scholarly journals Prospective multicentre randomised clinical trial comparing survival rates, quality of life and nutritional status between advanced gastric cancer patients with different follow-up intensities: study protocol for the STOFOLUP trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e056187
Author(s):  
Bang Wool Eom ◽  
Dong-Hoe Koo ◽  
Ji Yeong An ◽  
Han Hong Lee ◽  
Hyoung-Il Kim ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Stomach Cancer ◽  
Diagnostic Tools ◽  
Life Questionnaire ◽  
European Organization ◽  
Free Survival

IntroductionPatients who underwent curative gastrectomy for gastric cancer are regularly followed-up for the early detection of recurrence and postoperative symptom management. However, there is a lack of evidence with regard to proper surveillance intervals and diagnostic tools. This study aims to evaluate whether frequent surveillance tests have a survival benefit or improve the quality of life in patients who underwent curative resection for advanced gastric cancer.Methods and analysisThe STOFOLUP trial is an investigator-initiated, parallel-assigned, multicentre randomised controlled trial involving 16 hospitals in the Republic of Korea. Patients (n=886) diagnosed with pathological stage II or III gastric adenocarcinoma will be randomised to either the 3-month or the 6-month group at a 1:1 ratio, stratified by trial site and tumour stage. Patients allocated to the 3-month group will undergo an abdominal CT scan every 3 months postoperatively and those allocated to the 6-month group will undergo CT every 6 months. The primary endpoint is 3-year overall survival and the secondary endpoints are quality of life, as assessed using KOrean QUality of life in Stomach cancer patients Study group-40, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the stomach cancer-specific module (STO22), and nutritional outcomes. Other survival data including data concerning 3-year disease-free survival, recurrence-free survival, gastric cancer-specific survival and postrecurrence survival will also be estimated. The first patient was enrolled on July 2021 and active patient enrolment is currently underway.Ethics and disseminationThis study has been approved by the Institutional Review Board of eight of the participating hospitals (NCC 2021-0085, KBSMC2021-01-059, SMC 2021-01-140, KC21OEDE0082, 4-2021-0281, AJIRB-MED-INT-20-608, 2021-0515 and H-2102-093-1198). This study will be disseminated through peer-reviewed publications, national or international conferences.Trial registration numberNCT04740346.

Psychometric properties of the EORTC Quality of Life Questionnaire in inpatient cancer rehabilitation in Germany

2004 ◽  
Vol 2 (2) ◽  
pp. 115-124 ◽  
Author(s):  
JÖRG DIRMAIER ◽  
SILKE ZAUN ◽  
UWE KOCH ◽  
TIMO HARFST ◽  
HOLGER SCHULZ
Keyword(s):  
Quality Of Life ◽  
Psychometric Properties ◽  
Cancer Patients ◽  
Scale Structure ◽  
Cancer Rehabilitation ◽  
Life Questionnaire ◽  
European Organization ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

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.

Test/retest study of the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire.

1995 ◽  
Vol 13 (5) ◽  
pp. 1249-1254 ◽  
Author(s):  
M J Hjermstad ◽  
S D Fossa ◽  
K Bjordal ◽  
S Kaasa
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Reliability And Validity ◽  
Life Questionnaire ◽  
European Organization ◽  
Retest Reliability ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Test Retest Reliability

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.

scholarly journals Quality of life among Ethiopian cancer patients

2020 ◽  
Vol 28 (11) ◽  
pp. 5469-5478
Author(s):  
Yemataw Wondie ◽  
Andreas Hinz
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Depression Scale ◽  
Developed Countries ◽  
Anxiety And Depression ◽  
Life Questionnaire ◽  
European Organization ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

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.

Self-Reported Quality of Life of Individual Cancer Patients: Concordance of Results With Disease Course and Medical Records

2001 ◽  
Vol 19 (7) ◽  
pp. 2064-2073 ◽  
Author(s):  
Galina Velikova ◽  
Penny Wright ◽  
Adam B. Smith ◽  
Daniel Stark ◽  
Timothy Perren ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Medical Records ◽  
Social Issues ◽  
Life Questionnaire ◽  
Disease Course ◽  
Group Level ◽  
European Organization ◽  
Clinical Records

