|Ahead of print publication
Factors affecting quality of life of cervical cancer patients: A multivariate analysis
Uma Singh1, Manju Lata Verma1, Zakia Rahman1, Sabuhi Qureshi1, Kirti Srivastava2
1 Department of Obstetrics and Gynaecology, KGMU, Lucknow, Uttar Pradesh, India
2 Department of Radiotherapy, KGMU, Lucknow, Uttar Pradesh, India
Manju Lata Verma,
Type 4/76 Old Campus SGPGIMS, Lucknow, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Objective: The aim of good management for cancer survivors should not be limited to only clinical care, but rather it should also include best quality of life (QOL). The objective of this study was to find out various factors affecting QOL in cervical cancer patients so that by modifying these factors, the best QOL can be provided to them.
Materials and Methods: This was a prospective cohort study conducted in the Department of Obstetrics and Gynaecology and Department of Radiotherapy, King George's Medical University (KGMU), Lucknow, from May 2015 to July 2016. The cases were selected from patients visiting the outpatient department or who were admitted to the Department of Obstetrics and Gynaecology and Department of Radiotherapy, KGMU. The data information was collected in the form of face-to-face interview using European Organization for Research and Treatment of Cancer general cancer QOL Score 30 (EORTC QLQ C-30) and EORTC QOL questionnaire cervical cancer module (QLQ CX-24) questionnaire.
Results: QOL was assessed in 85 patients. Health-related QOL was separately studied in terms of overall general QOL and cancer cervix-specific QOL, and various factors affecting QOL were studied by multivariate analysis.
Conclusion: Education, tobacco use, degree of differentiation of tumor, and size of tumor were the independent factors found to have statistically significant effect on QOL of cervical cancer survivors.
Keywords: Cervical cancer, cervical cancer survivor, cervical malignancy, quality of life
|How to cite this URL:|
Singh U, Verma ML, Rahman Z, Qureshi S, Srivastava K. Factors affecting quality of life of cervical cancer patients: A multivariate analysis. J Can Res Ther [Epub ahead of print] [cited 2019 Dec 10]. Available from: http://www.cancerjournal.net/preprintarticle.asp?id=251392
| > Introduction|| |
Management of any malignancy should not be limited to only treating the clinical disease, but it should also involve the plan which can give the overall best quality of life (QOL) to these patients. QOL is not a new concept, and early references can be found even in Greek literature. In most developed world, consideration of QOL is now too ubiquitous as investigation of hemoglobin or blood group. QOL is defined by the WHO as the way an individual perceives his or her own position in the context of culture and system of values in which he or she exists together with own aims, limitations, standards, and concerns; a wide conception comprehensively was influenced by individual's state of health, cognitive state, social relations, level of independence, and relation to the surrounding environment.
A total of 122,844 women are diagnosed with carcinoma cervix every year in India. It is the second most common cancer in women aged 15–44 years. Since overall survival in cancer cervix patients are satisfactorily good, so the concept of provision of a good QOL is of utmost importance. QOL encompasses two distinct domains. One is health-related QOL (HRQOL) and the other is nonhealth QOL. HRQOL encompasses domains of life which are directly affected by changes in health. Measuring HRQOL is a standardized way of describing the physical, psychological, and social effects of a disease and its treatment. It is based on the patient's own rating of simple questions and can provide an overview of how and to what extent a disease and its treatment affect the lives of patients. QOL is overall an important aspect for survivors of all malignancies and that too for carcinoma cervix. Hence, besides giving clinical treatment, providing best QOL should be the aim of treatment of every clinician. QOL in carcinoma cervix is affected by many factors. QOL is not only affected by cancer stage and grade but also may be altered by sociodemographic characters. Individual characteristic of patients may have their effect on general QOL in either positive or negative mode. There is a paucity of data related to QOL in cancer cervix patients in Indian literature, especially comparing the QOL before and after treatment in these patients. Hence, this multivariate analysis is done to find out various factors affecting QOL in cancer cervix patients and provide treatment accordingly for attainment of best QOL.
