|Ahead of print publication
Exploring quality of life among head-and-neck cancer patients in Western India using European organization for research and treatment of cancer questionnaires
Sujal Parkar1, Abhishek Sharma2, Mihir Shah3
1 Department of Public Health Dentistry, Siddhpur Dental College and Hospital, Patan, Gujarat, India
2 Department of Community and Family Medicine, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India
3 Department of Periodontology, Ahmedabad Dental College and Hospital, Gandhinagar, Gujarat, India
|Date of Submission||11-Apr-2020|
|Date of Decision||01-Jun-2017|
|Date of Acceptance||04-Aug-2020|
|Date of Web Publication||09-Mar-2021|
B-25 Krishna Bunglows-I, Gandhinagar Highway, Motera, Ahmedabad - 380 005, Gujarat
Source of Support: None, Conflict of Interest: None
Background:Head-and-neck cancers (HNCs) are one of the major public health problems for both patients and the health-care providers in India. The clinical manifestations of HNC and its treatment can lead to negative effects on the quality of life (QoL) of the patient. The study is aimed to explore the QoL using the European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaires among HNC patients in Western part of India.
Materials and Methods: A cross-sectional prospective study was conducted among 400 HNC patients attending the tertiary cancer center. The QoL was assessed by using the EORTC core questionnaire (EORTC QLQ-C30) and EORTC head- and neck-specific questionnaire (EORTC QLQ-H and N35). The data were explored using means, standard deviation, medians, ranges, and proportions.
Results:All the 400 patients had completed the questionnaire having a compliance rate of 100%. There was no missing data at the item level for the EORTC QLQ-C30 questionnaire. While the missing items for EORTC QLQ-H and N35 were: problems while swallowing food, problems with teeth, and sexuality. The mean functional score ranged from 74.22 to 93.49 for EORTC QLQ-C30. The mean symptoms score was found in the range from 3.25 to 81.50 for EORTC QLQ-H and N35.
Conclusion: Both questionnaires were comprehensive and well accepted by the patients. These questionnaires provided the information-related disease-specific QoL data, which otherwise is often missed. Health-care providers should not only focus on the clinical effects of treatment but also on QoL issues because it will improve overall patient care and survival.
Keywords: European organization for research and treatment of cancer QLQ-C30, European organization for research and treatment of cancer QLQ-H and N35, head-and-neck cancer, quality of life, questionnaire
|How to cite this URL:|
Parkar S, Sharma A, Shah M. Exploring quality of life among head-and-neck cancer patients in Western India using European organization for research and treatment of cancer questionnaires. J Can Res Ther [Epub ahead of print] [cited 2021 Jul 25]. Available from: https://www.cancerjournal.net/preprintarticle.asp?id=311037
| > Introduction|| |
Head-and-neck cancers (HNCs) are considered as a public health problem in developing countries like India, constituting approximately one-third of all cancer cases in contrast to 4%–5% in the developed world. With 77,000 cases diagnosed per year, HNCs are the second-most common cancers in the Indian population. HNC refers to malignancies that arise from the oral cavity, pharynx, larynx, paranasal sinuses, and nasal cavity. These areas are structurally complex and functionally imperative for critical activities such as phonetics, mastication, and deglutition. As a result, patients with HNC often gain importance for specific care than those of patients with cancers of other sites.,
Quality of life (QoL) is a broad concept which includes person's physical health, mental state, beliefs, social relationships, and their relationship to salient features of their surrounding environment. Since the beginning of the century, there has been a growing interest in QoL outcome measures in HNC. The assessment of QoL has become an integral part of cancer management as cancer disease itself and treatment significantly affects the functional, social, and esthetic aspects of cancer patients. Exploring QoL among these patients can also help to refine cancer care protocol with integrated clinical, social, rehabilitation measures.
A number of multidimensional assessment instruments have been developed and validated across the globe to satisfy the unique breath of QoL related to HNC. Some questionnaires are framed as modules with individual questionnaires for general cancer and HNC-specific cancer. For example, the European Organization for Research and Treatment for Cancer (EORCT QLQ-C30 and EORTC QLQ-H and N35), Functional Assessment of Chronic Illness Therapy, while other questionnaires focus on solely HNC and combine functional, emotional and social items, for example, University of Washington QoL Scale., The selection of questionnaire depends on the context in which it is being used, based on the hypothesis being tested. The EORTC has gained the popularity because it has been included as a secondary outcome in clinical trials where different treatments might impact on QoL.
