Health-related quality of life in treatment-naive, older patients with cancer from India: A prospective observational study : Cancer Research, Statistics, and Treatment

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Original Article: Geriatric Oncology Section

Health-related quality of life in treatment-naive, older patients with cancer from India: A prospective observational study

Soni, Nidhi; Banerjee, Joyita; Saravanan, Manicka1; Rao, Abhijith Rajaram2; Upadhyay, Ashish D.3; Dey, Aparajit Ballav4

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Cancer Research, Statistics, and Treatment: Jul–Sep 2022 - Volume 5 - Issue 3 - p 474-481
doi: 10.4103/crst.crst_177_22
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Abstract

INTRODUCTION

The World Health Organization (WHO) defines quality of life (QoL) as, “An individual’s perception of their position in life in the context of the culture in which they live and their goals, expectations, standards, and concerns.”[1] Health-related Quality of Life (HRQoL) is a multidimensional concept that incorporates domains related to physical, mental, emotional, and social functioning, apart from the direct measures of health.[2] In patients with cancer, HRQoL is affected by symptoms caused by cancer and treatment-induced toxicity.[3]

Prolonged survival and improved HRQoL are the most common patient-centered aims of medical treatment.[45] With advancing age, the effects of treatment on patients’ QoL, their functional and cognitive capacity, and their social situation may be of more importance than the prolongation of life itself. This is in contrast to the situation in younger patients, where the primary focus is prolonging survival.[56] The management of older patients with cancer is challenging because of reduced life expectancy, multiple age-related physiological changes, and comorbidities which increase the risk of treatment toxicity.[7] Aggressive treatment protocols with the hope of increasing survival may not always be the appropriate choice in older patients.[3-6] Judicious assessment of the health and functional condition and patient-centered communication should influence the final treatment plan.[38]

In present-day research and practice, patient-reported outcome measures (PROMs) are important endpoints for planning the comprehensive management of cancer[9] Patient-reported outcomes identify unmet needs in both supportive and palliative care and addressing those needs may positively impact patients’ QoL.[3] The European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30) is one of the most widely used, multidimensional, PROMs in oncology.[31011]

In a study by Mendoza et al.,[12] done in treatment-naïve patients with lung cancer, fatigue, disturbed sleep, pain, distress, dyspnea, and sadness were the severe symptoms (obtained via the M.D. Anderson Symptom Inventory [MDASI]) and the poorest QOL domain was physical well-being followed by overall QoL and emotional well-being. In another study, the global QOL score was 68.43 ± 19.96 (EORTC QLQ-C30) in treatment-naïve patients with cancer.[13] In a study done to assess the QoL using the EORTC QLQ-C30 in south Indian patients (median age of 60 years) with multiple myeloma on novel agents, the mean QoL score for global QoL was 55.3, and patients reported a significantly lower physical function, and higher financial strain.[14] In a study by Kannan et al.,[15] 84% of the patients had average and below-average QoL.

There have been limited studies on QoL in India, with very few studies done exclusively in the older population. We, therefore, conducted the current study to understand the various QoL domains in our older patients with cancer.

MATERIALS AND METHODS

General study details

This was an observational study done in the Outpatient Department (OPD) of Geriatric Medicine of the All India Institute of Medical Science, New Delhi, India from July 2015 to June 2017. Ethical approval was obtained from the Institute Ethics Committee (IESC/T-107/01.03.2013) (Supplementary appendix 1). Written informed consent was taken from all the participants before enrolling them in the study. This study was conducted according to ethical guidelines established by the Declaration of Helsinki, Good Clinical Practice Guidelines, and the Indian Council of Medical Research guidelines. No funding was used for the study. Since this not an interventional clinical trial, it was not registered in a publicly accessible clinical trials database like the Clinical Trials Registry-India.

Participants

All patients attending the OPD during the study period were screened and those who satisfied the eligibility criteria were enrolled. We enrolled patients aged 60 years and above, with a proven diagnosis of malignancy (solid tumors/hematologic malignancy), who were treatment-naïve and able to read and write in either English or Hindi. Patients with any stage of had an malignancy were enrolled. Patients who were illiterate, and Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS) of 4 were excluded.

Aims/objectives

Our primary aim was to evaluate the various QoL domains in treatment-naïve older patients with cancer.

