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Table of Contents
ORIGINAL ARTICLE
Year : 2022  |  Volume : 5  |  Issue : 1  |  Page : 26-34

Preference and Satisfaction with Cancer Institute quality of life questionnaire, (CI - QoL) V. II and EORTC QLQ-C30 Tamil version: An observational study


1 Department of Psycho-Oncology, Cancer Institute (WIA), Chennai, Tamil Nadu, India
2 Fenivi Research Solutions, Chennai, Tamil Nadu, India

Date of Submission09-Jun-2021
Date of Decision02-Feb-2022
Date of Acceptance02-Mar-2022
Date of Web Publication31-Mar-2022

Correspondence Address:
Sasikala Athikesavan
Cancer Institute (WIA), Chennai, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/crst.crst_218_21

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  Abstract 


Background: Quality of life (QoL) is an important clinical outcome in oncology and various tools are available for its assessment. The Cancer Institute QoL Questionnaire, Version II (CI-QoL II) is a questionnaire standardized for use in the Indian setting.
Objectives: This study was aimed at evaluating the preference for and satisfaction with CI-QoL II and the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30) (Tamil version) among patients with cancer.
Materials and Methods: This study was conducted in the Department of Psycho-Oncology of the Cancer Institute (WIA), Chennai, India, in patients with cancer between September and October 2017. Participants were administered the CI-QoL II and EORTC QLQ-C30, questionnaires 15 min apart, and a debriefing interview was conducted to explore relevant, confusing, or upsetting items.
Results: A total of 60 participants were included in the study. The mean age was 38 years (range, 18–60). CI-QoL II was preferred by 43% of the patients and EORTC QLQ-C30 by 20%. Around 85% of patients reported satisfaction with both questionnaires, 12% with CI-QoL II, and 3% with EORTC QLQ-C30. In EORTC QLQ-C30, items on daily activities (10%) and leisure activities (10%) were reported as confusing; impact on family (1.7%), social life (1.7%), and financial life (1.7%) were reported as upsetting; need for rest (5%), irritability (5%), daily activities (13.3%), and leisure activities (18.3%) were reported as irrelevant. In CI-QoL, items on dependency on medication (5%) were reported as confusing, spousal support (6.7%), and sex life (5%) were reported as upsetting, and dependency on medication (23.3%), sex life (31.7%), and spousal support (16.7%) were reported as irrelevant.
Conclusion: Over twice the number of patients prefer the CI-QoL II questionnaire to EORTC QLQ-C30; more patients are satisfied with CI-QOL II. The CI-QoL II obtains more information on the QoL of patients to facilitate psychological counseling in the clinical setting, whereas EORTC QLQ-C30 is more appropriate in eliciting responses without bias.

Keywords: Preference, quality of life, questionnaires, satisfaction


How to cite this article:
Athikesavan S, Elangovan V, Chidambaram S, Veeraiah S. Preference and Satisfaction with Cancer Institute quality of life questionnaire, (CI - QoL) V. II and EORTC QLQ-C30 Tamil version: An observational study. Cancer Res Stat Treat 2022;5:26-34

How to cite this URL:
Athikesavan S, Elangovan V, Chidambaram S, Veeraiah S. Preference and Satisfaction with Cancer Institute quality of life questionnaire, (CI - QoL) V. II and EORTC QLQ-C30 Tamil version: An observational study. Cancer Res Stat Treat [serial online] 2022 [cited 2022 May 28];5:26-34. Available from: https://www.crstonline.com/text.asp?2022/5/1/26/341237




  Introduction Top


Quality of life (QoL) assessment is important for improving symptom relief, care, and rehabilitation of patients. QoL assessment is also used to identify the range of problems that affect patients.[1] Many studies have been conducted to compare the validity of a standardized QoL assessment tool with that of a locally developed tool.[2],[3] There are no “worst” or “best” tools that can be used consistently in clinical trials. The decision to use one tool over another, a combination of two or more tools, preference-based measures or a generic measure along with a targeted measure is driven by the purpose of the assessment for patients with cancer. The decision varies between individuals from different countries owing to differences in culture, socioeconomic status, lifestyle, education, behavior, and environmental factors. Hence, the choice of tool depends on a variety of factors, including the characteristics and needs of the population being studied in the clinical trial.[3]



Several questionnaires are available to assess the QoL of patients with cancer.[4] The two most widely used questionnaires are the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-General (FACT-G). These are core questionnaires supplemented with symptom-, disease-, and treatment-specific modules available in multiple languages. Combined use of core and supplementary questionnaires is recommended as it enhances the sensitivity to capture various aspects related to the disease and treatment effects.[5] Both questionnaires are used in the Indian setting and are available in several regional languages. Comparison of effectiveness and feasibility of questionnaires in the cultural context is important to accentuate the utility of QoL questionnaires in clinical settings.