| > Materials and Methods|| |
A prospective cohort study was conducted in the Department of Obstetrics and Gynaecology and Department of Radiotherapy, King George's Medical University (KGMU), Lucknow, from May 2015 to July 2016. After obtaining the approval from the institutional ethical committee (9376/ethics/R.cell-16), the cases were selected from patients visiting the outpatient department (OPD) or who were admitted to the Department of Obstetrics and Gynaecology and Department of Radiotherapy, KGMU, who were fulfilling the set criteria. The data information was collected in the form of face-to-face interview using questionnaire. Inclusion criteria were patients of cancer cervix before the start of treatment and the same patients 3 months and 6 months from completion of treatment, patients with no recurrence, patients who have been treated with either surgery or chemoradiation, patients who have ability to understand and communicate in Hindi or English, and patients consented to participate in the study. Exclusion criteria used were patients not willing to participate, patients having major systemic illness such as cardiac failure, renal failure, or pulmonary edema, patients with psychiatric disorders, patients who are in immediate posttreatment phase, patients with stage 4 disease, and patients treated with both chemoradiation and surgery. Sample size calculation was done using the formula: SS = Z2(P)(1 − P)/C2 126, where Z = Z value (1.96 for 95% confidence level), P = Percentage picking a choice, expressed as decimal (0.5 used for sample size needed), C = confidence interval, expressed as decimal (0.95). Using above the formula, the sample size was 80. To increase power and confidence, allowance of 12.5% was taken, and hence, 90 patients were recruited. Written and informed consent was taken from the patients in an especially designed consent form. Detailed history about epidemiological factors and obstetric details was taken. All the history, examination findings, relevant investigations, and imaging findings were collected via working pro forma in the form of a questionnaire, which included two sections: Section A and Section B, which are described later. The baseline values were recorded when a patient first reported to the hospital, the second evaluation was done at a follow-up visit 3 months posttreatment, and the third evaluation was done at a follow-up visit 6 months posttreatment. Section A includes sociodemographic profile, stage and grade of cancer, imaging findings, treatment method, and comorbidities. Women's characteristics consist of questions related to demographic features (age, education, marital status, income level) and disease-related information (cancer stage, histological type). Section B has European Organization for Research and Treatment of Cancer general cancer QOL Score 30 (EORTC QLQ C-30) and EORTC QOL questionnaire cervical cancer module (EORTC QLQ CX-24) questionnaire. The EORTC QLQ C-30 and its cervical cancer module which is specific for cervical cancer (EORTC QLQ CX-142 24) questionnaires were used to measure HRQOL. These questionnaires have been extensively tested in multicultural and multidisciplinary settings and have been confirmed to be reliable and valid., The EORTC QLQ C-30 questionnaire comprises 30 questions, which includes five-functional scale (physical, role, cognitive, emotional, social), three-symptom scale for pain, fatigue, nausea, and vomiting, six single items for dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact, and a global health status score which assesses the overall QOL. Each of the multi-item scales includes a different set of items – no item occurs in more than one scale. The EORTC QLQ CX-24 questionnaire which consists of 24 questions assesses functioning (body image, sexual enjoyment, sexual/vaginal functioning) and symptoms (symptoms experience, lymphedema, peripheral neuropathy, menopausal symptoms, sexual worry)., Both the questionnaires use a four-point response scale (not at all, a little, quite a bit, and very much) to assess each functional or symptom item, and a seven-point response scale is used to assess global health status (from very poor to excellent). For model development, the categorical raw scores were linearly transformed into a score of 0–100 for processing according to the EORTC scoring manual. The principle for scoring was to estimate the average of the items that contributed to the scale; this was the raw score. A high scale score represents a higher response level. The higher scale score for the functional scale or the global health status/QOL represents a higher level of functioning or higher QOL, whereas the higher level of symptoms/problems for the symptom/item scales represents a higher level of dysfunction. Missing values were calculated such that if at least one-half of the items from the scale had been completed, it was assumed that the missing items would have had values equal to the average of the items present. Demographic and clinical data were calculated using descriptive statistics. The results are presented in mean ± standard deviation and percentages. The continuous variables were tested for normalcy using Kolmogorov–Smirnov test. The nonparametric Wilcoxon signed-ranks test was used to compare median scores of QOL scales between the examined groups of patients. A 5% level of statistical significance was used for variables (P < 0.05). Data were analyzed using SPSS for Windows (version 19.0; SPSS Inc., Chicago, IL, USA).