Study methodology

The Geriatric OPD was the first point of contact for the patients and after the initial geriatric assessment and evaluation, they were referred to the specific departments for their further management.

We recorded the demographic and the clinical details. Demographic details included age, sex, socioeconomic status, literacy, living status (living alone/with spouse/with spouse and children/assisted), substance abuse, site, and stage of malignancy. Socioeconomic status was determined by the modified Kuppuswamy scale. This scale consists of a composite score, including the family head’s education and occupation, along with the family’s monthly income (the scale is consumer price index-based). The total score ranges from 3 to 29. This scale divides the population into upper (score, 26–29), middle (score, 11–25), and lower socioeconomic status (score, 3–10).[16]

HRQoL was measured by the EORTC QLQ-C30.[101117] The QoL questions were asked in Hindi/English (as per the patient’s comfort). These questions have been validated and copyrighted and permission was taken for use before starting the study. The EORTC QLQ-C30 consists of nine multi-item scales and six single-item measures.[10] It has five functional scales, i.e. role, physical, cognitive, emotional, and social. Additionally, there are a total of nine symptom scales: diarrhea, fatigue, dyspnea, pain, appetite loss, constipation, nausea and vomiting, sleep disturbance, and financial difficulties. The global health status/QoL scale contains two questions. The response to the first 28 questions (EORTC QLQ –C30 version 3) consists of a 4-point Likert format which ranges from 1 (not at all) to 4 (very much).[11] Responses to questions 29 and 30 have a Likert-type 7-point rating scale which ranges from 1 (very poor) to 7 (excellent).

Statistics

This study was a part (the secondary objective) of a PhD study dealing with the geriatric assessment (GA) of older adults with malignancy and the formulation of an optimal tool for their assessment.[18] All the patients who underwent evaluation during this period and who consented to participate were included. Out of a total of 419 patients, 360 patients had complete data for QoL, and these patients were included in the current study. Hence a formal sample size was not calculated for this QoL study. All statistical analysis was performed using the Statistical Package for the Social Sciences (IBM Corp. Released 2012. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.). Standard descriptive statistics were performed to assess the socio-demographic characteristics and the QoL domains. The EORTC QLQ-C30 was scored according to the methodology developed by the EORTC QLQ group.[1119] In this method, a raw score is first estimated by finding the average score of each domain. Then, a linear transformation is used to standardize the raw score, so that scores range from 0 to 100 based on the EORTC QLQ-C30 scoring manual.[11] A high score on the functional scale represents a high level of functioning, a high score on the global QoL scale represents high QoL, while a high score on the symptom scale represents a high level of symptomatology or other health problems. Continuous scores were converted into dichotomous variables by using a cut-off of 50, i.e. scores of less than 50 were graded as “low scores” while scores of 50 and above were graded as “high scores,” based on a previous study.[19]

RESULTS

Out of 419 questionnaires filled by patients, only 360 were included in the analysis, as 59 patients gave incomplete responses [Figure 1]. The mean age of the participants was 66 ± 6.2 years, with 238 (66%) males. The socio-demographic details are provided in Table 1. The most common malignancy was lung [164 (45.6%)], followed by gastrointestinal [76 (21.1%)] with the majority having metastatic disease [217 (60.3%)].

T1
Table 1:
Demographic and socioeconomic profile
F1
Figure 1:
Scheme of the inclusion of participants in the study. EORTC QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30

Most of the participants [238 (66%)] had a “low score,” i.e. <50 in the global QoL questions, which indicated that they had self-reported poor QoL [Figure 2]. Good functioning was noted in 238 (66%) and 239 (66.4%) patients in the cognitive and social domains, respectively. On the other hand, a poor score was noted in 268 (74%) patients in the emotional scale, 248 (68.9%) in the role scale and 200 (55.5%) in the physical functioning scale of the questionnaire.

Patients with “low scores” and “high scores” for the symptom scales of the questionnaires are provided in Table 2. Fatigue was present in most patients apart from pain and appetite loss. A score of >50 for financial difficulty was noted in 239 (66.4%) patients, suggesting financial constraints.

