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ORIGINAL ARTICLE
Year : 2017  |  Volume : 6  |  Issue : 4  |  Page : 824-831  

An assessment of reliability and validity of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 among breast cancer patients in Qatar


1 Department of Biostatistics and Medical Informatics, Cerrahpaşa Faculty of Medicine, Istanbul University; Department of Evidence for Population Health Unit, School of Epidemiology and Health Sciences, University of Manchester, Manchester, UK; Department of Public Health, Istanbul Medipol University, International School of Medicine, Dept. Public Health, İstanbul, Turkey, Turkey
2 Department of Oncology and Hematology, Al Amal Hospital, Hamad Medical Corporation, Qatar, France; Regent's University London, Scool of Psychoterapy and Psychology, Inner Circle, Regent's Park, London NW1 4NS, UK
3 Regent's University London, Scool of Psychoterapy and Psychology, Inner Circle, Regent's Park, London NW1 4NS, UK
4 Department of Public Health, Istanbul Medipol University, International School of Medicine, Dept. Public Health, İstanbul, Turkey; Department of Clinical Hematologist and A Stem Cell Transplantation, Hospital Saint Louis, Paris, France

Date of Web Publication15-Feb-2018

Correspondence Address:
Prof. Abdulbari Bener
Department of Biostatistics and Medical Informatics, Cerrahpasa Faculty of Medicine, Istanbul University, 34098 Cerrahpasa, Istanbul
Turkey
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jfmpc.jfmpc_17_17

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  Abstract 


Introduction: Breast cancer has been the most common cancer type that affects women worldwide and subsequent treatment is often associated with considerable psychological and quality of life (QoL). Aim: This study aimed to assess psychometric properties of the Arabic version of the European Organization for Research and Treatment of Cancer (EORTC) general QoL questionnaire (QLQ-C30) for breast cancer patients in Qatar. Materials and Methods: This is a cross-sectional hospital-based study conducted on 678 breast cancer patients using Arabic version of the EORTC QLQ-C30 tool. Results: The mean age of women was 47.7 ± 10.2 years and 33.4% of women had consanguineous parents. Six subscales out of the nine met the standards of reliability with coefficients ranging from 0.55 to 0.89. The mean score of all functioning scales was high >55. Advanced breast cancer stages of III–IV had higher symptomatic scores significantly than those in early stages for the physical function, cognitive, fatigue, insomnia, appetite loss, constipation, and financial difficulties. Correlation coefficients between each item ranged from –0.113 to 0.960, and item 21 (tense) and item 23 (irritable) had strongest negative correlations with their corresponding emotional functioning subscale, whereas items 29 (physical condition) and 30 (overall QoL) had the strongest positive correlation with Global Health/QoL subscale. Item 6 (limited work) showed a higher correlation with fatigue (r = 0.749). Likewise, item 19 (pain interfered with daily activities) of the pain subscale had higher correlations with physical functioning, role functioning, and fatigue subscales. Conclusion: Qatari Arabic version of the EORTC QLQ-C30 showed acceptable psychometric properties, which is a reliable and valid instrument, that can be used by oncologists.

Keywords: European Organization for Research and Treatment of Cancer and Quality of Life Questionnaire-C30, functional scale, internal consistency, oncology, quality of life, symptom scale, women


How to cite this article:
Bener A, Alsulaiman R, Doodson L, El Ayoubi HR. An assessment of reliability and validity of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 among breast cancer patients in Qatar. J Family Med Prim Care 2017;6:824-31

How to cite this URL:
Bener A, Alsulaiman R, Doodson L, El Ayoubi HR. An assessment of reliability and validity of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 among breast cancer patients in Qatar. J Family Med Prim Care [serial online] 2017 [cited 2019 Jul 24];6:824-31. Available from: http://www.jfmpc.com/text.asp?2017/6/4/824/225518




