United States Utility Algorithm for the EORTC QLU-C10D, a Multiattribute Utility Instrument Based on a Cancer-Specific Quality-of-Life Instrument

2021 ◽  
pp. 0272989X2110035
Author(s):  
Dennis A. Revicki ◽  
Madeleine T. King ◽  
Rosalie Viney ◽  
A. Simon Pickard ◽  
Rebecca Mercieca-Bebber ◽  
...  

Background The EORTC QLU-C10D is a multiattribute utility measure derived from the cancer-specific quality-of-life questionnaire, the EORTC QLQ-C30. The QLU-C10D contains 10 dimensions (physical, role, social and emotional functioning, pain, fatigue, sleep, appetite, nausea, bowel problems). The objective of this study was to develop a United States value set for the QLU-C10D. Methods A US online panel was quota recruited to achieve a representative sample for sex, age (≥18 y), race, and ethnicity. Respondents undertook a discrete choice experiment, each completing 16 choice-pairs, randomly assigned from a total of 960 choice-pairs. Each pair included 2 QLU-C10D health states and duration. Data were analyzed using conditional logistic regression, parameterized to fit the quality-adjusted life-year framework. Utility weights were calculated as the ratio of each dimension-level coefficient to the coefficient for life expectancy. Results A total of 2480 panel members opted in, 2333 (94%) completed at least 1 choice-pair, and 2273 (92%) completed all choice-pairs. Within dimensions, weights were generally monotonic. Physical functioning, role functioning, and pain were associated with the largest utility weights. Cancer-specific dimensions, such as nausea and bowel problems, were associated with moderate utility decrements, as were general issues such as problems with emotional functioning and social functioning. Sleep problems and fatigue were associated with smaller utility decrements. The value of the worst health state was 0.032, which was slightly greater than 0 (equivalent to being dead). Conclusions This study provides the US-specific value set for the QLU-C10D. These estimated health state scores, based on responses to the EORTC QLQ-C30 questionnaire, can be used to evaluate the cost-utility of oncology treatments.

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e048175
Author(s):  
Chloe Grimmett ◽  
Andrew Bates ◽  
Malcolm West ◽  
Samantha Leggett ◽  
Judit Varkonyi-Sepp ◽  
...  

IntroductionThe impact of the COVID-19 pandemic (caused by the SARS-CoV-2 virus) on individuals with cancer has been profound. It has led to increased anxiety, distress and deconditioning due to reduced physical activity. We aim to investigate whether SafeFit, a multimodal intervention of physical activity, nutrition and psychological support delivered virtually by cancer exercise specialists (CES), can improve physical and emotional functionings during the COVID-19 pandemic.Methods and analysisA phase III non-randomised intervention trial, target recruitment of 1050 adults with suspected or confirmed diagnosis of cancer. All recruited participants will receive the multimodal intervention delivered by CES for 6 months. Sessions will be delivered 1-to-1 using telephone/video conferencing consultations. CES will work with each participant to devise a personalised programme of (1) physical activity, (2) basic dietary advice and (3) psychological support, all underpinned by behaviour change support.Primary outcomePhysical and emotional functioning as measured by the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC-QLQ-C30). Secondary outcomes: overall quality of life measured by EORTC-QLQ-C30 and EQ-5D-5L, health economics, patient activation, self-efficacy to self-manage chronic disease, distress, impact of COVID-19 on emotional functioning, self-reported physical activity, functional capacity and nutrition. Adherence to the intervention will also be measured and a process evaluation conducted.Ethics and disseminationEthical approval was obtained from the Health Research Authority (reference number 20/NW/0254). Results of this trial will be disseminated through publication of peer-reviewed articles, presentations at scientific conferences, and to the public and people with cancer in collaboration with our patient and public involvement representatives and partners.Trial registration numberNCT04425616.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8046-8046
Author(s):  
Evangelos Terpos ◽  
Meletios A. Dimopoulos ◽  
Mario Boccadoro ◽  
Sosana Delimpasi ◽  
Meral Beksac ◽  
...  

8046 Background: APOLLO (NCT03180736) is a phase 3 trial of pomalidomide and dexamethasone (Pd) ± subcutaneous daratumumab (1800 mg, co-formulated with recombinant human hyaluronidase PH20 in 15 mL) in patients with RRMM and ≥1 prior line of therapy including lenalidomide and a proteasome inhibitor. After 16.9 months (mo) median follow-up, D-Pd significantly reduced the rate of progression or death by 37% relative to Pd. Patients with RRMM have reduced HRQoL compared with age- and sex-matched populations. Here, we present PROs from the APOLLO trial. Methods: Patients were randomized 1:1 to D-Pd or Pd and treated in 28-day cycles until disease progression/unacceptable toxicity. PROs were assessed on Day 1 of each cycle using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30), EORTC QLQ Multiple Myeloma Module 20-item (MY20), and EuroQol 5-dimensional descriptive system. PRO analyses were performed on patients from the intent-to-treat population with a baseline (BL) and ≥1 post-BL assessment. Treatment effect was assessed by a mixed effects model with repeated measures. Time to worsening was estimated using the Kaplan-Meier method. Results: A total of 304 patients were included (151 D-Pd, 153 Pd). Median treatment duration was 11.5 mo with D-Pd vs 6.6 mo with Pd. At Cycle 16 (Cyc 16), 63 and 40 patients remained on treatment in the D-Pd and Pd groups, respectively. Compliance rates for PRO instruments were high and comparable between groups. Patients treated with D-Pd had a reduction in pain (maximum improvement: 6.8 points at Cyc 12) measured with the EORTC QLQ-C30 and no mean change in disease symptoms or the treatment side effects subscales of the EORTC QLQ-MY20. Group mean physical and emotional functioning were unchanged from BL with D-Pd but worsened in the Pd group (maximum worsening: 6.4 at Cyc 4 and 9.1 points at Cyc 14). The proportion of patients with a meaningful improvement from BL was 55.0% vs 49.0% for disease symptoms, 43.0% vs 35.3% for physical functioning, and 41.7% vs 31.4% for emotional functioning with D-Pd vs Pd, respectively. Median time to worsening was ̃4 mo, except for the disease symptoms subscale (̃10 mo); there were no differences between groups. Conclusions: When daratumumab was added to Pd, patients did not experience any decrements in HRQoL while on treatment, but some patients experienced reductions in pain as well as clinically meaningful improvements in symptoms and emotional/physical function. These findings complement the clinical benefits of D-Pd in RRMM patients and further support its use in this RRMM population. Clinical trial information: NCT03180736.


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.


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.


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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