| > Results|| |
Ninety subjects fulfilling the set criteria were selected for the study, from the patients of cancer cervix visiting the OPD of the Department of Obstetrics and Gynaecology and the Department of Radiotherapy or who were admitted to these departments. The information was collected using the questionnaire. The sociodemographic data, history, examination findings, relevant investigation, and imaging findings were collected and analyzed via working pro forma in the form of a questionnaire. Subsequently, of 90 patients, five cases were lost to follow-up. Three patients expired before the completion of the treatment while one was lost to follow-up and one developed vesicovaginal fistula, who was subsequently lost to follow-up. Hence, data information at 3 months after treatment and 6 months after treatment could be collected of only 85 cases. Moreover, hence, the results of comparison of QOL of the survivors include only 85 cases. Of 90 patients, 65.9% were between age group of 50 and 60 years, 14.9% were less than 50 years of age, and 20% were more than 60 years of age. 70.4% were illiterate and only 29.4% were literate. Age at first intercourse was less than 20 years in 75% of patients. 49.6% of patients were from rural population, while 50.4% were from urban. 89.4% patients were from low-income group. Of total 90 patients, in 49 (54.1%) patients, parity was more than 5 and rest were with parity of 5 or less than 5. There was no nullipara patient in study. In our study, 66 (72.9%) patients were postmenopausal. In 31 (34.1%) patients, history of tobacco use was present. In 24 (26.6%) patients, associated comorbidities were present in the form of anemia, hypertension, and diabetes. 45.9% of patients were from stage 3b while only 1.2% of patients were from stage 1a and 10.6% had stage 1b. 55.3% patients had moderately differentiated cancer while 23.5% had well-differentiated and 21.6% had poorly differentiated cancer. 68 (75.3%) patients had tumor size of less than 4 cm while 22 (24.7%) had it to be >4 cm. Treatment modality was chemoradiation in majority of cases (94.1%), while in only 5.9%, surgery was done. The global health score showed improvement after 3 months of treatment but was not statistically significant, but there was significant improvement in the global health score after 6 months of treatment as shown in [Table 1]. On comparing functional scale score of general QOL, statistically significant difference was noted in physical and emotional function, which is shown in [Table 2]. [Table 3] shows the results of cancer cervix-specific QOL functional score and shows statistically significant difference from baseline to post-6 months treatment in vaginal/sexual function. In general cancer QOL symptom scale, pain and fatigue were significantly lower in both posttreatment groups (3 and 6 months) than baseline as depicted in [Table 4]. Cervix cancer-specific QOL symptom score has shown reduction of symptom experience [Table 5]. For analysis of independent factors affecting general cancer QOL and cervix cancer-specific QOL, multivariate analysis was done. It has shown education, tobacco use, degree of differentiation of tumor, and tumor size were the independent factors affecting general cancer QOL as depicted in [Table 6]. For cancer cervix-specific QOL, the above-mentioned factors along with stage of cancer were found to be the independent variables affecting QOL in multivariate analysis [Table 7].
|Table 1: Comparison of global health score (overall health) from baseline to 3 months and 6 months after treatment (n=85)|
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|Table 2: Comparison of general cancer quality of life functional scale score (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30) from baseline to 3 months and 6 months after treatment (n=85)|
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|Table 3: Comparison of cancer cervix-specific quality of life functional scale score (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CX-24) from baseline to 3 months and 6 months after treatment (n=85)|
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|Table 4: Comparison of General cancer quality of life symptoms scale score (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30) from baseline to 3 months and 6 months after treatment (n=85)|
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|Table 5: Comparison of cancer cervix-specific quality of life symptom scale score (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CX-24) from baseline to 3 months and 6 months after treatment (n=85)|
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|Table 6: Multivariate linear regression model evaluating independent indicators at baseline for different general quality of life indicators (European Organization for Research and Treatment of Cancer Q 30) (n=85)|
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|Table 7: Multivariate linear regression model evaluating independent variables for different cancer cervix-specific quality of life indicators (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CX-24)|
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| > Discussion|| |
EORTC QLQ-30 and EORTC QLQ CX-24 questionnaire were used in our study because these questionnaires have undergone extensive testing in multicultural and multidisciplinary research settings and have been confirmed to be a reliable and valid.,,, In our study, QOL was studied in cervical cancer patients before treatment (baseline), 3 months after treatment, and 6 months after treatment, and treatment was either by surgery or by radiotherapy. This allowed us to identify the changes that the subjects were going through with regard to the general QOL, general evaluation of their health, as well as their biocognitive-socio-cultural function.