T2
Table 2:
Scores of symptom dimensions on EORTC QLQ-C30
F2
Figure 2:
Functional domains and global QoL domain in EORTC QLQ-C30. There are five functional scales- Role, Physical, Cognitive, Emotional, and Social. The scores have been divided into < 50 and ≥ 50 denoting poor and good scores, respectively. EORTC QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, QoL: Quality of life

DISCUSSION

Our study throws light on the QoL domains in newly diagnosed, treatment-naïve older patients with cancer. Functional scales of EORTC QLQ-C30, like physical, emotional, and role functioning were found to be areas of concern in this study. A self-perception question of the global QoL scale showed that more than half of the participants considered their QoL to be poor. Scores of symptoms like loss of appetite, pain, and fatigue were high, similar to the results of a previous study,[20] thus showing that these symptoms start early in the course of the disease and affect the QoL.[3]

An assessment of the QoL in older patients is challenging due to their difficulty in interpreting these questionnaires as a result of illiteracy or cognitive impairment, reduced hearing and eyesight, their reluctance to fill lengthy questionnaires, or the use of instruments not validated in the aged population.[321]

In our study, the mean age of the participants was 66 ± 6.2 years, with the cohort being relatively younger, similar to the study by Ximenes et al.,[22] in which the age of the patients varied between 61 and 94 years, and 69.3% of the cohort was below 75 years old. Functional decline and failing health with increasing age might deter older people from accessing health care facilities.[23] Additionally, the cut-off for the geriatric age group is lower in India, due to lower life expectancy in general, leading to the enrollment of a comparatively younger study population.

Male predominance was seen in this study, similar to that noted in previous studies,[2024] likely due to sex differences in health-seeking behavior. Access of women to healthcare is restricted because of societal gender norms, leading to variable healthcare-seeking patterns in men and women.[25] Lower socioeconomic status and poor literacy were the main social deterrents found in the present study, similar to the observations from a previous study.[26] Poor education and low socioeconomic status increase the risk of an unhealthy lifestyle, poor health literacy with limited knowledge regarding signs and symptoms of disease, and limited access to health care. This barrier causes a delay in diagnosis, leading to advanced stages at presentation, thus increasing morbidity, and carrying a poorer prognosis. The majority of the participants in the study lived with their families, as the joint family system is still quite prevalent in India. Older patients staying in joint families have better social support systems in place to deal with the physical, emotional, and financial stress of the disease and they have a better QoL than those residing in nuclear families.[27] Almost 70% of the participants gave a history of tobacco or alcohol use. In India, tobacco is used in many ways and a lot of research implicating these different methods of tobacco use in carcinogenesis comes from India.[28] Lung cancer was the most common site followed by gastrointestinal malignancy, similar to what has been noted in previous studies done among the geriatric population in India.[24] The majority of patients had stage IV malignancy similar to previous studies.[7]

Fatigue at diagnosis or during survivorship has a negative impact on functioning, HRQoL,[29] and survival.[30] This is routinely underdiagnosed and undertreated,[31] as patients think this is something they have to live with, is unimportant, or they fear that their treatment might be changed or discontinued.[30] Clinicians also do not trigger discussions on fatigue, because of similar misperceptions or lack of resources.[3031]

Loss of appetite was prevalent in numerous patients in our study. Loss of appetite leads to the cancer anorexia cachexia syndrome. Anorexia can occur because of nausea, change in taste, difficulty in swallowing, or mood changes like depression. This is an important factor with an impact on the physical and psychological domains of QoL.[32] Multiple drugs like megestrol acetate, cannabinoids, and corticosteroids along with new drugs like anamorelin, thalidomide, and mirtazapine are likely to improve appetite, further improving QoL.[32]

Cancer pain was seen in almost half of the patients in the current study. Cancer pain is a critical symptom affecting all dimensions of QoL, causing functional impairment, psychological distress, cognitive dysfunction (likely because of medications used for treatment), decreased social activities, and impaired sleep quality.[3334] Effective management of pain improves HRQoL and adherence to the treatment of malignancy.[34]

Patients in our study scored poorly in the emotional functioning domains, which is similar to the observations noted in several other studies. This underlines the well-recognized fact that depression and anxiety have a detrimental effect on the QoL of older patients with cancer.[3536] There are multiple risk factors that lead to depression in these patients. These are tumor-related (severity of symptoms, site of the primary tumor, and stage of disease), chemotherapy-related, patient-related (age, gender, poor physical status, etc.), and number and type of comorbidities.[37] Interventions dealing with these emotional issues in treatment-naïve patients with cancer may improve the QoL of these patients. Hence, psychological screening with appropriate directed interventions can greatly enhance patient care.[35]