Even though HNC is considered as a though a major public health problem with a strong psycho-social setup in India, very few studies,, had been conducted to assess the QoL among cancer patients in India. While there is a lack of knowledge concerning the QoL among HNC patients in the state of Gujarat. Thus, the study is aimed to explore the QoL using among HNC patients using EORTC QoL questionnaires in context to Indian culture. The information gathered in this study can provide new insight into the healthcare experience and is capable of improving the delivery and satisfaction with care in HNC patients.
| > Materials And Methods|| |
A cross-sectional prospective study was conducted among HNC patients admitted to the tertiary cancer center in Gujarat, India. Total 400 HNC patients were enrolled in the study having eligibility criteria of histo-pathologically proven case of HNC, both male and female patients >18-year-old, had Karnofsky's Performance Status score (KPS) >60 and those patients who gave written consent to participate in the study. While patients age >65 years had clinical evidence of disease recurrence or a secondary tumor, unable to read or write Gujarati language and had survived for >18 months after treatment in any form were excluded from the study.
The permission to conduct the study was obtained from the Ethics committee and institutional review board of the tertiary cancer center. The study was conducted in accordance with the Declaration of Helsinki. Once the eligibility criteria were met the patients were enrolled in the study. The purpose of the study was explained to patients and the completion of the questionnaire was a condition for entering the study and was regarded as written consent.
The data were collected at different time phases right from the diagnosis of cancer, during treatment and after completion of treatment who had a survival of <18 months. The data collection includes two sections: (1) to collect general information and medical details of patients and (2) to collect the data related to QoL of patients. Pretested, self-designed questionnaire was used to collect the demographic details (age, gender, socioeconomic status [SES], residence, marital status, type of family) through personal interview. The SES of the patients was assessed as per the Kuppuswamy's scale. The clinical details (stage of cancer, treatment of cancer, and KPS) were retrieved from patient medical records. The QoL of patients was assessed using self-administered questionnaires developed by the EORCT: Core (QLQ-C30) and Head and Neck specific module (QLQ-H and N35). The Gujarati version of the EORTC QLQ-C30 and QLQ-H and N35 questionnaires is copyrighted instruments. Copies of the questionnaires, scoring instructions, and permission to use them (free of charge for academic users) were obtained from the EORTC Data Centre, QoL Unit, Avenue E Mounier 83 Bte 11, 1200 Brussels, Belgium.
Instruments to assess quality of life
EORTC QLQ-C30 version 3.0 consists of 30 questions: presenting various aspects of QoL: five functional scales - PF: Physical functioning (5 items); SF: Social functioning (2 items); EF: Emotional functioning (4 items); RF: Role functioning (2 items) and CF: Cognitive functioning (2 items), FA: three symptom scales-fatigue (3 items), PA: Physical functioning (2 items), nausea and vomiting (2 items), as well as six, are single-item scales (Dyspnoea, Insomnia [SL], Appetite Loss [AP], Constipation [CO], Diarrhoea [DI] and Financial Difficulties [FI]) describing different cancer relevant symptoms and the last two items deal with the overall health assessment and overall QoL (QL). The first 28 items are scored on a four-point Likert scale with response ranging from “not at all” to “very much” (measured on a 1–4 interval scale) while the items concerning overall health condition and overall QoL are measured on a seven-point scale from “very poor” to “excellent” (measured on a 1–7 interval scale).
The EORTC QLQ-H and N35 is meant to be used in conjunction with the QLQ-C30 in patients with HNC, irrespective of site, stage, and treatment. Thirty-five questions are related to symptoms and side effects of treatment for HNC. The 35 questions grouped into seven multi-item symptoms scales: HNPA: pain (4 items), HNSW: swallowing (5 items), HNSE: senses (2 items), HNSP: speaking (3 items), HNSO: eating in the company of others (4 items), HNSC: social contacts (4 items), HNSX: sexuality (2 items), and 11 single-item symptoms scales concerning teeth problems (HNTE), difficulties with opening the mouth (HNOM), dry mouth (HNDR), sticky saliva (HNSS), coughing (HNCO), feeling ill (HNFI), use of painkillers (HNPK), using food supplements (HNNU), feeding tube requirement (HNFE) and losing (HNWL) or gaining weight (HNWG). The time frame the module addresses is “during the last week.” The first 30 items are scored on a four-point Likert scale with response ranging from “not at all” to “very much” (measured on a 1–4 interval scale), whereas the last five items have a Dichotomous scale having no/yes format.
The patients were asked to complete the questionnaires by themselves and in case of some difficulties in understanding the questions, they asked to the principal investigator or their family members for help. Offering and providing assistance with surveys encouraged participants with lower educational and literacy abilities to complete surveys accurately.