PURPOSE: To investigate the applicability of a standard quality of life (QL) questionnaire to individual cancer patients and to explore the potential for impact of QL information on the process of care by comparing at group level the QL results with the medical records. PATIENTS AND METHODS: One hundred fourteen consecutive patients at the oncology clinics at St James’s Hospital, Leeds, United Kingdom, completed the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 on a touch-screen computer over a 6-month period. The QL results were compared with the corresponding medical records at individual and group level. RESULTS: For individual patients, the serial measurement of QL allowed recognition of patterns over time corresponding to disease course. At group level, a higher proportion of patients reported problems on EORTC QLQ-C30 than were mentioned in the medical records (McNemar paired test, P < .01). Most often clinicians mentioned pain (22% to 39%), and at the initial visit role (66%), and social issues (77%). For the rest of the symptoms and functions, the problems were recorded in between 1% and 25% of the notes, but 20% to 76% of the patients reported QL impairment. Problems that were not recorded in the medical notes tended to be of low severity, with a significant trend observed for pain, fatigue, nausea/vomiting, dyspnea, loss of appetite, and physical function scale (χ2 test, 11.55 to 34.42, df = 1, P < .001). CONCLUSION: The QL data on individual patients was consistent with the clinical records, thus providing evidence for the validity of these measures in assessment of the individual. The QL profiles had more information on symptoms and particularly on functional issues, such as emotional distress and physical performance.

Automated Collection of Quality-of-Life Data: A Comparison of Paper and Computer Touch-Screen Questionnaires

1999 ◽  
Vol 17 (3) ◽  
pp. 998-998 ◽  
Author(s):  
G. Velikova ◽  
E. P. Wright ◽  
A. B. Smith ◽  
A. Cull ◽  
A. Gould ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Data Quality ◽  
Cancer Patients ◽  
Touch Screen ◽  
Time Interval ◽  
Life Questionnaire ◽  
European Organization ◽  
Quality And Reliability ◽  
Global Agreement

PURPOSE: To evaluate alternative automated methods of collecting data on quality of life (QOL) in cancer patients. After initial evaluation of a range of technologies, we compared computer touch-screen questionnaires with paper questionnaires scanned by optical reading systems in terms of patients' acceptance, data quality, and reliability. PATIENTS AND METHODS: In a randomized cross-over trial, 149 cancer patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30, version 2.0 (EORTC QLQ-C30), and the Hospital Anxiety and Depression Scale (HADS) on paper and on a touch screen. In a further test-retest study, 81 patients completed the electronic version of the questionnaires twice, with a time interval of 3 hours between questionnaires. RESULTS: Fifty-two percent of the patients preferred the touch screen to paper; 24% had no preference. The quality of the data collected with the touch-screen system was good, with no missed responses. At the group level, the differences between scores obtained with the two modes of administration of the instruments were small, suggesting equivalence for most of the QOL scales, with the possible exception of the emotional, fatigue, and nausea/vomiting scales and the appetite item, where patients tended to give more positive responses on the touch screen. At the individual patient level, the agreement was good, with a kappa coefficient from 0.57 to 0.77 and percent global agreement from 61% to 97%. The electronic questionnaire had good test-retest reliability, with correlation coefficients between the two administrations from 0.78 to 0.95, kappa coefficients of agreement from 0.55 to 0.90, and percent global agreement from 56% to 100%. CONCLUSION: Computer touch-screen QOL questionnaires were well accepted by cancer patients, with good data quality and reliability.

scholarly journals European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30: factorial models to Brazilian cancer patients

2018 ◽  
Vol 16 (1) ◽  
Author(s):  
Juliana Alvares Duarte Bonini Campos ◽  
Maria Cláudia Bernardes Spexoto ◽  
Wanderson Roberto da Silva ◽  
Sergio Vicente Serrano ◽  
João Marôco
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Convergent Validity ◽  
Discriminant Validity ◽  
Theoretical Models ◽  
Life Questionnaire ◽  
Factorial Validity ◽  
European Organization ◽  
Quality Of Life Questionnaire

ABSTRACT Objective To evaluate the psychometric properties of the seven theoretical models proposed in the literature for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), when applied to a sample of Brazilian cancer patients. Methods Content and construct validity (factorial, convergent, discriminant) were estimated. Confirmatory factor analysis was performed. Convergent validity was analyzed using the average variance extracted. Discriminant validity was analyzed using correlational analysis. Internal consistency and composite reliability were used to assess the reliability of instrument. Results A total of 1,020 cancer patients participated. The mean age was 53.3±13.0 years, and 62% were female. All models showed adequate factorial validity for the study sample. Convergent and discriminant validities and the reliability were compromised in all of the models for all of the single items referring to symptoms, as well as for the “physical function” and “cognitive function” factors. Conclusion All theoretical models assessed in this study presented adequate factorial validity when applied to Brazilian cancer patients. The choice of the best model for use in research and/or clinical protocols should be centered on the purpose and underlying theory of each model.

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