Measuring Quality of Life among Colorectal Cancer Patients in Jordan

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1 See discussions, stats, and author profiles for this publication at: Measuring Quality of Life among Colorectal Cancer Patients in Jordan ARTICLE in JOURNAL OF PALLIATIVE CARE OCTOBER 2014 Impact Factor: 0.68 READS AUTHORS, INCLUDING: Nizar M Mhaidat 75 PUBLICATIONS 607 CITATIONS SEE PROFILE Karem Alzoubi Jordan University of Science and Technol 150 PUBLICATIONS 1,753 CITATIONS SEE PROFILE Qais Alefan Jordan University of Science and Technol 18 PUBLICATIONS 48 CITATIONS Sayer Al-Azzam Jordan University of Science and Technol 63 PUBLICATIONS 273 CITATIONS SEE PROFILE SEE PROFILE Available from: Qais Alefan Retrieved on: 23 March 2016

2 Measuring Quality of Life among Colorectal Cancer Patients in Jordan Nizar M. Mhaidat, Tahani J. Al-Wedyan, Karem H. Alzoubi, Qais M. Al-Efan, Sayer I. Al-Azzam, Qosay A. Balas, and Ziad A. Bataineh NM Mhaidat (corresponding author): Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, 22110, PO Box 3030, Jordan; TJ Al-Wedyan, KH Alzoubi, QM Al-Efan, SI Al-Azzam, QA Balas: Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan; ZA Bataineh: Department of Surgery, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan 133 Keywords: colorectal cancer, EORTC QLQ-CR29, EORTC QLQ-C30, HRQL Abstract / Quality of life among colorectal cancer (CRC) patients was evaluated using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and EORTC QLQ-CR29. We interviewed 74 CRC patients, and our results indicated lower anxiety functional scores and higher abdominal pain and embarrassment symptom scores among patients aged 55 and under. Patients with disease metastasis showed significantly lower global health scores and higher fatigue, loss of appetite, hair loss, and change in taste symptom scores. Scores for emotional functioning were significantly lower among patients with stage IV disease. Fatigue, nausea and vomiting, loss of appetite, abdominal pain, and change in taste symptom scores were significantly higher in patients treated with a combination of surgery and chemotherapy compared to surgery alone. Age, disease metastasis, late disease stage, and combined treatment modalities were associated with lower scores on health-related quality-of-life scales; patients likely to have low scores on these measures should receive special attention from healthcare pro - viders and be targeted by supportive care strategies. Résumé / Nous avons évalué la qualité de vie de patients atteints du cancer colorectal à l aide du Questionnaire C30 et EORTC QLQ-CR29 de l Organisation européenne pour la recherche et le traitement du cancer. Nous avons interviewé 74 patients et nos résultats indiquent que les patients agés de 55 ans et moins éprouvent un moindre niveau d anxiété alors que le niveau de douleurs abdominales et du sentiment de gêne est élevé. Les patients atteints de métastases ont démontré lors des tests que leur état général de santé était plutôt mauvais et qu ils souffraient de fatigue accrue, de perte de cheveux et de la perte du goût L état émotionel était à son plus bas chez les patients au stade IV de la maladie. La fatigue, la nausée, le vomissement, la perte d appétit, les douleurs abdo - minales, et la perte de goût étaient significativement plus élevés chez les patients ayant été traités par chirur gie et chimiothérapie comparativement à ceux qui n avaient subi que la chirurgie. L âge, les métastases et le stade avancé de la maladie combinés à divers traitements médicaux sont les facteurs ayant contribué aux scores plus bas observés sur l échelle de qualité de vie. Les patients susceptibles de démontrer de faibles résultats devraient recevoir une attention spéciale de la part des soignants et être la cible de soins de soutien appropriés à leur état. INTRODUCTION Colorectal cancer (CRC) is a malignant neoplastic disease of the large intestine in which cancerous growths appear on the inner lining of the colon and/or the rectum epithelial wall (mucosa). It is a major health problem in Jordan (1-2). According to the American Cancer Society, CRC was the third most commonly diagnosed cancer among both genders in the United States in 2012 (3). Jordan is a modernized and developing Middle Eastern country. It exemplifies a successful blending of old values and Western cultures. However, Jordan is also a country in which cancer is a leading cause of mortality and morbidity. It is the second most common cause of death (14 percent) after cardiovascular disease (35 percent) (1). CRC is the most prevalent cancer type among males and the second most prevalent type among females (1). Furthermore, the incidence of CRC in Jordan increased from 1.1/100,000 per year before 1980 (4), to 3.8/100,000 per year over the period (5), to about 5.0/100,000 per year in 2009 (6). Diet is one of the most important influences on the development of CRC; a diet high in animal fat is an especially significant factor (7). Among the many other contributing factors are inherited Journal of Palliative Care 30:3 / 2014; Institut universitaire de gériatrie de Montréal