A systematic review was conducted by Luckett et al. in 2010 to help cancer clinical researchers choose between FACT-G and EORTC, in which the authors reported that psychometric evidence did not recommend one questionnaire over the other in general. However, important differences between the scale structure, social domains, and tone were observed.[6] The Cancer Institute QoL Questionnaire (CI-QoL) (versions I and II) was developed and validated for use in the Indian oncology setting. It is currently available in two languages, English and Tamil.[7],[8] Version II has 41 items and its psychometric properties were established and presented earlier.[8]

Although, the questionnaires are available in regional languages, the preferences for and satisfaction with the international questionnaires across various cultures are unknown. Although CI-QoL was developed in India and EORTC QLQ-C30[9] is also being used in the Indian setting, preferences for these questionnaires among Indian patients have not yet been studied. This study was therefore conducted to evaluate the preference for and satisfaction with the items of CI-QoL II and EORTC QLQ-C30 among patients with cancer from Tamil Nadu.


  Materials and Methods Top


General study details

This study adopted a descriptive research design and was conducted in the Department of Psycho-Oncology of the Cancer Institute (WIA), Chennai, India, among patients with cancer admitted to the regional cancer center between September and October 2017. The study was approved by the Institutional Thesis Review Committee and Institutional Ethical Committee of Cancer Institute (WIA) (Registration No: ECR/235/Inst/TN/2013/RR-16) on Aug 17, 2017 [Supplementary Appendix 1]. Written informed consent was obtained from participants before enrollment in the study. The study was conducted according to ethical guidelines established by the Declaration of Helsinki and other guidelines like Good Clinical Practice Guidelines and those established by the Indian Council of Medical Research. The study was not registered in a publicly accessible clinical trials registry and there was no funding for the study.

Participants

Patients aged above 18 years, diagnosed with any type of cancer, receiving treatment with curative intent and who were fluent in speaking or reading Tamil were approached during the course of their treatment and briefed about the purpose of the study. There were no specific exclusion criteria.

Variables

The primary objective was to assess the preference for and satisfaction of Indian patients with cancer with the CI-QoL II and EORTC QLQ-C30 QoL questionnaires.

Study methodology

Tamil versions of CI-QoL II and EORTC QLQ-C30 were administered 15 min apart from one another to the participants. The order of administration of the questionnaires changed for every other patient to eliminate researcher bias. Following the self-administration of each questionnaire, a debriefing form was provided to each participant; it consisted of eight items measuring the time taken to complete each questionnaire and assessing the items that were confusing, upsetting, missing, relevant, and irrelevant, along with the participants' willingness or unwillingness to answer particular questions. The overall satisfaction with and preference for the questionnaires were assessed on completion [Table 1]. The demographic and clinical details of the patients were collected from the case record form and recorded in a separate pro forma.
Table 1: Debriefing questions

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The tools used for the study are described below:

Cancer Institute – Quality of Life Questionnaire Version II

This is a 41-item cancer-specific QoL questionnaire developed at the Cancer Institute (WIA) Chennai, India, in 2005.[7] The modified version of CI-QoL II was published in 2011.[8] It assesses the QoL of patients with cancer in 11 dimensions: General, physical, psychological, cognitive, and economic well-being, interpersonal relationships, sexual and personal ability, optimism and belief, informational support, patient-physician relationship, and body image. This questionnaire comprises 41 items with 39 items rated on a 4-point Likert scale and the last 2 items that assess the overall QoL rated on a 10-point semantic differential scale. The questionnaire was tested for its reliability (Cronbach alpha score of 0.90 and split-half reliability score of 0.80) and validity.[8]

European Organization for Research and Treatment for Cancer Quality of Life Questionnaire - Core 30 Version 3

This questionnaire developed by Aaronson et al. in 1993 is a 30-item cancer-specific QoL questionnaire initially validated for the European populations.[9] It is currently being used worldwide and has been translated into 110 languages.[10] The questionnaire consists of multi-item scales as well as single-item measures with five functional scales, three symptom scales, a global health status/QoL scale, and six single items. Functional scales include physical, role, emotional, cognitive, and social functioning. Symptoms include fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. The total score of the questionnaire ranges from 0 to 100. A high score represents higher (”better”) level of functioning or higher (”worse”) level of symptoms. The questionnaire has high reliability and validity, with a Cronbach alpha score of > 0.70.[9]

Statistics

Sample size calculation was not performed as this study was conducted as part of a dissertation and was time-restricted. Hence, all the eligible patients who reported to the institute during the timeframe of the study were evaluated for enrolment. Descriptive statistics were used to summarize the number and proportion of patients who were satisfied with EORTC QLQ-C30 and CI-QoL II and their preferences. The demographic and clinical variables were also reported using descriptive statistics. Statistical analysis was performed with the Statistical Package for the Social Sciences (SPSS Inc. Released 2008. SPSS Statistics for Windows, Version 17.0. Chicago: SPSS Inc.) with an alpha level set at 0.05 for all analyses.