  Introduction Top


Breast cancer is one of the most common and important health problems of women in developed and developing countries and accounts for almost 30% of all cancer types among women.[1],[2] As for Qatar, breast cancer has been the most common cancer type that affects women and in the majority of developed and developing countries.[3] Cancer is one of the most common causes of death worldwide, accounting for 7.6 million deaths in 2008,[1] and it has been estimated that this number will rise to 11 million in 2030. The breast cancer mortality rate is also expected to rise significantly in developed and in developing countries.[4] Breast cancer is one of the most frequent causes of morbidity and mortality among women in the world and receiving a diagnosis of cancer is extremely stressful and depressive.[5] Breast cancer can have major adverse psychological, social, psychosocial, physical, and economic consequences for both the individuals with the illness and their families.[5] Psychological distress is frequently observed in cancer patients during the clinical course of this disease. The prevalence of psychiatric disorders following a primary diagnosis of cancer has been reported to range from 14% to 38%, and the feeling of depression is a common psychiatric disorder in cancer patients.[5],[6] An extensive literature review has shown that nearly a third to a half of female breast cancer patients are likely to experience psychological distress,[7] and up to one-third suffer from psychological morbidity, such as anxiety or depression.[5],[8]

The diagnosis and subsequent treatment of cancer is often associated with considerable psychological and social difficulties for patients. Quality of life (QoL) has become a part of the evaluation criteria for cancer therapy besides the classical biomedical criteria.[5],[6],[7] It is the most frequently used outcome measure in oncology research.[9] The most commonly used QOL tool in oncology is the European Organization for Research and Treatment of Cancer QoL questionnaire (EORTC QLQ-C30).[9],[10],[11] In Qatar, there is very little information available about the QoL of cancer patients.[5] The EORTC QLQ-C30 is a questionnaire used to assess the QoL in breast cancer patients. The QLQ-C30 questionnaire has been used worldwide. It has been translated to over 55 languages [11] and its psychometric properties have been studied in different cultures.[11],[12],[13] The aim of this study was to assess the psychometric properties of the Arabic version of the EORTC general QLQ-C30 for breast cancer patients in Qatar.


  Materials and Methods Top


In Asian and Arabian Gulf countries, breast cancer is the leading cancer among women,[1],[2] and the increasing morbidity and mortality rates could be due to the late diagnosis of the disease. Qatari patients accounted for 32% of all the breast cancer diagnoses in females aged 40–50 years and 36% of all affected women.[3],[15],[16],[17]

This is an observational cohort hospital study based on the National Cancer Disease Registry of Al-Amal hospital, Hamad Medical Corporation. All cancer cases were coded using the International Classification of Diseases-10 (ICD-10) criteria. According to the ICD-10, malignant neoplasms of breast were coded under C50.

A list of 964 eligible breast cancer patients was prepared from the disease registry from December 2012 to June 2015 who could be contacted. From the list, 678 breast cancer patients agreed to take part in this study, thus a response rate of 68.1%. Meanwhile, 317 women either refused or were not available to take part in the study due to personal reasons and lack of time. The data of sociodemographic information, type of consanguinity, menopause status, medical history, lifestyle habits, and dietary intake were collected using a questionnaire. The anthropometric measures of the studied patients were collected and measured by qualified and well-trained nurses. Height and weight were measured using standardized methods. Body mass index was calculated as weight in kilograms divided by height in meter squared.

Questionnaire

The EORTC QLQ-C30[12],[13],[14],[15] is a 30-item questionnaire composed of five functional subscales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), and a Global Health (GH) Status and QoL scale.[10] The remaining five single items assess symptoms commonly reported by cancer patients (dyspnea, insomnia, appetite loss, constipation, and diarrhea).[18] Scores of subscales are calculated based on the scoring manual of the instrument. All subscale scores range from 0 to 100, where high scores represent better levels of functioning, in contrast to symptom scales, where higher scores indicate higher levels of problems.[12],[13]

The study was approved by the Research Ethics Committee of Hamad General Hospital, Hamad Medical Corporation, and conducted in accordance with the Declaration of Helsinki. All the individuals who agreed to participate in this study gave their informed consent prior to their inclusion in the study.