3 134 mutations, immune system disorders, and metabolic disturbances (8). Treating patients diagnosed with CRC continues to be a therapeutic burden, mainly due to the aggressiveness of the disease, inadequate responsiveness to conventional chemo - therapeutic and biological reagents, an increased rate of relapse, and related psychological disorders such as anxiety and depression (9). Patients with CRC are treated with different modalities depending on the stage of their disease. When the disease is considered resectable, surgery followed by adjuvant chemotherapy (CT) is the treatment of choice. The decision to pursue this treatment option is made through discussion between clinician and patient focusing on the contraindications and the side effects of CT (10-12). Health-related quality of life (HRQL) is a subjective evaluation based on a patient s level of psychological, social, and physical ability. It has become an important concern for cancer patients, and it is linked to their capacity to derive benefits from therapy (13). There are many tools to assess the HRQL of cancer patients, the most important of which are the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQs): EORTC QLQ-C30 and EORTC QLQ-CR29 (13). In this study, we used the two questionnaires to evaluate HRQL among CRC patients in Jordan. MATERIALS AND METHODS This cross-sectional study was conducted between January 2009 and February 2013 at the oncology unit of King Abdullah University Hospital (KAUH), a tertiary referral centre affiliated with Jordan University of Science and Technology (JUST), located in the north of Jordan. The JUST institutional review board approved this study. A total of 114 patients with a histological CRC diagnosis were asked to participate in this study; 11 declined for personal reasons and 29 were not interviewed because they were difficult to contact. The final study sample was composed of 74 CRC patients. Inclusion criteria were: being between 18 and 79 years of age; having a diagnosis based on the TNM Classification of Malignant Tumours of stage I, II, III, or IV CRC, as per clinical oncologist; and having no speech difficulties. Patients who had received palliative therapy and those with psychological defects were excluded from the study. Informed consent forms were signed by all parti cipants. They were told that any data they provided would be kept confidential and that they would receive no financial recompense for their participation. Participants were interviewed either on inpatient wards or at KAUH outpatient clinics by the same trained researcher, and they were asked to fill in a three-part questionnaire. The patient interviews were designed to ensure that participants fully understood the questionnaire and completed it. In the first part of the questionnaire, sociodemographic factors such as age, gender, and education level were covered. In the second and third parts, participants HRQL was assessed using the EORTC QLQ-C30 and the EORTC QLQ-CR29. Additionally, participants medical records from the KAUH database were reviewed in the presence of an oncologist to obtain patient disease data. Collected data in - cluded specific diagnosis, stage of disease, and treatment modality. Questionnaire results on scales and on single items were compared based on patient age, tumour metastasis, cancer stage, and treatment type. INSTRUMENTS FOR QUALITY-OF-LIFE ASSESSMENT Participants HRQL was assessed using the EORTC QLQ-C30 version 3.0, a 30-item, cancerspecific questionnaire that has been validated in different geographical areas (14-17). The questionnaire consists of five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea and vomiting, and pain), six single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties), and two items measuring global health status. The EORTC QLQ-CR29 is a reliable, CRC-specific questionnaire (18-19). The version used in this study was validated in Arabic (14), Jordan s official language. The questionnaire consists of 5 functional scales (body image, anxiety, weight, sexual interest among males, and sexual interest among females) and 18 single items related to symptom scales of either disease or adverse effects of treatment (urinary frequency, blood and mucus in stool, urinary incontinence, stool frequency, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, change in taste, flatulence, fecal incontinence, embarrassment, stoma care problems, and sore skin). The raw scores for all scales (functional and symptom) and single items measured in both questionnaires were calculated using the EORTC QLQ-C30 scoring manual. A high score on functional scales indicates a high level of functioning, a high score on global health status represents a high HRQL, and a high score on symptom scales correlates with a high degree of problems (20).