After the collection of data, the data were compiled, and coding was done. The data were entered in Microsoft Excel 2007. The data were analyzed using the Statistical Package for the Social Sciences (SPSS® version 22; IBM Corp., Armonk NY, USA). The missing items were calculated as per the EORTC scoring manual. The data were explored by using means, standard deviation, medians, ranges, and proportions as appropriate.
| > Results|| |
[Table 1] shows the demographic and clinical characteristics of the patients. The mean age of the patients was 45.47 ± 10.31 years. Out of 400 patients, 350 (87.50%) were male showing the predominance of HNC among male subjects. Half of the patients (n = 214, 53.50%) belong to the rural community and having lower SES (57.50%). The reporting of patients at the advanced stage (III/IV) was high. Patient's medical records revealed that 80 (20%) of the patients received no treatment (either newly diagnosed), while 71 (17.75%) of patients received a combination of all three types of treatment. The common surgical procedure was mandibulectomy (n = 84, 21%) followed by Commando operation having (n = 45, 11.25%). 222 (55.50%) of the patients had received curative radiotherapy. Cisplatin was the commonly used chemotherapeutic drug either alone or in combination with another chemotherapeutic drug.
|Table 1: Demographic and clinical characteristic of head and neck patients (n=400)|
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Compliance of questionnaires
All 400 patients had completed the questionnaire having compliance rate of 100%. The response time varies from 15 to 25 min with a mean time of 17 min to complete both questionnaires. Few patients (12.00%) requiring some form of assistance to answer the questions. There was no missing data at the item level for the EORTC QLQ-C30 questionnaire. While the missing items for EORTC QLQ-H and N35 were: problems while swallowing food (HN5–HN8) (missing 0.75%, 2.00%, 17.00%, and 1.50%, respectively), problems with teeth (HN9) (missing 3.25%), and sexuality (HN29, HN30) (missing: 11.75% for both the questions).
Response to questionnaires
The percentage-wise response to each item of the EORTC QLQ-C30 and EORTC QLQ-H and N35 is shown in [Table 2] and [Table 3], respectively. The median value for items of QLQ-C30 ranges from 1 to 6 and for QLQ-H and N35 ranges from 1 to 3.
|Table 2: Distributions of responses for European Organization for Research and Treatment of Cancer QLQ-C30|
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|Table 3: Distributions of responses for the European Organization for Research and Treatment of Cancer QLQ-H and N35|
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Instruments score characteristic
The mean scores, skewness, and kurtosis for EORTC QLQ-C30 are presented in [Table 4]. All the functional scales of EORTC QLQ-C30 were negatively skewed to the left side ranging from −2.89 (CF) to −0.07 (QL). All the symptoms scales of EORTC QLQ-C30 were positively skewed to the right side ranging from 0.56 (FI) to 6.10 (DI). All the items of EORTC QLQ-C30 showed positive kurtosis (high peakedness), indicating leptokurtic distribution except FI having negative kurtosis (flat) indicating platykurtic distribution. The functional score ranges from the mean score of 74.22 (QL) to 93.49 (CF). The common problems were with FI (mean score: 34.83), followed by AP (mean score: 22.33). Diarrhea was an infrequent problem having a mean score of 1.92.
|Table 4: European Organization for Research and Treatment of Cancer QLQ-C30 Scores characteristics |
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The mean scores, skewness, and kurtosis for EORTC QLQ-H and N35 are presented in [Table 5]. All the symptoms scales/items of EORTC QLQ-H and N35 were positively skewed to the right side ranging from 0.47 (HNDR) to 5.29 (HNNU) expect for HNPK (−1.63) and HNWL (−0.44). Most of the items of EORTC QLQ-H and N35 showed positive kurtosis (high peakedness), indicating leptokuric distribution. Social eating, problem with teeth, mouth opening, dry mouth, sticky saliva and weight loss showed negative kurtosis (flat) indicating platykurtic distribution. The mean score was ranging from 3.25 (HNNU) to 81.50 (HNPK).
|Table 5: European Organization for Research and Treatment of Cancer QLQ-H&N35 scores characteristicsEuropean Organization for Research and Treatment of Cancer QLQ-H&N35 scores characteristics|
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| > Discussion|| |
HNC and its treatment have a profound role on the patient's physical, functional, and emotional status, which affects the level of QoL. The aspect of the evaluation of QoL is important for the oncological as well as psycho-social research pertaining to important parameters such as treatment outcomes, survival, mortality, and complication rates., Hence, assessment of QoL among HNC patients become a vital part in the field of oncology as well as in the file of psycho-social research.
In this study, the QoL was measured using a self-administered questionnaire, which provides an excellent medium for effective conversation between the patients and their physicians. Self-administered QoL questionnaire may prove beneficial in assessing various symptoms among HNC patients, which are often difficult to communicate by the patient to their physician due to various reasons on behalf of patients such as social stigma, cultural norms and on behalf of physicians such as time constraint and busy practice schedule.
