Health-related quality of life and its socio-economic and cultural predictors among advanced cancer patients: evidence from the APPROACH cross-sectional survey in Hyderabad-India

This study was part of a multi-country cross-sectional survey titled “Asian Patient Perspectives Regarding Oncology Awareness, Care and Health (APPROACH)” to assess gaps in care received by advanced cancer patients at major public hospitals in low- and middle-income countries (LMIC) in Asia. The study site is Mehdi Nawab Jung Institute of Oncology and Regional Cancer Center (MNJIORCC) in Hyderabad, India. It is the only government cancer hospital in Telangana and Andhra Pradesh, serving a population of 85 million, which provides cancer treatment and palliative care free of cost to all patients, sponsored by the government. The oncology department sees 12,000 new cancer patients annually and more than half the patients present with advanced cancer at the time of diagnosis.

The inclusion criteria at this site was being over the age of 21, being diagnosed with solid tumor stage 4 cancer, and being aware of diagnosis. We recruited only patients with solid cancer since patients with hematological malignancies tend to have a very different quality of life trajectory as well as prognosis compared to those with solid tumors [34]. In order to avoid having a very heterogeneous sample, we also excluded those on hospice or home-based care or those taking only palliative care treatment for more than 2 weeks. Eligible patients were recruited between September 2017 and December 2017 at inpatient wards and outpatient clinics of medical and radiation oncology departments of the MNJIORCC. The study was approved by the Institutional Ethics Committee of MNJIORCC and the National University of Singapore.

Targeting a sample of 200 patients, the research team screened 253 medical records for the eligibility criteria and 234 patients were identified as eligible (Fig. 1). Trained interviewers then approached these patients and found that 10 deemed ineligible, either because they were not aware of their cancer or they were cognitively impaired or lacked capacity to complete the survey (which was either observed by the interviewers or informed by accompanying family caregivers of the patients). From 224 patients, 4 refused to be part of the study since they were not interested. From 220 patients who consented to the study, 10 did not complete the interview after they felt too fatigue to continue to the survey. This resulted in a response rate of 83% (100*210/234).

The questionnaire was developed in consultation with oncologists and comprised questions developed by the study investigators as well as validated instruments (Table 1).

Internal consistency of FACT-G, BPI and FACIT-SP and HADS were measured by Cronbach alpha [44]. To compare the FACT-G and FACIT-SP scores with those from U.S-based studies, we calculated Cohen’s D effect sizes to compare the means from the two samples, and effect sizes 0.8 and over were considered to be large [45].

We used ordinary least square (OLS) regressions to investigate the association between the HRQoL outcomes and predictors. A separate model was estimated for each HRQoL outcome, where the dependent variable was patients’ self-reported quality of life (FACT-G, FACT-GP, FACT-GF, FACT-GE, FACT-GS), pain experiences (BPI-S, BPI-I), anxiety and depression (HADS, HADS-A, HADS-D), and spiritual well-being (FACIT-SP, FACT-SPMP, FACIT-SPF), totaling 16 models. The predictors or independent variables were financial difficulties score, gender (female = 1, male = 0), years of education, marital status (unmarried (separated/divorced/widowed/never married) = 1, otherwise = 0), religion (non-Hindu = 1, Hindu = 0), and type of caste (non-General Caste = 1, General Caste = 0). Age was included in all regression as a control variable.

We used marital status as a proxy for social/family support in the analysis, where being married represented higher social/family support. However, married women from disadvantaged backgrounds have a low status within the household especially if they live with their in-laws [29]. We thus investigated whether the effect of marital status on social/family well-being varies based on gender by adding an interaction effect between marital status and gender.

To examine association of BPI-S and BPI-I with HRQoL domains, we also used OLS models adjusting for covariates (financial difficulties, gender, education, marital status, religion, caste and age) described above. Statistical significance was measured at the 5% level. All analyses were conducted at STATA 14.