4 STATISTICAL ANALYSIS Data were analyzed using SPSS 17.0 statistical software (SPSS Inc., 2008). Descriptive statistics were made for each variable. Normality was assessed using the Kolmogorov-Smirnov normality test; non-normal data were analyzed using a nonparametric ranking test. The differences between quantitative variables were studied using the Mann-Whitney U test (for two independent] variables) and the Kruskal-Wallis test (for more than two independent variables). Significance was established as p<0.05. RESULTS Data pertaining to 74 patients were analyzed. Average patient age was 49.5 ± percent (42) men and 43.2 percent (32) women. In terms of education level, 34 (45.9 percent) did not complete high school and 45 (54.1 percent) had a higher level of education, such as a diploma, a bachelor s degree, a master s degree, or a PhD. Of our participants, 62 (83.8 percent) had been diagnosed with localized disease, and 12 ( Table 1 / Comparison of the EORTC QLQ-C30 and EORTC QLQ-CR29 in Relation to Patient Age (Kruskal-Wallis H Test) 55years years years (n=35) (n=22) (n=17) Variable median (range) median (range) median (range) p-value EORTC QLQ-C30 Physical functioning (20-100) ( ) ( ) Role functioning (20-100) ( ) ( ) Emotional functioning 50 (0-100) (0-100) 50 (0-100) Cognitive functioning ( ) ( ) 100 (0-100) Social functioning 100 (0-100) 100 (0-100) ( ) Global health scale ( ) (0-100) ( ) Fatigue (0-100) (0-100) (0-100) Nausea and vomiting 0 (0-100) 0 (0-50) 0 (0-50) Pain (0-100) 0 (0-100) ( ) Single-item questions Dyspnea 0 (0-100) 0 ( ) 0 ( ) Insomnia (0-100) 0 (0-100) (0-100) Loss of appetite 0 (0-100) 0 (0-100) 0 (0-100) Constipation 0 (0-100) 0 ( ) 0 (0-100) Diarrhea 0 (0-100) 0 (0-100) 0 (0-100) Financial difficulties (0-100) 0 (0-100) 0 (0-100) EORTC QLQ-CR29 Body image (0-100) ( ) ( ) Anxiety (0-100) 100 ( ) 100 ( ) Weight 100 (0-100) 100 ( ) 100 ( ) Urinary frequency (0-100) (0-100) 50 (0-100) Blood and mucus in stool 0 ( ) 0 ( ) 0 ( ) Stool frequency (0-100) ( ) (0-100) Urinary incontinence 0 (0-100) 0 ( ) 0 (0-100) Dysuria 0 (0-100) 0 ( ) 0 ( ) Abdominal pain (0-100) 0 (0-100) 0 ( ) Buttock pain (0-100) 0 (0-100) 0 (0-100) Bloating (0-100) (0-100) (0-100) Dry mouth 0 (0-100) 0 (0-100) 0 ( ) Hair loss 0 (0-100) 0 ( ) 0 (0-100) Change in taste 0 (0-100) 0 (0-100) 0 (0-100) Flatulence (0-100) (0-100) (0-100) Fecal incontinence 0 (0-100) 0 ( ) 0 ( ) Sore skin 0 ( ) 0 ( ) 0 ( ) Embarrassment (0-100) 0 (0-100) 0 (0-100) Stoma care problems 100 (0-100) 0 ( ) 50 (0-100) 0.119

5 136 percent) had metastatic disease. With regard to the TNM staging system, 14 patients (18.92 percent) were diagnosed at stage I, 16 (21.62 percent) at stage II, 27 (36.49 percent) at stage III, and 17 (22.97 percent) at stage IV. Of the 74 participants, 19 (25.68 percent) were treated with surgery alone and 48 (64.86 percent) were treated with surgery combined with chemotherapy, whereas 7 patients were not treated by any modality. The results of the EORTC QLQ-C30 and EORTC QLQ-C29 in relation to age are shown in Table 1. Lower scores on the anxiety functional scale and higher scores on the abdominal pain and embarrassment symptom scales were found among patients aged 55 and younger in comparison with older patients (p<0.05). The effect of disease metastasis on the EORTC QLQ-C30 and EORTC QLQ-C29 scores was also evaluated (Table 2). Patients with disease metastasis showed significantly lower global health scores and higher fatigue, loss of