The data were analyzed using the Statistical Package for the Social Sciences (IBM SPSS Statistics for Windows, Version 22.0. IBM Corp., Armonk, NY). Reliability (internal consistency) of the questionnaire was tested by Cronbach's alpha coefficient and the acceptable value to be met was >0.70. Multitrait scaling analysis was used for evaluating item convergent and discriminant validity. In addition, convergent validity was predicted if the correlation value of an item with its own scale was >0.40 and discriminant validity was predicted if the correlation of an item with its own scale was higher than that with other scales. Meanwhile, construct validity was evaluated under the hypothesis that the QLQ-C30 subscales correlated with each other (acceptable correlation coefficients were >0.40) and by known-groups comparisons analyzing the correlation between subgroups of patients differing in disease stage and education level. Student's t-test was used to ascertain the significance of differences between the mean values of two continuous variables and it was confirmed by nonparametric Mann–Whitney test. Chi-square and Fisher's exact tests were performed to test for differences in proportions of categorical variables between two or more groups. One Way Analysis of variance (ANOVA) and non-parametric statistical method the Kruskal-Wallis one way analysis of variance were employed for comparison of several group means and to determine the presence of significant differences between group means. The Spearman rank correlation coefficient was used to evaluate the strength association between two variables. The level P < 0.05 was considered as the cutoff value for significance.


  Results Top


[Table 1] shows the sociodemographic characteristics of the breast cancer patients (n = 678). The mean age of the studied women was 47.7 ± 10.2 years. Among the studied patients, 34.7% were Qataris and 65.3% were Arab expatriates. Nearly 43% of the patients were in premenopausal status and 57% in postmenopausal status. About 86.1% of women were married, 14.6% were illiterate women, 20.9% were university graduates, 37.2% were homemakers, and 33.4% of the women had consanguineous parents. Smoking habit was less common in the studied Arab women (9.1%), but shisha smoking was more common (17.7%).
Table 1: Sociodemographic characteristics of breast cancer patients (n=762)

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[Table 2] presents the lifestyle and clinical characteristics of the study sample. Daily physical activity was less practiced among women during hot climates, only 25.7% walked 30 min per day and 14% walked 60 min per day. Breastfeeding was practiced among 67.7% of women and over 73% were considered overweight and obese. Furthermore, over 75% of breast cancer women were at the Stage 3 (40.9%) and Stage 4 (35.8%) of the disease. The percentage of patients who underwent mastectomy and lumpectomy was 49.3% and 50.7%, respectively.
Table 2: Lifestyle and clinical characteristics of the study sample (n=762)

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Reliability

[Table 3] shows the Cronbach's alpha coefficients and the mean scores of the subscales. Six subscales out of the nine met the standards of reliability with coefficients ranging from 0.55 to 0.89. Cognitive subscale had the lowest alpha value of 0.55, indicating an adequate scale reliability. The mean score of all functioning scales was >55, thus indicating a higher level of functioning. Similarly, the mean scores of symptom scales were found to be <50, thus representing less symptomatology and problems with the exception of the financial impact.
Table 3: Mean scores and internal consistency of each subscale/item of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 among breast cancer patients (n=762)

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[Table 4] presents summary of the EORTC-C30 subclasses by disease stage among breast cancer patients. As shown in table, findings of known-group comparisons according to the disease stage generally showed that patients with advanced stages of breast cancer (Stages III–IV) had higher symptomatic scores significantly than those in early stages for the physical function, cognitive, fatigue, insomnia, appetite loss, constipation, and financial difficulties.
Table 4: Summary of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 subclasses by disease stage among breast cancer patients (n=762)