  Results Top


A total of 60 participants who completed the assessment were included in the study [Figure 1]. The median age of the participants was 38 (range, 18–60) years. Sociodemographic characteristics of the patients are presented in [Table 2]. About 28.3% of the patients were employed as daily wage workers, and 38.3% had completed college education. More than half the patients (66.7%) lived in urban areas. The mean time taken to complete CI-QoL II was 8.6 min (standard deviation [SD], 2.6). The mean time taken to complete EORTC QLQ-C30 was 5 min (SD, 1.8).
Figure 1: Flow chart of enrolling patients in the study

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Table 2: Demographic and clinical characteristics of patients

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Responses to CI-QoL II (41 items, [Table 3])
Table 3: Responses to debriefing questions for Cancer Institute quality of life questionnaire version II

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Confusing

Thirty items (73.2%) were reported as not confusing by the participants. One item related to dependency on medication was reported as confusing by 3 patients (5%) who were either survivors or young adults. Four items related to roles and responsibilities, managing financial needs, economic status of the family, and working capacity were reported as confusing by 1 patient (1.7%) each who were young adults and dependents. Similarly, 1 item on sex life was reported as confusing by 1 young adult (1.7%) who was unmarried.

Upsetting

Thirty items (73.2%) were reported as not upsetting. One item related to support received from spouse and family members and one related to sex life was reported as upsetting by 4 (6.7%) and 3 (5%) of the respondents, respectively, who were either separated or unmarried. Similarly, 1 item related to fear of disease recurrence and one to fear of rejection were reported as upsetting by 2 (3.3%) young adult respondents each.

Answered and unanswered

A total of 28 items were answered by 60 patients (68.3%). One item related to satisfaction with sex life was not answered by 12 (20%) respondents who were both young and unmarried or separated. One item related to support from spouse, family, and one on the importance of self were left unanswered by 5 (8.3%) and 3 (5%) respondents, respectively, who were either separated or unmarried. In addition, one item related to managing financial needs was left unanswered by 2 (3.3%) of the respondents who were young and dependent.

Relevant and irrelevant

Sixteen items (39%) were reported to be relevant. The item on sex life satisfaction was reported as irrelevant by 19 (31.7%) respondents who were either young, unmarried, separated, or on treatment. One item related to dependency on medication was reported as irrelevant by 14 (23.3%) respondents who were survivors and young adults. One item on support received from spouse was also reported as irrelevant by10 (16.7%) respondents who were either separated or unmarried, and one item on time management was reported as irrelevant by 7 (11.7%) respondents who were young and hospitalized at the time. Similarly, the items on responsibilities and importance of self were reported as irrelevant by 5 (8.3%) respondents each, who were young adults and dependents.

Unwillingness

Respondents reported unwillingness to answer 16 (39%) items. Five (8.3%) respondents who were either unmarried or separated reported unwillingness to answer 5 questions (12.1%) related to interpersonal relationships. In addition, one respondent (1.7%) each reported unwillingness to respond to items related to responsibilities fulfilled and managing time, as they were young adults and on treatment.

Responses to EORTC QLQ-C30 (30 items, [Table 4])
Table 4: Responses to debriefing questions for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30

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Twenty-eight items (93.3%) were reported as not confusing by the respondents. The remaining 2 items on daily and leisure activities were reported as confusing by 6 (10%) of the respondents each, who were hospitalized at the time.

Upsetting

Twenty-six items (86.6%) were reported as not upsetting. Three items (10%) on the impact of disease or treatment on physical, social, and financial life were reported as upsetting by 1 (1.7%) of the respondents each, who were young adults and unmarried. One item 1.7% on memory difficulty was reported as upsetting by one young adult respondent who had memory issues.

Answered and unanswered

Twenty-eight items (93.3%) were answered by all respondents. The remaining 2 items on daily and leisure activities were left unanswered by 5 (8.3%) respondents who were all hospitalized at the time.