appetite, hair loss, and change in taste symptom scores. Stage of the disease also affected HRQL (Table 3). Table 2 / Comparison of the EORTC QLQ-C30 and EORTC QLQ-CR29 in Relation to Patient Diagnosis (Mann-Whitney U Test) CRC CRC with metastasis (n=62) (n=12) Variable median (range) median (range) p-value EORTC QLQ-C30 Physical functioning ( ) 6.67 (20-100) Role functioning ( ) 6.67 (20-100) Emotional functioning 50 (0-100) (0-100) Cognitive functioning (0-100) ( ) Social functioning 100 (0-100) (0-100) Global health scale (0-100) 50 ( ) Fatigue (0-100) (0-100) Nausea and vomiting 0 (0-100) 8.33 ( ) Pain (0-100) 25 (0-100) Single-item questions Dyspnea 0 (0-100) 0 ( ) Insomnia (0-100) ( ) Loss of appetite 0 ( ) (0-100) Constipation 0 (0-100) (0-100) Diarrhea 0 (0-100) 0 (0-100) Financial difficulties 0 (0-100) (0-100) EORTC QLQ-CR29 Body image ( ) (0-100) Anxiety 100 (0-100) 100 (0-100) Weight 100 (0-100) 100 ( ) Urinary frequency (0-100) (0-100) Blood and mucus in stool 0 ( ) 0 ( ) Stool frequency (0-100) 25 (0-100) Urinary incontinence 0 (0-100) 0 (0-100) Dysuria 0 (0-100) 0 (0-100) Abdominal pain 0 (0-100) ( ) Buttock pain 0 (0-100) (0-100) Bloating (0-100) 50 (0-100) Dry mouth 0 (0-100) ( ) Hair loss 0 (0-100) (0-100) Change in taste 0 (0-100) 50 (0-100) Flatulence (0-100) (0-100) Fecal incontinence 0 (0-100) 0 (0-0) Sore skin 0 ( ) 0 ( ) Embarrassment 0 (0-100) 0 (0-100) Stoma care problems (0-100) 100 ( ) 0.094

6 For example, among patients with stage IV disease, scores for emotional functioning were significantly lower than scores for fatigue, nausea and vomiting, loss of appetite, buttock pain, hair loss, and change in taste (p<0.05). Finally, treatment approach also had an impact on HRQL measures (Table 4). The individual symptom scores for fatigue, nausea and vomiting, loss of appetite, abdominal pain, and change in taste were significantly higher among patients who underwent both surgery and chemotherapy than those who had surgery only (p<0.05). DISCUSSION CRC is a major health problem in Jordan. It is a treatable cancer if diagnosed in its early stages, so many patients do survive it. This means that the impact of treatment, stage of disease, and patient age on HRQL is an important consideration for both patient and physician (17). The results of the present study indicate the importance of age- and disease-specific factors for HRQL among Jordanian CRC patients, and these findings are generally consistent with those of previous studies conducted with other populations (14-19). 137 Table 3 / Comparison of the EORTC QLQ-C30 and EORTC QLQ-CR29 in Relation to Stage of Disease (Kruskal-Wallis H Test) Stage I Stage II Stage III Stage IV (n=14) (n=16) (n=27) (n=17) Variable median (range) median (range) median (range) median (range) p-value EORTC QLQ-C30 Physical functioning 90 ( ) (20-100) ( ) (20-100) Role functioning 90 ( ) (20-100) ( ) (20-100) Emotional functioning ( ) (0-100) 50 (0-100) 25 (0-100) Cognitive functioning (50-100) ( ) (0-100) ( ) Social functioning 100 (50-100) 100 ( ) (0-100) (0-100) Global health scale ( ) 75 ( ) (0-100) 50 ( ) Fatigue ( ) ( ) (0-100) (0-100) Nausea and vomiting 0 (0-0) 0 (0-100) 0 (0-50) ( ) Pain 0 ( ) (0-100) (0-100) (0-100) Single-item questions Dyspnea 0 ( ) 0 ( ) 0 ( ) 0 (0-100) Insomnia (0-100) 50 (0-100) (0-100) (0-100) Loss of appetite 0 (0-0) 0 ( ) 0 (0-100) (0-100) Constipation 0 ( ) 0 (0-100) 0 (0-100) (0-100) Diarrhea 0 (0-100) 0 (0-100) 0 (0-100) (0-100) Financial