Table 2 presents the demographic information of the respondents. The mean age of the patients was 49 years and mean years of education was 2.8 years. Approximately 52% (95% confidence interval (CI):46–59%) of the patients were female. Most patients reported that they belonged to disadvantaged castes or tribes (84%; CI: 79–89%), were Hindus (83%; CI: 78–88%) and married (75%; CI: 69–81%). The most common cancer types were lung (23%; CI: 18–29%), breast (23%; CI: 17–29%), cervical (15%; CI: 10–20%) and oral (11%; CI: 7–15%) cancer. Most patients (88%; CI: 83–92%) were recruited from inpatient clinics. The mean financial difficulties score was 7.9 (Standard Deviation (SD): 1.4) (3 reflecting the least and 9, the most financial difficulty).

Except for the faith subscale score (0.48), the total scores and sub-scales scores from FACT-G (total score = 0.79, physical well-being score = 0.64, social/family well-being score = 0.66, emotional well-being score = 0.72 and functional well-being score = 0.71), BPI (total score = 0.89, pain severity score = 0.88 and pain interference score = 0.90), HADS (total score = 0.79, anxiety score = 0.77 and depression score = 0.65), and FACIT-SP (total score = 0.80, meaning score = 0.83) had good internal consistency reliability.

Patients in our sample reported a mean score of 62 (SD: 10) for FACT-G (Table 3). Compared to the U. S patients, the reported general well-being scores were lower in all subscales, especially for functional well-being (effect size (ES) = 1.5; CI: 1.6–1.3) and social/ family well-being (ES = 1.1; CI: 1.3–1.0), indicating worse HRQoL than the U. S sample. The mean pain severity and pain interference scores were 3.2 (SD: 1.8) and 4 (SD: 1.6) out of 10, respectively, signifying mild to moderate pain. The mean scores for the HADS anxiety and depression scores were 5.6 (SD: 3.1) and 9.7 (SD: 3.3), respectively, indicating normal anxiety but suggestive of borderline depressive symptoms for the patients in our sample. Patients also reported a mean score of 33 (SD: 5.5) for spiritual well-being which is worse than that of the advanced cancer patients in the U. S (ES = 1.1; CI: 1.3–0.9).

Table 4 presents outcomes of the OLS regressions. As hypothesized, patients with higher financial difficulty scores reported lower functional well-being (FACT-GF), lower emotional well-being (FACT-GE), lower meaning/peace subscale of the spiritual well-being (FACIT-SPMP), and higher anxiety and depressive symptoms (HADS, HADS-A, HADS-D). Also consistent with our hypothesis, non-Hindu patients reported lower physical well-being (FACT-GP) and higher pain severity compared to Hindu patients.

Table 5 presents results of 16 regressions showing whether BPI-S/ BPI-I are significant predictors of general well-being domains (FACT-G, FACT-GP, FACT-GF, FACT-GE, FACT-GS), anxiety, and depression (HADS), after adjusting for covariates. Consistent with our hypotheses, higher pain severity and higher pain interference were significantly associated with all but one (P > 0.10 between BPI-S and FACT-GE) domains of general well-being, anxiety, and depression (P ≤ 0.01 for all; but P ≤ 0.05 between BPI-I and FACT-GS).

Compared to those in the U.S. patient sample, patients in our sample reported lower functional, physical, emotional, and social/family well-being. The difference was especially striking for functional and social/family well-being. Low literacy levels (average years of education = 2.8) in our sample also suggest that patients’ and their families may not fully comprehend the disease, its affects, and how to support the patient, pushing down social/family well-being scores at the site. Furthermore, stigma associated with advanced cancer in the Indian context could further impact social/family well-being negatively. On the supply-side, the difference in well-being scores could be explained by the availability of well-resourced allied health services such as physiotherapy and social work in high income countries and the relative lack of these services in the study setting and the Indian public health system context in general [46].