Relevant and irrelevant

Fourteen items (46.6%) were reported as relevant. Two items on leisure and daily activities were reported as irrelevant by 11 (18.3%) and 8 (13.3%) respondents, respectively. These respondents were young adults and were hospitalized at the time One item on the need for rest was reported as irrelevant by 3 (5%) of the respondents who were hospitalized at the time, and the item on feeling irritable was reported as irrelevant by 3 (5%) respondents.

Unwillingness

Participants were willing to respond to all items (100%) in EORTC QLQ-C30.

Preference and satisfaction

Twenty-six (43%) patients preferred CI-QoL II, whereas 12 (20%) preferred EORTC QLQ-C30; 22 (37%) preferred both the questionnaires. Seven (11.6%) patients were satisfied with CI-QoL II and 2 (3.3%) with EORTC QLQ-C30; 51 (85%) were satisfied with both the questionnaires [Figure 2].
Figure 2: Preference for and satisfaction with the Cancer Institute Quality of Life Questionnaire Version II and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 questionnaires

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  Discussion Top


Our study examined the preference for and satisfaction with the Tamil versions of EORTC QLQ-C30 and CI-QoL II among Tamil-speaking patients with cancer. Satisfaction was found to be greater with CI-Qol II than with EORTC QLQ-C30, This could be attributed to the nature of CI-Qol II, which contains a larger number of items than EORTC QLQ-C30, thereby assessing the concerns of patients in greater detail.

The present study revealed that there were critical remarks with respect to both the questionnaires. CI-QoL II was more culture specific and the items were reported as being more satisfactory to answer compared to EORTC QLQ-C30. Moreover, CI-QoL II was better in terms of feasibility, as the patients could relate better to the items due to their significance and relevance their socioeconomic, cultural, and lifestyle context.

For EORTC QLQ-C30, younger, unmarried patients reported that items related to fulfilling family needs, financial burden, and sexual life were irrelevant. Young adults were confused about their responsibilities in their families and unaware of the medical expenditures incurred due to treatment. This could be attributed to the guarded nature of the families handling the process, in an attempt to buffer the patients from distress.

Although CI-QoL II was preferred and found more satisfactory by patients in general, younger patients felt that responding to EORTC QLQ-C30 was more feasible. This might be because CI-QoL II involved detailed questioning in each domain, whereas EORTC QLQ-C30 dealt only with trouble or interferences in activities. This clearly indicates that the structure of the questions and the objectives play a vital role in determining the comfort of patients responding to them.[11]

Similarly, the items that were left unanswered or found to be confusing in CI-QoL II were those that focused on emotions and family support. Questions on emotions, in general, are measured differently in different questionnaires, and there are important differences in terms of their structure, domain, and tone. These factors could greatly influence the preference for a questionnaire among patients.

As CI-QoL II contained 11 more questions than EORTC QLQ-C30, it required 3 additional minutes to complete. Despite the longer time, the satisfaction was greater with CI-QoL II due to its domains, and more patients preferred it. For example, “Did you feel irritable?” in the EORTC QLQ-C30 is translated to “Were you irritated?” in Tamil which might not have been completely understood by the Tamil-speaking participants, as the cultural appropriateness was lost during translation even though the context was maintained. EORTC QLQ-C30 is focused more on the symptoms, while CI-QoL II is focused on the emotional aspects of the patients' lives; it is well documented in the literature that patients prefer phrasing of questions in a manner that shows greater personal involvement.[8]

When answering the questions in CI-QoL II, it was observed that patients were more narrative and emotional when sharing their experiences of life events during their cancer journey; this allowed for obtaining additional qualitative data describing their feelings and quoting incidents while filling out the questionnaire. This could be because CI-QoL II focuses on activities that can be construed, thus representing the patients' condition more appropriately than EORTC QLQ-C30 which contains questions that are explicit and direct. For example, EORTC QLQ-C30 includes the following question: “Do you need help with eating, dressing, washing yourself, or using the toilet?” The same question is phrased as, “Do you need any assistance to do your day-to-day activities?” in CI-QoL II. The latter question elicits additional information from the patient to describe the kind of assistance required for specific jobs, whereas the former elicits only a yes or no response. Similarly, a few important questions can be compared between EORTC QLQ-C30 and CI-QoL, which are as follows - “Have you lacked appetite?” versus “Is your appetite normal?; Have you had trouble sleeping?” versus “Do you have any problems in sleep?; Has your physical condition or medical treatment interfered with your social activities?” versus “Are you comfortable attending social functions as usual?; Has your physical condition or medical treatment interfered with your family life?” versus detailed questioning about family support. In our experience, we found that questions in EORTC QLQ-C30 were formal, and the participants seemed relatively detached from the process; on the other hand, they actively participated when answering the CI-QoL II questionnaire. CI-QoL II was found to be more relatable due to the easy phrasing of questions. Patients were able to connect emotionally with this tool, and hence, it can be used in clinical settings to explore the patients' concerns in depth and tailor appropriate interventions. EORTC QLQ-C30 may be more suitable for research purposes due to its ability to elicit responses without a subjective bias. Thus, the overall comprehensibility of CI-QoL II was better than that of EORTC QLQ-C30 in the Indian setting.