High scores on the financial burden were seen in 66% of patients, implying high financial constraints. The lack of universal health care and medical insurance coverage is the likely cause of the high financial burden in patients with cancer.[3839] Older adults are more prone to this due to financial dependence on others.[18]

All the QoL domains are interdependent and have a profound effect on the QoL of the patient. Studies have shown that pre-treatment (baseline), and self-reported QoL data scores provide important information to help clinicians establish prognostic criteria to treat their patients with cancer and can help predict overall survival.[3184041]

In developing countries like India, the sudden shift of the disease burden from communicable to non-communicable diseases (NCD) with an increased burden of NCDs in the rapidly ageing population has jeopardized the health care machinery. There is a lack of preparedness to deal with such an emergency. Cancer is a major NCD that increases with age, causes significant morbidity, and takes a toll on the QoL of the older patient. The older population is heterogeneous, with multidimensional needs because of the ageing process, comorbidities, decreased functionality, presence of geriatric syndromes, and unique psychosocial issues. Added to these, a diagnosis of malignancy tremendously compromises the QoL. Although there is a growing population of older patients in the oncology clinics, there is a paucity of evidence-based data in the field of geriatric oncology.[3] Standard management protocols designed for the younger population may not be optimally suited for older adults. Selecting the best treatment protocol is a difficult task as it has to be tailored to the individual needs of this population. Goals need to be decided after discussion between the patient and the physician, giving importance to patient preferences.[38] Palliation of the symptoms in older patients with cancer should feature early in the management plan, along with the cancer-directed treatment in order to enhance their quality of remaining life. The lack of robust cancer screening programs adds to the existing problems resulting in presentation at advanced stages, further compromising the prognosis.[42] Thus, the health care provider has a great responsibility of identifying the needs of the older patient with cancer at diagnosis and planning the ideal management protocol accordingly.

Awareness of these QoL determinants in treatment-naïve patients will help in formulating an optimal management care plan for them.[43] Early and timely interventions will help to minimize morbidity and maintain the QoL over the duration of treatment. A multidisciplinary approach to managing older patients with cancer has to incorporate the different domains of their HRQoL. The health care provider, as well as the policymakers, need to join hands in order to formulate a comprehensive care plan for the rapidly increasing ageing population afflicted with cancer. This will help in enhancing patient-centered care and improve patient satisfaction.

The limitations of the study were that it was an observational study with a relatively small sample size and a male predominance, done in a single institution. This was a heterogenous cohort, so we did not use disease specific QOL questionnaires. We also did not use a geriatric-specific QoL form (EORTC QLQ-ELD14). Follow-up data were not collected; hence no comments can be made regarding the impact of therapeutic interventions on the QoL or correlation of the QoL domains with clinical outcomes like survival. A larger study focusing on specific cancer types taking into account the impact of therapeutic interventions could probably address these limitations.

CONCLUSION

Older patients with cancer have poor functioning in the physical, role, and emotional domains of QoL. Fatigue, loss of appetite and pain are the predominant symptoms in these patients, and the majority have financial constraints impacting their QoL. This knowledge can help in developing an early comprehensive care plan thereby enhancing QoL in older patients with cancer.

Author contributions

Conception and design-NS, JB, ABD; data collection-JB; analysis and interpretation of data-NS, JB, MS, ARR, ADU, ABD; statistical analysis-ADU; manuscript writing-NS, JB, MS, ARR, ADU, ABD; approval of final article-NS, JB, MS, ARR, ADU, ABD.

Data sharing statement

Data of the participants (individual de-identified) will be made available on reasonable request from Dr. Joyita Banerjee ([email protected]) starting from the date of publication, until 10 years after publication. Request beyond this timeframe will be considered on a case-by-case basis. In addition, the study protocol, including the statistical plan are already available as a Supplementary Appendix attached to this manuscript.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

F3

Acknowledgments

We acknowledge the contribution of all patients and their families who agreed to participate in this study.

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Keywords:

Cancer; elderly; EORTC QLQ C30; geriatric; HRQoL; older patients

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