Despite the presence of a palliative care service at the study site which prescribes opioid analgesics for management of severe cancer pain, most patients in our sample reported mild to moderate pain severity and interference. Less than 3% of cancer patients in India have access to pain relief, largely due to cumbersome processes and legislation for procuring and dispensing oral morphine in India [24]. We therefore believe that the experience of other advanced cancer patients in other parts of the country with little or no access to palliative care services may be worse than the patients in our sample.

We also found that pain interference was a predictor of HRQoL, with the largest effect on physical well-being and anxiety and depression, and pain severity a predictor of all but emotional well-being. The significant relationship between pain interference and emotional and social/family well-being also shows that pain affects patients’ lives in several dimensions. Although these results are not unique to this study [47, 48], they underscore the need for healthcare providers to give further attention to effective pain management and how pain interacts with different domains of patients’ well-being.

Patients in our sample also reported depressive symptom levels suggestive of borderline depression, and lower spiritual well-being than those in the U.S. These findings suggest that advanced cancer patients receive little psycho-social and spiritual support from the medical system or religious community, consistent with evidence in low and middle income countries alike [49].

Financial difficulty was the most important predictor of lower HRQoL at the site. This is consistent with findings of other studies which show that lower socio-economic status is positively associated with lower physical, psychological and social well-being [26, 50‐52]. Our findings show that even in a setting where cancer treatment is free, those with higher financial difficulty scores report lower quality of life outcomes. This could be indicative of severe financial distress due to loss of daily income of patients and working caregivers [53], which could increase the burden on meeting other household expenditure needs. We recommend that even in settings where treatment is free, patients should be systematically screened for financial distress and targeted for financial support interventions.

Belonging to a minority religion was associated with lower physical well-being and higher pain severity. This could be an indicator of poorer health among those belonging to minority religions [54], which are considered socially disadvantaged by the Indian government [55]. Furthermore, we can draw comparisons from the U.S. setting, where studies examining unrelieved pain among racial minorities points towards factors such as limited access to health care and appropriate analgesics, and limited access and utilization of pain specialists [56]. In addition, this may be due to Hindu patients’ accepting pain better than those from other religions [33]. To the best of our knowledge, there are no studies comparing how those practising Hinduism perceive pain as compared to those practising other religions. However, studies show that greater acceptance of pain was associated with lower reports of pain and higher functioning [57]. Future studies could examine disparities in health, access to healthcare services, and pain management among religious groups with advanced cancer such that a greater understanding can confirm or reject our hypotheses and reveal whether or not specific interventions are warranted.

In this study, a particularly interesting result was the association between marital status and social/family support. Contrary to previous studies [50] and our hypothesis, we found marriage, a proxy for social/family support, to be a complicated indicator affected by both marital status and gender at our site. Unmarried women reported higher mean scores for social/family well-being compared to married women. Married women in India who typically have low status may lose any social support they used to have once they fall ill [58, 59]. Further studies could be explored in the Indian context to examine the impact of an advanced cancer diagnosis on the marital and family relationship and the effectiveness of psycho-social interventions to support relationships through the clinical trajectory.

This study has several limitations. First, patients are sampled from a single hospital in Hyderabad. As such, our results may not be nationally representative. However, the study site is the only government cancer hospital in Telangana and Andhra Pradesh, serving a population of 85 million, a substantial segment of the nation. Second, the sample was not drawn at random and we excluded those who were not aware of their cancer or were cognitively impaired to complete the survey. Unlike the western societies where patient autonomy is the norm, patients in India may not know their cancer diagnosis since families ask physicians not to disclose diagnosis in desire to ‘protect the patient’ and physicians usually comply with this request. Patients who are unaware of their cancer can constitute half of the patients [60, 61]. Hence, our sample may not be representative of the overall advanced cancer population seen in the study site or in the region. Third, the comparison of scores with the reference cancer population in the U.S. did not control for demographics and disease severity differences. However, this is the first to study the relationship between socio-demographic factors and all domains of HRQoL for advanced cancer patients in India using standardised and widely used instruments. Fourth, concerns about social stigma associated with cancer, which are quite common in India [62], may have led patients to provide socially desirable answers.