difficulties 0 (0-100) 0 (0-100) 0 (0-100) (0-100) EORTC QLQ-C30 Body image 100 ( ) ( ) ( ) (0-100) Anxiety 100 ( ) 100 (0-100) (0-100) 100 (0-100) Weight 100 ( ) 100 ( ) 100 (0-100) 100 ( ) Urinary frequency (0-100) (0-100) (0-100) 50 (0-100) Blood and mucus in stool 0 ( ) 0 ( ) 0 ( ) 0 ( ) Stool frequency 25 (0-100) (0-100) (0-100) (0-100) Urinary incontinence 0 ( ) 0 (0-100) 0 (0-100) 0 (0-100) Dysuria 0 ( ) 0 ( ) 0 ( ) 0 (0-100) Abdominal pain 0 ( ) ( ) 0 (0-100) (0-100) Buttock pain 0 (0-100) 0 (0-100) 0 (0-100) (0-100) Bloating (0-100) (0-100) (0-100) (0-100) Dry mouth 0 ( ) (0-100) 0 ( ) (0-100) Hair loss 0 ( ) 0 (0-100) 0 ( ) (0-100) Change in taste 0 (0-0) 0 (0-100) 0 (0-100) (0-100) Flatulence (0-100) (0-100) (0-100) (0-100) Fecal incontinence 0 ( ) 0 ( ) 0 ( ) 0 (0-100) Sore skin 0 ( ) 0 ( ) 0 ( ) 0 ( ) Embarrassment 0 (0-100) 0 (0-100) 0 (0-100) 0 (0-100) Stoma care problems 0 (0-0) ( ) 0 (0-100) 100 ( ) 0.065

7 138 Our results reveal that age has a significant effect on the psychological problems and on certain CRC-specific symptoms of patients, which accords with the results of a study conducted in Germany (21). In addition, disease metastasis, stage of disease, and treatment modalities all have a strong influence on general and specific HRQL measures among CRC patients. These findings match those of previous studies that explored the effects of these variables among European populations (22, 23). In studies performed in the US (24, 25), age and gender were identified as major determinants of quality of life. In the current study, patient diagnosis and stage of disease were also important determinants. Future studies with larger sample sizes are warranted to confirm our results. Younger patients were associated in the current study with lower anxiety functional scores and higher abdominal pain and embarrassment symptom scores. Although the overall burden of disease is greater among elderly CRC patients, younger patients report that difficulties with emotional and social functioning as well as financial Table 4 / Comparison of the EORTC QLQ-C30 and EORTC QLQ-CR29 in Relation to Treatment Approach (Mann-Whitney U Test) Surgery only Surgery plus chemotherapy (n=19) (n=48) Variable median (range) median (range) p-value EORTC QLQ-C30 Physical functioning ( ) (20-100) Role functioning ( ) (20-100) Emotional functioning 75 (0-100) 50 (0-100) Cognitive functioning ( ) 75 (0-100) Social functioning 100 ( ) 100 (0-100) Global health scale ( ) ( ) Fatigue ( ) (0-100) Nausea and vomiting 0 ( ) 0 (0-100) Pain 0 ( ) 25 (0-100) Single-item questions Dyspnea 0 ( ) 0 (0-100) Insomnia (0-100) (0-100) Loss of appetite 0 (0-0) 0 (0-100) Constipation 0 (0-100) 0 (0-100) Diarrhea 0 (0-100) 0 (0-100) Financial difficulties 0 (0-100) 0 (0-100) EORTC QLQ-CR29 Body image ( ) (0-100) Anxiety 100 (0-100) 100 (0-100) Weight 100 ( ) 100 (0-100) Urinary frequency (0-100) (0-100) Blood and mucus in stool 0 ( ) 0 ( ) Stool frequency (0-100) (0-100) Urinary incontinence 0 (0-100) 0 (0-100) Dysuria 0 ( ) 0 (0-100) Abdominal pain 0 ( ) (0-100) Buttock pain 0 (0-100) 0 (0-100) Bloating (0-100) (0-100) Dry mouth 0 (0-100) 0 (0-100) Hair loss 0 (0-100) 0 (0-100) Change in taste 0 (0-0) 0 (0-100) Flatulence (0-100) (0-100) Fecal incontinence 0 ( ) 0 ( ) Sore skin 0 ( ) 0 ( ) Embarrassment 0 (0-100) 0 (0-100) Stoma care problems 0 (0-100) (0-100) 0.600