The QoL was assessed by using the EORTC QLQ-C30and EORTC QLQ-H and N35. The reasons of selecting the combination of these instruments are: (1) Both these instruments are purely patient based, multidimensional self-administered questionnaires, (2) commonly used by many researchers around the world and were developed using patients of different cultures and languages to ensure cross-cultural validity and cultural acceptance, (3) provides a better assessment of QoL as affected by the adverse effect of cancer treatment and (4) the combined 65 items of the EORTC QLQ-C30 and EORTC QLQ-H and N35 covers all the important aspects of the patients suffering from HNC and aid in effective assessment.
The questionnaire was accepted by the patients as a sign of concern about their QoL and with little reluctance. The mean time for completing both questionnaires was 17 min as acceptable and similar to other studies.,,.Missing items where a particular point in the questionnaire are not respond or having any adverse effect of the morale of patients was generally very low. The few missing values were for swallowing solid food; the possible reasons for this might be due to the fact that some patients were on feeding tube and were advice to have only liquid diet; hence the patients considered such questions as inappropriate. Similarly, the edentulous patients consider the question related to the problem in teeth as irrelevant. There was a higher proportion of missing values for the sexuality items; this was consistent with the findings of the original study conducted by Bjordal et al. and other studies by Fang et al. and Vartanian et al. The main reason for the patients not answering these questions was because they were sexually inactive either due to their advanced age or because of their marital status (few were unmarried and few were window/divorced). Besides, it should be accepted that the matter related to the sexual behavior of an individual is more of personal and not much vocal even in the case of a highly educated person. Hence, it is natural that there is bound to be a vacuum in this information.
The overall global QoL score was satisfactory in the present study. This was in accordance with the results of previous studies.,, The financial difficulty was high. This might be due to the patients in the present study had a very low income. The lower SES may act as one of the risk factors for HNC. These similar findings from the Indian population indicate patients belonging to such a deprived group show difficulty in dealing with HNC and its consequences., Nearly half of the patients had mild-to-moderate levels of emotional disturbance in the present study.
The most common problems associated with HNC in the present study were the difficulty in the wide opening of the mouth, dry mouth, and sticky saliva. These results were in accordance with a previous investigation conducted by Chaukar et al., Dong et al., and Liao et al. Such treatment-related complications are not preventable and need to be discussed with the patients preoperatively. These problems are commonly associated with HNC patients globally regardless of different populations, or geographic location studied. Few patients had experienced moderate-to-severe levels of difficulties in swallowing the food and had a problem in enjoying their meals as well as in talking with others; this result was in contrast to the findings of research conducted by Dong et al. Rehabilitation in the form of obturators will prevent the regurgitation of the food in the nasal cavity and also help in the proper pronunciation of words while speaking.
Most of the patients reported that they do not face any problems in having social contact with their family and friends, as the family members and their peers have been able to accept and adapt to the patients' altered physical and emotional conditions due to cancer.
Almost all the patients used pain killers; this could be due to the possibility that some patients might be using pain killers to relieve pains in mouth/jaws. Furthermore, there is pain during treatment due to RT and/or computed tomography which results in increased use of pain killers. As with other studies,,, majority of patients had lost their weight. The possible explanation for this finding was the patients were disabled to chew and swallow the food following the treatment; some patients were on feeding tube that cannot enjoy and take their meals satisfactory. Losing weight is not only due to less of improper food intake, but the weight factor has a direct relation with the mental peace and happiness of a person.
The results should be interpreted very cautiously. There are few limitations that should be kept in mind and should consider for the future aspect of this study. First, in this study, QoL was evaluated just once in a cross-sectional fashion, and thus, one cannot rule out the possibility that QoL is a dynamic process that keeps on changing at the different time period, and this is our major limitation. Hence, a longitudinal study is required to further investigate QoL issues. Second, both the questionnaire used in this study are the lengthier questionnaires than other questionnaires, which result in burden to patients for filling the questionnaire. From a psychometric perspective, multiple items scale offers greater reliability, however, there is always a doubt regarding reliability on single items. Though these questionnaires are lengthier it does not assess important issues related to shoulder disability, self-esteem changes associated with facial disfigurement, xerostomia, anxiety/depression level. However, both are well-known instruments that have been validated in a number of studies, and they are sensitive to changes which support the reliability of the QoL results of the present study. Finally, the present study was limited to only one institute. However, it is the regional hospital and considered as a center for registration of cancer, which thus improves the external validity of the study.
| > Conclusion|| |
Within the limitations of the study, it can be concluded that the questionnaires were comprehensive and were well accepted by the patients. The items included are all relevant in Indian context except for few items which may vary based on cultural differences. A combination of both questionnaires is helpful in assessing QoL outcomes. The major concerns were functional status, pain, difficulties in eating, speech, dry mouth, problems in disfigurement, and problems in social contact, indicating that these patients are having poor QoL. The adoption of a QoL assessment as a standard procedure in hospital settings can help in the early interventions and thus reducing the impact of therapeutic complications and thus improving patient's QoL.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]