Our study had its limitations. It was a single-institution study. Moreover, our findings do not recommend or conclude the utility of one questionnaire over another in different settings as further research is warranted in this area. Future studies may focus on the utility of the questionnaires in various clinical and research settings.


  Conclusion Top


Majority of patients prefer CI-QoL II over EORTC QLQ-C30 and more patients were satisfied with CI-QoL II. CI-QoL II obtains more information on the QoL of patients to facilitate the process of psychological counseling in the clinical setting, whereas EORTC QLQ-C30 is more appropriate in eliciting responses without bias.

Acknowledgment

We are grateful for the support and guidance extended by Dr. K. Niraimathi, Fenivi Research, and Ms. Revathy Sudhakar, Cancer Institute (WIA) toward the revision of the manuscript.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

Data sharing statement

Individual participant data that underlie the results reported in this article, after deidentification will be made available on reasonable request to [email protected] immediately after publication and ending 5 years after article publication. The data will be shared with researchers who provide a sound proposal.


  Supplementary Appendix 1: Study Protocol Top



  Preference Between Cancer Institute- Quality Of Life Questionnaire Version II And European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 Among Cancer Patients Top



  Background Top


Over 11 lakh new cases of cancer are being diagnosed every year in India, of which around 63,000 new cases are diagnosed in Tamil Nadu. Mortality from cancer is reducing as a result of both advances in medicine and technology, and slightly increasing cancer awareness among the public. This has led to an increase in the number of cancer survivors in India. Current estimates indicate that 5 lakh people are living in India with or beyond the diagnosis of cancer and this number is expected to increase yearly. However, this success has not been without cost. Short-term, long term, and delayed treatment toxicity have been associated with many of the experimental and proven treatments implemented over the past two decades. The past decade witnessed a growing interest in including and assessing the impact of the disease and its treatment on the patient's quality of life (QOL), and by now several clinical trials has introduced QOL assessment as a standard component. QOL is an important aspect in cancer which varies among individuals.

QOL has been defined by WHO as “an individual's perception of their position in life in the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards and concerns.” It is a broad ranging concept which is affected by a person's physical, psychological aspect and personal beliefs, and their interaction with the environment (WHOQOL Group, 1994). QOL measurements give us an insight into the current status of a person. The researchers are now emphasizing that QOL has become an important aspect of the cost to utility in evaluating treatment recommendations based on clinical trial data.

There are numerous cancer-specific QOL tools that have been used globally, over the years. One of the most commonly used tools is European Organization of Research and Treatment for Cancer Core Quality of Life Core 30 (EORTC-QOL-C30) questionnaire. The EORTC QLQ scale is a reliable and valid instrument for measuring quality of life from the perspective of the patient. It focuses on domains such as physical functioning, role functioning, cognitive functioning, emotional functioning, global QOL, symptoms, mental health, psychological functioning (Burckhardt C and Anderson K, 2003). Other commonly used tools are the Functional Assessment of Cancer Therapy-General (FACT-G) (Cella et al., 1993), World Health Organization Quality of Life I-Abbreviated Version WHOQOL-BREF(Bushnell DM, 2002), Health-Related Quality of Life Questionnaires(Jacek A. Kopec 2002), Functional Living Index-Cancer (FLIC) (Schipper et al., 1984) and Expanded Prostate Cancer Index Composite (Wei et al., 2000).

A number of QOL tools were developed and validated in developing countries meet to the needs of the local population (Ferndale, 2014; Thomas et al., 2002). One such tool is the Cancer Institute's Quality of Life Questionnaire (CI-QOL) which consists of 41 items with 11 dimensions (Vidhubala et al., 2005). It was further modified and revalidated to give rise to CI-QOL version II (Vidhubala et al., 2011). Many studies have been conducted to study the validity of a QOL tool developed in one country in another in comparison with a locally developed validated QOL (Kemmler et al., 1999; Apolone et al., 1998). Apart from this, a few preference studies have been conducted between two well-established QOL tools, EORTC-C30 and FACT-G (Sato et al., 2014; Luckett et al., 2011). The purpose of this study is to compare the EORTC-QOL-C30-General and CI-QOL version II general questionnaire for their ease of use, relevance, comprehension and difference, accuracy, and patient preference; identify factors related to patient preference; identify differences in patient completion rates; and to identify factors associated with patient completion of these questionnaires.