8 problems continue to disrupt their HRQL (21). Consistent with other studies (26, 27), we found that younger CRC patients experienced more psychological disturbance; their anxiety functional scores were significantly higher than those of elderly patients. This might be related to the fact that younger patients tend to attribute changes in their health to the disease, whereas older patients attribute them to the aging process (28). Moreover, older patients usually describe their health as good, reporting better HRQL despite their many functional disabilities (29). However, a study conducted in the US reported that younger patients with chronic disease suffer more economic complications as a result of their condition than older patients do (25). This may be due to the fact that many younger patients still have jobs and are forced to take time off to undergo treatment for their disease; and they may need additional time off work to recover from treatment-related problems, such as infections, which occur often in this patient group. Participants in our study diagnosed with advanced disease had worse emotional functioning and more severe symptoms, including fatigue, nausea and vomiting, loss of appetite, buttock pain, hair loss, and change in taste. Furthermore, patients with disease metastasis had lower global health scores and higher fatigue, loss of appetite, hair loss, and change in taste symptom scores. These findings are consistent with those of a previous study conducted with a Spanish population (13). The lower HRQL among patients at an advanced stage of disease may be due to the systemic dysfunctions that tend to occur at advanced stages these dysfunctions include anemia and multi-organ perturbations. In addition, patients with advanced disease may require more aggressive chemotherapy regimens, which have more serious side effects, which in turn will affect functionality (30-32). Finally, better HRQL-related individual symptom scores were noted in patients who received surgery but not chemotherapy; this, also, was consistent with the findings of other studies (33). This might be explained by the diverse negative effects of chemotherapy, including loss of appetite, dry mouth, change in taste, hair loss, and gastrointestinal upset. LIMITATIONS AND CONCLUSION A limitation of this study is that the published validation study of the EORTC QLQs with an Arabicspeaking population (14) did not examine ceiling or floor effects. Additionally, the cross-sectional design of the study did not yield data on causality among different factors. Future work could involve validating the ceiling and floor effects of the EORTC QLQs in an Arabic population, carrying out specially designed studies to establish causality, and confirming current results using other tools for assessing HRQL (34). The current study determined that disease metastasis, late disease stage, and combined treatment modalities are associated with lower scores on HRQL measures. Loss of appetite and fatigue were the symptoms most prominently related to the study variables. Patients likely to have low scores on these measures should receive special attention from healthcare providers and be targeted by supportive care strategies. Received: September 23, 2013 Final version accepted: May 21, 2014 REFERENCES 1. Al-Tarawneh M, Khatib S, Arqub K. Cancer incidence in Jordan, East Mediterr Health J 2010; 16(8): Mandel JS, Church TR, Bond JH, et al. The effect of fecal occult-blood screening on the incidence of colorectal cancer. 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