To address limited health-related quality of life (QoL) real-world evidence with immunotherapies in AM, we compared QoL in AM patients receiving either treatment in clinical practice. Methods A prospective US observational study enrolled adult AM patients initiating first-line PEMBRO or IPI + NIVO between June 2017 and March 2018. Endpoints included the QLQ-C30 global health score (GHS) and EuroQol visual analog scale (EQ-VAS) scores. Mean changes were compared using repeated measures mixed-effects models and are presented covariate adjusted. Results 225 PEMBRO and 187 IPI + NIVO patients were enrolled. From baseline through week 24, PEMBRO was associated with 3.2 mean GHS score increase (95% CI 0.5, 5.9; p = .02), while no change was observed with IPI + NIVO; 0.2 (95% CI − 2.6, 3.0; p = 0.87). Among objective treatment-responders, GHS scores associated with PEMBRO increased 6.0 (95% CI 3.1, 8.8; p < .0001); IPI + NIVO patients increased 3.8 (95% CI 0.8, 6.9; p = .01). In treatment non-responders, IPI + NIVO was associated with GHS/QoL deterioration of − 3.7 (95% CI − 6.8, − 0.6; p = .02), PEMBRO non-responders demonstrated no change; 0.7 (95% CI − 2.3, 3.7; p = 0.6). Between treatments, PEMBRO patients increased 2.6 greater in EQ-VAS (95% CI 0.6, 4.5; p = .01) vs IPI + NIVO at 24 weeks. Conclusions PEMBRO was associated with better 24-week QoL compared to IPI + NIVO in actual clinical practice settings. Real-world data has known limitations, but with further confirmation these results may have implications for treatment selection.


2020 ◽  
Vol 28 (11) ◽  
pp. 5469-5478
Author(s):  
Yemataw Wondie ◽  
Andreas Hinz

Abstract Purpose Cancer is of increasing prevalence in less-developed countries. However, research on the patients’ quality of life (QoL) in these countries is very limited. The aim of this study was to examine QoL of cancer patients in Africa. Method A sample of 256 cancer patients treated in an Ethiopian hospital was examined with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-C30, the Multidimensional Fatigue Inventory, and the Hospital Anxiety and Depression Scale. A group of 1664 German cancer patients served as a comparison group. Results Most of the scales of the EORTC QLQ-C30 showed acceptable reliability in the Ethiopian sample. Compared with the German cancer patients, the Ethiopian patients showed lower QoL in most dimensions, especially in financial difficulties, physical functioning, pain, and appetite loss (effect sizes between 0.52 and 0.75). Illiteracy, tumor stage, and treatment (surgery and chemotherapy) were associated with QoL in the Ethiopian sample. QoL was strongly correlated with fatigue, anxiety, and depression. Conclusion The EORTC QLQ-C30 is a suitable instrument for measuring QoL in Ethiopia. The detriments in QoL in the Ethiopian patients indicate specific cancer care needs for the patients in a developing country.


2003 ◽  
Vol 21 (10) ◽  
pp. 1944-1951 ◽  
Author(s):  
Louise Bordeleau ◽  
John Paul Szalai ◽  
Marguerite Ennis ◽  
Molyn Leszcz ◽  
Michael Speca ◽  
...  

Purpose: To evaluate the effect of a standardized group psychosocial intervention on health-related quality of life (HrQOL) in women with metastatic breast cancer and to explore the effect of missing data in HrQOL analyses. Patients and Methods: Between 1993 and 1998, seven Canadian centers randomly assigned 235 eligible women to participate in a weekly, 90-minute, therapist-led support group that adhered to principles of supportive-expressive (SE) therapy or to a control arm (no SE). All women received educational material and any type of medical or psychosocial care deemed necessary. HrQOL data were prospectively collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) at baseline, 4, 8, and 12 months. The primary HrQOL analyses compared scores in the two study arms. Analyses were limited to women with appropriate baseline HrQOL information (n = 215). Results: Baseline EORTC QLQ-C30 scores were not different between the two study arms (all P > .05). Primary analysis of all subscales failed to show a significant influence of the intervention on HrQOL (all P > .05). There was a significant deterioration over time in several functional scales of the EORTC QLQ-C30: global (P = .03), physical (P = .0002), role (P = .01), and cognitive functioning (P = .04); and in symptom scales: dyspnea (P = .007), appetite loss (P = .04), and fatigue (P = .003); these changes were independent of randomization allocation. Results were similar in additional analyses of overall HrQOL using a variety of approaches to handling missing data. Conclusion: Supportive-expressive group therapy in patients with metastatic breast cancer does not appear to influence HrQOL, as measured by the EORTC QLQ-C30.


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