  Rationale Top


EORTC is the core QOL questionnaire used with the site specific tools to get a comprehensive understanding about the QOL of the cancer patients under various phases of treatment. By just focusing on the tools developed in the west, we often fail to utilize the locally developed tools, in turn limiting the opportunity to explore them in India. EORTC core questionnaire is often used along with CIQOL questionnaire in most of the assessments in Cancer Institute (WIA). In this process, many items were found to be overlapping in these two scales. Patients are observed to become tired as it is very tedious and cumbersome. It is also time-consuming to ask the same questions repeatedly. In this context, understanding the similarities and differences of these tools and understanding the patient's preference over these two tools is essential. Very few preference studies have been done between EORTC-C30 and locally developed QOL questionnaires. Exploring the possibility of replacing the EORTC-C30 with CI-QOL with site-specific module can help researchers to make a nonjudgmental choice on the tool selection. Hence, the purpose of the study is to re-evaluate the relevance, ease of use, comprehension and difference, accuracy, and patient preference; identify factors related to patient preference; identify differences in patient completion rates; and to identify factors associated with patient completion of between EORTC-C30 and CI-QOL. This will help in getting a better understanding of the sociocultural differences and to make the tools more culturally applicable.

Objectives

To understand the cancer patients' preference between CI QOL questionnaire and EORTC QOL C30 in Indian setting.

To re-evaluate the relevance, ease of use, comprehension and difference, accuracy, and identify differences in patient completion rates and factors associated with patient completion between EORTC-C30 and CI-QOL.


  Relevant Review of Literature International Status Top


The EORTC QLQ-C30 showed satisfactory acceptability and the psychometric analyses confirming the multi-dimensional conceptualization in terms of convergent and discriminate validity. Several clinical trials have introduced QOL assessment as a standard component of new trials. Few sociodemographic (age, gender, and schooling) and clinical (type of cancer disease) variables were associated with HR-QOL. The validity and robustness of the EORTC QLQ-C30 in long-term Italian cancer survivors. The validity of the EORTCQLQ-C30, when used in long-survival cancer patients, is quite satisfactory. There are many instruments for evaluating HR-QOL, ranging from generic ones designed for use across a wide range of chronic diseases such as the SF-36 Health Survey, to specific measures such as FLIC, CARES, FACT, and RSCL (Apolone et al., 1998).

The validity of measuring separate areas, or dimensions of QOL was supported by the differential responsiveness of subscales when applied to groups known to differ along the dimensions of physical, functional, social, and emotional well-being (Apolone et al. 1998).

Hundreds of generic and specific HR-QOL instruments have been developed. Generic HR-QOL instruments are designed to be applicable across a wide range of populations and interventions. Specific HRQOL measures are designed to be relevant to particular interventions or in certain subpopulations. The FACT-G, including ease of administration, brevity, reliability, validity, and responsiveness to clinical change adds the capability to assess the relative weight of various aspects of quality life from the patient's perspective.

Seven generic HR-QOL instruments namely (i) the Medical Out-comes Study 36-Item Short Form (SF-36) health survey; (ii) the Nottingham Health Profile; (iii) the Sickness Impact Profile; (iv) the Dartmouth Primary care Cooperative Information Project (COOP) Charts; (v) the Quality of Well-Being Scale; (vi) the Health Utilities Index; and (vii) the Euro QOL Instrument (EQ-5D) were selected because they are commonly used. There are no uniformly “worst” or “best” performing instruments. These generic instruments are most commonly used and cited (Cella et al., 1993). The seven tools reviewed comprise of 1 general and six site specific QOL tools, out which, all the questionnaires were developed with local language and standardized in developed countries. All the tools measure the overall or site specific QOL; they vary vastly with respect to their dimensions and items. All the tools were established reliability and validity of the tools and using the research and clinical setting. There is a great need to examine cultural influences of QOL. It has particular relevance for long term cancer survivors (Ferrell, et al., 1995). Quality of life is a multidimensional concept and subjective experience of life, which is influencing the various factors determined (Schipper, 1983). Measurement of QOL gives us understanding of a person's the quality of life at any point of time. Culture varies between the countries, population and individuals. Sociocultural factors is determined their perception of one's life. Previous studies provide an understanding about the various influential factors culture can imply on a patient's quality of life. Two studies show that the most frequent factors differentiating the various ethnic groups are the demographic details and these studies were conducted in the developed countries and their original language. People's perceptions, belief systems and coping were also reported to vary between ethnic groups(Jalali R. and Dutta D, 2012). However, the tools used are mostly global QOL tools, rather than local-culture specific ones.