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Multitrait scaling analysis

[Table 5] summarizes Pearson's correlation coefficients between each item and its own scales. With the exception of item 5 (help in eating/dressing), all item-scale correlation coefficients exceeded the set value of 0.40, indicating satisfactory convergent validity (96.2%). The correlation coefficients ranged from −0.113 to 0.960. For example, item 21 (tense) and item 23 (irritable) had the strongest negative correlations with their corresponding emotional functioning subscale, whereas items 29 (physical condition) and 30 (overall QoL) had the strongest positive correlation with its corresponding GH/QoL subscale. In terms of discriminant validity, item 6 (limited work) showed a higher correlation with fatigue (r = 0.749) rather than its corresponding role functioning subscale. Likewise, item 19 (pain interfered with daily activities) of the pain subscale had higher correlations with physical functioning, role functioning, and fatigue subscales.
Table 5: Pearson's correlation coefficient between the items and scales in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30

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[Table 6] presents the correlation coefficients among the 16 subscales. All the inter-scale correlation coefficients were statistically significant.
Table 6: Pearson's correlation coefficient of subscales among the Arabic version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30

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  Discussion Top


The current study was designed to validate the psychometric properties of the Qatari's Arabic EORTC QLQ-C30 in a heterogeneous sample of 762 breast cancer patients in Qatar. For the reliability tests of the new Arabic EORTC QLQ-C30, six subscales out of the nine met the standards of reliability with coefficients ranging from 0.55 to 0.89. Cognitive subscale had the lowest alpha value of 0.55, indicating an adequate scale reliability. The mean score of all functioning scales was >55, thus indicating a higher level of functioning. Similar results were found in other studies reporting for Cronbach's alpha for six subscales.[19],[20],[21]

Multitrait scaling analysis results revealed that all correlation coefficients between an item with its own subscales were >0.40 with the exception of item number 5 (r = −0.135), thus successfully supporting convergent validity. A similar finding regarding item number 5 (help in eating/dressing) was reported by Abo Huijer [19] and Hoopman et al.[22]

To some extent, our results were similar and confirmative in the area of role functioning with other reported studies in Kuwaiti women with breast cancer[21] and in UAE Awad et al.[20] and Lebanese patients with breast cancer.[19] In total, there was 85.6% scaling success with respect to item discrimination which is probably attributed to the heterogeneity of the current Qatari sample in terms of different cancer types compared to studies by Kontodimopoulos et al.[23] that reported 86.5% item discrimination success among Greek patients with breast cancer.

The validity of the Arabic version of the QLQ-C30 was evident by its ability to discriminate between subgroups of patients known to differ in clinical condition. The role function subscale, which measures the effect of the disease on the ability to carry out job and home duties, discriminated well between stages of patients with disease. Results of known-group comparison analysis showed that there were no statistically significant differences between patients differing in disease stage. Our results were compatible with studies that reported that the stage of disease is not associated with QoL. This finding is consistent with previous studies in Western patients with breast cancer.[23],[24],[25] Overall, Qatari Arab women in the current study population reported generally high QoL outcomes and good physical, role, emotional, cognitive, social functioning symptoms, and well-being. These results are confirmative with earlier reported studies in Albania,[9] Turkey,[24],[25] the UAE,[20] Lebanon,[19] Singapore,[23] Sweden,[26] and Japan.[28]

The present study had some limitations. First of all, it is an observational cohort hospital-based study and may not precisely assess participants' changes over time accurately. A second limitation of the study is that the EORTC QLQ-C30 was tested only in patients with breast cancer. This questionnaire is applicable to all cancer patients, and the researchers are planning to conduct additional testing on a larger group of Arab patients with different types of malignancies. Another limitation is the absence of intervention, and further study is thus needed to generalize the findings.


  Conclusion Top


The present study indicates that the translated Qatari Arabic version of the psychometric properties of the EORTC QLQ-C30 is a reliable and valid instrument that can be used by Oncologist, clinicians and researchers in Qatar in order to enhance research related to the quality of life of patients diagnosed or living with breast cancer. Given these findings' concordance with our previous analysis, these QLQ-C30 cut-offs could be implemented in clinical practice and their usefulness evaluated.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patients have given their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal identity, but anonymity cannot be guaranteed.

Acknowledgments

This study was generously supported and funded by the Hamad Medical Corporation. The authors would like to thank the Hamad Medical Corporation for their support and ethical approval (HMC RP# 12215/12 and HMC RP# 12061/12).

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]


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