For global health score, in our study, it was found that although there was improvement in it from baseline to 3 months posttreatment, statistically significant difference was only seen at 6 months posttreatment. These results were similar to Klee et al. As in our research, they also found that patients evaluated their state of health better at 6 months following the treatment as compared to immediately after the therapy. In a study done by Lutgendorf et al., the participants expressed a significant improvement of the QOL despite a worsening of their physical function possibly because of adaptation to physical limitations. However, Miller et al. in their study on women with gynecological cancers showed differing data. At 6 months following the treatment, they found that longer the period after the treatment, the lower was the patients' opinions about their own physical state. Physical functioning was assessed by the ability of the patients in eating, dressing, washing themselves, using the toilet, or going for a walk. It depicts the motor function of the subjects. In the present study, there was a significant increase in physical functioning posttreatment. Physical functioning was assessed to be the worst before the treatment, but it improved gradually throughout the follow-up period after treatment. Pasek et al. reported a significant improvement inphysical functioning of the subjects which was greatest after 6 months of treatment. However, in another study, Wenzel et al. (2015) found significant difference between their cancer patients even after treatment and healthy controls with regard to physical functioning The diagnosis and treatment of a tumor impart chronic psychological and physiologic stress that leads to disruption of multiple domains, which are interconnected via the psycho-neuroimmune axis and which lead to decreased psychological and biologic health, resulting in compromised survivorship.
In our study, there was an improvement in the role functioning of the patient such as ability to pursue their hobby or doing their routine work. It depicts the ability of the subjects to carry out their role in day-to-day activity. Although there was an improvement in the role functioning during the follow-up period, it was not statistically significant. According to Pasek et al., role functioning was highest immediately after the treatment and lowest before treatment. In our study, there was a statistically significant improvement in the emotional function of the survivors of cancer cervix after treatment. This improvement in the emotional functioning may be due to decreased worry about cancer. The fear of local recurrence was found to have increased levels of worry in patients who underwent the treatment for cancer of the cervix with radiotherapy. Pasek et al. and Ljuca et al., have also shown significant improvement in the emotional function of the subjects after treatment. In contrast to these results, according to Cull et al., long-term survivors may be compromised not only by persistent late physical effects of treatment but also by the psychological reaction to having a life-threatening illness and by the challenges of recovering the premorbid lifestyle. Explanation of differing opinion about psychological function may be because of short-term follow-up of our study.
Social function has been described as the ability of the subjects to interact with the society. In our study, there was no impact of treatment on the social functioning of the subjects. Worst social functioning and body image were reported by Park et al. Their study demonstrated that long-term survivors of cancer of the cervix who were treated with chemoradiation experienced significantly worse social functioning. Jensen et al. stated that chemo-radiotherapy side effects such as nausea and fatigue were highly associated with reduced social functioning. Wenzel et al. (2015) and Pfaendler et al., also stated that there is negative impact of radiotherapy on social functioning. However, Ljuca et al. (2011) and Pasek et al. reported improvement in the social functioning of the subjects after treatment.
Cognitive function was defined as the ability of patients to realize their own potential, ability to cope with the normal stresses of life, ability to work productively, and ability to contribute to their community. In our study, although there was improvement in the cognitive function, it was not statistically significant. Korfage et al. showed no relationship of cognitive function with treatment. However, in the studies done by Ljuca et al. (2011) and Pasek et al., there was significant improvement of cognitive function probably because of decrease of worry related to cancer.
In our study, there was a slight increase in the sexual activity after treatment, but it was not significant. As the patients were free from the disease, there was increase in the sexual activity. On the other hand, there was persistent decrease in sexual enjoyment, and there was significant sexual dysfunction. Patients after radiotherapy had significant shortening of the vagina due to radiation-induced fibrosis, with decreased lubrication and increased pain with sexual intercourse. These results were similar to previous studies.