  National Status Top


EORTC-C30 is the most commonly used tool in India. Both clinicians and researchers often choose to include condition-specific measures such as the EORTC QLQ-C30 in trials rather than generic preference-based measures because they need measures which are sensitive to the effects of interventions across a range of relevant symptoms, side effects and aspects of functioning and quality of life. Although studies use a mixture of various tools for QOL assessment, the number of preference studies of QOL questionnaires in India is very minimal.


  Methodology Top


A total of 100 Patients between the ages of 18 and 60 years, receiving treatment with curative intent at Cancer Institute (WIA), Chennai, will be enrolled. The patients will be chosen through convenient sampling. The Tamil version of the questionnaires will be used for the ease of administration and self-administrative purposes. The CI-QOL and EORTC-C30 Tamil version is already available. The translated and validated version of CI-QOL and the existing Tamil version of EORTC-C30 will be administered to the patients. The CI-QOL-30 will be given first, following which the EORTC C-30 will be given after a gap of 15 min. The time taken to complete the questionnaire, queries asked, support required answering, missing response will be noted. After the administration of these two tools, a debriefing interview will be conducted to evaluate in terms of their relevance, time taken, inappropriate word, missing data, intrusiveness, uniqueness, clarity and upset or embarrassment for each of their items. The total time taken to complete each questionnaire will be noted. The overall preference between the two questionnaires among the patients will be studied in the present study. The tools will be administered without interfering with the patients' routine clinical care.

Inclusion criteria

  • Age group – 18–60 years
  • Patients who know to read and write Tamil and English
  • Patients with any site of cancer and treated with curative intent
  • Patients with no past history of psychiatric or neurological disorders.


Tools used

Cancer Institute – Quality of Life Version II

It is a 41-item cancer-specific QOL tool developed at Cancer Institute (WIA) Chennai, India in 2005. The revised version was published in 2011. It assesses the QOL of cancer patients in 11 dimensions: General well-being, Physical well-being, Psychological well-being, Familial relationship, Sexual and personal ability, Cognitive well-being, Optimism and belief, Economic well-being, Informational support, Patient-physician relationship, Body image scales (Vidhubala et al., 2011).

European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 Version 3

It was developed by the EORTC Study Group on QOL in 1993. The current version was published in 1997. It is a 30-item cancer-specific QOL tool initially validated for the European population. It is currently being used worldwide in either its original format or translated version. It studies patients' QOL in 9 dimensions: Physical functioning, Role functioning, Cognitive functioning, Emotional functioning, Social functioning, Fatigue, Pain nausea and vomiting, Global health and QOL scales (Aaronson et al., 1993).

Study period

March to August, 2017.

Analysis

Descriptive statistics will be used for the present study.


  References Top


Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European organization for research and treatment of cancer QLQ-C30: A quality-of- life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365-76.

Apolone G, Filiberti A, Cifani S, Ruggiata R, Mosconi P. Evaluation of the EORTC QLQ-C30 questionnaire: A comparison with SF-36 Health Survey in a cohort of Italian long-survival cancer patients. Ann Oncol 1998;9:549-57.

Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, et al. The Functional Assessment of Cancer Therapy scale: Development and validation of the general measure. J Clin Oncol 1993;11:570-9.

Coons SJ, Rao S, Keininger DL, Hays RD. A comparative review of generic quality-of-life instruments. Pharmacoeconomics 2000;17:13-35.

Crott R, Briggs A. Mapping the QLQ-C30 quality of life cancer questionnaire to EQ-5D patient preferences. Eur J Health Econ 2010;11:427-34.

Damodar G, Gopinath S, Vijayakumar S, Rao AY. Reasons for low quality of life in South Indian cancer patient population: A prospective observational study. Indian J Pharm Sci 2014;76:2-9.

Ferrell BR, Dow KH, Grant M. Measurement of the quality of life in cancer survivors. Qual Life Res 1995;4:523-31.

Ferndale L. Asymptom-Specific Quality of Life Questionnaire for Dysphagia; 2014. Available form: http://researchspace.ukzn.ac.za/xmlui/handle/10413/12277GLOBOCAN.

Kannan G, Rani V, Ananthanarayanan RM, Palani T, Nigam N, Janardhan V, et al. Assessment of quality of life of cancer patients in a tertiary care hospital of South India. J Cancer Res Ther 2011;7:275-9.

Kemmler G, Holzner B, Kopp M, Dünser M, Margreiter R, Greil R, et al. Comparison of two quality-of-life instruments for cancer patients: The functional assessment of cancer therapy-general and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. J Clin Oncol 1999;17:2932-40.

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Luckett T, King MT, Butow PN, Oguchi M, Rankin N, Price MA, et al. Choosing between the EORTC QLQ-C30 and FACT-G for measuring health-related quality of life in cancer clinical research: Issues, evidence and recommendations. Ann Oncol 2011;22:2179-90.

Rani L, Vidhubala E, Jeyaram S. Establishing Concurrent Validity for CI-QOL Questionnaire Against EORTC QLQ-C30. 1st Indian Cancer Congress; 2013.

Sato K, Shimizu M, Miyashita M. Which quality of life instruments are preferred by cancer patients in Japan? Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and the Functional Assessment of Cancer Therapy-General. Support Care Cancer 2014;22:3135-41.

Schipper H. Why measure quality of life? Can Med Assoc J 1983;128:1367-70.

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  Debriefing Questionnaire Top


Patient ID: Date of Interview:

  1. How long did it take you to complete the questionnaire? Minutes
  2. How did you complete the questionnaire? Self-completed/Orally (researcher read questions to participant and recorded their response)
  3. Did anyone help you to complete the questionnaire? Yes/No If so:


    1. Who? Interviewer/Relative/friend
    2. What kind of help? Practical help/Supportive help/Help with understanding the questionnaire
    3. How much help do you feel you needed? Please rate


    Very little A Little Average Quite a bit

    1 2 3 4

    Very much

    5

  4. Why do you feel the items were irrelevant?
  5. How would you like to re-frame the items you found confusing?
  6. How would you like to re-frame the items you found upsetting?
  7. Did we miss anything that you find important for your quality of life?
  8. Any other suggestions?



  Appendix Top






 
  References Top

1.
Haraldstad K, Wahl A, Andenæs R, Andersen JR, Andersen MH, Beisland E, et al. A systematic review of quality of life research in medicine and health sciences. Qual Life Res 2019;28:2641-50.  Back to cited text no. 1
    
2.
Apolone G, Filiberti A, Cifani S, Ruggiata R, Mosconi P. Evaluation of the EORTC QLQ-C30 questionnaire: A comparison with SF-36 Health Survey in a cohort of Italian long-survival cancer patients. Ann Oncol 1998;9:549-57.  Back to cited text no. 2
    
3.
Coons SJ, Rao S, Keininger DL, Hays RD. A comparative review of generic quality-of-life instruments. Pharmacoeconomics 2000;17:13-35.  Back to cited text no. 3
    
4.
Goodyear MD. Incorporating quality of life assessment into clinical cancer trials. In: Spilker B, editor. Quality of Life and Pharmacoeconomics in Clinical Trials. Philadelphia, PA: Lipincott Raven; 1996. p. 1003-13.  Back to cited text no. 4
    
5.
Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, et al. The Functional Assessment of Cancer Therapy scale: Development and validation of the general measure. J Clin Oncol 1993;11:570-9.  Back to cited text no. 5
    
6.
Luckett T, King MT, Butow PN, Oguchi M, Rankin N, Price MA, et al. Choosing between the EORTC QLQ-C30 and FACT-G for measuring health-related quality of life in cancer clinical research: Issues, evidence and recommendations. Ann Oncol 2011;22:2179-90.  Back to cited text no. 6
    
7.
Vidhubala E, Kannan RR, Mani SC, Karthikesh K, Muthuvel R, Surendran V, et al. Validation of quality of life questionnaire for patients with cancer – Indian scenario. Indian J Cancer 2005;42:138-44.  Back to cited text no. 7
[PUBMED]  [Full text]  
8.
Vidhubala E, Latha, Ravikannan R, Mani CS, Muthuvel R, Surendren V, et al. Validation of cancer institute quality of life questionnaire version II for cancer patients in India. Indian J Cancer 2011;48:500-6.  Back to cited text no. 8
[PUBMED]  [Full text]  
9.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365-76.  Back to cited text no. 9
    
10.
EORTC. Core – EORTC – Quality of Life: EORTC – Quality of Life. Available form: https://qol.eortc.org/core/. [Last accessed on 2021 Aug 31].  Back to cited text no. 10
    
11.
Sato K, Shimizu M, Miyashita M. Which quality of life instruments are preferred by cancer patients in Japan? Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and the Functional Assessment of Cancer Therapy-General. Support Care Cancer 2014;22:3135-41.  Back to cited text no. 11
    


    Figures

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    Tables

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



 

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