When analyzing the occurrence of physical symptoms in the conducted study, it has been noticed that diarrhea most often occurred directly at the end of the treatment and rarely 5–6 months later. Radiation damages the vaginal mucosa and epithelium of the gastrointestinal tract and may induce side effects including nausea, vomiting, diarrhea and mucositis. In our study, patients evaluated pain to be the greatest before treatment and decreased during the follow-up after treatment and there was significant reduction in pain after 6 months of treatment. Studies which have shown increased pain after 6 months have given reason of radiation-induced fibrosis. There was decrease in lymphedema and peripheral neuropathy in the subjects of our study, but it was not statistically significant. Park et al. found that cancer cervix survivors reported more impaired chronic leg lymphedema. They stated that it was possible that the lymphedema was related to lymph node damage that resulted from metastases. Another possiblilty of increased lymphedema was that it may not discriminate between lower extremity swelling or deep venous thrombosis as cause. Menopausal symptoms were not increased in our study as has been shown in other studies and explanation for this may be because more than half of patients in our study were already menopausal. We could not compare the effect of treatment modality on QOL because maximum patients were treated with radiotherapy because our center is a tertiary care center and all these cases were referred cases in later stages.
Multivariate linear regression analysis was done to analyze the effect of independent variables on the QOL of the subjects. Education, tobacco use, degree of differentiation of tumor, and size of tumor were the independent factors found to have statistically significant effect on general QOL health including all the three, global health, functional score, symptom scale. Our study showed that there was no significant impact of stage of cancer on the global health or general functional score or general symptom score of the subjects, but the stage of cancer had a statistically significant impact on the cancer cervix-specific function and symptom score. Earlier was the stage of cancer, better was the QOL.
The degree of differentiation and tumor size had significant impact on the cancer cervix-specific function and symptom score. Subjects with well-differentiated tumor and tumor size <4 cm had better global health, function score, and better general symptom score. However, in the present study, type of treatment modality (chemotherapy or surgery) did not show significant impact on the QOL. These results are probably due to small size of patients in the surgery group and also due to the fact that all the patients in surgically treated group were sexually inactive. Similar study using multivariate analysis was done by Kumar et al. and they showed that the age, marital status, stage of cancer, and type of treatment individually affect the QOL of the subjects. In their study, they concluded that subjects of lower age group had better QOL. Married women had significant improvement in their general QOL, functional, and symptom scale. Stage of cancer also had an impact on the QOL; lower the stage of cancer, better was the overall general QOL. In another similar type of study by Kim et al., univariate and multivariate analyses of individual demographic factors as prognostic factor were done. They reported that age had a significant influence on QOL, and survivors of younger age group had better QOL. However, in their study, education had no significant impact on the QOL. They also showed that early the stage of cancer, better is the QOL of the survivors. Park et al. reported that the QOL and sexual activity differ in early and late stage of cervical cancer, but these differences disappear after the 1st year of treatment. In addition, among long-term cervical cancer survivors, QOL may depend more on type of treatment than on stage. Comparison of QOL according to the stage with adjustment for type of treatment yielded no clinically meaningful differences in EORTC QLQ C-30 or CX-24 subscales. According to Awadalla et al., although age was not significantly associated with patients' QOL, higher QOL was associated with patients being married, as well as having higher levels of employment and higher educational attainments. While there are no consistent findings on the role of these sociodemographic factors, it is reasonable to assume that marriage, higher educational attainment, and employment will increase the potential for awareness of disease, social support, and use of positive coping methods, all of which can contribute to higher QOL. Mantegna et al. did a multivariate analysis of sociodemographic features and QOL score in cancer cervix-treated patients. They found that higher level of education and higher socioeconomic status were associated with better QOL, while age had no significant impact on the QOL of the survivors. Similar results were reported by Osann et al. A study with a bigger sample size and longer duration of follow-up is recommended for better results and to compare the QOL of survivors treated with surgery and chemoradiation.
| > Conclusion|| |
Education, tobacco use, degree of differentiation of tumor, and size of tumor were the independent factors found to have statistically significant effect on QOL of cervical cancer survivors.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]